linjc16/ctgov huggingface dataset:
Sleep Quantity and Quality in the ICU: a Prospective Observational Stud

Study Overview
=================
Brief Summary
-----------------
Several evidences in the literature suggest sleep interruption in critical care patients. Nowadays, the amount and the quality of sleep phases during the length of stay in the intensive care unit are largely unknown. In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during sleep is quantified.

Official Title
-----------------
Sleep Quantity and Quality in the ICU: a Prospective Observational Study

Conditions
-----------------
Sleep Disturbance, Critical Illness

Intervention / Treatment
-----------------
* Device: Sleep Profiler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years Exclusion Criteria: Pregnancy Previous enrollment in the same study (sleep recording during previous night) Previous use of hypnotic drugs
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br>age > 18 years | Device: Sleep Profiler<br>* Patients are observed through a Sleep profiler, routinely used in the intensive care unit (ICU). This device is applied at every patient in the ICU and it acquires EEG, electrooculography, and electromyography from three frontopolar EEG signals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep N2 phase | describe the percentage of the total sleep time spent by the patient in N2 stage | The sleep architecture will be observed during the first night spent in the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep N1 phase | describe the percentage of the total sleep time spent by the patient in N1 stage | The sleep architecture will be observed during the first night spent in the ICU | 
| Sleep N3 phase | describe the percentage of the total sleep time spent by the patient in N3 stage | The sleep architecture will be observed during the first night spent in the ICU | 
| Sleep REM phase | describe the percentage of the total sleep time spent by the patient in REM stage | The sleep architecture will be observed during the first night spent in the ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care unit, Sleep interruption, Sleep phases
Pharyngeal Carriage Rates and Genetic Typing of Group A Streptococcus and Streptococcus Pneumonia Among Israeli Military Basic Trainees

Study Overview
=================
Brief Summary
-----------------
The study is aimed at assessing pharyngeal and nasopharyngeal Streptococcus pneumonia carriage and pharyngeal Group A streptococcus carriage among field units new recruits.

Official Title
-----------------
Pharyngeal Carriage Rates and Genetic Typing of Group A Streptococcus and Streptococcus Pneumonia Among Israeli Military Basic Trainees

Conditions
-----------------
Carriage, Group A Streptococcus, Streptococcus Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Israeli Military Basic Trainee Exclusion Criteria: None

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Official Title
-----------------
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

Conditions
-----------------
Cannabis

Intervention / Treatment
-----------------
* Drug: THC
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least one lifetime exposure to cannabis good physical and mental health Exclusion Criteria: cannabis naive individuals major current or recent stressors taking estrogen supplements or oral contraceptive pills (for women)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC<br>Active THC (0.015mg/kg) administered intravenously over 10 minutes. | Drug: THC<br>* Active THC (0.015mg/kg) administered over 10 minutes<br>* Other names: Delta-9-Tetrahydrocannabinol;|
| Placebo Comparator: Placebo<br>Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes. | Drug: Placebo<br>* Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rewarding Effects measured by Visual Analog Scale (VAS) | subjective measure of THC induced high | changes in high assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins | 
| Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT) | measured as delay recall on the AVLT | 25 minutes after THC infusion begins |
Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3101 Study (NCT00103610).

Study Overview
=================
Brief Summary
-----------------
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).

Detailed Description
-----------------
This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled investigational study to evaluate granulocyte colony stimulating factor (G-CSF) plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's Lymphoma (NHL) patients (protocol AMD3100-3101 [NCT00103610]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).

Official Title
-----------------
Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 5X 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation

Conditions
-----------------
Non-Hodgkin's Lymphoma, Autologous Transplantation

Intervention / Treatment
-----------------
* Drug: granulocyte colony-stimulating factor (G-CSF)
* Drug: plerixafor
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who received a dose of study treatment (plerixafor or placebo)in protocol AMD3100-3101 (NCT00103610) Exclusion Criteria: No Exclusion Criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G-CSF plus plerixafor<br>Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received plerixafor, prior to undergoing apheresis. | Drug: granulocyte colony-stimulating factor (G-CSF)<br> <br> Drug: plerixafor<br> <br> * Other names: AMD3100;|
| G-CSF plus placebo<br>Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received placebo, prior to undergoing apheresis. | Drug: granulocyte colony-stimulating factor (G-CSF)<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610). |  | 5 years |
Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

Detailed Description
-----------------
The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.

