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Results 2261-2270 of 470744

Pretomanid in Adults With Hepatic Impairment

Tuberculosis

This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects. There will be approximately 36 total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be conducted at 2 sites, study duration is approximately 24 months, and subject participation duration is approximately 5 weeks (including screening). Primary objective: To evaluate the pharmacokinetics of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects.

Recruiting92 enrollment criteria

Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway...

Postoperative Ileus

Hypothesis: Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an anti-inflammatory effect. Aims: In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of prucalopride. The following aims are formulated: to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS) to evaluate whether prucalopride leads to accelerated post-operative recovery

Recruiting7 enrollment criteria

Study to Weigh the Effect of Exercise Training on BONE (SWEET-BONE) Quality and Strength in Type...

Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) is associated with increased fracture risk despite normal to increased bone mass, thus suggesting poor bone quality. This study is aimed at weighing the effect of an exercise intervention program on parameters of bone quality in patients with type 2 diabetes mellitus. Two hundred patients with T2DM will be randomized to supervised exercise training on top of standard care (exercise, EXE, group; n=100) versus standard care (control, CON, group; n=100) for 24 months.

Recruiting23 enrollment criteria

Compassionate Access of the Miltenyi Device for CD34+ Cell Selection

Blood And Marrow Transplantation

Objectives: Primary Objective To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).

Recruiting2 enrollment criteria

Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke...

Acute Ischemic Stroke

The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.

Recruiting12 enrollment criteria

Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma...

Lymphoma

The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.

Recruiting38 enrollment criteria

A Phase II Evaluation of Afatinibin Patients With Persistent or Recurrent HER2-positive Uterine...

HER2/Neu+ Uterine Serous Carcinoma

Primary Objective: To assess the activity of Afatinib in patients with persistent or recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients who survive progression-free for at least 6 months after initiating therapy. Secondary Objectives: To assess objective response rate and durable disease control rate. To assess overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma patients.

Recruiting18 enrollment criteria

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Acquired Immunodeficiency SyndromeBK Virus Infection6 more

This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.

Recruiting10 enrollment criteria

Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

Full Thickness Rotator Cuff Tear

The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs). Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines and by supplying growth factors to their implanted environment. They have been shown to be effective in improving both overall healing and tendon integrity in rotator cuff repair. This study will follow 100 patients in the United States and track their clinical outcomes for at least one year post-operatively.

Recruiting6 enrollment criteria

Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric...

Von Willebrand Disease

Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD).

Recruiting16 enrollment criteria
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