linjc16/ctgov huggingface dataset:
Metabolic Effects of Rowing Multi-races Events

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess the relevance of NRI or athletes' NRI (ANRI) utilization to detect nutrition-related risks of failure in competition in the particular population of rowers. In the morning, 60 to 90 minutes before the first race of a national level multi-races competition (three races for each subjects), body weight were measured and blood samples were collected with subjects at rest and in post-absorptive condition (last meal at least 2.5 hours before blood collection). Body weight was also recorded in the same conditions six weeks before the competition to calculate weight state (actual weight /usual weight ´ 100) and subjects were asked to identify the date of diet beginning. Body weight was measured using a floor scale (Mettler-Toledo floor scale, France), body mass index (BMI) was calculated from the ratio of weight (in kg) by height squared (in meters) and training volume (total duration of training in a week) was determined after discussion with athletes and coaches.

Official Title
-----------------
Nutritional and Metabolic Context in Rowers

Conditions
-----------------
Diet, Nutritional Status, Fatigue, Maximal Exercise

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Competitors, volunteers Exclusion Criteria: non competitors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 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 |
| --- | --- |
| Diet counseling, nutritional index<br>Lightweight as athletes with weight limit | |
| nutritional index<br>Heavyweight athletes without weight limit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infrared spectroscopy for serum albumin concentrations determinations |  | 30/05/2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fatigue clinical signs | assessment of fatigue clinical signs by questionnary | 25/04/06 |
IGF-1, Sarcopenia and Mortality: a Cohort Study in Patient With Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation of this hormone has been reported to influence the genesis of cognitive impairment and dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.

Official Title
-----------------
Insulin Like Growth Factor 1 and Risks of Sarcopenia and Mortality in Patients With Cognitive Impairment

Conditions
-----------------
Cognitive Impairment, Insulin-like Growth Factor 1

Intervention / Treatment
-----------------
* Procedure: IGF-1 serum value


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cognitive impairment (MMSE < 24) Age > 65 ys Exclusion Criteria: Diagnosis of pancreatic disorders Diagnosis of acromegaly Diagnosis of GH-related disorders Recent bone fractures or immobility before the enrollment (3 months) Cancer

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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 |
| --- | --- |
| IGF-1 1st and 2nd quartile<br>Reduction of IGF-1 serum value in a cohort of patients with cognitive impairment | Procedure: IGF-1 serum value<br>* Evaluation of IGF-1 serum value at baseline, 24 and 48 months<br>|
| IGF-1 3rd and 4rd quartile<br>Reduction of IGF-1 serum value in a cohort of patients with cognitive impairment | Procedure: IGF-1 serum value<br>* Evaluation of IGF-1 serum value at baseline, 24 and 48 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 reduction in patients with sarcopenia | IGF-1 reduction could be linked to sarcopenia in patients with cognitive impairment | baseline, 24 months, 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 reduction and mortality in patients with cognitive impairment | IGF-1 could be an independent risk factor for mortality in patients with cognitive impairment | baseline, 24 months, 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcopenia, mortality
MK0859 Dose-Ranging Study (0859-003)

Study Overview
=================
Brief Summary
-----------------
To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of MK-0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Conditions
-----------------
Hypercholesterolemia, Mixed Hyperlipemia

Intervention / Treatment
-----------------
* Drug: MK0859


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol Exclusion Criteria: Patients with CHD or CHD-equivalent disease (except diabetes) Diabetics on statins

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0859|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the cholesterol changing effects of MK0859 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable safety profile |  |  |
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Official Title
-----------------
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

Conditions
-----------------
Haemophilia A

Intervention / Treatment
-----------------
* Biological: Optivate® (Human Coagulation Factor VIII)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optivate®<br>Optivate® (Human Coagulation Factor VIII) | Biological: Optivate® (Human Coagulation Factor VIII)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Recovery |  | Comparison of Baseline with 3 months post-baseline |
Ghrelin Changes After Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.

Official Title
-----------------
Ghrelin Changes After Roux-en-Y Gastric Bypass: Does Gastric Pouch vs. Gastric Remnant Feeding Affect Secretion?

