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NCT ID: NCT05024422 Completed - Clinical trials for Lactation Suppressed

Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Start date: December 31, 2021
Phase: N/A
Study type: Interventional

Some mothers may seek lactation suppression on personal, social, or medical grounds. To reduce congestion symptoms and shorten the duration of milk production lactation suppression can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems or liver disease. Vitamin B6 has also been studied for this indication with no significant side effects. All those studies conducted before 1980. There is no current literature on the subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication. Purpose: The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for lactation suppression. method: A prospective randomized study in the maternity ward at Haemek medical center in Afula, Israel. Postpartum women without contraindication to any one of the treatments, who are interested in a pharmaceutical induced lactation suppression will be divided into two randomized groups: 1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days) 2. Administration of Vitamin B6 (200 mg X 3 per day for a week) All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.

NCT ID: NCT05021835 Recruiting - Inflammation Clinical Trials

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

ZEUS
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

NCT ID: NCT05020665 Terminated - Clinical trials for Nucleophosmin 1-mutated Acute Myeloid Leukemia

Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML

Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).

NCT ID: NCT05019417 Recruiting - Clinical trials for Monocarboxylate Transporter 8 Deficiency

Glycerol-Phenylbutyrate Treatment in Children With MCT Mutation (Allan-Herndon- Dudley Syndrome)

Start date: June 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Thyroid hormone (TH) is crucial for normal brain development. The transporter monocarboxlate transporter 8 (MCT8), located at various organs including brain neurons, is crucial for cellular transport of TH, mainly T3 . A defect in this transporter causes Allan-Herndon-Dudley syndrome (AHDS), which characterized by severe motor and cognitive retardation. Serum TH tests typically show low T4, high T3 and mildly elevated TSH. The neurological phenotype entails diminished TH transport into the brain. On the other hand, elevated serum T3 leads to hypermetabolic status in peripheral tissues. Subsequently, AHDS patients have a low body weight and muscle mass. Currently, no effective treatment is available. Over the last decade, several studies focused on the effect of T3 analogues, that their trans-membrane transport is not mediated by MCT8. Two analogues were studied: Diiodothyropropionic acid (DITPA) and tetraiodothyroacetic acid (Triac). Both agents have demonstrated improvement in serum TH levels (mainly T3 and TSH) but no change in the neurocognitive status of the patients. Recently, several studies have demonstrated that sodium phenylbutyrate (PB) acting as a chaperon and increase the expression of MCT8 in the cell membrane. Subsequently, cells transfected with various mutations in MCT8 have shown remarkable improvement in T3 transport into the cytoplasm. We hypothesize that treatment of AHDS patients with glycerol phenylbutyrate (GPB) will improve thyroid function and neurodevelopmental parameters and relieve symptoms resulting from toxic T3 levels in peripheral tissues. Objective: To test safety and efficacy of PB treatment in AHDS patients. Primary objectives: To determine the effect of PB treatment on serum levels of TH. Secondary objective: 1. To determine the effect of PB on T3-associated hyperthyroid state in peripheral tissues. 2. To determine the effects of PB treatment on the neurodevelopmental status. Study design: therapeutic prospective trial. Study population: Up to 6 AHDS patients with genetically proven ADHD. Intervention: all participants will receive an escalating dose of PB in the form of Glycerol-PB (commercial name Ravicti) until individual serum T3 levels have been normalized or dose limiting toxicities occur. Duration of treatment: 12 months including the wash-out period of 1 month from the current Triac therapy

NCT ID: NCT05018455 Completed - Fall Clinical Trials

The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face

Start date: November 28, 2021
Phase: N/A
Study type: Interventional

Falls are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large. This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. This study design is a randomized control trial (RCT) with a cross-over in group allocation. The population will include 106 home-dwelling elderly, aged 65 years or more, with low to moderate risk of fall. Participants will be randomized to start intervention in the remote or face-to-face group. Training will be twice weekly for 3 months, after which there will be two weeks of washout, followed by a cross-over between groups. Outcome measures will include fall rate over a year (primary measure), balance, functional testing, subjective measures of fear of falls, quality of life, satisfaction from intervention, adherence, and compliance.

NCT ID: NCT05018286 Active, not recruiting - Clinical trials for Short Bowel Syndrome

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

STARS extend
Start date: July 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

NCT ID: NCT05018260 Completed - Clinical trials for Social Anxiety Disorder

Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)

NCT ID: NCT05016583 Completed - Clinical trials for Low Anterior Resection Syndrome

Paula Method of Exercises in Patients With LARS Syndrome

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

NCT ID: NCT05016336 Completed - Cognitive Decline Clinical Trials

Cognitive Training and Social Interaction Effects on Cognitive Performance of Older Adults

Start date: November 18, 2018
Phase: N/A
Study type: Interventional

Aging is associated with a decline in almost all aspects of cognitive functions, particularly memory. Recent research suggests that combining cognitive training with ongoing social interaction may aid in improving cognitive functioning for older adults. Furthermore, accumulative evidence suggests that strategy-based cognitive training may also improve the trainee's memory. In this study, the investigators examined the effects of a combined strategy-based cognitive training and a socially interactive learning method on cognitive performance and transfer effects in older adults.

NCT ID: NCT05014672 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

TRANSFORM
Start date: February 14, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).