cyrilzakka/clinical-trials huggingface dataset:
Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This association could be mediated by an improvement of insulin sensitivity with moderate alcohol consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This could lead to accumulation triglyceride storage in muscle, which could interfere with insulin signaling. Whether such mechanism can also play a role with moderate alcohol consumption is unknown and will be investigated in this study.

In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic response in healthy subjects is unknown. This is a secondary objective of this trial.

To investigate the effect of moderate alcohol consumption on

* enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
* transporters of fatty acids and glucose in fat tissue
* post-prandial glycemic response in healthy, lean or overweight, young men

Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design

Participants

* Description : Healthy, lean and overweight young (18-40 years) men
* Number : 20

Study substances

* Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol)
* Reference substance : 100 ml mineral water (Spa blauw)

Duration: 2 treatment periods of 4 weeks (28 days)

Test parameters:

* Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase, cytochrome c oxidase
* Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA etc.)
* Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin, HbA1c)
* Liver enzymes (safety)
* Body weight
* Urinary ethyl glucuronide (compliance)

Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged between 18 and 40 years
* Lean subjects BMI 18.5-25 kg/m2 and overweight/obese subjects BMI \>27 kg/m2 (including 18.5, 25 and 27)
* Alcohol consumption between 7 and 28 units/week (including 7 and 28)

Exclusion Criteria:

* Smoking
* Family history of alcoholism
* History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
* Recent blood donation
* More than 8 hours/week of intense exercise
* Blood haemoglobin concentration below 8.4 mmol/l
* Allergic to betadine or lidocaine.
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the newborn intensive care unit
* TPN cholestasis of at least 2.5 mg/dl
* Anticipated TPN treatment for at least one month
* signed informed consent

Exclusion Criteria:

* Enrollment in another trial
* Lack of consent
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)

An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

Main objectives are:

* Description of the clinical and histological characteristics, treatment and evolution of these NHL.
* Study their physiopathology by immunological, virologic and molecular studies.

The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.

The enrolment period is 6 years and the total study lasts 8 years.

* "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
* "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.

The enrollment is estimated at 140 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with evolving NHL whatever its histological type
* At diagnosis or relapse or failure previous treatments stopped over 3 months
* Patients with HCV infection with positive quantitative viral load
* 18 years or more of age
* Life expectancy greater than 6 months
* Signed and informed consent
* Benefit from social security

Exclusion Criteria:

* Active uncontrolled infection (out hepatitis C)
* HIV (Human immunodeficiency virus) infection
* Severe psychiatric history
Effects of Short Duration High-intensity Interval Training on Peak Oxygen Consumption

High-intensity interval training (HIIT) is an effective tool to improve cardiovascular fitness and maximal anaerobic power. Different methods of HIIT have been studied but the effect of a maximal effort cycling and very short exercise time (i.e., 4-s) with short recovery time (15-30 s) and a high number of repetitions (i.e., 30 bouts) is unknown.

The investigators examined the effects of training at maximal anaerobic power during cycling (PC) on maximal anaerobic power, peak oxygen consumption (VO2peak), and total blood volume in 11 young healthy individuals (age: 21.3±0.5 y) (6 men, 5 women). Methods: Participants trained three times a week for eight weeks performing a PC program consisting of 30 bouts of 4-s at an all-out intensity (i.e., 2 minutes of exercise per session). The cardiovascular stress progressively increased over the weeks by decreasing the recovery time between sprints (30 to 24 to 15-s) and thus session time decreased from 17 to \< 10 min.

Eligibility Criteria:
Inclusion Criteria:

Young (18-30), Healthy, Recreationally active, but untrained (not meeting ACSM's recommendations of 150 min/week of moderate-vigorous aerobic exercise) -

Exclusion Criteria:

Cardiovascular disease Smoking Subjects who were exercising regularly (\>75 min/week) were excluded.

