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NCT ID: NCT04113616 Terminated - Clinical trials for Relapsed or Refractory Acute Myeloid Leukemia (AML)

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

Start date: September 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).

NCT ID: NCT04107675 Terminated - Clinical trials for Stem Cell Transplant Complications

A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)

BOSTON-4
Start date: February 11, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients. Secondary Objectives: The secondary objectives of this study are to assess PK and exploratory efficacy and quality of life of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.

NCT ID: NCT04106570 Terminated - Obesity Clinical Trials

Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age

PLANEUROB
Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).

NCT ID: NCT04104594 Terminated - Nasal Polyps Clinical Trials

Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

OIPN
Start date: February 5, 2020
Phase: N/A
Study type: Interventional

Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.

NCT ID: NCT04103359 Terminated - Clinical trials for Myelodysplatic Syndromes

Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy

FITME
Start date: October 20, 2020
Phase: N/A
Study type: Interventional

At present, it is unclear why some myelodysplastic patients (MDS) receiving blood transfusion therapy exhibit an increase in Hemoglobin (Hb) without a concurrent improvement in fatigue. Research is thus required to elucidate on why fatigue persists in some MDS patients in order to devise strategies to alleviate fatigue in "non-responders" to blood transfusion.

NCT ID: NCT04099888 Terminated - Cholangiocarcinoma Clinical Trials

PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

RELEASE
Start date: May 23, 2019
Phase: Phase 2
Study type: Interventional

This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

NCT ID: NCT04096560 Terminated - Clinical trials for Narcolepsy Type 1 (NT1)

A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy

Start date: February 27, 2020
Phase: Phase 2
Study type: Interventional

The main aims of the study are: - To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. - To check what dose range provides adequate relief of narcolepsy symptoms. - To check how much TAK-994 stays in the blood of participants, over time. The study will have 4 parts. Participants can only join 1 of the parts. A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it. B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days. C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days. D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

NCT ID: NCT04095793 Terminated - Clinical trials for Symptomatic Neurogenic Orthostatic Hypotension

Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

OAK
Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.

NCT ID: NCT04094077 Terminated - Brain Metastases Clinical Trials

Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases

NANOSTEREO
Start date: January 17, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.

NCT ID: NCT04086953 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Validation of a Walk-Time Limit Test (WTLT) Derived From the 6-Minute Walk Test (6-MWT) in Patients With Chronic Cardiovascular or Respiratory Diseases

TTLM
Start date: February 20, 2020
Phase: N/A
Study type: Interventional

Many exercise tests are commonly used to evaluate the changes of exercise tolerance following rehabilitation programs in patients with chronic respiratory diseases. Among the tests (6-MWT, incremental test, ...), the literature seems to indicate that endurance time is the most responsive parameter for detecting and quantifying changes in exercise capacity following a rehabilitation program. Although its clinical interest is undeniable, the endurance shuttle walking test is rarely used because it requires the prior performance of two incremental shuttle walking tests to determine the walking speed imposed on the patient. In this protocol, we propose to test a Walk-Time Limit Test (WTLT) derived from the 6-minute walk test (6-MWT) and based on the average walking speed achieved in this test commonly used in the follow-up of patients with chronic diseases. TTLM validation would improve the functional assessment of patients with chronic diseases while limiting the number of exercise tests.