[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EMS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":348},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,42,67,87,108,130,153,174,195,219,237,259,283,304,325],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100488447","phase-3-efficacy-and-safety-of-cde100-in-the-treatment-of-menstrual-cramp-pain-associated-with-primary-dysmenorrhea-100488447",false,"NCT05640232","Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea","A National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III, Crossover Study to Assess the Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.","ASTRAL","Inclusion Criteria:\n\n* Patient has given written informed consent to participate in the study prior to admission to the study;\n* Female patients aged between 16 and 35 years old, inclusive;\n* History of regular menstrual cycles, occuring between every 21 to 35 days;\n* Clinical history compatible with the diagnosis of primary dysmenorrhea;\n* Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.\n\nExclusion Criteria:\n\n* Diagnosis of secondary dysmenorrhea;\n* History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;\n* Onset of primary dysmenorrhea after starting to use oral contraceptives;\n* Use of oral contraceptives for \\\u003C 3 months prior to study selection;\n* Use of an intrauterine device (IUD), hormonal implants or contraceptive injections in the last six (06) months;\n* Previous diagnosis or physical examination findings and\u002For clinical and\u002For surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovary and\u002For pelvic varicocele;\n* History of recurrent pelvic and\u002For lower abdominal pain outside the menstrual period;\n* Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;\n* History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, to acetylsalicylic acid or other NSAIDs;\n* History or diagnosis of peptic\u002Fhemorrhagic ulcer;\n* History of gastrointestinal bleeding or perforation related to the use of NSAIDs;\n* Presence of compromised bone marrow function or diseases of the hematopoietic system;\n* Diagnosis of acute intermittent hepatic porphyria;\n* Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);\n* Diagnosis of untreated angle-closure glaucoma;\n* Presence of mechanical stenosis in the gastrointestinal tract;\n* Diagnosis of megacolon and\u002For paralytic or obstructive ileus;\n* Diagnosis of myasthenia gravis;\n* Treatment with psychoactive drugs (such as, for example, antidepressants, antipsychotics, etc.) in the 30 days prior to selection for the study;\n* Participants with a history of alcohol or illicit drug use disorder in the last two (02) years;\n* Participants with a current medical history of cancer and\u002For cancer treatment in the last five (05) years;\n* Presence of any serious illness, at the discretion of the investigator;\n* Any finding of clinical observation (clinical\u002Fphysical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);\n* Participants who are pregnant, nursing or planning to become pregnant;\n* Disagreement with the use of a known effective barrier contraceptive method, unless using a stable oral contraceptive for three months or more (which must be maintained throughout the study), or surgically sterile or who expressly declare themselves exempt from risk of pregnancy for not exercising sexual practices or exercising them in a non-reproductive manner;\n* Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;\n* Presence of any condition that, at the discretion of the investigator, makes the patient unfit to participate in the study.","FEMALE","16 Years","35 Years",{"count":21,"type":22},238,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study if to evaluate the efficacy and safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.",[28],"Primary Dysmenorrhea","RECRUITING","2025-12-01",{"date":32,"type":33},"2025-12-08","ACTUAL",{"date":35,"type":33},"2025-06-11",{"date":37,"type":22},"2027-01-30",{"name":39,"class":40},"EMS","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100441421","phase-3-efficacy-and-safety-of-piemonte-association-in-the-treatment-of-type-ii-diabetes-mellitus-100441421","NCT05028140","Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus","National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus","PIEMONTE","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;\n* Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;\n* History of alcohol abuse or illicit drug use;\n* Participation in a clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnacy and lactating participants;\n* Known hypersensitivity to any of the formula compounds;\n* Type 1 diabetes.","ALL","18 Years","85 Years",{"count":54,"type":22},480,[25],"The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus",[58],"Type II Diabetes",[60],"Type II diabetes mellitus",{"date":32,"type":33},{"date":63,"type":33},"2024-10-08",{"date":65,"type":22},"2027-09",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100413982","phase-3-efficacy-and-safety-of-madalena-association-in-the-treatment-of-type-ii-diabetes-mellitus-100413982","NCT04670666","Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus","National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus.","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants with 18 years of age or greater;\n* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy);\n* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \\> 100 mg\u002FdL at the screening visit;\n* BMI (body mass index) \\> 19 Kg\u002Fm2 and ≤ 45 Kg\u002Fm2.