linjc16/ctgov huggingface dataset:
Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections

Study Overview
=================
Brief Summary
-----------------
Intravitreal injection can induce perioperative stress for the patients. Different factors can modulate the pre-operative fear and physiologic reaction.

Detailed Description
-----------------
The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.

Official Title
-----------------
Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors

Conditions
-----------------
Age-related Macular Degeneration, Stress

Intervention / Treatment
-----------------
* Behavioral: Preoperative information and perioperative care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First intravitreal injection received ever Exclusion Criteria: No known affective or mental disorder Condition does not allow standardized survey

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: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Presentation of factual information video | Behavioral: Preoperative information and perioperative care<br>* Patients receive different information and care in addition to the basic medical consultation.<br>|
| Active Comparator: B<br>Presentation of injection syringe/needle | Behavioral: Preoperative information and perioperative care<br>* Patients receive different information and care in addition to the basic medical consultation.<br>|
| Active Comparator: C<br>Presentation of emotional information video | Behavioral: Preoperative information and perioperative care<br>* Patients receive different information and care in addition to the basic medical consultation.<br>|
| Active Comparator: D<br>Stress relaxation music | Behavioral: Preoperative information and perioperative care<br>* Patients receive different information and care in addition to the basic medical consultation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective parameters of stress reaction |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Response (state-trate anxiety) in respect of coping behaviour |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intravitreal injection
Perioperative Risk Factors for Intensive Care Delirium After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to identify the incidence of early postoperative delirium in intensive care patients after cardiac surgery and detect possible risk factors associated with increased risk for developing delirium after cardiac surgery.

Detailed Description
-----------------
A consecutive series of patients scheduled for elective cardiac surgery is included in the study. Delirium screening is performed using Intensive Care Delirium Screening Checklist. Preoperative cognitive state is evaluated with Mini-Mental State Examination. Information of possible risk factors is collected from patient's history and chart. The Snoring, Tiredness, Observed apnea, high blood Pressure-Body mass index (BMI), Age, Neck circumference and Gender questionnaire (STOP-BANG questionnaire) is used for obstructive sleep apnea screening.

Official Title
-----------------
Incidence and Perioperative Risk Factors for Early Intensive Care Delirium Following Cardiac Surgery

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective cardiac surgery patient spends more than 1 day in the intensive care unit after the surgery Exclusion Criteria: refusal to participating in the study documented severe central nervous system, cognitive or psychiatric disorder unable to be screened with Intensive Care Delirium Screening Checklist up to 6th postoperative day (e.g. deeply sedated, intubated patients)

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 |
| --- | --- | --- |
| Incidence of early postoperative delirium in intensive care patients after cardiac surgery |  | Within 5 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative risk factors for delirium after cardiac surgery | Preoperative risk factors include demographic data, comorbidities and standard preoperative laboratory and instrumental testing results as well as preoperative cognitive status evaluation, performed a day before the surgery. If the patient does not develop delirium, information on intraoperative and postoperative risk factors is collected up to discharge from intensive care unit or maximum 5 postoperative days, whichever happens earlier. If delirium occurs, data on risk factors is collected up to the beginning of delirium. | Up to 5 postoperative days or occurence of delirium if it develops earlier | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative, Cardiac surgery
Beet Root Supplement Trial

Study Overview
=================
Brief Summary
-----------------
To examine the effects of two forms of beetroot juice supplementation on exercise performance in trained cyclists.

Official Title
-----------------
Effects of Two Forms of Beetroot Juice Supplementation on Exercise Performance in Cyclists

Conditions
-----------------
Trained or Competitive Cyclists

Intervention / Treatment
-----------------
* Dietary Supplement: Beetroot juice
* Dietary Supplement: Beetroot powder
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good physical health trained or competitive cyclist between 18-40 years of age Exclusion Criteria: - have used any anabolic or ergogenic supplementation in the last 1-3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concentrated Beet Root Juice<br>500ml per day for 6 days | Dietary Supplement: Beetroot juice<br> <br> |
| Active Comparator: Beet root powder<br>500ml per day for 6 days | Dietary Supplement: Beetroot powder<br> <br> |
| Placebo Comparator: Placebo juice<br>Negligible nitrate | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to completion |  | Baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| O2 consumption |  | Baseline to Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Beet root, exercise performance, cyclists
Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity

Study Overview
=================
Brief Summary
-----------------
Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene (monogenic obesity). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.