-
Prematurity and Ophthalmological Changes

Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity

Aims: To compare functional (visual acuity and refractive error) and anatomical (biometric values, foveal and choroidal thickness) ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity (ROP).

Settings and Design: Prospective Cross-Sectional Study

Methods and Material: The study was conducted prospectively in the ophthalmology department of Ankara Bilkent City Hospital. Subjects were divided into three groups: 29 children who were treated with laser photocoagulation (ROP-TxGroup), 26 children who developed ROP and did not need treatment (ROP-non-TxGroup), and 25 children who did not develop ROP (Premature Group). The 27 healthy children with a history of full-term born (Control Group), who were in a similar age group for 'control eye examination', were accepted as the control group. A total of 107 patients and 211 eyes were included in the study. Non-cycloplegic and cycloplegic refraction, best corrected visual acuity (BCVA), keratometry, axial length (AL) and anterior chamber depth (ACD), optical coherence tomography (OCT) macular and OCT subfoveal choroidal measurements were performed in all cases.

Eligibility Criteria:
Inclusion Criteria:

Children with a history of ROP

Exclusion Criteria:

Stage 4-5 ROP, Presence of media opacities (such as cataract) Ocular trauma or ocular surgery Hydrocephalus or grade 3 and above intracerebral hemorrhage, Uncooperative children
Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria (Cohort #1):

* Diagnosis of B-CLL by NCI criteria
* Require chemotherapy and have fully recovered from previous administered chemotherapy
* Subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. Failing at least one purine analogue regimen
* Subjects have received three or fewer prior treatment regimens
* ECOG status of 0 - 2

Inclusion Criteria (Cohort #2):

* If dose level + 3 is reached, the criteria is the same as outlined for Cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)

Exclusion Criteria:

* Unwilling or unable to use an acceptable method to avoid pregnancy
* Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
* History of significant bleeding disorder, unrelated to CLL
* Prior concurrent malignancy
* Drugs that generally accepted to have the risk of causing Torsades de Pointes
* Autoimmune hemolytic anemia requiring therapy or transfusion support
* Autoimmune thrombocytopenia requiring steroid therapy or transfusion support
* Richter's Syndrome
* Transformation to prolymphocytic leukemia
Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders

Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. On the other hand, immersive virtual reality using a head-mounted display has not yet been attempted in the rehabilitation of patients with brain disorders. In addition to the benefits of existing virtual reality or game rehabilitation, immersive virtual reality can further enhance brain plasticity, such as the effect of mirror therapy or action observation, through self-awareness of the body in the virtual space. The purpose of this study is to investigate the feasibility of applying the immersive virtual reality using a head-mounted display in patients with upper extremity dysfunction due to brain disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients with upper extremity dysfunction due to brain disorders (eg, stroke, traumatic brain injury, brain tumor, etc.)
* Patient who can move the upper limb against the gravity (MRC grade 3 or above in both shoulder and elbow flexion)
* Patient who can maintain stable sitting position
* Adults over 18 years old
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* A moderate-to-severe cognitive impairment score of 18 or less in Mini-Mental Status Examination (MMSE)
* Peripheral nerve injury, joint disease, other diseases of the upper extremity dysfunctions other than brain disorders
* Patients with a history of severe dizziness or epilepsy
* Patients with other medical illness that are difficult to participate in the study
COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia or high-risk myelodysplastic syndrome
* Age between 18 and 70 years
* Eligible for an intensive chemotherapy
* Eligible for allograft
* Able to answer a questionnaire

Exclusion Criteria:

* Diagnosis of acute promyelocytic Leukemia
* Palliative treatment
* Contraindication to moderate physical activity
* Performans status 4, unless it is related to the disease
* Patient who does not understand French
* Patient unable to use a smartphone
* Patient deprived of liberty or placed under the authority of a tutor,
* Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
* Platinum-resistant disease, defined as:
* For participants who had only 1 line of platinum-based therapy: progression between \> 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles.
* For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy.
* Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
* Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
* Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRα assessment prior to randomization.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Exclusion Criteria:

Medical Conditions

* Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer.
* Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
* Pulmonary function test (PFT) abnormalities: FEV1 \< 70% or FVC \< 60%, and DLCO \< 80%.
* Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
* Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.

