linjc16/ctgov huggingface dataset:
The Effects of Mindfulness Training on School Staff

Study Overview
=================
Brief Summary
-----------------
The primary research objective is to investigate psychological, behavioral, and physiological changes in school staff as a result of undergoing meditation and stress reduction training. Specifically, we hypothesize that school staff undergoing meditation and stress reduction training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, and decreased stress levels as indexed by salivary cortisol.

Official Title
-----------------
The Effects of Mindfulness Training on School Staff Emotions, Attention, and Stress

Conditions
-----------------
Teachers

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based stress reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Staff from Madison, WI area elementary school Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mindfulness-based stress reduction|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report; behavioral task; diurnal cortisol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report measures |  |  |
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Study Overview
=================
Brief Summary
-----------------
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.

Official Title
-----------------
A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Drug: conivaptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum sodium levels less than or equal 130mEq/L Euvolemic or Hypervolemic hyponatremia Exclusion Criteria: Clinical evidence of volume depletion or dehydration Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

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>Lower dose | Drug: conivaptan<br>* IV<br>* Other names: YM087;|
| Experimental: 2<br>Higher dose | Drug: conivaptan<br>* IV<br>* Other names: YM087;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted change in AUC for serum sodium |  | 96 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of safety between patients in each study arm |  | 96 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyponatremia, hypervolemic, euvolemic, treatment outcomes, YM087
Perioperative Complications of Deep Extubation in Adults

Study Overview
=================
Brief Summary
-----------------
The investigators propose a prospective observational cohort study in order to investigate the perioperative respiratory complications of deep extubation in adults undergoing eye and head-and-neck surgery at Massachusetts Eye and Ear. Data pertaining to perioperative respiratory complications from adult patients presenting to MEE for eye and head and neck surgery who undergo deep extubation will be collected for this study.

Official Title
-----------------
Perioperative Complications of Deep Extubation in Adults Undergoing Head and Neck Surgery at Massachusetts Eye and Ear Infirmary.

Conditions
-----------------
Anesthesia Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men and women who present to MEE for eye and head-and-neck surgery and undergo deep extubation will be included. Exclusion Criteria: The study does not exclude anyone from the study.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation | Desaturation to less than 95% for more than 10 seconds; | 1 hour | 
| Cough | Episodes of persistent cough, defined as 3 or more consecutive coughs | 1 hour | 
| Laryngospasm | Episodes of complete or partial laryngospasm | 1 hour | 
| Bronchospasm | Episodes of bronchospasm | 1 hour | 
| Negative pressure pulmonary edema | Incidence of negative pressure pulmonary edema | 1 hour | 
| Interventions | Obstruction that requires intubation or maneuvers, oral airway or jaw thrust | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time from the end of surgery to leaving the OR |  | 1 hour |
A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.

Conditions
-----------------
Myocardial Infarction, Coronary Disease

Intervention / Treatment
-----------------
* Drug: fondaparinux sodium
* Drug: heparin
* Procedure: percutaneous coronary intervention (PCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for ad hoc PCI are also eligible). Exclusion criteria: Age < 21 years Activated Clotting Time (ACT) > 200 seconds immediately prior to PCI Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI Currently receiving an oral anticoagulant (OAC) agent with an INR > 1.8 Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI Active internal bleeding or history of hemorrhagic diathesis Thrombocytopenia (platelet count < 100 x 10-9/L) Pregnant women or women of childbearing potential who are not using an effective method of contraception Known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel Absolute contra-indication to anticoagulation Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: fondaparinux sodium|nan|
|Drug: heparin|nan|
|Procedure: percutaneous coronary intervention (PCI)|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
-----------------
Elective PCI, Heart catherization, Acute coronary syndromes
Immunological Interaction Between the Host and Candida Albicans Biofilm

Study Overview
=================
Brief Summary
-----------------
Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis.

Official Title
-----------------
Immunological and Molecular Interaction Between the Host and Candida Albicans Biofilm

Conditions
-----------------
Candidiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected with Candida albicans Patients not infected with Candida albicans Exclusion Criteria: Underage patients Non consenting patients Unconscious patients

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Candida Infection<br>Patients infected with Candida albicans | |
| No infection<br>Patients with no Candida albicans infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological phenotyping of patients |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mannose Binding Lectin levels |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candida albicans, Candidiasis, Biofilm, Flow cytometry, Mannose Binding Lectin
Prospective Cohort Study of Rapid Response Team

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data of rapid response team activated patients prospectively

Detailed Description
-----------------
acutely deteriorating patients including sudden cardiac arrest in general ward who are monitored and intervened by rapid response team

Conditions
-----------------
Hospital Medical Emergency Team, Medicine, Emergency, Hospital Rapid Response Team

