linjc16/ctgov huggingface dataset:
Sedentary Behavior in Overweight Women

Study Overview
=================
Brief Summary
-----------------
Objective activity data will be collected using accelerometry for a minimum of seven days on 38 adult, female, women recruited from the metabolic Clinic at the University of Mississippi Medical Center. Following objective measurement of activity, participants will complete self-report and objective activity data, as well as the relationship between sedentary activities and food cravings will be examined. It is hypothesized that minutes of sedentary behavior, especially time spent in television viewing, will be significantly correlated with total and specific food cravings.

Official Title
-----------------
Sedentary Behavior in Overweight Women

Conditions
-----------------
Sedentary Behavior, Overweight

Intervention / Treatment
-----------------
* Other: Behavioral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian or African American women between the ages of 18 and 65 Exclusion Criteria: Males and women who are younger than 18 and older than 65

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I<br>Caucasian and African American females between the ages of 18 and 65. | Other: Behavioral<br>* Participants will be asked to wear an accelerometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minutes of sedentary behavior, especially time spent in television viewing, will be significantly correlated with total and specific food cravings |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female
Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania

Conditions
-----------------
Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis, Mania, Manic State, Psychoses, Manic-Depressive

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate (Seroquel) SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed Inpatient hospital admission for the first 4 days of study treatment Exclusion Criteria: >8 mood episodes within the last 12 months Use of prohibited medication Substance or alcohol abuse or dependence Current suicide risk or suicide attempt within last 6 months.

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: Quetiapine fumarate (Seroquel) SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to final visit in the YMRS total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Bipolar Mania, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (>48 hours) dexmedetomidine infusions in humans. The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.

Official Title
-----------------
Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. Need for dexmedetomidine sedation (determined by the responsible physician). Predicted length of dexmedetomidine sedation ≥ 48 hours. Written informed consent from the patient or the relatives of the participating patient. Exclusion Criteria: A previous history of intolerance to the study drug or related compounds and additives. Existing significant haematological, endocrine, metabolic or gastrointestinal disease

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving dexmedetomidine sedation | Drug: Dexmedetomidine<br>* The patients are given a normal loading dose (10 min infusion at a rate of 3-6 μg/kg/h) of dexmedetomidine followed by continuous infusion of 0.1 - 2.5 μg/kg/h for the period of time the responsible physician finds reasonable.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | Blood samples are taken three times daily for characterizing the pharmacokinetic parameters | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU patients, Dexmedetomidine, Sedation, Judged, Attending, Physician
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.

Official Title
-----------------
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control of Muscle Sympathetic Nerve Activity in Heart Failure Patients

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

Intervention / Treatment
-----------------
* Other: Aerobic Exercise Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systolic heart failure; New York Heart Association (NYHA) class II-III; Left ventricular ejection fraction less than 40%; Peak Oxygen Consumption less than 20 ml/Kg/min; Stable Clinical Status. Exclusion Criteria: Chronic Obstructive Pulmonary Disease; Neuromuscular Diseases; Orthopedic Diseases; Neurologic Diseases; Neoplastic Diseases; Recent myocardial infarction or cardiac surgery (less than 6 months); Unstable angina pectoris; Atrial Fibrillation; Pacemakers users; Changing medication or hospital admission.

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Heart Failure Untrained Group<br>Control Group | |
| Experimental: Heart Failure Exercise-trained Group<br>Aerobic Exercise Training | Other: Aerobic Exercise Training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic Control | Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest | 4 months | 
| Muscular Evaluation | Muscular evaluation will be done by muscle gene expression | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity | Functional Capacity will be determined by cardiopulmonary exercise testing | 4 months | 
| Muscle Blood Flow | Forearm blood flow will be assessed by venous occlusion plethysmography | 4 months | 
| Blood Pressure | Blood pressure will be monitored non-invasively | 4 months |
Assessment of Oxygenation With Oxygen Reserve Index for General Anesthesia

Study Overview
=================
Brief Summary
-----------------
To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.

Official Title
-----------------
Assessment of Oxygenation With Oxygen Reserve Index for Different Fresh Gas Flows in General Anesthesia Administration

Conditions
-----------------
Hyperoxia

Intervention / Treatment
-----------------
* Device: Oxygen reserve index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) risk class I-II, Undergoing tympanomastoidectomy Exclusion Criteria: Morbid obesity Opioid sensitivity Alcohol or drug addiction Chronic obstructive pulmonary disease Coronary artery disease, Congestive heart failure Pronounced anemia Have a history of liver or kidney disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high flow rate<br>After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 4 L/min for Group High flow rate. | Device: Oxygen reserve index<br>* eveluating oxygen reserve in blood<br>|
| low flow rate<br>After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 1 L/min for Group Low flow rate. | Device: Oxygen reserve index<br>* eveluating oxygen reserve in blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia. | to assess oxygenation with the oxygen reserve index (ORI) in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries. | During the surgery procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
General anesthesia, Oxygen reserve index, Oxygenation, Hyperoxia
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
Examine the ability of thymopentin (Timunox) to: Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

Official Title
-----------------
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Thymopentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. Prior Medication: Allowed: Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded. Concurrent Medication: Excluded within 90 days of study entry: Zidovudine (AZT). Prior Medication: Excluded within 30 days of study entry: Immunomodulatory or experimental therapy. Excluded within 90 days of study entry: Zidovudine (AZT). Patients must not have: Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. AIDS as defined by the CDC (except for those with HIV wasting syndrome). Significant hepatic disease. Thrombocytopenia (< 75000 platelets/mm3). Patient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions. Patients with HIV wasting syndrome are included. Intravenous drug abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymopentin|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
-----------------
Thymopentin, Acquired Immunodeficiency Syndrome
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.