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* History of alcohol abuse or illicit drug use;\n* Participation in a clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Known hypersensitivity to the formula components used during the clinical trial;\n* Type 1 diabetes mellitus;\n* Fasting blood glucose \\> 300 mg\u002FdL;\n* Risk factors for volume depletion;\n* Impaired renal function and end-stage renal disease;\n* Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;\n* Impaired hepatic function;\n* Medical history of pancreatic diseases that may suggest insulin deficiency;\n* Bariatric surgery in the last two years and\u002F or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;\n* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;\n* Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;\n* Current medical history of cancer and\u002F or cancer treatment in the last 5 years;\n* Medical history of metabolic acidosis and\u002For using drugs that may cause lactic acidosis;\n* Medical history of blood dyscrasia or any other hemolytic disorders;\n* Participants using sulfonylureas and\u002For insulin therapy;\n* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.",{"count":75,"type":22},270,[25],"The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.",[79],"Type 2 Diabetes Mellitus",[79],{"date":32,"type":33},{"date":83,"type":33},"2024-11-18",{"date":85,"type":22},"2027-06",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":107,"locationsCount":41},"100408767","phase-3-efficacy-and-safety-of-berlim-2520-association-in-the-treatment-of-type-ii-diabetes-mellitus-and-dyslipidemia-100408767","NCT04602754","Efficacy and Safety of Berlim 25\u002F20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.","National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25\u002F20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;\n* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;\n* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \\> 100 mg\u002FdL at the screening visit;\n* Participants with high or very high cardiovascular risk according to the Brazilian guideline on the prevention of cardiovascular diseases in patients with diabetes (2017), which have not reached the goal of LDL-c ≤ 70 mg\u002FdL or ≤ 50 mg\u002FdL, respectively, with lifestyle changes, who are or aren't using low or moderate potency statins;\n* BMI (body mass index) \\> 19 Kg\u002Fm2 and ≤ 45 Kg\u002Fm2.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* History of alcohol abuse or illicit drug use;\n* Participation in a clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Known hypersensitivity to the formula components used during the clinical trial;\n* Type 1 diabetes mellitus;\n* Fasting blood glucose \\> 300 mg\u002FdL;\n* Risk factors for volume depletion;\n* Participants with total cholesterol \\> 500 mg\u002FdL or triglycerides \\> 500 mg\u002FdL;\n* Impaired renal function and end-stage renal disease;\n* Participants with known heart failure, class III to IV (New York Heart Association);\n* Impaired hepatic function;\n* Medical history of pancreatic diseases that may suggest insulin deficiency;\n* Participants who had any cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset stable angina, stroke, unstable congestive heart failure requiring treatment change), underwent revascularization or vascular surgery in the 6 months prior to screening;\n* Bariatric surgery in the last two years and\u002F or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;\n* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;\n* Current medical history of cancer and\u002F or cancer treatment in the last 5 years;\n* Participants with known uncontrolled hypothyroidism or TSH levels \\> 5 mIU\u002FL;\n* History of known muscle disease or prior statin intolerance;\n* Participants using SGLT2 inhibitors, sulfonylureas and\u002For insulin therapy or PCSK9 inhibitors;\n* Participants who used other medications with prominent action in the control of serum triglyceride and cholesterol levels in the last 4 weeks or who are using low or moderate-intensity statins that cannot be replaced by rosuvastatin 20 mg;\n* Participants using medications that may interfere with triglyceride and cholesterol metabolism started less than 4 weeks ago or with dose adjustment in the last 4 weeks prior to the screening visit;\n* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.",{"count":95,"type":22},228,[25],"The purpose of this study is to evaluate the efficacy and safety of Berlim 25\u002F20 association in the treatment of type 2 diabetes mellitus and dyslipidemia.",[99],"Dyslipidemia Associated With Type II Diabetes Mellitus",[101,102],"Dyslipidemia","Type II Diabetes Mellitus",{"date":32,"type":33},{"date":105,"type":33},"2023-12-01",{"date":65,"type":22},{"name":39,"class":40},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":115,"minAge":51,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":129,"locationsCount":41},"100408097","phase-3-efficacy-and-safety-of-finlndia-hair-lotion-association-on-androgenetic-alopecia-100408097","NCT04594018","Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia","National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.\n\nExclusion Criteria:\n\n* Known hypersensitivity to the formula components used during the clinical trial;\n* History of alcohol and\u002For substance abuse within 2 years;\n* Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;\n* Participants with a history of surgical treatment for hair loss or shaved scalp;\n* Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;\n* Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;\n* Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;\n* Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;\n* Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;\n* Participants with diseases that can affect hair growth;\n* Participants with a current medical history of cancer and \u002F or cancer treatment in the last 5 years;","MALE","60 Years",{"count":118,"type":22},190,[25],"The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.",[122],"Androgenetic Alopecia",[124],"androgenetic alopecia",{"date":32,"type":33},{"date":127,"type":33},"2023-02-02",{"date":65,"type":22},{"name":39,"class":40},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100595257","phase-3-a-study-to-investigate-efficacy-and-safety-of-a-tca108-in-participants-18-years-with-uncontrolled-hypertension-100595257","NCT07030101","A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension","A Phase 3 Double-blind, Multicenter, Randomized, Double-blind, Triple-dummy, Controlled Trial to Assess the Efficacy and Safety of a TCA108 in Participants ≥18 Years of Age With Uncontrolled Hypertension","TRÍADE-HA","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing the informed consent.