[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clinical Academic Center (2CA-Braga)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":121},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,70,92],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100561606","phase-2-modafims-a-trial-to-evaluate-predictors-of-response-to-modafinil-in-patients-with-multiple-sclerosis-100561606",false,"NCT06592352","MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis","MODAFIMS: An Open-label, Single-center Clinical Trial to Evaluate Predictors of Response to MODAFinil in the Treatment of Cognitive Deficits in Patients With Multiple Sclerosis","MODAFIMS","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for the participation in the trial.\n* Patients that are able to read and write.\n* Male or female, aged between 18 and 64 years old at the time of signing the ICF.\n* Diagnosed with Relapsing-Remitting MS or Clinically Isolated Syndrome, according to McDonald 2017 diagnostic criteria (Thompson et al., 2018).\n* Expanded disability status score (EDSS) less than 6.5.\n* Presence of subjective cognitive complaints.\n* SDMT score (number of correct responses within 90 seconds) at Screening ≤ 55 (Benedict et al., 2016; Parmenter et al., 2007).\n* Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use protocol's recommended effective contraception methods, which is not based only on hormonal methods, during all the 6 months of the trial (3 months of treatment plus 3 months of safety follow-up).\n* Male participants must agree to refrain from donation of semen from first study treatment administration up to at least 90 days after last administration.\n* Participants, that in the medical investigator's opinion, are able and willing to comply with all trial requirements.\n\nExclusion Criteria:\n\n* Female participant who is pregnant, breastfeeding or planning pregnancy during the trial.\n* Participants who have participated in another research trial involving an investigational product within the past 5 half-lives of the other investigational product.\n* Participants who have any disability that, in the opinion of the investigator, significantly interferes with the neuropsychological testing and\u002For the tasks in the functional MRI.\n* Participants not able to undergo MRI scanning.\n* Participants who have any contra-indication for taking modafinil, according to the prescribing information and SmPC, such as hypersensitivity to the active substance and any excipient present in the modafinil or any documented adverse reaction after modafinil intake.\n* Participants with known hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.\n* Participants with a history of left ventricular hypertrophy or cor pulmonale and patients with mitral valve prolapse who developed mitral valve prolapse syndrome when previously treated with central nervous system stimulants.\n* Current use of modafinil, armodafinil.\n* Current use of other psychostimulants, including amphetamines, cocaine, bupropion, gingko biloba, among others, and beverages or food containing methylxanthines (e.g., coffee, tea, cola, caffeine, chocolate, sodas) exceeding 500 mg methylxanthines per day (for example, consumption of more than 5 espresso coffees or 100 mg of dark chocolate per day; Sanchez, 2017).\n* Significant neurological history aside from MS (e.g., Epilepsy).\n* Significant psychiatric history (e.g., Schizophrenia, Bipolar Disorder, Major Depression, severe anxiety disorder, aggressive or hostile behaviour).\n* A documented history of attempted suicide in the last 2 years OR suicidal ideation with intent, with or without a plan or method (e.g., positive response to items 4 or 5 in the assessment of suicidal ideation on the C-SSRS) over the 6 months prior to the Screening Visit.\n* Significant insomnia (grade \\> 1 according to Common Terminology Criteria for Adverse Events, CTCAE v5)\n* History of severe hypersensitivity reactions to any medicine.\n* Presence of any clinically significant abnormality in ECG morphology or ECG parameters.\n* Known immunodeficiency syndrome.\n* Have serum alanine aminotransferase (ALT) values greater than 3 times the upper limit of normal at screening.\n* Positive test for anti-Human Immunodeficiency virus 1 or 2 antibodies, Hepatitis B surface antigen (HBsAg) or anti Hepatitis C virus antibodies.\n* Creatinine clearance \\< 20 ml\u002Fmin determined by Cockcroft-Gault equation.\n* History of alcoholism or drug abuse.\n* Average daily consumption of more than 20 cigarettes.\n* Participants with disability that interferes with the performance of the CT procedures (for example, motor deficit in upper limb, decreased visual acuity even with correction).\n* Participants with increased risk of epileptic seizures, history of cardiac arrhythmias, or uncontrolled moderate to severe hypertension.\n* Participants taking warfarin or any other prohibited medication.\n* Sleep complaints confirmed by Epworth Sleepiness Scale (ESS) scale score \\>10 at screening visit OR known sleep disorder.\n* Any other condition that, in the opinion of the investigator, contra-indicates the participation of the patient.","ALL","18 Years","64 Years",{"count":21,"type":22},64,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a phase II\u002Fexploratory clinical trial with a single-center, open-label design to evaluate the effect of modafinil on cognitive deficits in adult patients with multiple sclerosis and identify predictors of response using functional Magnetic Resonance Imaging (fMRI).",[28,29],"Multiple Sclerosis","Cognitive Impairment",[31,32,33],"multiple sclerosis","cognitive impairment","functional MRI","RECRUITING","2025-08-12",{"date":37,"type":38},"2025-08-13","ACTUAL",{"date":40,"type":38},"2024-08-27",{"date":42,"type":22},"2026-09",{"name":44,"class":45},"Clinical Academic Center (2CA-Braga)","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100470884","maintenance-optimization-of-the-fully-implanted-venous-catheter-100470884","NCT05411666","Maintenance Optimization of the Fully Implanted Venous Catheter","OTIMACAT","Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Cancer patients, undergoing placement of CVCTI for chemotherapy, in follow-up, who finished chemotherapy up to a maximum period of 10 weeks.\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Evidence of signed and dated informed consent indicating that the patient has been informed of all relevant aspects of the study and agrees to participate.