[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Università degli Studi dell'Insubria\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":210},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,52,80,107,133,157,180],{"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":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100570305","mediterranean-diet-effects-on-parkinsons-disease-100570305",false,"NCT06705517","Mediterranean Diet Effects on Parkinson's Disease","Mediterranean Diet Effects on Parkinson's Disease (MED-PARK): a Randomized Controlled Trial","MED-PARK","Inclusion Criteria:\n\n1. PD diagnosis according to international guidelines;\n2. Age between 40 and 85 years;\n3. Naive to medication or with a stable dosage of anti-Parkinson's therapy for at least two weeks;\n4. Hoehn \\& Yahr stage ≤3;\n5. Normal independent feeding;\n6. Ability to complete informed consent;\n7. Willingness to maintain the usual diet in the period between T0 and T1;\n8. Willingness to maintain the usual diet if randomized to the control group in the T1-T2 period;\n9. Willingness to make changes in their diet to follow a Mediterranean diet if randomized to the intervention group in the T1-T2 period;\n10. Willingness to fill out questionnaires;\n11. Willingness to provide blood samples during the study collection periods;\n12. Willingness to provide stool samples during the study collection periods;\n13. Willingness to fast (without food or drink except water, tea or coffee) at least 12 hours before each sample collection;\n14. Willingness to discontinue taking supplements, probiotics, herbal or high- dose vitamins or minerals that could impact inflammation during the period between T0 and T1 and for the duration of the study protocol;\n15. No medical and\u002For social conditions that could interfere with participation in a six-month interventional study.\n\nExclusion Criteria:\n\n1. Atypical or secondary parkinsonism;\n2. Underweight (\\\u003C18.5);\n3. Obesity (BMI\\>30);\n4. Pregnancy or suspected pregnancy;\n5. Normal assisted nutrition;\n6. Enteral nutrition;\n7. Chronic autoimmune diseases;\n8. Chronic use of immunosuppressive drugs in the past year;\n9. Chronic use of cytotoxic cancer drugs in the past year;\n10. Major abdominal surgeries;\n11. Concurrent participation in other interventional studies;\n12. Intentional change in diet after PD diagnosis.","ALL","40 Years","85 Years",{"count":21,"type":22},44,"ESTIMATED","INTERVENTIONAL",[25],"NA","Currently, there are no disease-modifying treatments for Parkinson's disease (PD), the second most common neurodegenerative disorder worldwide, making it crucial to find interventions that can change the disease's trajectory. Epidemiological studies suggest that the Mediterranean diet (MD) is linked to improved motor and non-motor symptoms, slower disease progression, and lower mortality in PD patients. However, few interventional studies have explored this connection. This study assesses whether an MD can improve motor and non-motor symptoms in PD patients. Additionally, the study will examine the effects of the diet on a patient's quality of life, gastrointestinal symptomatology, adaptive immune system, fecal and nasal microbiome, and fecal and urinary metabolomics.\n\nThis is a randomized, controlled, non-pharmacological, single-center, masked trial with two parallel groups. It will evaluate the safety and efficacy of the MD on motor and non-motor symptoms reported by PD patients. Forty-four participants, aged 40-85, meeting the inclusion criteria will be enrolled and block-randomized into two groups: one maintaining their usual diet (control) and the other following a MD for six months (intervention).\n\nThe primary outcome is patient-reported symptoms, measured using the MDS-UPDRS I+II score.\n\nSecondary outcomes include the analysis of adaptive immune system cells, nasal and fecal microbiome composition, and inflammatory and metabolic markers. Additional assessments include disease severity (MDS-UPDRS), non-motor symptoms (Non-Motor Symptoms Scale), participant well-being (36-Item Short Form Health Survey), gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale and Patient Assessment of Constipation Quality of Life), and the intensity of dopaminergic therapy (levodopa equivalents). Evaluations will be performed at baseline and after six months.",[28,29,30,31],"Parkinson","Parkinson Disease","Parkinson Disease, Idiopathic","PARKINSON DISEASE (Disorder)",[33,34,28,35,36,37,38],"Diet","Mediterranean Diet","Parkinson disease","MIND diet","plant based diet","unprocessed diet","RECRUITING","2025-07-08",{"date":42,"type":43},"2025-07-11","ACTUAL",{"date":45,"type":43},"2025-01-17",{"date":47,"type":22},"2026-09",{"name":49,"class":50},"Università degli Studi dell'Insubria","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":4,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":51},"100319540","temporary-application-of-abdominal-jackson-pratt-drain-to-reduce-pain-after-laparoscopic-surgery-in-gynecology-100319540","NCT03440086","Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology","Evaluation of One-hour Application of Abdominal Jackson-Pratt Drain in Order to Reduce Pain After Laparoscopic Surgery in Gynecology","DRAIN-1","Inclusion Criteria:\n\n* Patients affected by uterine fibroids, undergoing laparoscopic surgery;\n* American Society of Anesthesiologists physical status classification I-II.