linjc16/ctgov huggingface dataset:
Biomechanical Properties in Intensive Care Unit (ICU) Survivors 12-month After Discharge

Study Overview
=================
Brief Summary
-----------------
Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors report persevering limitation of physical capacity for years after discharge. Limited information is available about the underlying biomechanical properties responsible for this muscle function impairment.

Official Title
-----------------
Biomechanical Properties in ICU Survivors 12-month After Discharge

Conditions
-----------------
Intensive Care (ICU) Myopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU length of stay > 72 hours Informed consent Exclusion Criteria: BMI>30 Neuromuscular or psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU survivors<br>Male ICU survivors 12 month after discharge | |
| Controls<br>Age and gender matched controls | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU acquired weakness
Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the stool microbiota, serum and fecal bile acid composition, and changes in blood glucose and lipid profile before and after one month of metformin or YH1 treatment.

Official Title
-----------------
Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Metformin and YH1 in Patients With Treatment-naïve Type 2 Diabetes Mellitus: A Pilot Observational Study

Conditions
-----------------
Diabetes Mellitus, Type 2, Metformin, YH1

Intervention / Treatment
-----------------
* Drug: YH1
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment-naïve male patients with type 2 diabetes; Aged 20-65 years; Body mass index (BMI) ≥ 24 kg/m2; 4.7 % ≤ glycated hemoglobin (HbA1c) < 9 %; 5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month Exclusion Criteria: type 1,or other specific types of diabetes; female; history of oral hypoglycemic agents (OHAs) treatment or insulin therapy; use of lipid-lowering drugs within the past six months; serious gastrointestinal (GI) tract diseases, including peptic ulcers and GI tract bleeding; hepatic insufficiency with ALT >72 U/L or renal insufficiency with an eGFR < 60 mL/min/1.73 m2; history of stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, infectious disease, or surgery in the previous month; mental illness; current smoking status, alcohol or drug abuse; hemoglobin disease or chronic anemia; underlying conditions that could lead to poor compliance; severe organic diseases, including cancer, coronary heart disease, myocardial infarction or cerebrovascular disease; continuous antibiotic or probiotics use for over 3 days within 3 months prior to enrollment; continuous use of weight loss drug for over 1 month; history of YH1 therapy, or Chinese medicine treatment within the past one month.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| YH1 group<br> | Drug: YH1<br>* YH1 treatment for one month<br>|
| Metformin group<br> | Drug: metformin<br>* metformin treatment for one month<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bile acid profile | before and after YH1 or metformin treatment | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bile acid, Microbiota
T Cell Profiling in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to to learn more about the body's immune response in patients with multiple sclerosis (MS). In MS, the body's immune cells mistakenly attack an important part of the nerves of the brain and spinal cord. The immune cells responsible for attacking the nerves in MS patients is primarily the T cells. A marker was recently discovered that might specifically identify these damaging T cells from all other T cells in the body. Understanding which T cells cause the damage in MS patients and understanding more about these specific T cells may help doctors better understand how MS occurs and could possibly prevent MS in the future.

Official Title
-----------------
T Cell Profiling in Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Blood Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
MS Group Inclusion criteria -diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup or are admitted to the inpatient floor with acute symptoms. Exclusion criteria Have an active infection Take T cell modulating drugs Control Group Inclusion criteria -scheduled for elective surgery without any immunological diseases. Exclusion criteria Have an active infection.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis Stable Conditions<br>Multiple sclerosis patients presenting for a routine clinic visit. | Other: Blood Sample<br>* a blood sample will be collected<br>|
| Multiple Sclerosis Acute Flare Up<br>Multiple sclerosis patients admitted to the hospital with acute symptoms. | Other: Blood Sample<br>* a blood sample will be collected<br>|
| Control patients<br>Patients without any immunological diseases who present for elective surgery. | Other: Blood Sample<br>* a blood sample will be collected<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell populations | compare T cell populations between patients with Multiple Sclerosis and healthy controls | up to one week |
6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer.

Detailed Description
-----------------
OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene (HMAF) in patients with metastatic renal cell carcinoma. II. Investigate the safety of HMAF given to this patient population. OUTLINE: Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed after every 2 treatment courses. PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 6-19 months.

Official Title
-----------------
A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Drug: irofulven


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma and evidence of metastatic disease Bidimensionally measurable disease No active brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal range ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine within 1.5 times ULN AND Creatinine clearance at least 50 mL/min Other: Not pregnant or lactating Fertile patients must use effective contraception No prior malignancy within 5 years and at low risk for recurrence Must have undergone potentially curative therapy for prior malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biological therapy and recovered Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since hormone therapy and recovered Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irofulven|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV renal cell cancer, recurrent renal cell cancer
Functional Neurological Disorders in Patients Admitted in Stroke Units

Study Overview
=================
Brief Summary
-----------------
Functional neurological disorders are an important subgroup of patients with stroke mimics admitted to stroke unit.Their clinical profile and outcome are poorly known. The goal of this study is to describe the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.