\n2. Participants with a diagnosis of arterial hypertension presenting with SBP ≥ 140 mmHg and ≤ 170 mmHg and DBP ≥ 90 mmHg and ≤ 110 mmHg, confirmed by triplicate measurements from the reference arm at the screening visit.\n\n   d. Participants on dual antihypertensive therapy at a stable dose for at least four weeks prior to screening, meeting the following criterion:\n\n   • Receiving dual therapy with any antihypertensive agents at low or intermediate doses, or a dual combination in which only one of the drugs is at the maximum dose; except for dual therapy involving telmisartan combined with a thiazide diuretic or amlodipine, which will only be allowed when both drugs are at low doses.\n\n   Participants who meet the above criteria at the screening visit must also meet criterion \"e\" at the randomization visit:\n3. Participants with uncontrolled hypertension, confirmed by ambulatory blood pressure monitoring (ABPM) performed during the screening period, defined as SBP ≥ 130 mmHg and DBP ≥ 80 mmHg.\n4. Participant is male or female at birth.\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   * Not a childbearing potential (CBP) participant as defined below:\n   * surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy as confirmed by review of the participant's medical records, medical examination, or medical history interview), or postmenopausal (defined as no menses for 12 months).\n6. If the participant is a female of childbearing potential, they must have a negative urine pregnancy test at the screening visit and the randomization visit and they must be willing to use any of the following highly effective acceptable forms of contraception for the course of the study:\n\n   * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)\n   * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)\n   * intrauterine device\n   * intrauterine hormone-releasing system\n   * bilateral tubal occlusion (if not recently performed, should be established, or confirmed if any doubt)\n   * vasectomized partner (if not recently performed, should be established, or confirmed if any doubt)\n   * complete sexual abstinence (only if this is within the patients preferred lifestyle).\n7. Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n1. Any clinical observation (clinical\u002Fphysical assessment) or laboratory condition interpreted by the investigator as posing a risk to the participant's involvement in the clinical trial, or the presence of uncontrolled chronic disease(s).\n2. Known contraindication or history of hypersensitivity or intolerance to any components of the medications used during the clinical trial.\n3. Essential hypertension with DBP \\> 110 mmHg and\u002For SBP \\> 170 mmHg.\n4. Participants who have experienced any cardiovascular event (acute myocardial infarction, unstable angina, newly diagnosed stable angina, stroke, unstable congestive heart failure requiring treatment adjustment), undergone revascularization procedure, or vascular surgery within the 6 (six) months prior to screening.\n5. Body mass index (BMI) \\> 45 kg\u002Fm².\n6. Uncontrolled type 1 or type 2 diabetes mellitus (glycated hemoglobin \\[HbA1c\\] \\> 8.5%).\n7. Known heart failure, New York Heart Association (NYHA) Classes III and IV.\n8. Coronary artery disease with planned percutaneous intervention within the next 6 months.\n9. Current ventricular arrhythmia requiring treatment.\n10. Participants with prolonged corrected QT interval (QTc) \\[male \\> 450 ms, female \\> 470 ms\\] or tachyarrhythmia.\n11. Evidence of a secondary form of hypertension, including but not limited to: aortic coarctation, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease.\n12. Renal insufficiency with estimated glomerular filtration rate \\[eGFR\\] \\\u003C 30 mL\u002Fmin (2021 Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] Creatinine Equation), end-stage renal disease requiring dialysis or kidney transplant.\n13. Serum potassium levels ≥ 5.5 mEq\u002FL or ≤ 3.5 mEq\u002FL.\n14. Alanine aminotransferase (ALT) \\> 2.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2.5 × ULN, bilirubin \\> 2 × ULN.\n15. Symptomatic hyperuricemia (history of gout or uric acid stones).\n16. Blood dyscrasias.\n17. Any chronic inflammatory condition requiring chronic anti-inflammatory therapy.\n18. Disease, physical impairment, or mental condition that, in the judgment of the principal investigator, may interfere with study conduct, including outcome assessments.\n19. History of malignancy in any organ system, treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastasis, except for localized basal cell carcinoma of the skin.\n20. Any chronic disease that contraindicates participation according to the investigator's judgment.\n21. Current treatment with any of the following concomitant medications that may interfere with the evaluation of efficacy, safety, and tolerability:\n\n    * Prolonged treatment (\\>15 days) with systemic corticosteroids within the 3 months prior to screening. Prolonged systemic corticosteroid use is also prohibited during study participation. Short-term treatment (\\\u003C5 days) is acceptable during the study.\n    * Chronic stable or unstable use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid, with chronic use defined as ≥1 week of treatment. Intermittent NSAID use is discouraged throughout the study; if necessary, NSAIDs should not be used for more than one week in total. For participants requiring analgesic or antipyretic agents, acetaminophen is recommended during the study.\n    * Use of short-acting oral nitrates (e.g., sublingual nitroglycerin) is permitted; however, participants must not take short-acting oral nitrates within 4 hours prior to any study visit\u002FBP assessment and within 4 hours prior to and during ABPM.\n    * Use of long-acting oral nitrates (e.g., Isordil) is permitted; however, the dose must be stable for at least 2 weeks prior to screening and maintained throughout the study.\n    * Use of sympathomimetic decongestants is permitted; however, not within 1 day prior to any study visit\u002FBP assessment and within 1 day prior to and during ABPM.