\n\nExclusion Criteria:\n\n* inability to express pain;\n* any concomitant diseases requiring upper abdominal surgery, such as cholecystectomy or adhesiolysis;\n* laparoscopic procedures that were converted to open surgery;\n* other causes of known pain;\n* oncological cases;\n* use of drugs for chronic pelvic pain or hormones in the previous 3 months (wash-out period);\n* application of other drainages;\n* intra- or post-operative complications.","FEMALE",{"count":62,"type":22},94,[25],"Recent evidence has shown that the onset and intensity of post-operative pain are significantly related to the amount of residual pneumoperitoneum at the end of the surgical procedure. In addition, the use of low pressures of carbon dioxide (CO2) for induction of the pnemoperitoneum has been associated with a reduction in post-operative pain, probably due to a lower abdominal distension and a consequent reduced compression of the pelvic, abdominal and sub-diaphragmatic pain nerve fibers.\n\nThe reduction of the residual pnemoperitoneum at the end of the surgical procedure could therefore play a key role in the reduction of post-operative pain, with consequent greater comfort for the patient and reduction of the use of analgesics.\n\nIn view of the available evidence, the aim of the present study is to evaluate whether the application of Jackson-Pratt drain, for one hour from the end of the surgical procedure, can significantly reduce post-operative pain and the need of analgesics in patients undergoing laparoscopic gynecological surgery.",[66],"Postoperative Pain",[68,69,70],"Laparoscopic surgery","Pain","Jackson-Pratt drain","NOT_YET_RECRUITING","2022-10-31",{"date":74,"type":43},"2022-11-02",{"date":76,"type":22},"2025-06-01",{"date":78,"type":22},"2027-06-15",{"name":49,"class":50},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100368321","survey-of-dysmorphic-uterus-knowledge-among-gynecologists-100368321","NCT04075786","Survey of Dysmorphic Uterus Knowledge Among Gynecologists.","DUS-1","Inclusion Criteria:\n\n* Practicing gynecologist specialist or fellow\u002Fresident (in training);\n* Knowledge of the ESGE\u002FAFS and T-Y-I uterine anomalies classification.\n\nExclusion Criteria:\n\n• None.","18 Years",{"count":89,"type":22},300,"OBSERVATIONAL","Uterine malformations were initially described by Cruveilhier and Von Rokitansky in the 1800s. Many proposed classifications had been presented over the years, although only two are mostly used worldwide: the first proposed by the American Fertility Society (AFS) and the one recently published by European Society on Gynecologic Endoscopy \u002F European Society of Human Reproductive Endocrinology (ESGE\u002FESHRE). Both classifications describe a special type of uterus, with an abnormally shaped narrow uterine cavity. This type of uterus was initially defined, before the use of ultrasound, as \"hypoplasic uterus\" by K. Menge and K.V. Oettingen in 1930. Subsequently, the AFS in its classification defined it as type VII as Diethylstilbestrol-related and the ESGE\u002FESHRE classification defined it as class U1a or T-shaped uterus.\n\nAt present there are no clear diagnostic criteria for this type of uterus and the only parameter widely accepted is that of \"narrow uterine cavity due to thickened lateral walls\". The purpose of this study is to conduct a survey of gynecologists in active clinical practice and resident (in training) gynecologists to establish the degree of concordance when cataloging 3D ultrasound images of normal or dysmorphic uteri, with the aim to identify common parameters that allow to identify the dysmorphic uterus with narrowing of the side walls.\n\nThe study will be carried out in two stages: in an initial step, participants will complete a survey evaluating their knowledge of uterine malformations and their involvement in assisted reproduction in their current clinical practice.