Official Title
-----------------
A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Other: Red Bull™ Sugar-Free Drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed prostate cancer Currently receiving LHRH-agonist therapy for greater than 6 months Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale Able to swallow Red Bull™ Sugar-Free Drink Life expectancy of at least 1 year Able to read and write in English Willing to limit consumption of alcohol to one drink per day Exclusion Criteria: Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer) Myocardial infarction within past 6 months Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders Evidence of drug or alcohol abuse Known hypersensitivity to caffeine Known history of liver and kidney insufficiencies Known contraindications to Red Bull™ use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red Bull™ Sugar-Free Drink<br>Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days | Other: Red Bull™ Sugar-Free Drink<br>* Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in overall fatigue as measured by Bruera global fatigue severity scale. |  | Within 4 days after completion of intervention (28 days of Red Bull™) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36) |  | Within 4 days after completion of intervention (28 days of Red Bull™) |
Integrated Molecular and Clinical Profiling to Optimize Outcome Prediction in Splenic Marginal Zone Lymphoma

Study Overview
=================
Brief Summary
-----------------
The study aims at developing and validating an integrated clinico-molecular model for an accurate survival prognostication in newly diagnosed SMZL. Already existing and coded tumor biological material and health-related personal data will be retrospectively collected. Mutation analysis will be performed by targeted deep next generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on nuclei isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status will be analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status of target genes will be assessed by methylation specific PCR on tumor genomic DNA. The adjusted association between exposure variables and OS will be estimated by Cox regression. This approach will provide the covariates independently associated with OS that will be utilized in the development of a hierarchical molecular model to predict OS. The hierarchical order of relevance in predicting OS among covariates will be established by recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal nodes showing homogenous OS. The discrimination capacity of the model will be assessed by calculating the c-index. Relative survival analysis will be used to provide a measure of the excess mortality experienced by patient's subgroups stratified according to the developed hierarchical molecular models, irrespective of whether the excess mortality is directly or indirectly attributable to the disease. The model developed in the training set will be tested in the validation sets and the model performance (c-index) in the validation set will be compared with that in the training set.

Conditions
-----------------
Splenic Marginal Zone Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults 18 years or older Diagnosis of SMZL on spleen histology before Dec 31st 2010 (to provide the cohort with a minimum follow-up of at least 5 years) Availability of tumor material (from spleen, peripheral blood or bone marrow) collected before initiation of medical therapy Availability of the baseline and follow-up annotations Exclusion Criteria: Having received any medical therapy including anti CD20 monoclonal antibody, chemotherapy or biological agents before splenectomy

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 |
| --- | --- | --- |
| Overall survival (OS) |  | From date of enrollment to study ending at 2 years |
Evaluate the Rotator Cuff Repair With InSpace VS Without InSpace

Study Overview
=================
Brief Summary
-----------------
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer

Official Title
-----------------
Evaluate the Rotator Cuff Repair With InSpace VS Without InSpace

Conditions
-----------------
Repair of a Cuff Tear

Intervention / Treatment
-----------------
* Device: repair of a cuff tear
* Device: repair of a cuff tear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First intention of the rotator cuff Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head) No surgical history Patient who has given his participation agreement to participate in the observational study after information by the surgeon, Patient living in France and having the capacity to answer alone to the survey. Subject affiliated to a social security scheme Lack of participation in another clinical study Exclusion Criteria: Major subject protected by law, under curatorship or tutorship Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer) Osteoporosis Damaged cartilage Isolated rupture of the suprascapularis Glenohumeral instability Pseudo-paralytic shoulder- Infection Necrosis Major joint trauma Pregnant or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patient with inspace device<br> | Device: repair of a cuff tear<br>* Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon<br>|
| Placebo Comparator: patient without inspace device<br> | Device: repair of a cuff tear<br>* Group (Control): standard Arthroscopic repair of the cuff rotator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the re-rupture rate | with radiological imaging | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate mobility | the Constant score | up to 12 months | 
| Assess shoulder pain | VISUAL ANALOGIC SCALE | up to 12 months | 
| the quality of life assessed | Simple Shoulder Test, Subjective Shoulder Value and American Shoulder and Elbow Surgeons Shoulder Score | up to 12 months | 
| resumption of work | Physicians Global Assessment for resumption of work | up to 12 months |