\n    * Use of theophylline is permitted; however, the dose must be stable for at least 4 weeks prior to screening and maintained throughout the study.\n    * Use of phosphodiesterase type V inhibitors is permitted; however, participants must abstain from taking these medications within 1 day prior to screening or any subsequent study visit, as well as 1 day prior to and during ABPM.\n    * Use of α-blockers is not permitted, except for alfuzosin and tamsulosin for prostatic symptoms, provided the dose is stable for at least 4 weeks prior to screening and maintained throughout the study.\n    * Use of drugs acting on the central nervous system (such as antidepressants, antipsychotics, and antiepileptics) is permitted, provided the dose is stable for at least 3 months prior to screening and maintained throughout the study.\n22. Research participants who have participated in clinical trial protocols within the past 12 (twelve) months (Resolution CNS 251, August 7, 1997, item III, subitem J), unless the investigator determines that there may be direct benefit to the participant.\n23. Participants who do not have an indication for modification of current therapy, in the judgment of the principal investigator or another physician responsible for the participant.\n24. Participants who are pregnant, breastfeeding, or planning to become pregnant, or female participants of childbearing potential not using a reliable contraceptive method as described in section 13.2.\n25. History of drug or alcohol abuse within the past 2 years.",{"count":139,"type":22},400,[25],"The purpose of this study if to evaluate the efficacy and safety of TCA108 in the treatment of hypertension.",[143],"Hypertension","NOT_YET_RECRUITING","2025-11-19",{"date":147,"type":33},"2025-11-24",{"date":149,"type":22},"2026-11",{"date":151,"type":22},"2029-11",{"name":39,"class":40},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":41},"100413678","phase-3-efficacy-and-safety-of-praga-formulation-in-the-treatment-of-neuropathic-pain-100413678","NCT04666714","Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain","National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants of 18 years and older;\n* Diagnosis of type 2 or type 1 diabetes for at least 1 year;\n* No change in antidiabetic medication winthin 3 months;\n* Diagnosis of painful sensorimotor diabetic polyneuropathy;\n* Presence of at least one of the following symptoms: i. numbness in the toes, feet and \u002F or legs; ii. paresthesias (tingling and \u002F or neuropathic pain) in the toes, feet and \u002F or legs.\n* Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes;\n* Glycated hemoglobin ≤ 11%;\n* Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points);\n* Participants with moderate to severe neuropathic pain who recorded in the diary a minimum of 4 of the 7 days from the period to assess the baseline pain score.\n\nExclusion Criteria:\n\n* Known hypersensitivity to the formula components used during the clinical trial;\n* History of alcohol and\u002For substance abuse within 2 years;\n* Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;\n* History of pernicious anemia, uncontrolled hypothyroidism, chronic hepatitis B;\n* HIV diagnosis;\n* History of neurological disorder unrelated to diabetic neuropathy;\n* Non-responders to previous pregabalin treatment;\n* High variability in the baseline pain score;\n* Other conditions that may alter the sensitivity in the affected dermatome or in the area involved in neuropathic pain that may confuse pain assessment;\n* Severe psychiatric condition;\n* Cognitive decline that affect the participant from correctly answering the scales and questionnaires;\n* Clinically relevant cardiac abnormalities, which at the researcher's discretion represent a risk to participation in the trial;\n* Participant who has amputated lower limb due to complications from diabetes;\n* Renal failure, defined by the estimated glomerular filtration rate \\[eGFR\\] \\\u003C60 mL \u002F min \u002F 1.73 m2.",{"count":161,"type":22},136,[25],"The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.",[165],"Neuropathic Pain","2025-03-12",{"date":168,"type":33},"2025-03-14",{"date":170,"type":33},"2023-05-15",{"date":172,"type":22},"2025-12-31",{"name":39,"class":40},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100558778","efficacy-and-safety-of-deh113-in-the-treatment-of-menstrual-cramp-pain-in-primary-dysmenorrhea-a-pilot-study-100558778","NCT06555549","Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain in Primary Dysmenorrhea: a Pilot Study","A National, Multicenter, Randomized, Double-blind, Single-dose, Crossover Clinical Trial to Preliminary Evaluate the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated With Primary Dysmenorrhea","Inclusion Criteria:\n\n* Patient has given written informed consent to participate in the study before admission to the study;\n* Female patients aged between 16 and 35 years old, inclusive;\n* History of regular menstrual cycles, occurring between every 21 to 35 days;\n* Clinical history compatible with the diagnosis of primary dysmenorrhea;\n* Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.\n\nExclusion Criteria:\n\n* Diagnosis of secondary dysmenorrhea;\n* History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;\n* Onset of primary dysmenorrhea after starting to use oral contraceptives;\n* Use of oral contraceptives for \\\u003C 3 months prior to study selection;\n* Use of an intrauterine device (IUD), hormonal implants, or contraceptive injections in the last six (06) months;\n* Previous diagnosis or physical examination findings and\u002For clinical and\u002For surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovary and\u002For pelvic varicocele;\n* History of recurrent pelvic and\u002For lower abdominal pain outside the menstrual period;\n* Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;\n* History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, to acetylsalicylic acid or other NSAIDs;\n* Previous diagnosis of glaucoma;\n* Previous diagnosis of kidney and\u002For liver failure;\n* Presence