Conditions
-----------------
High-grade Glioma

Intervention / Treatment
-----------------
* Drug: C13 N15 Valine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more or equal than 18 years old patient affiliated to social security or similarly regime informed consent form signed High-grade Glioma tumor suspicion Resective surgery indication Hematological assessment : neutrophils > 1500/mm3 Platelet > 150 000 blood Creatinin normal alkaline Phosphatases and transaminases no more than two times normal Bilirubin < 1.5 times normal Exclusion Criteria: Pregnant women and lactating mothers Ward of court or under guardianship Adult unable to express their consent Person deprived of freedom by judicial or administrative decision Person hospitalized without their consent Person under legal protection Precedent complete macroscopic tumor resective surgery No valid inclusion criteria Intratumoral hemorrhage MRI detected Treatment anticoagulant or antisludge treatments Active Infections and non controled or medical affection or psychiatric intercurrent non treated Evolutive cerebral oedema without corticoid response Non controled Epilepsy without antiepileptics response Karnofsky score < 40% Weight > 100 kg No possibility of resective surgery

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C13 N15 Valine<br>Intervention C13 N15 Valine | Drug: C13 N15 Valine<br>* C13 N15 Valine administration<br>* Other names: CARBONOMIC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass spectrometry measurement of C13 labelled proteins |  | during 30 hours |
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures

Study Overview
=================
Brief Summary
-----------------
Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using such cells to treat patients suffering from distal tibial shaft fractures. The cells will be isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the fracture site.

Official Title
-----------------
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures

Conditions
-----------------
Tibial Fracture

Intervention / Treatment
-----------------
* Procedure: autologous mesenchymal stem cells implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18 and 65. males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation. Exclusion Criteria: active systemic or local infection. history of malignancy radiotherapy or chemotherapy. active autoimmune disease. any past or present immunosuppressive treatment. fracture treated by open reduction. fracture grade gustillo grade IIIB, IIC. use of steroids in past 6 months. chronic renal insufficiency. administration of marrow suppressive drugs. history of metabolic bone disease. administration of drugs that may interfere with bone metabolism.

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

| Intervention/Treatment |
| --- |
|Procedure: autologous mesenchymal stem cells implantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Number of patients reaching clinical union of fracture |  |  |
Cardiovascular Risk Stratification in Covid-19

Study Overview
=================
Brief Summary
-----------------
This retrospective double-cohort study seeks to: Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and Develop a method of cardiovascular risk stratification in COVID-19

Official Title
-----------------
Cardiovascular Risk Stratification in Covid-19

Conditions
-----------------
Covid19, Cardiovascular Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >=18y available data on Covid19 test in the electronic medical record (either positive or negative) Exclusion Criteria: no data of Covid19 test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Covid19-positive<br>Covid19 test positive. age >= 18 y. | |
| Covid19-negative<br>Covid19 test negative. age >=18y | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and rate of persons with cardiovascular composite outcome | Number and rate of persons with composite of all-cause death, critical care utilization (ICU bed), development of a life-threatening arrhythmia (ventricular tachycardia/ventricular fibrillation or sudden cardiac arrest), acute heart failure, myocardial infarction (STEMI, NSTEMI, or silent MI), or incident stroke, whichever comes first. | 6 months after Covid19 test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause death outcome | Rate of all-cause death outcome | 6 months after covid19 test | 
| Rate of cardiac arrhythmia | Rate of any documented cardiac arrhythmia (tachy - or brady- arrhythmia) | 6 months after covid19 test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, cardiovascular risk factor, electrocardiogram, risk stratification
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder

Conditions
-----------------
Binge Eating Disorder, Obesity

Intervention / Treatment
-----------------
* Drug: sibutramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants were men and women between the ages of 18 and 65 with Body Mass Index (BMI) <45 kg/m2 who met DSM-IV criteria for BED Exclusion Criteria: Participants were excluded for blood pressure >140/90 mm Hg with pulse >95 beats/min history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids) current participation in a weight loss program surgical treatment for obesity bulimia nervosa or purging in the past 6 months alcohol or drug abuse in the past 12 months current psychiatric condition being treated with a psychoactive agent current major depressive disorder history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts psychotherapy within the previous 2 months Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges) |  | 6 months | 
| Change from baseline in Body Weight |  | 6 months | 
| Change from baseline in BMI |  | 6 months | 
| Change from baseline in global improvement |  | 6 months | 
| Change from baseline in eating pathology (TFEQ) |  | 6 months | 
| Change from baseline in quality of life (IWQOL-Lite). |  | 6 months |
Clinical Trial of Teriparatide in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.

Official Title
-----------------
Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Teriparatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese women with primary osteoporosis Postmenopausal women aged at least 55 years Patients with a high risk for fracture Exclusion Criteria: History of metabolic bone disorders other than osteoporosis History of any secondary causes of osteoporosis History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated Severe or chronically disabling conditions other than osteoporosis

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

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: Teriparatide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of LY333334 |  |  |