Official Title
-----------------
Functional Neurological Disorders in Patients Admitted in Stroke Units: Clinical Profile et and 6 Months Follow-up

Conditions
-----------------
Functional Neurological Disorders

Intervention / Treatment
-----------------
* Other: Description


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old Patients admitted in stroke unit for a neurological deficit, without evidence of neurovascular or othe neurological disease. NIHSS ≥ 1 at time of admission Informed and consent patient to study Health insured Exclusion Criteria: Patient receiving legal protection Pregnant or breastfeeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients | Other: Description<br>* description of the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | Cognitive/behavioural characteristics of patients assessed for stroke using the National Institute of Health Stroke Score ranging from 0 to 42 (0: no stroke; 1-4: minor stroke; 5-15: moderate stroke; moderate to severe stroke; 21-42: severe stroke) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms of patients | Description of symptoms at 3 and 6 months after transition in stroke unit | 3 and 6 months |
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic solution, 1% on signs and symptoms of blepharitis.

Official Title
-----------------
A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Two Weeks in Subjects With Posterior Blepharitis

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: AzaSite®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of moderate to severe chronic posterior blepharitis if female of childbearing potential, are non-pregnant and non-lactating Exclusion Criteria: had ocular surface surgery (LASIK, refractive, etc.) within the past year unwilling to discontinue use of contact lenses during the study have glaucoma unable or unwilling to withhold the use of lid scrubs during the study have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AzaSite®<br>* ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for  12 days<br>* Other names: AzaSite;|
| No Intervention: 2<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical signs and symptoms associated with blepharitis |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard ocular safety assessments |  | 2 weeks |
Effect of Magnesium Supplementation in COPD

Study Overview
=================
Brief Summary
-----------------
Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar endothelial cells and low-grade inflammation, a typical state of COPD. In this sense, several randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since long-period oral supplementation of Mg leads to a clinical and spirometric improvement. Subjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction in pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent clinical and instrumental improvement. These evidences suggest that a chronic supplementation with Mg could improve COPD in clinical and instrumental parameters, but, at the best of our knowledge, no study was available in this sense.

Official Title
-----------------
Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Dietary Supplement: 300 mg of citrate Mg
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (>18 years). Moderate-severe COPD (FEV1 between 30-80% of theorical values). Exclusion Criteria: Already taking magnesium or calcium supplementations. Severe renal (creatinine clearance< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia). Hypermagnesemia (serum Mg>1.85 mmol/L).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>300 mg of citrate Mg/daily | Dietary Supplement: 300 mg of citrate Mg<br>* This group will take an oral supplementation of 300 mg of citrate magnesium<br>|
| Placebo Comparator: Placebo<br>placebo group | Other: Placebo<br>* This group will take a placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forced expiratory volume in the 1st second between baseline and 6 months |  | 0-3-6 months |
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Study Overview
=================
Brief Summary
-----------------
This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib

Official Title
-----------------
A Phase I, Single Center, Open-label, Single Oral Dose, Study to Assess the Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult male (18 -70 yrs) Body weight must be ≥ 50 kg and < 120 kg, with a body mass index (BMI) >18 but < 35. Laboratory parameters values within the normal range Exclusion Criteria: Contraindication or hypersensitivity to receiving nilotinib Smokers or those who use of tobacco products or products containing nicotine A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome. History of fainting spells. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nilotinib<br> | Drug: Nilotinib<br> <br> * Other names: AMN107;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of nilotinib |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact on hepatic function assessed by laboratory values and an electrocardiogram |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PK, nilotinib, hepatic impairment, Child-Pugh scale, healthy, subject(s), Subjects with impaired hepatic function and healthy subjects
Individual Patient Compassionate Use of Mirdametinib

Study Overview
=================
Brief Summary
-----------------
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Conditions
-----------------
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, Histiocytic Neoplasm, Other MAP-K Pathway Driven Diseases

Intervention / Treatment
-----------------
* Drug: Mirdametinib (MEK Inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a serious, debilitating or life-threatening medical condition with no suitable treatment available, has exhausted current standard of care or declined medically appropriate treatment for ethical or medical reasons. Patient does not qualify to participate in any ongoing clinical trial sponsored by SpringWorks in an accessible geographical location.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mirdametinib (MEK Inhibitor)|Patients will receive oral mirdametinib.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NF1, RASopathies, Neurofibromatosis, Plexiform Neurofibromas, Langerhans