Official Title
-----------------
Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity

Conditions
-----------------
Monogenic Obesity

Intervention / Treatment
-----------------
* Biological: Salivary Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recruitment age: 2-17 years Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5 Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital Informed consent signed Exclusion Criteria: no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| Patient with salivary sampling<br> | Biological: Salivary Sampling<br>* The DNA study will be carried out from saliva sample 1 saliva sample per patient will be performed at the inclusion visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed. |  | Inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients eligible for a drug targeting single-gene obesity |  | Inclusion visit | 
| Number of patients for whom a genetic finding will have changed management and description of changes. |  | Inclusion visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monogenic obesity, pediatric, early onset obesity, genetic disease
Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Study Overview
=================
Brief Summary
-----------------
The two purposes of this study are to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and on the stimulant effect of bupropion and to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has on the blood levels of bupropion and its major breakdown products in the blood and on the stimulant effect of bupropion. Two groups of volunteers will be recruited for this study: volunteers who drink moderate to heavy amounts of alcohol frequently and volunteers who usually do not drink alcohol. Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.

Official Title
-----------------
Human CYP2B6: Induction by Ethanol and Polymorphisms

Conditions
-----------------
Alcohol Drinking, Depression, Smoking Cessation, Attention Deficit Disorder

Intervention / Treatment
-----------------
* Other: Trial Withdrawn 1
* Other: Trial Withdrawn 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults who are 21 - 55 years of age. Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol. Exclusion Criteria: Participants who are currently taking prescription medications (including oral contraceptives) Pregnancy Body mass index (BMI) greater than 30 History of seizures or eating disorders

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trial Withdrawn 2<br>Trial Withdrawn 2 | Other: Trial Withdrawn 2<br>* Trial Withdrawn 2<br>|
| Other: Trial Withdrawn 1<br>Trial Withdrawn 1 | Other: Trial Withdrawn 1<br>* Trial Withdrawn 1<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
-----------------
Boston, Alcohol, Bupropion, Chlorzoxazone, Interaction, Induction, Depression, Smoking, Drinking, Cytochrome P450 Enzyme, CYP2B6, CYP2E1, Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Tufts University
Project Sexual Awareness for Everyone (SAFE)

Study Overview
=================
Brief Summary
-----------------
This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.

Detailed Description
-----------------
Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.

Official Title
-----------------
Preventing Recurrent Sexually Transmitted Infections in Minority Women

Conditions
-----------------
Sexually Transmitted Disease, Secondary Prevention, Behavioral Modification, Public Health

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mexican American, 14 - 45 years old, English Speaking, non-viral sexually transmitted infection Exclusion Criteria: Non-English speaking, viral sexually transmitted infection

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAFE Intervention<br>Behavioral Intervention | Behavioral: SAFE Behavioral Intervention<br>* Group cognitive behavioral intervention sessions<br>|
| Other: Control<br>Sexually Transmitted Infection Risk Reduction Counseling | Other: Control<br>* Individual Sexually Transmitted Infection Risk Reduction Counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-infection with a non-viral sexually transmitted infection |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in risky sexual behavior |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexually Transmitted Infections, Secondary Prevention, Cognitive Behavioral Intervention
Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.

Official Title
-----------------
Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: glucarpidase (50 Units/kg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent by patient or legally valid representative Patients receiving high-dose MTX (>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma) Age ≥ 18 years Serum MTX >5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX >1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX >0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine >1.5 × the upper limit of normal (ULN) and/or oliguria (urine output < 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation). Exclusion Criteria: Pregnant or lactating females Unwillingness of patient or relative/legal representative to give informed consent

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glucarpidase (50 Units/kg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in serum MTX concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum blood-urea-nitrogen |  |  | 
| serum creatinine |  |  | 
| creatinine clearance |  |  | 
| haematology (complete blood count and differential) |  |  | 
| biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein) |  |  | 
| urinalysis (dip-stick) |  |  | 
| MTX-related toxicity |  |  | 
| Adverse events |  |  | 
| Mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate, delayed elimination, renal insufficiency, CPG2, Voraxaze
CRT RENEWAL Registry

Study Overview
=================
Brief Summary
-----------------
This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.

Detailed Description
-----------------
The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. The registry will also assess clinical outcomes including quality of life (QOL), physical activity habits, and events rates, along with device diagnostics such as Activity Log Index and heart rate

Official Title
-----------------
Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices

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

Intervention / Treatment
-----------------
* Device: cardiac resynchronization therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads Patients who have had an ejection fraction measured within six months of enrollment Patients who sign and date a Patient Informed Consent form at the enrollment visit Patients who remain in the clinical care of the enrolling physician in approved centers Exclusion Criteria: Patients who are expected to receive a heart transplant during the duration of the registry Patients who currently have or who are likely to receive a tricuspid valve prosthesis Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility Patients who are younger than 18 years of age Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry Patients who are pregnant

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cardiac resynchronization therapy|nan|

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

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