\n\nExclusion Criteria:\n\n* Presence of metastases or any other condition that may be an indication for intravenous treatments or additional chemotherapy regimens\n* History of CVCTI-related adverse events during the treatment phase\n* Patients on anticoagulant medication\n* History of thrombophilia\n* Pregnancy\u002FBreastfeeding",{"count":55,"type":22},176,[57],"NA","Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring.\n\nThe fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration.\n\nThe maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods.\n\nThe objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications.\n\nParticipants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance.",[60],"Cancer",[62],"Central venous catheter",{"date":64,"type":38},"2025-08-15",{"date":66,"type":38},"2020-06-30",{"date":68,"type":22},"2026-07",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":46},"100563086","phase-2-safety-and-efficacy-of-pramipexole-treatment-in-resistant-obsessive-compulsive-disorder-ocd-100563086","NCT06611592","Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD)","Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial","OCD-RT","Inclusion Criteria:\n\n1. Age between 18 and 64 years;\n2. European Portuguese as mother tongue;\n3. Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and\u002For ICD-10 criteria;\n4. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16;\n5. Patients resistant to the first-line treatment for OCD:\n\n5.1 Patients who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic dose during at least 12 weeks, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% relative to the score obtained before starting treatment with SSRIs.\n\n5.2 Patients who do not respond to treatment with risperidone or aripiprazole as potentiation of the SSRIs at the maximum tolerated therapeutic dose during at least 12 weeks, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% relative to the score obtained before starting treatment with the antipsychotic or patients in whom the Y-BOCS score is kept ≥ 16 after the treatment with the antipsychotic.\n\nExclusion Criteria:\n\n1. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);\n2. Patients with bipolar disorder;\n3. Patients with tick disorder;\n4. Patients with borderline personality disorder;\n5. Patients with social anxiety disorder;\n6. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);\n7. Patients with a history of neurological disease or traumatic brain injury;\n8. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);\n9. Patients who are passing or have passed in the last 6 months by a major depressive episode;\n10. Patients that undergo deep brain stimulation;\n11. Presence of sensory deficits impeding participation in clinical study;\n12. Pregnant or in breastfeeding period;\n13. Patients who are doing or have done psychotherapy in the last 6 months;\n14. Patients doing medication or receiving prohibited treatments;\n15. Patients with allergy to pramipexole or any of the excipients;\n16. Patients with creatinine clearance ≤ 50 ml\u002Fmin (calculated by Cockcroft-Gault formula);\n17. Patients with NYHA III or IV heart failure or any other severe cardiovascular disease;\n18. Hypotension (\\<90\u002F60 mmHg) sitting position and hypotension orthostatic (drop in systolic AT ≥20 mmHg or diastolic AT ≥10 mmHg after 2-3 minutes of orthostatism) at the screening;\n19. Patients with contraindication to perform MRI cannot participate in the assessment of the exploratory endpoint (i.e., other pre-specified outcomes).",{"count":79,"type":22},48,[25],"The most common and effective treatment for OCD is pharmacological therapy that includes selective serotonin reuptake inhibitors (SSRIs) antidepressants and, in the case of patients resistant to this approach, a combination with antipsychotics. Risperidone and aripiprazole are atypical antipsychotics that act on dopamine (D2) and serotonin receptors. Studies have shown that these drugs are effective in boosting SSRIs for the treatment of OCD in resistant patients.\n\nCurrently a high percentage of people diagnosed with OCD do not respond to the existing treatments. Pramipexole is a dopaminergic receptor agonist that specifically binds to dopamine D2 and D3 receptors, having demonstrated benefit in resistant depression.\n\nThe aim of this clinical trial is to explore how pramipexole can act in the treatment of OCD in resistant patients, evaluating its safety and efficacy.",[83],"Obsessive-Compulsive Disorder","2025-01-03",{"date":86,"type":38},"2025-01-06",{"date":88,"type":38},"2024-08-20",{"date":90,"type":22},"2028-08-20",{"name":44,"class":45},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":46},"100470069","phase-2-proof-of-concept-study-to-evaluate-the-safety-and-efficacy-of-tryptophan-in-patients-with-bph-100470069","NCT05401032","Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.","TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH","TryptoBPH","Inclusion Criteria:\n\n* Written informed consent;\n* Male patients with BPH for which tamsulosin is the therapeutic option per SoC;\n* Aged ≥50 and less than 75 years old;\n* With prostate volume ≥30 cm3 by TRUS;\n* Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.\n\nExclusion Criteria:\n\n* Patients with post-void bladder residual volume ≥250 ml;\n* Patients with intravesical obstruction from any cause other than BPH;\n* History of any procedure considered an intervention for BPH;\n* Patients with active urinary tract infection;\n* History of recurrent urinary tract infections;\n* Current prostatitis or diagnosis of chronic prostatitis;\n* History of prostate or invasive bladder cancer;\n* Use of 5 α-reductase inhibitors within 6 months;\n* Phytotherapy within 2 weeks before entry;\n* Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;\n* Patients with acute or chronic kidney failure;\n* Patients with diagnosed or suspicion of intolerance to lactose;\n* Patients submitted to general anesthesia in the past 4 weeks;\n* Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.","MALE","50 Years","74 Years",{"count":104,"type":22},70,[25],"Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies.\n\nOxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition.\n\nThis is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.",[108,109],"BPH","LUTS(Lower Urinary Tract Symptoms)",[108,111,112,113,114],"LUTS","5-HTP","Oxitriptan","Tamsulosin",{"date":86,"type":38},{"date":117,"type":38},"2024-12-20",{"date":119,"type":22},"2026-12-31",{"name":44,"class":45},""]