\n\nIn the second step, participants will then watch a video of hysteroscopies and 3D ultrasound images of different cases highlighting the hysteroscopic\u002Fultrasound correlation of the different variants of the uterus with narrowing of the side walls. Each participant will be shown 40 (forty) 3D ultrasound images of uterus of normal women without infertility and 40 (forty) infertile women with uterus with narrowing in the middle third diagnosed by hysteroscopy + 3D ultrasound and associated infertility (in T, Y or I shape). Once the survey is finished, the degree of concordance will be evaluated, with the aim to identify common parameters of diagnosis of dysmorphic uterus by 3D ultrasound.",[93],"Dysmorphic Uterus",[95,96,97,98],"Uterine malformations","Hysteroscopy","3D ultrasound","Infertility","2021-04-28",{"date":101,"type":43},"2021-04-29",{"date":103,"type":22},"2023-11",{"date":105,"type":22},"2027-04",{"name":49,"class":50},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":60,"minAge":87,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":51},"100350091","evaluation-of-sexual-functions-with-validated-measurement-scale-after-transvaginal-extraction-of-tissue-by-laparoscopic-surgery-with-uterus-preservation-fsf-tve-100350091","NCT03838302","Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)","Evaluation of Female Sexual Functions With Validated Measurement Scale (Female Sexual Function Index) After Transvaginal Versus Trocars Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation","FSF-TVE","Inclusion Criteria:\n\n* Benign uterine and adnexal pathology\n* Preservation of the uterus\n* Sexually active women\n* Premenopausal women\n\nExclusion Criteria:\n\n* Pelvic inflammatory disease, endometriosis and pre-existing dyspareunia or chronic pelvic pain of any origin\n* Previous Hysterectomy\n* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases, psychopathology, mental and sensory-motor disabilities) comorbidities\n* Language barrier","50 Years",{"count":117,"type":22},40,"The retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with preservation of the uterus, required for a long time intraperitoneal electromechanical morcellation, until the Food and Drug Administration expressed concern about intraperitoneal dissemination of malignant cells, in the case of unrecognized sarcomas.\n\nTransvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in the bag is one of the possible alternatives.\n\nAvailable data suggested the effectiveness and safety of this technique, also in terms of time and costs, without a increased risk intra and post-operative complications.\n\nThe available evidence shows the lack of sequelae also on fertility and sexual function.\n\nNevertheless, sexual function has never been evaluated qualitatively in all its aspects nor quantitatively with a validated measurement scale, which can allow us to inform the consequences on the real risk of implications on sexual function determined by vaginal incision. In view of these elements, the aim of the investigator's study is to compare patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or without it with removal from the trocars.",[120],"Transvaginal Tissue Extraction",[122,123,124,125,126],"Sexual functioning","Laparoscopy","Colpotomy","Specimen retrieval","Transvaginal extraction",{"date":101,"type":43},{"date":129,"type":22},"2023-06",{"date":131,"type":22},"2027-06",{"name":49,"class":50},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":60,"minAge":87,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":51},"100346284","suture-of-the-ovary-after-enucleation-of-ovarian-endometrioma-100346284","NCT03788720","Suture of the Ovary After Enucleation of Ovarian Endometrioma","Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma","SOAVE-1","Inclusion Criteria:\n\n* Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;\n* Normal AFC at the enrollment (baseline).\n\nExclusion Criteria:\n\n* Any other disease;\n* Bilateral endometriomas;\n* Deep infiltrating endometriosis;\n* No previous pelvic surgery (even not gynecological);\n* Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);","35 Years",{"count":143,"type":22},100,[25],"Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.\n\nAccording to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).\n\nTo date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.\n\nIn this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.",[147],"Endometrioma",[147,123,149,150],"Suture","Ovary",{"date":101,"type":43},{"date":153,"type":22},"2023-05",{"date":155,"type":22},"2027-05",{"name":49,"class":50},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":60,"minAge":87,"maxAge":141,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":4},"100340848","surgery-and-art-for-endometrioma-100340848","NCT03717870","Surgery and ART For Endometrioma","Evaluation of Reproductive Outcomes After Different Management of Ovarian Endometrioma Prior to Assisted Reproduction Technology (ART): Laparoscopic Enucleation Vs Prolonged Pituitary Downregulation With Gonadotropin Releasing Hormone (GnRH)-Agonists","Inclusion Criteria:\n\n* Indication for ART: compromised tubal function, male factor infertility, other treatments have failed and\u002For prolonged infertility of more than 4 years.