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NCT ID: NCT04438837 Not yet recruiting - Clinical trials for Coronavirus Disease 2019 (COVID-19)

Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers

Start date: July 2020
Phase: N/A
Study type: Interventional

Background: The rapid spread and high infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important. One of the important target populations for such intervention who are at high risk of exposure are health care workers (HCWs) who may develop disease and/or expose patients and other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus replication and immunomodulation, an important role in the inhibition of pre-entry step of the virus to host cells. Such activity in the early stage of infection may play a role in prevention of disease progression. Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of viral shedding among HCWs following exposure to confirmed COVID-19 patients. Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a confirmed case of COVID-19 without full adherence to droplet precautions. Participants will be eligible in a period no longer than 72 hours after exposure. Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days. Participants in the control group will receive no treatment. Treatment will be started no longer than 72 hours following exposure. Outcomes: The primary outcome will be the number of participants who develop clinical signs compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary outcomes will include virologically-confirmed COVID 19, disease severity (need for hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration (time between first positive PCR to last of two consecutive negative tests) for confirmed COVID 19 cases. Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a power of 80% (alpha 0.05) is 291 participants per each group.

NCT ID: NCT04436146 Recruiting - Globus Clinical Trials

The Effect of Laryngeal Manual Therapy as a Management of Globus

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).

NCT ID: NCT04435782 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging

RESTORE
Start date: July 7, 2021
Phase: Phase 4
Study type: Interventional

The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).

NCT ID: NCT04435626 Active, not recruiting - Heart Failure Clinical Trials

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

FINEARTS-HF
Start date: September 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.

NCT ID: NCT04435431 Completed - Parkinson Disease Clinical Trials

A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia

Start date: October 29, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.

NCT ID: NCT04435405 Completed - Clinical trials for Mental Health Disorders

Micro-Analysis of Processes in a Group Music Therapy for People Living With MHC in the Community

Start date: March 1, 2020
Phase:
Study type: Observational

People with mental health conditions (MHC) often face significant barriers in obtaining personal valued social roles and feeling a sense of belonging to their community. With the growing emphasis on community integration, and the fact that the vast majority of people with MHC live in the community, there is an effort to develop interventions and services which focus on recovery, wellbeing, and community integration, to reclaim "right to a safe, dignified, and personal and gratifying life in the community despite his or her psychiatric condition" (Davidson, Tondora, Lawless, O'Connell, & Rowe, 2009, p.11).Music therapy (MT) has been practiced for many decades with growing evidence for its effectiveness in different populations, including people with MHC. Music has pivotal influences on socialization and in building inter-personal skills and has the potential to be effective as a community-based therapeutic approach in bringing people together in a shared experience, an important step towards integration back to the community. MT encourages verbal and non-verbal interactions and offers opportunity to practice interpersonal skills, build relationships and peruse common goals. The proposed study has a potential to shed additional light on the processes of recovery in people living in the community with MHC who are participating in group CoMT. Although the study will pinpoint to the domains where MT was mostly studied before (social skills, group cohesion and emotional expression), it is unique in two main aspects: 1. Majority of previous MT studies on people with MHC were testing short-term MT interventions in in-patient brief settings. This has limited significance in understanding the generalization of MT into everyday life and promoting wellbeing. In the proposed study, on the other hand, I will try to evaluate the significance of recovery-oriented long-term group CoMT in the community, where most people live, focusing on behavioral domains where MT is expected to benefit most: The client's social skills development, group cohesion and emotional expression (affect improvement). 2. This study, to my knowledge, is the first that is based on longitudinal quantitative micro-analysis of filmed video sessions. This approach bypasses the participants subjective reaction to a qualitative interview (which by itself is important) allowing an additional un-biased angle of observation on the interaction process (assuming that the participants may ignore the presence of the video camera over time).

NCT ID: NCT04435366 Completed - Clinical trials for Macular Degeneration

A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad pegol) intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

NCT ID: NCT04435106 Completed - Clinical trials for Coronavirus Infections

Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)

Start date: April 3, 2020
Phase:
Study type: Observational

Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

NCT ID: NCT04434872 Terminated - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT). FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability. Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm. At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level. Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.

NCT ID: NCT04433663 Completed - Eating Disorders Clinical Trials

Eating Disorders, Self Regulation and Mentalization

Start date: September 2, 2018
Phase: N/A
Study type: Interventional

A randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome to assess two interventions for eating disorders. Six experienced therapists, and their consecutively 8-9 admitted clients, were randomly allocated to the intervention group and control group. The sample included a total of 52 participants, all women, mean age 24.2 yrs. old. In the intervention group, participants received mentalization-based psychotherapy with ECOSA - a novel developed mentalization tool and in the control group, participants received interpersonal psychotherapy that focused on resolving interpersonal problems and symptomatic recovery. Four randomized samples for each participant were checked for therapy-focused fidelity by two different psychotherapists.