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NCT ID: NCT05175599 Active, not recruiting - Pregnancy Related Clinical Trials

Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

This study aims to explore outcomes of waterbirth in comparison to conventional land birth for low-risk healthy women and neonates in a hospital setting in Milwaukee, WI. This study hypothesizes that women who labor and birth in water will use less pain medication, have a shorter labor, will be more likely to initiate breastfeeding prior to discharge, will not experience more negative outcomes, and will experience greater satisfaction than women who labor and birth on land.

NCT ID: NCT05175261 Active, not recruiting - STEMI Clinical Trials

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

Start date: January 20, 2022
Phase:
Study type: Observational

This is a Prospective, Observational Multicenter Non-Interventional Cohort Study. The primary objective is to determine whether platelet expression of FcγRIIa is associated with risk of myocardial infarction (MI), stroke and death. Secondary objectives include: 1) Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death; and 2) Determine whether platelet expression of FcγRIIa is associated with risk of major bleeding. The primary endpoint is the composite of death, MI and stroke. A secondary endpoint is the incidence of clinically significant bleeding according to the Bleeding Academic Research Consortium (BARC) scale type 2-5. Approximately 800 male and female subjects with confirmed MI [ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)] will be enrolled before hospital discharge for the index event. Approximately 10 sites in the United States will participate in this study. It is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. The study and subject follow-up will continue until 1) at least 80 ischemic events (MI, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.

NCT ID: NCT05174806 Active, not recruiting - Diabetic Foot Clinical Trials

Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients

Start date: June 13, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied three times per week for up to 12 weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.

NCT ID: NCT05174559 Active, not recruiting - Phenylketonurias Clinical Trials

Additional Dietary Large Neutral Amino Acids (LNAA) for Improved Symptoms in Adult Classical Phenylktonuria (PKU)

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This research investigates the effects of combining a phenylalanine restricted diet (usual care) with LNAA supplementation (adjuvant LNAA) in well-controlled adults with classical PKU. The hypothesis is that symptoms are improved in well-controlled patients who receive adjuvant LNAA therapy compared with diet monotherapy. Six symptomatic classical PKU adults will be enrolled to test the hypothesis in a small series of N-of-1 randomized controlled trials over 18-weeks. All assessments will be collected in patient's homes. A 3-month follow-up period will assess the longer-term effects of adjuvant LNAA in patients who show clinical benefit at the end of the intervention period.

NCT ID: NCT05174221 Active, not recruiting - Kidney Disease Clinical Trials

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

Start date: November 9, 2022
Phase: Phase 1
Study type: Interventional

This study will have two parts. The main aims are to: - check the side effects from mezagitamab. - check for long-term side effects from mezagitamab. Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period. Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.

NCT ID: NCT05174078 Active, not recruiting - Obesity Clinical Trials

Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management

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

The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level. The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.

NCT ID: NCT05174039 Active, not recruiting - Batten Disease Clinical Trials

An Open-label Safety, Pharmacokinetic, and Efficacy Study of Miglustat for the Treatment of CLN3 Disease

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

This is an open label study in approximately 6 subjects in 2 centers to assess the safety, PK, and efficacy of the maximum tolerable dose (MTD) of oral miglustat (100 mg once daily [QD] to 200 mg 3 times daily [TID]) in subjects ≥ 17 years of age with CLN3 disease over a period of 104 weeks.

NCT ID: NCT05174026 Active, not recruiting - Clinical trials for Metastatic Malignant Neoplasm in the Bone

18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery

Start date: November 30, 2018
Phase: N/A
Study type: Interventional

This trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.

NCT ID: NCT05173987 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Start date: February 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

NCT ID: NCT05173961 Active, not recruiting - Clinical trials for Malignant Solid Neoplasm

A Mobile Application, Oncpatient, to Assist Patients Undergoing Radiation Therapy

Start date: June 29, 2022
Phase: N/A
Study type: Interventional

This clinical trial determines how well the oncpatient mobile application work in assisting patients undergoing radiation treatment. Radiation therapy can be complex. The technology, daily treatments, and possible side effects can be confusing to prevent and manage. Traditional radiation patient education includes a large amount of information, including details of treatment logistics, side effect prevention, and management. However, this information is not always readily accessible or memorable through the long course of therapy, and critical details can be missed. Oncpatient is a mobile application intended to be a more convenient and accessible form of patient education and guidance that is readily available to help patients and their caretakers navigate through radiation treatment.