Conditions
-----------------
Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Other: Liquid diet for 3 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum creatinine and liver function tests < upper limits of normal Stable body weights for the past three months Women will have a negative pregnancy test patients who are already scheduled for RYGB with gastrostomy tube placement Exclusion Criteria: Significant hepatic enzyme elevations (more than 100% of upper limits of normal) Serum creatinine > 1.5 mg/dl history of ketoacidosis or current metabolic acidosis current use of oral anticoagulants Positive pregnancy test (beta-human chorionic gonadotrophin) for females intercurrent infections patients with prior gastric operations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| 1 RYGB<br>Subjects undergoing RYGB with gastric tube placement | |
| 2 Matched controls<br>Subjects matched by BMI, age, gender to RYGB group | Other: Liquid diet for 3 days<br>* The control group were given a 3 -day liquid diet similar to the RYGB post-op diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ghrelin |  | pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA |  | pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op | 
| metabolic hormones |  | pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Insulin resistance, Gastric tube, Ghrelin
Readmission in the Case of Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries. Investigators goals are to make an inventory of PRADO-IC project in terms of its effectiveness on readmission of patients with heart failure.

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 or over Patient readmitted for heart failure Exclusion Criteria: Population whose age is less than 18 years

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost of re-hospitalization in the case of patients with heart failure reach |  | during 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, heart disease, left ventricular
Immune Response in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.

Official Title
-----------------
Immune Response in Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) score of 0-1 Patients with histologically documented non-small cell lung cancer Control group - patients without non-small cell lung cancer Written (signed) Informed Consent to participate in the study Exclusion Criteria: Any other malignancies within 5 years Any unstable systemic disease (including active infections, significant cardiovascular disease) Prior chemotherapy or radiotherapy Autoimmune disease Nursing or pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Lung cancer<br>Newly diagnosed and untreated non small cell lung cancer patients who underwent surgical resection for NSCLC (pathological stage I-III) | |
| Control<br>Subjects who will have surgery due to recurrent spontaneous pneumothorax Patients without lung cancer or other malignancies | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | one year after enrolment to the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune response, Cancer
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.

Official Title
-----------------
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: BAY81-8973
* Drug: Advate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, age 18 to 65 years Subjects with Severe hemophilia A with a documented plasma FVIII level of <1% ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records Exclusion Criteria: Evidence of current or past inhibitor antibody History of any congenital or acquired coagulation disorders other than hemophilia A Platelet count <75,000/mm3 Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range) Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY81-8973<br>BAY81-8973 infusion to analyze pharmacokinetics | Drug: BAY81-8973<br>* BAY81-8973 infusion to analyze pharmacokinetics<br>|
| Other: Advate<br>Advate infusion to analyze pharmacokinetics. | Drug: Advate<br>* Advate infusion to analyze pharmacokinetics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-tlast) | Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantification | Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment |
Pain Control in Renal Colic

Study Overview
=================
Brief Summary
-----------------
Renal colic is very common in emergency department patients. Our aim of this study is which combination of drug is more effective in renal colic.

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Drug: buscopan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult, clinical suspicion of renal colic Exclusion Criteria: under 15 do not consent contraindication of morphine, ketorolac, or buscopan previously pain controlled

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>morphine, ketorolac, and buscopan | Drug: buscopan<br> <br> |
| No Intervention: 2<br>morphine and ketorolac | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain control |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal colic
Trial of Montelukast in Eosinophilic Esophagitis

Study Overview
=================
Brief Summary
-----------------
Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE. Also evaluate tolerance and safety of oral montelukast in treatment of EE.

Detailed Description
-----------------
We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.

Official Title
-----------------
A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Drug: Montelukast/ Singulair
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older > 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months. Abnormal dysphagia questionnaire (Question 1a yes, question 1c >/= mild and question 2 >/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated. Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>20 mg montelukast daily for 6 months | Drug: Montelukast/ Singulair<br>* 20 mg daily for six months<br>* Other names: Singulair;|
| Placebo Comparator: Placebo<br>20 mg daily placebo | Drug: Placebo<br>* Placebo 20 mg daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate effectiveness of oral montelukast in treatment of EE. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate safety of montelukast in eosinophilic esophagitis |  | 6 months |
Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED)

Study Overview
=================
Brief Summary
-----------------
Midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern of hemodynamic instability. We would like to investigate that the low dose midazolam could be used rather than the standard recommended dose, and also compare it to the etomidate, recently used sedatives, with respect to the side effects and the easy performance of intubation.

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Drug: Low dose midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who need rapid sequence intubation in emergency room Exclusion Criteria: in hypotension(systolic blood pressure less than 90 mmHg severe trauma patients pregnant allergic to midazolam, etomidate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose midazolam<br> | Drug: Low dose midazolam<br> <br> |

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
-----------------
intubation