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NCT ID: NCT06209333 Recruiting - Clinical trials for Overactive Bladder Syndrome (OABS)

Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS

OABS/BT/PFET
Start date: October 15, 2023
Phase: N/A
Study type: Interventional

The aim of this study was to examine the effects of bladder training and pelvic floor exercise training programs given in addition to Botulinum Toxin-A (BTx-A) application on urinary symptoms and quality of life in patients with Overactive Bladder Syndrome (AAMS) who do not respond to conservative treatments. Individuals who meet the criteria for inclusion in the study and agree to participate in the study will be divided into 2 separate research branches.The patients to be included in the study will be divided into two groups as "Group 1=Botox + physiotherapy " or "Group 2=Botox group ". In addition to the BTx-A application, bladder training and pelvic floor exercise training will be applied to patients in the first group, while standard patient training will be provided to patients in the second group. Severity of urinary symptoms, quality of life and subjective perception of improvement Before BTx-A application, 2 weeks and 12 weeks after BTX-A application, International Incontinence Consultation Questionnaire - Women's Lower Urinary Tract Symptoms (ICIQ-FLUTS), 1-hour ped test, International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS) and Global Perception of Improvement will be evaluated.

NCT ID: NCT06209008 Completed - Clinical trials for Interstitial Cystitis

Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome

PRP
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

Interstitial cystitis/painful bladder syndrome (IC/PBS) is characterized by a constellation of bladder symptoms, including urinary frequency, urgency, nocturia, and pelvic pain. Current intravesical IC/PBS treatment strategies include substances injected submucosally such as botulinum toxin A (BoNTA), or installed intravesically such as bacillus Calmette-Guerin (BCG), resiniferatoxin (RTX), lidocaine, chondroitin sulfate (CS), oxybutynin, and pentosan polysulfate (PPS). Plasma Rich Protein (PRP) is rich in growth factors, such as platelet-derived growth factor, epidermal growth factor, and transforming growth factor. With the help of these growth factors the defective epithelium can undergo proliferation, differentiation, and wound healing.

NCT ID: NCT06208670 Not yet recruiting - Clinical trials for Premenstrual Syndrome

Progressive Muscle Relaxation Exercises on Premenstrual Syndrome

PMS
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence. Materials and Methods: The research was planned as an experimental study with a pretest-posttest control group, with female patients coming for examination at Siirt Training and Research Hospital Gynecology Polyclinics between December 2023 and August 2024. "Personal Information Form, Premenstrual Syndrome Scale and Violence Tendency Scale" were used to collect data in the study. Percentage distributions and t-test in independent groups were used to evaluate the data.

NCT ID: NCT06208527 Not yet recruiting - Aging Clinical Trials

The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging

NADage
Start date: March 2024
Phase: Phase 2
Study type: Interventional

This clinical study, designed as a double-blind, randomized, placebo-controlled trial, aims to investigate the potential of nicotinamide riboside (NR) to decelerate functional decline in the elderly frail population. In animal studies, NR, which is converted to nicotinamide adenine dinucleotide (NAD), has shown potential as a neuroprotective agent, with indications of protection against amyotrophic lateral sclerosis (ALS), Alzheimer's dementia, and Parkinson's disease. Furthermore, aging is commonly associated with decreased tissue NAD levels, a phenomenon linked to premature aging and a spectrum of age-related disorders, including cardiovascular diseases and cancers. Existing preclinical and clinical research highlights the promise of NAD replenishment through enhanced DNA repair, sirtuin activity, and improved mitochondrial function. The research center has conducted two phase II clinical trials on NR for Parkinson's disease (NAD-PARK and NR-SAFE), administering up to 3000 mg of NR daily. These trials have shown promising results, indicating NR's potential as a treatment that may alter the course of the disease and possibly as neuroprotective treatment in Parkinson's disease. The NAD age trial primarily aims to determine: - The efficacy of NAD therapy in improving clinical symptoms of frailty, evaluated through standardized physical and cognitive function tests. - The safety of administering 2000 mg NR daily in an elderly frail population. The study will include 100 individuals, classified as frail based on the Fried Frailty Phenotype. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo. Over a 52-week period, participants will undergo: - Clinical evaluations, including actigraphy and questionnaires. - Cognitive assessments. - Bio sampling. - Magnetic resonance imaging (MRI). - Positron emission tomography (FDG-PET) scanning. The outcomes of this study could potentially demonstrate that NR effectively reduces signs of frailty, offering considerable advantages to the individuals affected, their families, and society as a whole.

NCT ID: NCT06208020 Recruiting - Clinical trials for Deglutition Disorders

Cortical Function Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome

Start date: May 31, 2023
Phase:
Study type: Observational

The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are: - The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects. - The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects. fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.