of blood dyscrasias and situations of bone marrow suppression;\n* Diagnosis of acute intermittent hepatic porphyria;\n* Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);\n* Previous diagnosis of acute intermittent hepatic porphyria;\n* Presence of mechanical stenosis in the gastrointestinal tract;\n* Previous diagnosis of paralytic ileus or intestinal atony\n* Diagnosis of myasthenia gravis;\n* Previous diagnosis of severe ulcerative colitis or toxic megacolon complicated with ulcerative colitis\n* Treatment with psychoactive drugs (such as for example, antidepressants, antipsychotics, etc.) in the 30 days prior to selection for the study;\n* Participants with a history of alcohol or illicit drug use disorder in the last two (02) years;\n* Participants with a current medical history of cancer and\u002For cancer treatment in the last five (05) years;\n* Any finding of clinical observation (clinical\u002Fphysical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or the presence of uncontrolled chronic disease(s);\n* Participants who are pregnant, nursing, or planning to become pregnant;\n* Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;",{"count":182,"type":22},60,[184],"NA","This study aims to evaluate the preliminary efficacy and safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated with Primary Dysmenorrhea.",[28],"2024-08-14",{"date":189,"type":33},"2024-08-15",{"date":191,"type":22},"2024-09",{"date":193,"type":22},"2026-02",{"name":39,"class":40},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":50,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100537021","phase-3-efficacy-and-safety-of-dep114-in-the-treatment-of-moderate-to-severe-persistent-allergic-rhinitis-in-children-100537021","NCT06272409","Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.","Phase III, Multicenter, Double-blind, Planned, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children Aged Between 6 and 11 Years","SIERRA","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible;\n* Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible;\n* Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA);\n* Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and\u002For the presence of specific IgE to the test radioallergoabsorbent (RAST);\n* Symptom intensity score \"nasal obstruction\" ≥ 2 points.\n* Total nasal symptoms score (TNSS) ≥ 8 points.\n\nExclusion Criteria:\n\n* Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion;\n* Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion;\n* Use or indication for the use of antibiotics at the screening visit and randomization;\n* Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator;\n* Diagnosis of severe or uncontrolled asthma;\n* Allergy to desloratadine, prednisolone or any other component of the formulation of investigational products (PSIs);\n* Presence of systemic fungal infection;\n* Presence of any uncontrolled infection;\n* Presence of any clinical observation finding (evaluation clinical\u002Fphysical) or laboratory condition that is interpreted by the investigator physician as a risk to participation in the trial clinical or presence of serious uncontrolled disease(s);\n* Participants who are pregnant or breastfeeding;\n* Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be direct benefit to the participant.","6 Years","11 Years",{"count":206,"type":22},318,[25],"The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.",[210],"Allergic Rhinitis","2024-02-20",{"date":213,"type":33},"2024-02-22",{"date":215,"type":22},"2025-02-15",{"date":217,"type":22},"2027-04-15",{"name":39,"class":40},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":236,"locationsCount":4},"100536686","phase-3-efficacy-and-safety-of-deh113-in-the-treatment-of-menstrual-cramp-pain-associated-with-primary-dysmenorrhea-100536686","NCT06268054","Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea","A National, Multicenter, Randomized, Double-blind, Phase III, Crossover Clinical Trial to Assess the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.","LIBERTÀ","Inclusion Criteria:\n\n* Patient has given written informed consent to participate in the study prior to admission to the study;\n* Female patients aged between 16 and 35 years old, inclusive;\n* History of regular menstrual cycles, occuring between every 21 to 35 days;\n* Clinical history compatible with the diagnosis of primary dysmenorrhea;\n* Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.\n\nExclusion Criteria:\n\n* Diagnosis of secondary dysmenorrhea;\n* History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;\n* Onset of primary dysmenorrhea after starting to use oral contraceptives;\n* Use of oral contraceptives for \\\u003C 4 months prior to study selection;\n* Use of an intrauterine device (IUD), hormonal implants or contraceptive injections in the last six (06) months;\n* Previous diagnosis or physical examination findings and\u002For clinical and\u002For surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovary and\u002For pelvic varicocele;\n* History of recurrent pelvic and\u002For lower abdominal pain outside the menstrual period;\n* Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;\n* History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, to acetylsalicylic acid or other NSAIDs;\n* Previous diagnosis of glaucoma;\n* Previous diagnosis of kidney and\u002For liver failure;\n* Presence of blood dyscrasias and situations of bone marrow suppression;\n* Diagnosis of acute intermittent hepatic porphyria;\n* Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);\n* Presence of mechanical stenosis in the gastrointestinal tract;\n* Previous diagnosis of paralytic ileus or intestinal atony\n* Diagnosis of myasthenia gravis;\n* Previous diagnosis of severe ulcerative colitis or toxic megacolon complicated with ulcerative colitis\n* Participants with a history of alcohol or illicit drug use disorder in the last two (02) years;\n* Participants with a current medical history of cancer and\u002For cancer treatment in the last five (05) years;\n* Any finding of clinical observation (clinical\u002Fphysical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);\n* Participants