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NCT ID: NCT03650114 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

ALITHIOS
Start date: December 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

NCT ID: NCT03633708 Recruiting - Clinical trials for Chronic Kidney Disease

A Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Start date: April 29, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3 Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

NCT ID: NCT03597854 Recruiting - Clinical trials for Acute Kidney Disease

Renal Outcome of Acute Kidney Disease

Start date: June 28, 2018
Phase:
Study type: Observational [Patient Registry]

Both, acute kidney injury (AKI) and chronic kidney disease (CKD) considered as a continuum of the disease process. The renal recovery after AKI is currently assessed by measuring serum creatinine, which has its limitations including change in muscle mass, volume distribution in critically ill patients. Also, despite complete return of serum creatinine after AKI, these patients remain at increased risk for developing CKD, which suggest that there may be persistent subclinical damage to the kidney. The new term acute kidney disease (AKD) has been proposed to define the renal disease after AKI. Recently (2017), Acute Disease Quality Initiative (ADQI) 16 workgroup published a consensus document on AKD and renal recovery, which provide definition as well as research recommendation for AKD. The consensus report of the ADQI 16 workgroup (2017) recommended that there is need for studies to describe the epidemiology, clinical course, natural history of patients having AKD; and also determine optimal methods to assess functional recovery and identify novel biomarker(s), functional tests, and imaging approach which can reveal ongoing injury and repair in these patients. This is an observational study to describe epidemiology, clinical course and recovery from AKD at 90 days in critically ill patients.

NCT ID: NCT03579303 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome

Start date: October 2018
Phase: N/A
Study type: Interventional

This study is undertaken to compare effectiveness of homoeopathic treatment versus integrated approach of homoeopathy and yoga in the treatment of menstrual disorders in females with Polycystic ovarian syndrome.

NCT ID: NCT03572699 Recruiting - Clinical trials for Diabetic Retinopathy

Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study

SMART
Start date: July 11, 2018
Phase:
Study type: Observational

This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.

NCT ID: NCT03568383 Recruiting - Tuberculosis, MDR Clinical Trials

Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

PHOENIx MDR-TB
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

NCT ID: NCT03563053 Recruiting - Clinical trials for Ataxia Telangiectasia

Open-label, Long-term, Extension Treatment Using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients With Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study

OLE-IEDAT
Start date: June 12, 2018
Phase: Phase 3
Study type: Interventional

This is an international (North America, Europe, Africa, Asia and Australia), multi-center, prospective, open-label treatment study, designed to continue to provide the study medication to all patients who completed 12 months of treatment (including those treated with placebo) in the IEDAT-02-2015 trial, completed the study assessments, do not present safety contraindication to continuation of treatment, and provided informed consent. The study aims to collect information on the long-term safety and efficacy of the trial treatment.

NCT ID: NCT03561961 Recruiting - Clinical trials for Prostate Adenocarcinoma

Prostate Radiotherapy Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)

PRIME
Start date: May 24, 2018
Phase: N/A
Study type: Interventional

Aim: The aim of the study is to compare the efficacy with SBRT and moderate hypo-fractionation in high risk and node positive prostate cancer PRIMARY STUDY OBJECTIVES: To assess whether extreme hypo-fractionation with SBRT in high risk prostate cancer is non inferior to moderately hypo-fractionated standard radiotherapy STUDY DESIGN: Two arm, Prospective Randomized Trial with a non-inferiority design TREATMENT REGIMEN: Arm 1-[standard arm] Moderate hypo-fractionated RT, total dose of 66-68 Gray(Gy) in 25# to the primary over 5 weeks, with treatment being delivered daily. All patients irrespective of nodal status will receive a dose of 50 Gy in 25# to the pelvic nodes.Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 60-66 Gy/25# as a simultaneous integrated boost (SIB). An option of equivalent biological dose using 60-62.5 Gy in 20# may be allowed for multi-centric accrual in the future. Arm 2 -[Experimental Arm] Extreme hypo-fractionation with SBRT,course of 5 fractions of radiation; each of size 7-7.25 Gy. The total dose will be 35-36.5 Gy. All patients irrespective of nodal status will receive a dose of 25 Gy in 5 # to the pelvic nodes. The 5 treatments will be scheduled to be delivered alternate day over approximately 7-10 days. An option of equivalent biological dose using 35-36.5 Gy in 5 weekly fractions may be allowed for multicentric accrual in the future. RECRUITMENT TARGET: 464 total (232 patients experimental arm and 232 patients standard arm) recruitment over 6 years, with a non-fixed follow up period and a uniform accrual rate. PRIMARY ENDPOINT To assess the 5 year Biochemical Failure free Survival (BFFS) between the two arms. Follow-up At 3-6 weeks from end of radiotherapy, followed by 3-6 monthly for the first two years and 6 monthly thereafter.

NCT ID: NCT03549754 Recruiting - Hypertension Clinical Trials

iCaReMe Global Registry

iCaReMe
Start date: February 17, 2018
Phase:
Study type: Observational [Patient Registry]

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

NCT ID: NCT03531515 Recruiting - Sepsis Clinical Trials

Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Start date: April 11, 2018
Phase:
Study type: Observational [Patient Registry]

Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. In critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent VTE. However, not all patients with infection respond with thrombocytosis. No study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.