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NCT ID: NCT03869502 Recruiting - Clinical trials for Chronic Myeloid Leukemia in Myeloid Blast Crisis

European CML Blast Crisis Register

BlastCrisis
Start date: October 25, 2018
Phase:
Study type: Observational [Patient Registry]

Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

NCT ID: NCT03869385 Recruiting - Septic Shock Clinical Trials

Albumin Replacement Therapy in Septic Shock

ARISS
Start date: October 21, 2019
Phase: Phase 3
Study type: Interventional

Albumin is a key regulator of fluid distribution within the extracellular space and possesses several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation, and buffer function. The accumulating evidence suggests that supplementation of albumin may provide survival advantages only when the insult is severe as in patients with septic shock. Prospective randomized trials on the possible impact of albumin replacement in these patients with septic shock are lacking. The aim of the study is to investigate whether the replacement with albumin and the maintenance of its serum levels at least at 30 g/l for 28 days improve survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. In this prospective, multicenter, randomised trial, adult patients (≥18 years) with septic shock will be randomly assigned within a maximum of 24 hours after the onset of septic shock after obtaining informed consents to treatment or control groups. Patients assigned to the treatment group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. The primary end point is 90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital mortality, organ dysfunction/failure, and length of ICU and hospital stay. In total 1412 patients need to be analyzed, 706 per group. Assuming a dropout rate of 15%, a total of 1662 patients need to be allocated.

NCT ID: NCT03866603 Recruiting - Parkinson´s Disease Clinical Trials

Rostock International Parkinson's Disease Study (ROPAD)

ROPAD
Start date: May 30, 2019
Phase:
Study type: Observational

Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.

NCT ID: NCT03865160 Recruiting - Myopia, Progressive Clinical Trials

Low-dose Atropine for Myopia Control in Children

AIM
Start date: October 19, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Myopia (nearsightedness) is the most common eye disorder. Only second to age, it is the main risk factor for major degenerative eye diseases such as glaucoma, macular degeneration or retinal detachment. Their risk increases with the degree of myopia. Hence, prevention of myopia and slowing its progression is of high relevance. Almost all clinical studies, including two large randomised clinical trials (RCT) were performed in Asia with Asian study participants. The results indicate that atropine eye drops can attenuate myopic progression in children, even in low concentrations thus minimizing unwanted side effects. However, the cumulative evidence is yet not strong enough to recommend their unrestricted use, especially in a Non-Asian population. We therefore intend to set up an adequately powered RCT comparing atropine 0.02% eye drops with placebo to validate previous findings and to test whether this therapeutic concept holds its promise in a European population.

NCT ID: NCT03857516 Recruiting - Clinical trials for Pacemaker Electrode Lead Displacement

MultipOlar Left Ventricular Electrode Instability Trial

MOVE IT
Start date: October 1, 2018
Phase:
Study type: Observational

Characterization of pacing thresholds in available pacing vectors of quadripolar leads used for cardiac resynchronization therapy in a short term follow-up.

NCT ID: NCT03854058 Recruiting - Clinical trials for Obesity Hypoventilation Syndrome

Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease

Start date: May 1, 2019
Phase:
Study type: Observational

Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to - identify potential determinants for the development of obesity hypoventilation - to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients

NCT ID: NCT03853616 Recruiting - Clinical trials for B-cell Lymphoma Refractory

MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)

Start date: November 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase l/ll multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. The trial consists of 2 parts: Part I and Part II. In total approximately 48 patients will be included in Part I of the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).

NCT ID: NCT03853356 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Evidence For Fusion In Spine With Orthoss®

EFFISO
Start date: January 18, 2019
Phase:
Study type: Observational

This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).

NCT ID: NCT03853070 Recruiting - Aneurysm Clinical Trials

Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

Start date: December 11, 2018
Phase:
Study type: Observational

This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.

NCT ID: NCT03850574 Recruiting - Clinical trials for Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

APTIVATE
Start date: March 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)