who are pregnant, nursing or planning to become pregnant;\n* Disagreement with the use of a known effective barrier contraceptive method, unless using a stable oral contraceptive for three months or more (which must be maintained throughout the study), or surgically sterile or who expressly declare themselves exempt from risk of pregnancy for not exercising sexual practices or exercising them in a non-reproductive manner;\n* Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;",{"count":228,"type":22},78,[25],"The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.",[28],{"date":213,"type":33},{"date":234,"type":22},"2025-02",{"date":65,"type":22},{"name":39,"class":40},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":115,"minAge":245,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":256,"leadSponsor":258,"locationsCount":41},"100536406","phase-3-efficacy-and-safety-of-the-dtt106-in-the-treatment-of-erectile-dysfunction-associated-with-benign-prostatic-hyperplasia-100536406","NCT06264414","Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","Phase III, Multicenter, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","AUSTRÁLIA","Inclusion Criteria:\n\n* men aged 40 years and older.\n* Sexually active men, with a defined partner, who have engaged in an average of 1 attempt at sexual intercourse per week in the last month.\n* Participants under stable treatment with dutasteride + tamsulosin combination therapy.\n* Diagnosis of erectile dysfunction, according to criteria established by the Guideline of the Brazilian Society of Urology and the American Society of Urology (2017);\n* Erectile Function domain score of IIEF ≤ 25 and ≥ 6 points at the time of screening.\n\nExclusion Criteria:\n\n* Any clinical or physical observation noted during evaluation by the investigating physician, or any laboratory condition, which is interpreted as posing a risk to participation in the clinical trial;\n* Presence of uncontrolled chronic diseases;\n* History of alcohol or illicit drug use disorder within the past 2 years;\n* Men who are planning to impregnate their partners, or fertile men who are not using a reliable contraceptive method;\n* Known allergy or hypersensitivity to the components of the medicinal products used during the clinical trial;\n* History of pelvic surgery, prostatectomy, radiation therapy, penile implant placement surgery, urinary tract trauma, or invasive procedures for BPH treatment.\n* Diagnosis of other diseases or conditions in the urinary tract, including, but not limited to: cancer, neurogenic bladder, urinary incontinence, recurrent infection, urethral stenosis, bacterial prostatitis.\n* Clinical evidence of prostate cancer;\n* Severe renal failure;\n* Severe liver failure;\n* Hypogonadism (supported by values below normal, as established by the local laboratory, for total testosterone) or absent libido (sex drive);\n* Severe psychiatric or psychosocial disorders;\n* Primary erectile dysfunction;\n* Polyneuropathy, neurodegenerative diseases, spinal cord trauma or injury, tumors in the central nervous system, or other conditions that may affect erections;\n* History of orthostatic hypotension.\n* Expected to undergo cataract or glaucoma surgery;\n* Concomitant use of any form of organic nitrate;\n* Concomitant use of guanylate cyclase stimulators such as riociguat;\n* Anatomical deformation of the penis that can significantly impair erection, including, but not limited to: angulation, cavernous fibrosis, and Peyronie's disease.\n* Conditions that may predispose to priapism, including but not limited to: sickle cell anemia, multiple myeloma, leukemia;\n* Prior diagnosis of pulmonary hypertension;\n* Presence of anterior ischemic optic neuropathy, or degenerative diseases of the retina, including retinitis pigmentosa;\n* Diagnosis of dysautonomia.\n* Cardiovascular disease for which sexual activity is inadvisable, including but not limited to: Myocardial infarction in the last 90 days; Unstable angina or angina that occurs during sexual intercourse; Class 2 or higher heart failure according to the New York Heart Association in the last 6 months; Arrhythmias not controlled; Hypotension (\\\u003C 90\u002F50 mmHg) or uncontrolled hypertension; Stroke in the last six months.\n* Diabetics with HbA1c greater than or equal to 10%, or with a history of retinopathy and\u002For neuropathy;\n* Use of prohibited medications as per the protocol;\n* Erectile dysfunction that has not responded to phosphodiesterase inhibitors type 5 (including but not limited to: sildenafil, tadalafil, vardenafil) at the time of screening.\n* Participation in clinical trial protocols within the last 12 (twelve) months.","40 Years",{"count":247,"type":22},262,[25],"The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia",[251,252],"Prostatic Hyperplasia, Benign","Erectile Dysfunction","2024-02-16",{"date":211,"type":33},{"date":234,"type":22},{"date":257,"type":22},"2027-07",{"name":39,"class":40},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":50,"minAge":267,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100534315","phase-3-efficacy-and-safety-of-dit112-in-the-treatment-of-moderate-to-severe-pain-after-dental-surgery-for-the-extraction-of-impacted-third-molars-100534315","NCT06237231","Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars","Phase III, Multicenter, Double-blind, Triple-dummy, Randomized, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars","ALIV","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the Free and Informed Consent Form (TCLE) and\u002For the Free and Informed Assent Form (TALE) in two copies;\n* Age equal to or over 15 years old;\n* Indication of extraction of two (02) impacted third molars, one (01) lower third molar and one (01) upper molar on the same side;\n* Third molar with bone impactions observed through panoramic radiography, with classification by Winter (1926) (1) mesioangular or vertical, and classification according to Pell \\& Gregory (1933) (2):\n\n  i. Class II position B; or ii. Class III position A or B\n* Presence of pain of moderate or severe intensity (score greater than or equal to 5 when assessed using an 11-point numeric pain scale) within up to four (04) hours after the end of the surgery.