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NCT ID: NCT03301558 Withdrawn - Clinical trials for Kidney Transplant; Complications

The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

This is a single-center, prospective, open-label, randomized, cross-over study.

NCT ID: NCT03291158 Withdrawn - Clinical trials for Normal Healthy Volunteers

Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV

Start date: April 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for injection in healthy adult subjects.

NCT ID: NCT03258801 Withdrawn - Clinical trials for Idiopathic Pulmonary Fibrosis

Pirfenidone as Bridging Therapy for Lung Transplant in Patients Suffering From Idiopathic Pulmonary Fibrosis

Start date: October 29, 2018
Phase:
Study type: Observational

The diagnosis of idiopathic pulmonary fibrosis (IPF) is currently one of the most common diagnoses for patients under evaluation for lung transplantation. In recent years, an absolute increase in prevalence/ incidence of IPF has been observed. There is evidence that patients with IPF on waiting list for lung transplantation might benefit from pirfenidone treatment. Until now, no data are published regarding this important issue in lung transplantation. Primary objective is to determine whether there is a difference in the duration time of mechanical ventilation (weaning) directly after lung transplantation between patients treated with pirfenidone and patients without pirfenidone treatment. The Secondary objectives are to determine whether there are differences between the pirfenidone treatment group and the control group regarding survival after LUTX, the score on the Saint Georges Respiratory Questionnaire and the decline in forced vital capacity (FVC%) In this Investigator initiated, non- interventional single center study , patients on the waiting list for transplant pirfenidone treatment receive oral pirfenidone at the standard dose of 2403 mg per day. The treatment duration will range from 6 to 12 months. A control group will be used to correlate the outcome-parameters for a descriptive comparison. The control group includes patients with IPF on the waiting list who were on another IPF specific (or no) treatment for IPF The Study Population are Patients aged between 40-70 years who are admitted to the lung transplantation department and fulfill the international criteria for idiopathic pulmonary fibrosis ( existence of a usual interstitial pneumonia (UIP) pattern in the high-resolution computed tomography (HRCT) is necessary). Variables: Duration of mechanical ventilation after LUTX (hours), Forced Vital capacity relative to reference value at baseline (FVC0%), Forced Vital capacity relative to reference value after 6 months (FVC6%),Forced Vital capacity relative to reference value after 12 months (FVC12%) Study Size: 30 patients in the Pirfenidone group, 20 patients in the control group. For the primary Endpoint, the mean, standard deviation, median, minimum and maximum of the weaning time of patients who received a pirfenidone treatment, as well as of patients from the control group will be computed and presented in a table. Additionally, a Kaplan-Meier curve will be estimated and plotted alongside the respective 95% CI calculated using the method of Brookmeyer and Crowley. Furthermore, a stepwise linear regression using forward selection and Age, RBMI, FVC0%, (FVC6%-FVC0%), TLC, FEV1% and ECMO, as well as the pirfenidone treatment as predictors will be computed. The null hypothesis is that the pirfenidone treatment has no influence on the weaning time. The according model coefficient estimate and standard error will be used to test the null hypothesis using a t-test at significance level α=0.05. For the secondary endpoints, the mean, standard deviation, median, minimum and maximum of patients who received a pirfenidone treatment, as well as of patients from the control group will be computed and presented in a tableStepwise Cox Regression using forward selection and Age, RBMI, FVC0%, (FVC6%-FVC0%) and ECMO, as well as the pirfenidone treatment as predictors will be computed in order to compare the treatment and the control group a . If p-values are calculated for the secondary endpoint analysis, they serve only descriptive purposes. Therefore no multiple testing corrections are applied.

NCT ID: NCT03239236 Withdrawn - Clinical trials for Anesthesia Intubation Complication

Modified Rapid Sequence Induction in Morbidly Obese Patients

Start date: February 2021
Phase: N/A
Study type: Interventional

This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.

NCT ID: NCT03192969 Withdrawn - Clinical trials for Giant Cell Arteritis

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Start date: July 15, 2017
Phase: Phase 3
Study type: Interventional

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

NCT ID: NCT02974777 Withdrawn - Clinical trials for Platelet Dysfunction Due to Drugs

The IDEAL-PCI Extended Registry

IDEAL-PCI ext
Start date: n/a
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer). IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit

NCT ID: NCT02974322 Withdrawn - Crohn Disease Clinical Trials

A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.

NCT ID: NCT02813590 Withdrawn - Microbiota Clinical Trials

Ascitic Fluid Microbiome in Liver Cirrhosis

Start date: June 2016
Phase:
Study type: Observational

Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP). All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.

NCT ID: NCT02702427 Withdrawn - Clinical trials for Cytomegalovirus Infection

Virus-specific ImmunoTherapy Following Allogeneic Stem Cell Transplantation

VISIT
Start date: August 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are treated with virusspecific donor derived or autologous virusspecific T-cells.

NCT ID: NCT02568891 Withdrawn - Clinical trials for End-stage Renal Disease

Modulation of Gut Microbiota in End-stage Renal Disease

MGM-dialysis
Start date: January 2017
Phase: N/A
Study type: Interventional

In end-stage renal disease (ESRD) cardiovascular and infectious complications are common. The gut microbiome might play an important pathophysiological role. ESRD is hypothesized to be associated with profound alterations of gut microbiome and gut permeability. The investigators aim to test whether a multispecies probiotic mixture is able to revert the microbiome changes and decrease gut permeability. Furthermore the investigators aim to test whether this improvement in microbiome composition and gut permeability is also associated with improvements in endotoxemia, uremia and cardiovascular risk factors.