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Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

Other Disorders of Vestibular FunctionBilateral8 more

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.

Recruiting35 enrollment criteria

Safety & Effectiveness of TENS Weight Management Compared to a Sham

ObesityMild

This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up

Recruiting45 enrollment criteria

A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery...

Venous Thromboembolism

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin The secondary objectives of the study are: To evaluate the bleeding risk (ie, major and clinically relevant non-major [CRNM] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin To assess overall safety and tolerability of REGN9933 in participants undergoing TKA To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways To assess immunogenicity following a single dose of REGN9933 over time To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA

Recruiting13 enrollment criteria

Effect of Exercises on Physical Health and Cardiorespiratory Fitness in Obese Women

Obesity

The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women. Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.

Recruiting10 enrollment criteria

Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)

Idiopathic Pulmonary Fibrosis

This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.

Recruiting10 enrollment criteria

Dapagliflozin Therapy In Cardiac Surgery

Diabetes MellitusType 21 more

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Recruiting13 enrollment criteria

Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma

Liver CancerHepatocellular Carcinoma

The present protocol (STRAT-aHCC trial) aims to prospectively evaluate the tolerability, quality of life and efficacy of an alternative regimen of regorafenib in patients with advanced hepatocellular carcinoma (HCC) after progression to first-line. Patients will receive increasing dose of regorafenib in the first 2 treatment cycles (initial dose of 80mg, with weekly increments of 40mg up to 160mg in the first 2 treatment cycles). From the 3rd cycle on, the maximum tolerated dose during the first 2 cycles will be maintained. The maximum tolerated dose will be considered the highest dose in which the patient does not present grade ≥3 adverse events. The primary endpoint is the proportion of evaluable patients completing cycle 4. Radiologic response rate, quality of life, time to progression and overall survival will be evaluated as secondary endpoints.

Recruiting41 enrollment criteria

Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma...

Plantar Fascitis

There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis.

Recruiting19 enrollment criteria

Public Health Nurse-Delivered 1-Day CBT Workshops for PPD

Postpartum Depression

Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months. The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family. Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.

Recruiting4 enrollment criteria

A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg

CML

This study investigates the safety, tolerability and dose equivalence of drug IkT-001Pro in healthy volunteers (18 to 55 years old) in comparison to imatinib mesylate. This study is designed in 2 parts. Part A consists of 3 cohorts. In cohort 1 healthy participants will take a single, oral dose of 400mg IkT-001Pro then will be followed by a single dose of 400mg Imatinib mesylate after a 7-day washout. Cohort 2 and 3 will follow the same structure as cohort 1 with a different Ikt-001Pro dose. Part B will be chosen using Part A data by statistical procedures. Part B will enroll 32 subjects to demonstrate the bioequivalence of IkT-001Pro (the 'Test') to 400 mg imatinib delivered as imatinib mesylase (the 'Reference').

Recruiting21 enrollment criteria
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