\n* Age between 18 and 35 years.\n* Ultrasound diagnosis of one ovarian endometriotic cyst with a diameter of 30 mm or more, according to the International Ovarian Tumor Analysis (IOTA)-criteria for reliable diagnosis of endometriomas in premenopausal women.\n\nExclusion Criteria:\n\n* Any comorbidity other than ovarian endometrioma.\n* Deep Infiltrating Endometriosis.\n* Previous ovarian surgery.\n* Bilateral endometriomas.\n* The use of donor oocytes\u002Fsperm.\n* ART with preimplantation genetic testing, as the number of embryos suitable. for transfer or cryopreservation is significantly lower compared to normal ART.",{"count":143,"type":22},[25],"Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of endometrial-like tissue, glands and stroma outside the uterine cavity. Although endometriosis is classified in four stage (minimal, mild, moderate, severe), from the clinical point of view it is possible to subdivide among peritoneal superficial lesions, ovarian endometriomas and Deep Infiltrating Endometriosis (DIE).\n\nAccording to the European Society for Human Reproduction and Embryology (ESHRE) Guideline on the management of women with endometriosis, it is recommended to clinicians that in infertile women with endometrioma larger than 3 cm, cystectomy should be considered prior to Assisted Reproduction Technology (ART) to improve endometriosis-associated pain or the accessibility of follicles. They further recommend that clinicians counsel women with endometrioma regarding the risks of reduced ovarian function after surgery, the possible loss of the ovary, and consider that the decision to proceed with surgery should be taken carefully if the woman has had previous ovarian surgery.\n\nIn addition, this Guideline suggests that clinicians can prescribe prolonged (3-6 months) pituitary downregulation with Gonadotropin Releasing Hormone-agonists (GnRH-a) prior to ART, in order to increase live birth rate by four-fold.\n\nDespite these recommendations, to date there is not robust evidence to choose between the two strategies prior to ART in order to improve reproductive outcomes.\n\nFor this reason, the aim of the current study will be to compare reproductive outcomes in infertile women affected by ovarian endometrioma, undergoing laparoscopic enucleation or prolonged pituitary downregulation with GnRH-a, prior to ART.",[168,169],"Ovarian Endometrioma","Infertility, Female",[147,98,123,171,172,173],"GnRH-a","Assisted Reproduction Technology","Reproductive outcomes",{"date":101,"type":43},{"date":176,"type":22},"2023-10",{"date":178,"type":22},"2027-10",{"name":49,"class":50},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":188,"sex":60,"minAge":87,"maxAge":18,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100330707","effects-of-oral-inositol-supplementation-on-obstetrics-outcomes-in-pcos-women-100330707","NCT03585738","Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women","Effects of Oral Inositol Supplementation on Obstetrics Outcomes in Polycystic Ovary Syndrome Women After Spontaneous Conception","IPOSI-1","Inclusion Criteria:\n\n* Pregnancy spontaneously conceived in women with PCOS diagnosed by Rotterdam criteria that starts oral supplementation before conception.\n\nExclusion Criteria:\n\n* Any kwon pre-pregnancy disease.\n* Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial, or until the development or pregnancy-induced\u002Frelated diseases requiring pharmacological treatments.",true,{"count":190,"type":22},80,[25],"Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS.\n\nVery few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited.\n\nNevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in Assisted Reproductive Technology (ART) in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies.\n\nFurthermore, independently by the effect on PCOS related infertility, few data are available about the role of inositol on obstetrics outcomes of pregnancies conceived after treatment with inositol and\u002For orally supplemented during pregnancy. Considering that the combination of MI and DCI alleviate many of the metabolic dysregulations typical of PCOS thanks to insulin-sensitizing actions, it is plausible consider a beneficial effects on pregnancy complications such as gestational diabetes and preeclampsia.",[194],"Polycystic Ovary Syndrome",[196,197,198,199,200,201],"Inositol","Polycystic ovarian syndrome","Pregnancy","Obstetrics outcomes","Gestational diabetes","Preeclampsia","2020-11-03",{"date":204,"type":43},"2020-11-05",{"date":206,"type":22},"2022-01-01",{"date":208,"type":22},"2026-12-31",{"name":49,"class":50},""]