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system. Exclusion Criteria: patients admitted to pediatric wards patients in emergency room, intensive care unit, and operating room

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| mortality or ICU admission of rapid response team activated patient |  | an average of 1 year | 
| incidence of preventable cardiac arrest |  | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of triggerring criteria(1) for activation of rapid response team | SBP <90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign | an average of 1 year | 
| Frequency of triggerring criteria(2) for activation of rapid response team | HR: <50/min or >140/min or symptomatic arrythmia | an average of 1 year | 
| Frequency of triggerring criteria(3) for activation of rapid response team | RR: <10/min or >30/min or stridor(sign of airway obstruction) or accessary muscle use | an average of 1 year | 
| Frequency of triggerring criteria(4) for activation of rapid response team | Oxygenation: SaO2 <90% in room air or FM 8L/min | an average of 1 year | 
| Frequency of triggerring criteria(5) for activation of rapid response team | Metabolic acidosis: Lactic acid<2.5 , TCO2 <15 | an average of 1 year | 
| Frequency of triggerring criteria(6) for activation of rapid response team | ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60 | an average of 1 year | 
| Frequency of triggerring criteria(7) for activation of rapid response team | ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60 | an average of 1 year | 
| Frequency of triggerring criteria(8) for activation of rapid response team | Any serious concern about overall deterioration detected by doctor, nurse and caregiver at bedside | an average of 1 year |
Post Marketing Surveillance for ADACEL™ in South Korea

Study Overview
=================
Brief Summary
-----------------
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 Basic standard for reexamination of new drug. The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.

Official Title
-----------------
Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

Conditions
-----------------
Diphtheria, Tetanus, Pertussis

Intervention / Treatment
-----------------
* Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis. Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject. Exclusion Criteria : None

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br> | Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined<br>* 0.5 mL, intramuscular (IM)<br>* Other names: Adacel™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ | All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. | 30 days post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adacel, Diphtheria, Tetanus, Pertussis
Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Study Overview
=================
Brief Summary
-----------------
Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.

Official Title
-----------------
Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.

Conditions
-----------------
Type 2 Diabetes, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Fenofibrate
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus and dyslipidemia. Exclusion Criteria: Type 1 diabetes.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Fenofibrate<br>* 160 mg<br>Drug: Metformin<br>* 2000 mg<br>|
| Active Comparator: 2<br> | Drug: Fenofibrate<br>* 160 mg<br>|
| Active Comparator: 3<br> | Drug: Metformin<br>* 2000 mg<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Dyslipidemia, Hyperinsulinemic, Clamp, Metformin, Fenofibrate
Drug Use Investigation for AVOLVE(BPH)

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.

Official Title
-----------------
Drug Use Investigation for AVOLVE(BPH)

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be male subjects Use dutasteride capsules for the first time Exclusion Criteria: Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor Subjects with severe hepatic function disorder Dutasteride capsules shall not be used to female or child

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Subjects prescribed dutasteride capsules<br>Subjects with BPH prescribed dutasteride capsules during study period | Drug: Dutasteride<br>* Collection of safety data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules |  | 1 year |
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The goal of this research project is to evaluate injections of botulinum toxin A (Botox) as the treatment for knee flexion contracture after total knee arthroplasty (TKA). The current treatment for patients who do not achieve full extension of the knee (flexion contracture) after TKA consists of an aggressive physical therapy program, home stretching program, and the use of an extension orthosis (brace). Many patients do not tolerate wearing these braces. This initial project is designed to use injections of Botox as an adjunct to the standard current treatment and evaluate its efficacy. It is our hypothesis that a single injection into the hamstrings in addition to routine postoperative rehabilitation will result in improved knee extension and this improvement in function should endure without further treatment.

Official Title
-----------------
Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Study

Conditions
-----------------
Flexion Contracture Following Total Knee Replacement

Intervention / Treatment
-----------------
* Drug: Botox
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject had a total knee replacement or total knee replacement revision surgery performed at Main Line hospitals such as Bryn Mawr Hospital, Lankenau Hospital, and Riddle Hospital Subject is measured to have at least 10 degree flexion contracture of the operative knee four to six weeks following surgery Subject has the willingness to complete scheduled follow up evaluations as described in the informed consent Exclusion Criteria: Subject is currently involved in another study or has received investigational product or treatment within the last 30 days Subject is a prisoner Subject is anticipated to be non-compliant Subject is known to be pregnant Subject is mentally incompetent or unable to understand what participation in the study entails The subject has a known sensitivity or allergic reaction to Botulinum Toxin A and albumin The subject is unwilling or unable to give consent or to comply with the follow up program

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox injection<br> | Drug: Botox<br> <br> |
| Placebo Comparator: Control<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion: knee |  | 1 year |