Physical and Laboratory Test Findings

* Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.

Allergies and Adverse Drug Reactions

* Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
* History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C.

Other protocol-defined inclusion/exclusion criteria apply.
Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

Recent studies show that gut microbiota strongly influences multiple sclerosis. These data suggest that the microbiota could have a direct effect on MS pathogenesis, although the mechanisms through which it modulates central nervous system (CNS) neuroinflammation and neurodegeneration are still poorly defined. The microbiota mediates its action principally through synthesizing specific metabolites that act as messengers in host functions, such as the modulation of the immune and nervous system, tissue repair, and stemness. The short-chain fatty acids (SCFAs- mainly acetate, propionate, and butyrate), produced by the fermentation of dietary fibers, are a class of microbial metabolites of primary importance for host physiology. Thus, the objective is to establish a mechanistic link between gut microbiota dysbiosis, reflected by a different level of SCFAs and SCFA-producing bacteria species, and neuroimmune alterations in MS. Preliminary data show a differential metabolomic profile in urine samples of MS patients compared to healthy controls. The authors now aim at deepening previous findings by analysing also the SCFAs concentration in the urines, plasma and CSF by GC-MS (their level turned out to be too low to be measured by NMR) and the microbiota composition by shotgun metagenomics analysis, to track changes in the abundance of SCFAs-producing bacteria species.


Eligibility Criteria:
Inclusion Criteria:

- Volunteers that have preventively signed the informed consent to use their samples for additional studies.

Exclusion Criteria:

- None
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 to 82 years of age, inclusive
* Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis
* eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2
* Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol
* Iron replete with ferritin and TSAT levels as defined per protocol

Key Exclusion Criteria:

* BMI \> 44.0 kg/m2
* Red blood cell transfusion within 11 weeks prior to the Screening visit
* Androgen therapy within the previous 21 days prior to the Screening visit
* Intravenous iron within the past 4 weeks prior to the Screening visit
* AST or ALT \>1.8x ULN, alkaline phosphatase \>2x ULN, or total bilirubin \>1.5x ULN
* Screening ECG with QTc \> 500 msec
* Uncontrolled hypertension
* Class III or IV congestive heart failure
* Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit
Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥18 to ≤55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Willing and able to provide written informed consent

Exclusion Criteria:

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 7 days of dosing
* Use of any investigational agent or study treatment within 30 days of Day -1
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to LX4211 or canagliflozin
* Daily use of \>5 cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study
* History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
* History of bowel resection, any malabsorptive disorder, severe gastroparesis, any GI procedure for the purpose of weight loss which would slow gastric emptying
* History of any major surgery within 6 months prior to Screening
* History of any hypersensitivity to the inactive components of LX4211, inactive components of canagliflozin, acetaminophen oral solution or any inactive component of acetaminophen liquid preparation
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 30 days prior to Day -1
* History of alcohol or substance abuse within 2 years prior to Day 1
* History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
* Donation or loss of \>500 mL of blood or blood product within 56 days of Day -1
* positive pregnancy test at Screening or Day -1
* Positive urine screen for drugs of abuse at Screening or Day -1
* Positive breath test for alcohol at Screening or Day -1
* Inability or difficulty swallowing whole tablets
* Unable or unwilling to communicate or cooperate with the Investigator
Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status.

Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (IFG).


Eligibility Criteria:
Inclusion Criteria:

* High risk population
* Age 40 to 70 yrs.
* BMI \> 25 and \< 40; FPG \>5.5 mmol/l and \< 7.8 mmol/l; IGT in OGGT

Exclusion Criteria:

* Known type 2 diabetes
* Drug intake affecting glucose tolerance
* Any cardiovascular events within the last 6 months