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NCT ID: NCT03834909 Withdrawn - Pregnancy Clinical Trials

Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)

Start date: April 2022
Phase: Phase 1
Study type: Interventional

This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery (postpartum) to achieve study objectives which include PK, safety monitoring for maternal and fetal/infant safety signals, and adherence.

NCT ID: NCT03843008 Withdrawn - Ischemic Stroke Clinical Trials

Melatonin in Acute Stroke

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

This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep.

NCT ID: NCT04018469 Withdrawn - Amputation Clinical Trials

Patterned Electric Dressing Effects on Open Wounds

PED
Start date: April 2022
Phase:
Study type: Observational [Patient Registry]

1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.

NCT ID: NCT04093739 Withdrawn - Hip Fractures Clinical Trials

MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

Start date: April 2022
Phase:
Study type: Observational

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

NCT ID: NCT04095546 Withdrawn - Clinical trials for Borderline Personality Disorder (BPD)

Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

Start date: April 2022
Phase:
Study type: Observational

The link between epigenetic changes as an effect of psychotherapy has been investigated recently. Genes investigated in these studies were brain-derived neurotrophic factor (BDNF), NR3C1, FKBP51, MAOA and GLUT1. Change in methylation of these genes could be a biomolecular mechanism of psychotherapy induced changes. This study project aims at providing evidence for a biological mechanism of personality disorder interventions in adolescence by investigating the link between epigenetic changes as an effect of psychotherapy. It investigates the correlation between changes in the methylation of the FKBP5 gene and psychotherapy induced changes in symptoms and functioning.

NCT ID: NCT04583748 Withdrawn - Depression Clinical Trials

Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers

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

Vision loss is common among older adults and leads to an increased risk for depression and difficulties in daily tasks, thus requiring dependence on caregivers. This study will assess the feasibility of providing two virtual interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), to supplement care of patients with irreversible age-related vision loss (IARVL) and their caregivers, with the goal of enhancing mental health and quality of life.

NCT ID: NCT04651374 Withdrawn - Covid19 Clinical Trials

COVID-19 And Geko Evaluation: The CAGE Study

CAGE
Start date: April 2022
Phase: N/A
Study type: Interventional

The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19. Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

NCT ID: NCT04685759 Withdrawn - Clinical trials for Cancer of Gastrointestinal Tract

Exercise Regimens and Neoadjuvant Chemotherapy

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

The purpose of this study is to assess the effectiveness of exercise therapy for patients undergoing neoadjuvant chemotherapy for primary gastrointestinal (GI) tract cancer, providing a reproducible exercise regimen designed to improve or preserve aerobic fitness, strength, and quality of life. In addition, this study will address shifts in healthcare delivery needed as a result of the coronavirus disease 2019 (COVID-19) pandemic, evaluating the effectiveness of telehealth instruction as a method for exercise therapy. The study hypotheses are: 1. To evaluate the effectiveness of exercise therapy for cancer patients undergoing neoadjuvant treatment when delivered via telehealth, as compared to an in-person setting. 2. To assess stair test instrumentation, previously validated in a healthy population, as a measure to gauge health status in cancer patients undergoing neoadjuvant treatment. 3. To assess patient satisfaction with exercise therapy when delivered via telehealth, as compared to an in-person setting.

NCT ID: NCT04869540 Withdrawn - Clinical trials for Autism Spectrum Disorder

Improving Transition Outcomes for Youth With ASD in a Medicaid Accountable Care Organization

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

Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). The investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large Medicaid Accountable Care Organization (ACO). The investigators will conduct a randomized pilot study of 40 families of TAY with ASD. All families will receive care by providers trained in the Got Transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. Families in the 'intervention refinement' arm will also receive a family-based problem solving education (PSE) intervention.

NCT ID: NCT04919096 Withdrawn - Clinical trials for Wet Age-related Macular Degeneration

Study of SCB-420 in Subjects With Neovascular Age-related Macular Degeneration

Start date: April 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-masked, multicenter, parallel-assignment, pilot study to evaluate the safety, tolerability, initial clinical effectiveness, pharmacokinetics (PK), and immunogenicity of SCB-420 as compared with Eylea (aflibercept), in subjects with Neovascular Age-related Macular Degeneration. A total of 20 subjects with Neovascular Age-related Macular Degeneration will be enrolled across up to 11 sites in 3 countries (Australia, New Zealand, and China). The study will be conducted in 2 parts - Sentinel Safety Cohort and Open Enrolment. Subjects will be administered with 2 mg of SCB-420 or Eylea via intravitreal (IVT) injection every 4 weeks for a total 3 doses.