\n\nExclusion Criteria:\n\n* Presence of local conditions (lesions in the region of the third molars) that may interfere with the extraction of third molars, such as, but not limited to, pericoronitis, periodontitis, tumors, cysts and inflammation and\u002For infection in the region to be operated;\n* Presence of any clinical observation finding (clinical\u002Fphysical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);\n* Presence of a known gastroduodenal ulcer or diagnosis of persistent gastritis;\n* Presence of compromised bone marrow function or diseases of the hematopoietic system;\n* Presence of known severe renal and\u002For hepatic insufficiency;\n* Diagnosis of epilepsy not adequately controlled;\n* Diagnosis of acute intermittent hepatic porphyria;\n* Presence of known congenital glucose-6-phosphatedehydrogenase deficiency;\n* History of allergy or intolerance to tramadol, diclofenac and pyrazolones (e.g. phenazone, propyphenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone) including, for example, previous experience of agranulocytosis with one of these substances;\n* Use of sedative, hypnotic or psychotropic medications in the last 24 hours before surgery;\n* Use of anticoagulant medications in the last seven (07) days before surgery;\n* Current chronic treatment with opioids or corticosteroids;\n* Current treatment with selective cyclooxygenase - 2 (COX2) inhibitors;\n* Use of monoamine oxidase inhibitors (MAOIs) such as, but not limited to, phenelzine, tranylcypromine and isocarboxazid, in the last 14 days prior to the day of surgery;\n* Use of any analgesic and\u002For anti-inflammatory medication in the three (03) days prior to the day of surgery;\n* Known allergy or hypersensitivity to the components of the medicines used during the clinical trial;\n* Surgery to extract third molars lasting more than 60 minutes, considering from the beginning of the incision until the end of the extraction;\n* Technical failure in anesthesia or need to administer more than three tubes of anesthetic for each molar;\n* Presence of temporomandibular joint dysfunction or limited mouth opening;\n* Occurrence of a surgical accident resulting from the extraction of impacted third molars which, in the opinion of the investigator, could interfere with the procedures or evaluations of the trial, such as, but not limited to, intraoperative hemorrhage, probable injury to the inferior alveolar nerve, board fracture bone and soft tissue laceration;\n* Current medical history of cancer and\u002For cancer treatment in the last 5 years;\n* History of alcohol and\u002For illicit drug abuse disorder in the last two (02) years;\n* Participants who are pregnant, breastfeeding or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;\n* Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be a direct benefit to the participant.","15 Years",{"count":269,"type":22},252,[25],"The purpose of this study is to evaluate the efficacy and safety of DIT112 in adolescents and adults with acute pain after dental surgery for the extraction of impacted third molars.",[273,274],"Moderate Pain","Severe Pain",[276],"pain","2024-02-15",{"date":211,"type":33},{"date":215,"type":22},{"date":281,"type":22},"2027-04-10",{"name":39,"class":40},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":41},"100502577","phase-3-efficacy-and-safety-of-oma102-in-the-treatment-of-female-pattern-hair-loss-100502577","NCT05824065","Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss","Phase III, National, Multicenter, Randomized, Double-Blind, Superiority Clinical Trial to Evaluate the Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss","GENERA","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Age greater than 18 and equal or under 50 years;\n* Confirmed diagnosis of female pattern hair loss, grade II to IV in Sinclair Scale;\n* Participants that are disposed to maintain the same hair color, style, approximate hair length throughout the Clinical Study.\n\nExclusion Criteria:\n\n* Any clinical or physical finding interpreted by the investigator as a risk to subject participation in the Clinical Study\n* History of alcohol or illicit drugs abuse in the last year;\n* Pregnant or breastfeeding women, who are planning to become pregnant or participants who have childbearing potential and are not using any reliable contraceptive method;\n* Allergy or sensibility to any knowing components of the formula;\n* Diagnosis of arterial hypertension;\n* History of vasovagal syncope;\n* Baseline systolic blood pressure lower than 90 mmHg and\u002For diastolic lower than 60 mmHg;\n* Diagnosis of orthostatic hypotension (reduction of systolic blood pressure equal or superior to 20 mmHg and\u002For diastolic equal or superior to 10 mmHg after 3 minutes in orthostatic position);\n* Body mass index (BMI) \\> 30 kg\u002Fm²;\n* Subjects that initiated any kind of continue use medication, including contraceptives with systemic effect, until 3 months previously the inclusion in the Clinical Study;\n* History of cardiovascular, liver and renal diseases;\n* History of hypothyroidism, hyperthyroidism or pheochromocytoma;\n* Signs or symptoms of cardiopathy or angina;\n* History of edema from any etiology;\n* Participants who are using tricycle antidepressants, benzodiazepines, antipsychotics, anticholinergics, sulfonamide derivatives, beta-blockers, sympathomimetics, arginine, glucocorticoid or monoamine oxidase inhibitors;\n* Use of inhibitor of 5-alpha reductase or androgenic blockers in the last 12 months;\n* Dermatologic diseases of the scalp, except mild seborrheic dermatitis or diagnosis of any kind of alopecia other than female pattern hair loss;\n* History of surgical treatment for hair loss or presence of shaved scalp;\n* Scalp microinfusion, microneedling or intradermotherapy in the last 3 years;\n* Vaginal or cesarean deliveries 6 months before the inclusion in the study;\n* Drastic modification of habitual diet, as food restrictions or hyperselectivity;\n* Current cancer or history of cancer in the last 5 