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NCT ID: NCT02891746 Withdrawn - Microbiota Clinical Trials

Maternal and Neonatal Microbiome

Start date: n/a
Phase: N/A
Study type: Observational

The aim of the study is to characterize and monitor the microbiome of premature infants born in the investigators facility until discharge from the NICU. The investigators will also examine the relationship between mode of delivery and the microbiome of the infant, while exploring various possible factors that may affect it. In addition, the investigators will compare the microbiome of premature infants to the microbiome of term babies born at the same time in the same facility.

NCT ID: NCT02864784 Withdrawn - Clinical trials for Castrate Resistant Prostate Cancer With Bone Metastasis

Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC

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

Studies objectives: To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below: - Safety and Tolerability: - Adverse events (AEs) and serious AEs - Safety laboratory measurements - Hypercalcemic and hypercalciuric episodes - Treatment withdrawal due to AEs and overall Efficacy: - Skeletal Related Events (SREs) - Measurable and evaluable disease progression - Progression Free Survival (PFS) - Pain assessment via the VAS scale

NCT ID: NCT02850419 Withdrawn - Breast Cancer Clinical Trials

Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients

EURO-DIGNITY
Start date: March 2017
Phase: Phase 2
Study type: Interventional

The 105-15-201 study is designed to assess the effectiveness and tolerability of the combination of heat-activated target therapy (radiotherapy + hyperthermia + lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer patients.

NCT ID: NCT02782481 Withdrawn - Parkinson's Disease Clinical Trials

A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations

Start date: August 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double blind, placebo controlled parallel group clinical study. Following a screening period of up to 28 days, eligible subjects will be randomized to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous subcutaneous infusion of ND0612 or matching placebo for 16 weeks.

NCT ID: NCT02733211 Withdrawn - Type 1 Diabetes Clinical Trials

Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes

Start date: March 2019
Phase: N/A
Study type: Interventional

The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial glucose to aid in the management of their diabetes. The product automatically adjusts basal insulin delivery and delivers correction boluses in response to real-time glucose measurements by CGM to maintain blood glucose within the desired range, to improve metabolic control without increasing the risk of hypoglycemia. The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the safety and efficacy of night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy in poorly controlled patients with type 1 diabetes at home The objective of this pilot study is to evaluate the safety and efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly controlled type 1 diabetes at patient's home

NCT ID: NCT02685579 Withdrawn - Sleep Apnea Clinical Trials

The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo

OSATDV
Start date: June 2016
Phase: N/A
Study type: Observational

Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.

NCT ID: NCT02674269 Withdrawn - Overactive Bladder Clinical Trials

Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

INTIMO2
Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.

NCT ID: NCT02645201 Withdrawn - Clinical trials for Helicobacter Infections

The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children

Gastrus
Start date: January 2016
Phase: N/A
Study type: Interventional

The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain. Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori bacteria.

NCT ID: NCT02605356 Withdrawn - Multiple Myeloma Clinical Trials

Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma

Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint of the phase 1b part is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study. The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization (1:1) in the phase 2 part will be stratified by: - Prior bortezomib treatment (yes, no) - Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately 30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2 part of the study.

NCT ID: NCT02588807 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis

ALS-PHL
Start date: January 1, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)