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NCT ID: NCT05811585 Recruiting - Adhesion Clinical Trials

PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Start date: June 26, 2023
Phase:
Study type: Observational

Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.

NCT ID: NCT05811364 Recruiting - Clinical trials for Peripheral Arterial Disease

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Start date: October 17, 2023
Phase: N/A
Study type: Interventional

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

NCT ID: NCT05811351 Recruiting - Geographic Atrophy Clinical Trials

A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Start date: March 6, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.

NCT ID: NCT05811234 Recruiting - Plaque Psoriasis Clinical Trials

A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults

PRO-SCALP
Start date: June 13, 2023
Phase:
Study type: Observational

The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.

NCT ID: NCT05810480 Recruiting - Clinical trials for Autoimmune Hepatitis

PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G

PIONEER
Start date: June 6, 2023
Phase:
Study type: Observational

The investigators identified polyreactive immunoglobulin G (pIgG) in adults (published in Hepatology: https://doi.org/10.1002/hep.32134) and children (in preparation). Quantification of these pIgG using a "home-made" ELISA facilitates the diagnosis of autoimmune hepatitis (AIH) as compared to non-AIH liver diseases and healthy controls. Positivity for pIgG was independent from ANA/SMA positivity and equally diagnostic for AIH even when conventional autoantibodies (ANA/SMA/SLA/LKM) were negative. Additionally, the frequency of pIgG was lower than conventional autoantibodies (ANA, SMA) in vaccinia/drug associated severe liver injury in a retrospective multicenter study after Covid-19 vaccination (https://doi.org/10.1016/j.jhepr.2022.100605). Aims of the study The study aims to evaluate the diagnostic capacity of pIgG to predict AIH in comparison to other liver diseases prospectively. To avoid diagnostic inaccuracy between AIH with long-term need for an immunosuppression and drug induced liver injury with autoimmune features, which can be indistinguishable from AIH at baseline and which has a very low relapse rate after a short steroid course, a follow-up after six months is obligatory for inclusion. Therefore, the investigators will collect one serum sample from every patient (without immunosuppressive treatment) that presents to the respective hospital for evaluation of liver disease by liver biopsy within one year after initiation of the study and that provided written informed consent. Follow-up for evaluation of steroid dependency at six months after diagnosis is obligatory.

NCT ID: NCT05809856 Recruiting - Clinical trials for Pulmonary Valve Insufficiency

Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve

GECT
Start date: December 18, 2023
Phase: N/A
Study type: Interventional

Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.

NCT ID: NCT05809635 Recruiting - Clinical trials for Retinitis Pigmentosa

Study of BEST1 Vitelliform Macular Dystrophy

Start date: March 30, 2021
Phase:
Study type: Observational

The purpose of this study is to establish the natural history of of participants with BESTROPHIN 1 Vitelliform Macular Dystrophy. The blinding disorder Best Vitelliform Macular Dystrophy (VMD) is caused by any one of more than 250 different mutations in the BEST1 gene. As new treatments are developed, a clear understanding of the natural history of disease progression of BEST1 VMD is necessary. The goals of this natural history study are to: 1. Report the natural history of retinal degeneration in participants with a clinical diagnosis of VMD with molecular confirmation of a pathogenic BEST1 mutation(s). 2. Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials for the treatment of BESTROPHIN 1 VMD. 3. Compare progression of the identified structural and functional measures between the two eyes to judge the suitability of the second untreated eye as a control for a future clinical trial involving unilateral treatment 4. Identify well-defined patient populations for future clinical trials of investigative treatments for BEST1 VMD.

NCT ID: NCT05808764 Recruiting - Clinical trials for Muscular Atrophy, Spinal

A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy

PUPFISH
Start date: April 26, 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate the pharmacokinetics (PK) and safety of risdiplam in participants with spinal muscular atrophy (SMA) under 20 days of age at first dose.

NCT ID: NCT05807932 Recruiting - Clinical trials for Myelodysplastic Syndromes

Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML

Start date: June 26, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)

NCT ID: NCT05806866 Recruiting - Parkinson Disease Clinical Trials

Progression in Cognitive ADLs in Parkinson's Disease

PRICOG-PD
Start date: March 22, 2023
Phase:
Study type: Observational

Mild cognitive impairment (PD-MCI) is one of the greatest risk factors for future Parkinson's disease dementia (PDD). A recent meta-analysis found that, on average, 31% of patients with PD-MCI converted to PDD within seven years; however, 24% of patients with PD-MCI reverted back to normal cognitive function. Consequently, the false positive rate for predicting PDD among patients with PD-MCI is high, and better predictive markers to define patients at high risk for PDD development are urgently needed. Therefore, a combination of different markers, including clinical, genetic, and other biomarker data, are proposed to increase ability to predict cognitive worsening and dementia. Based on data of the first follow-up of this cohort results indicated that presence of both mild cognitive instrumental activities of daily living (IADL) impairment and PD-MCI dramatically increases the risk for PDD (PubMed ID: 36240089). This study evaluates markers predicting cognitive and IADL long-term outcome in our sample. Additionally, focus of the study is the investigation whether ratings of patients or informants best predicted decline of cognitive impairment and/or everyday function. Clinical data along with other clinical marker and biomarker status will be investigated.