years;\n* Participation in others research protocols in the last 12 months, unless the investigator judges that there may be a direct benefit to the participant.","50 Years",{"count":293,"type":22},504,[25],"The goal of this clinical trial is to evaluate the efficacy and safety of OMA102 1 mg and OMA102 2 mg versus placebo in the treatment of female pattern hair loss.",[297],"Female Pattern Baldness",{"date":253,"type":33},{"date":300,"type":22},"2025-01",{"date":302,"type":22},"2027-01",{"name":39,"class":40},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":41},"100507338","phase-3-efficacy-and-safety-of-lid104-in-the-treatment-of-type-ii-diabetes-mellitus-100507338","NCT05886088","Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus","National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus","DÁLIA","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;\n* Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise and monotherapy with the maximum tolerated dose of metformin at a stable dose in the last 3 months and which, in the Investigator's discretion, may benefit from the addition of the trial drugs.\n* Participants with HbA1c ≥ 7.5% and ≤ 10.5% at the screening visit.\n* Participants with body mass index ≤ 45 kg\u002Fm2\n\nExclusion Criteria:\n\n* Any clinical observation or laboratory condition finding that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);\n* History of alcohol and\u002For illicit drug use disorder in the last two years;\n* Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using reliable contraception;\n* Participants with known allergy or hypersensitivity to the components of the drugs used during the clinical trial;\n* Participants with a current medical history of cancer and\u002For treatment for cancer in the last five years;\n* Participation in a clinical trial protocols in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit at the same;\n* Type 1 Diabetes Mellitus;\n* Fasting glucose above 300 mg\u002FdL;\n* Participants who have risk factors for severe volume depletion;\n* Participants on dialysis;\n* History of metabolic acidosis and\u002For using medications that may cause lactic acidosis;\n* Participants who have had a cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset of stable angina, stroke, unstable congestive heart failure requiring change in treatment), who underwent a revascularization procedure or vascular surgery in the six months prior to screening;\n* Known heart failure, class III to IV (New York Heart Association);\n* Moderate or severe renal insufficiency;\n* Participant with altered liver function, defined by serum levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase above three times the upper limit of normal or bilirubin \\> 1.5 times the upper limit of normal;\n* Participants who underwent bariatric surgery in the last two years and\u002For other gastrointestinal surgeries that may cause chronic malabsorption;\n* Medical history of haemoglobinopathies, blood dyscrasia or any other hemolytic disorders;\n* Known medical history of pancreatic diseases that may suggest insulin deficiency;\n* Known uncontrolled hypothyroidism or hyperthyroidism or thyroid-stimulating hormone (TSH) dosage greater than 1.5 times the reference value;\n* Known history of sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte changes or uncontrolled seizures in the six months prior to trial screening, or any other condition that, in the judgment of the investigator, may favor clinically significant alterations in the levels of the enzyme creatine phosphokinase (CPK) or participants with CPK dosages greater than ten times the value considered for normality;\n* Participants who started treatment with anti-obesity drugs less than three months ago or with a dose change in the last three months;\n* Participants with current and prolonged treatment for more than fifteen days with systemic steroids at the time of informed consent or in the last three months prior to the screening visit;\n* Participants on insulin therapy or using oral antidiabetics other than metformin;\n* Participants using prohibited medications according to the study protocol.","75 Years",{"count":314,"type":22},597,[25],"The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus.",[79],"2023-05-23",{"date":320,"type":33},"2023-06-02",{"date":322,"type":22},"2024-02",{"date":302,"type":22},{"name":39,"class":40},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":115,"minAge":51,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100443321","phase-3-efficacy-and-safety-of-toronto-association-in-the-treatment-of-erectile-dysfunction-and-premature-ejaculation-100443321","NCT05052879","Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation","National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Male participants, with age greater than or equal to 18 years;\n* Heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period;\n* Participants with erectile dysfunction, in stable and effective treatment with PDE-5 inhibitors;\n* Participants diagnosed with premature ejaculation;\n* Participants with IELT ≤ 2 minutes;\n* Participants with score ≥ 25 points in the erectile function questionnaire;\n* Participants (or partners) who use at least one contraceptive method.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Participation in a clinical trial in the year prior to this study;\n* Known hypersensitivity to any of the formula compounds;\n* Participants with cardiovascular disease for whom sexual activity is inadvisable\n* History or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation;\n* Diagnosis of other diseases or conditions in the urinary tract;\n* Participants with conditions that may predispose them to priapism;\n* History of severe psychiatric or psychosocial disorders;\n* Participant whose partner has clinically important sexual dysfunctions.",{"count":333,"type":22},232,[25],"The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.",[252,337],"Premature Ejaculation",[339,337],"Erectile dysfunction","2023-04-11",{"date":342,"type":33},"2023-04-12",{"date":344,"type":22},"2024-07",{"date":346,"type":22},"2026-08",{"name":39,"class":40},""]