NCT ID: NCT06206824 Recruiting - Healthy Volunteers Clinical Trials

Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease

LEUCETTA
Start date: January 18, 2024
Phase: Phase 1
Study type: Interventional

Leucettinib-21 First-in-Human Phase 1 Study in 4 Parts: Single (Part 1) and Multiple (Part 3) Ascending Doses, and Food-Effect (Part 2) in Healthy Subjects, and Single Dose (Part 4) in People with Down Syndrome (DS) and Alzheimer's Disease (AD). For Parts 1, 3 and 4, safety and tolerability of an oral administration of Leucettinib-21 will be assessed as primary objectives. Pharmacokinetics and pharmacodynamic biomarkers will be investigated as secondary objectives. For Part 2, the effect of high fat meal will be evaluated on the pharmacokinetics parameters after an oral administration of Leucettinib-21.

NCT ID: NCT06206746 Recruiting - Clinical trials for Polycystic Ovary Syndrome

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

NCT ID: NCT06206460 Recruiting - Clinical trials for Premenstrual Syndrome

Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome

Start date: January 4, 2024
Phase:
Study type: Observational

With the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (OLP) intervention in premenstrual syndrome (PMS) and to contribute to a broader understanding of how OLPs work. It is planned to survey participants of the intervention groups (OLP+ and OLP-) regarding symptom intensity and impairment due to PMS after the conclusion of our randomized controlled trial (RCT) and intervention provision. Additionally, it will be examined if there is a difference between the OLP group with and without a treatment rationale (OPL+ vs. OLP-) across time. More precisely, it will be investigated whether participants of the intervention groups with and without treatment rationale experience any long-term improvement.

NCT ID: NCT06206265 Recruiting - Clinical trials for Irritable Bowel Syndrome

Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS)

Start date: January 17, 2024
Phase: Phase 2
Study type: Interventional

Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS. The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session, monitor and participant ratings of subjective drug effects during and after each drug session. This study comprises approximately a 28-day screening period (Days 28 to 1). After screening and enrollment, participants will be randomized to an immediate treatment group or a delayed treatment group ("waitlist control" condition). Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation (Days 1 to 18), a 2-dose administration period (Days 22 and 37), integration (Days 23, 30, 38, and 45), the End of Therapy (EOT) visit (Day 52). Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments. As a safety precaution, participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period (i.e., telephone assessments during post-randomization weeks 1, 2, 3, 4, 5, 6, and 7; in-person assessment during post-randomization week 8) to assess suicide risk to determine if intervention is warranted. During week 8, IBS symptoms will also be assessed. At the end of the delay period, all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group. Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session. The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3-, 6 , and 12- month follow-up visits (Days 120, 240, 365).

NCT ID: NCT06205550 Not yet recruiting - Clinical trials for Andersen Tawil Syndrome

N-of-1 in ATS and MEPPC

Start date: April 2024
Phase: Phase 2
Study type: Interventional

Rationale: Andersen-Tawil syndrome (ATS) is a very rare heritable cardiac arrhythmia syndrome that is characterized by the triad of periodic paralysis, physical dysmorphisms, and ventricular arrhythmias, including bidirectional ventricular tachycardia (VT), polymorphic VT, and frequent multifocal premature ventricular contractions (PVCs). Multifocal ectopic Purkinje-related premature contractions (MEPPC) is a very rare syndrome characterized by frequent multifocal PVCs with relatively narrow QRS width. In both conditions, patients most often present with palpitations, but syncope and sudden cardiac arrest have also been reported. Left untreated, the large burden of PVCs can lead to PVC-induced cardiomyopathy. A number of therapeutic strategies are suggested in these conditions, but there is a lack of high-quality evidence on their efficacy. Objective: To investigate the efficacy of various therapeutic strategies for reducing ventricular ectopy burden in patients with ATS or MEPPC. Study design: Aggregated series of randomized, open-label N-of-1 trials. Each N-of-1 trial will consist of at least 2 treatment sets, each of which comprise two 7-day periods of treatment with therapy A and B, in a semi-randomized, counterbalanced order. Study population: Adult patients with ATS or MEPPC on flecainide therapy. Intervention: For ATS, flecainide monotherapy will be compared with combination therapy of flecainide and a β-blocker or calcium channel blocker. For MEPPC, flecainide monotherapy will be compared with combination therapy of flecainide and a β-blocker or calcium channel blocker (phase 1), and flecainide will be compared with quinidine (phase 2). Main study endpoint: Ventricular ectopy burden on electrocardiographic monitoring.