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NCT ID: NCT04856306 Active, not recruiting - Clinical trials for Heavy Menstrual Bleeding

Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

Magical
Start date: April 12, 2021
Phase:
Study type: Observational

This is a prospective cohort study comparing the novel FDA-approved oral GnRH antagonist ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) to uterine artery embolization (UAE) or myomectomy (abdominal, laparoscopic, or hysteroscopic) for treatment of heavy menstrual bleeding due to leiomyomas. Uterine leiomyomas, also called fibroids, are hormone-dependent growths in the uterine muscle that are common in reproductive-age women (1). Leiomyomas can often lead to heavy menstrual bleeding. Definitive treatment for abnormal uterine bleeding due to leiomyomas is hysterectomy, but for patients who desire uterine conservation, a variety of treatment options exist. Regulation of menses with combined oral contraceptives or progestin only oral formulations are generally considered first line treatment but are not curative or effective for many patients. Another treatment option is a myomectomy, which is the surgical resection or removal of myomas. Myomectomy can be performed via hysteroscopy or laparoscopy, or by a vaginal or an abdominal approach. The route of removal depends on myoma location and patient symptoms. Another treatment option is Uterine fibroid or uterine artery embolization (UFE/UAE). UAE is a minimally invasive procedure where permanent particles are delivered to and block/embolize the blood supply to the myoma via a fluoroscopy directed arterial catheter. This typically leads to a decrease in fibroid size and associated bleeding (2). ORIAHNN, an oral GnRH antagonist that was FDA-approved in 2020, has demonstrated significant decrease in myoma-associated heavy menstrual bleeding compared to placebo (1) but has not been compared to other standard of care interventions. The primary objective of this study is to compare this novel medication to the common AUB-L treatments UAE and Myomectomy.

NCT ID: NCT04899206 Active, not recruiting - Hypertension Clinical Trials

ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA

Start date: April 12, 2021
Phase:
Study type: Observational [Patient Registry]

A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.

NCT ID: NCT04918537 Active, not recruiting - Dysbiosis Clinical Trials

Analysis of Microbiota Variations in Industry Workers Working Different Shifts and Impact of a Nutritional Intervention

Start date: April 12, 2021
Phase: N/A
Study type: Interventional

Shift workers are a growing population. It is well established that these workers face an increased risk of developing chronic diseases, but the underlying mechanisms remain debated. Various factors such as internal circadian desynchronization, unhealthy lifestyle behaviours, and lack of sleep interact in complex ways. Recently, it has been suggested that the gut microbiota (GM) may play an important role in this increased risk. The goal of this study is to describe the variations of the GM composition in shift workers across three different rotating weekly shifts (morning, afternoon, night) and to measure the impact of a 3- week walnuts supplementation intervention consisting in a controlled experimental study. Therefore, we propose a 6-weeks study including an observational and an experimental part. First, in the observational part, we will compare the gut microbiota of shift workers across three shifts (morning, afternoon and night). In the second part of the study, participants will add to their usual intakes a daily serving of nuts (30g). Again, we will compare the gut microbiota composition across the three types of shifts. During the study, participants will record their food intake, sleep and defecation time. We will also monitor their blood glucose levels continuously during the 4 first weeks of the study.

NCT ID: NCT05955664 Active, not recruiting - Clinical trials for Pelvic Floor Dysfunction

Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound

EDITUS
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

To assess the feasibility of a novel MRI technique- diffusion tensor imaging with fibre tracking in understanding the anatomy of the pelvic floor and levator ani muscle injury. To compare this novel MRI technique with endocavity ultrasound in assessment of pelvic floor anatomy and deficiencies in patients with pelvic floor problems.

NCT ID: NCT05216250 Active, not recruiting - Clinical trials for Upper Limb Essential Tremor (UL ET)

Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

Start date: April 12, 2022
Phase: Phase 2
Study type: Interventional

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated. BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America. Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05221502 Active, not recruiting - Pulmonary TB Clinical Trials

Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

Start date: April 12, 2022
Phase: Phase 2
Study type: Interventional

This trial will assess the safety and efficacy of OPC-167832 combined with Delamanid and Bedaquiline in subjects with DS-TB administered for 4 months compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 6 months

NCT ID: NCT05274529 Active, not recruiting - Occupational Stress Clinical Trials

Effects of Personal Technology Driven Workplace Wellbeing Intervention Programme on Wellbeing, Productivity (Presenteeism) and Absenteeism - an Intervention Study

Coachbeat
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

In this study the effects of a technology-driven workplace wellbeing intervention programme on employees' wellbeing, productivity (presenteeism) and absenteeism will be studied with the help of mobile applications and remotely conducted questionnaires, different wellbeing intervention periods and HRV based measurements.

NCT ID: NCT05306210 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Forxiga CKD Japan Post-Marketing Surveillance (PMS)

Start date: April 12, 2022
Phase:
Study type: Observational

To capture safety when Forxige is administrated to CKD patients in the real world setting

NCT ID: NCT05359861 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

Start date: April 12, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2 trial composed of an open label Lead-In followed by a Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.

NCT ID: NCT05417269 Active, not recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

IMCY-0141 Safety and Efficacy in Multiple Sclerosis - ISEMIS Study

Start date: April 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The IMCY-MS-001 study is a study to test a new experimental drug, IMCY-0141, for the treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS). The pathophysiology of MS with known myelin autoantigens and T cell epitopes makes this disease a particularly attractive indication for development of an immunotherapeutic based on the Imcyse technology. Based on the unique mechanism of action of the drug, IMCY-0141 administered as early as possible after confirmation of the diagnosis may potentially switch-off the autoimmune process and limit the corresponding myelin destruction. Newly (recently) diagnosed patients will be targeted to tackle the disease at its onset. Before launching any efficacy studies, safety of IMCY-0141 in MS patients must be evaluated with a phase I, open-label, dose escalation clinical trial to evaluate the safety of three IMCY-0141 doses followed by a phase II, double-blind, randomized study with an adaptive design to determine if any IMCY-0141 dose(s) offer superior efficacy relative to placebo and to assess immune responses and biomarker data as potential early predictors of efficacy of IMCY-0141 in adults presenting with RR-MS.