linjc16/ctgov huggingface dataset:
Evaluation of DEX-IN During Outpatient Procedures

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.

Official Title
-----------------
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: DEX-IN
* Drug: Fentanyl
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntarily provide written informed consent Be planned to undergo a selected office-based or outpatient procedure Be naïve to the planned procedure, i.e. no repeated or revision procedures Not pregnant or planning to become pregnant, or using appropriate contraceptive measures. Exclusion Criteria: Known allergy to any study treatment or excipient Have another painful physical condition or anxiety related diagnosis that may confound study assessments Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEX-IN 50 µg<br>Dexmedetomidine Intranasal Spray | Drug: DEX-IN<br>* IN Dexmedetomidine + IV placebo<br>|
| Active Comparator: Fentanyl 50 µg<br>Intravenous Fentanyl | Drug: Fentanyl<br>* IN Placebo + IV Fentanyl<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* IN Placebo + IV Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pain Intensity - Mean Pain Score During Procedure | Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10) | Up to 4 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peri-procedural pain, Pain, Anxiety, Analgesia, Anxiolysis
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.

Official Title
-----------------
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension

Conditions
-----------------
Hypertension, Left Ventricular Hypertrophy

Intervention / Treatment
-----------------
* Procedure: stress echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential hypertension Exclusion Criteria: History of Myocardial Infarction Diabetes Mellitus Renal Failure Orthopedic problems

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertensives<br> | Procedure: stress echocardiography<br>* safety and efficacy of stress echocardiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of LVOT velocity before and after exercise by echocardiography |  | 1 day (before and after exercise stress) | 
| measurement of TDI S wave before and after exercise by echocardiography |  | 1 day (before and after exercise) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial regional functions measured by tissue Doppler imagination |  | 1 day |
Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to assess how a polygenic risk score (PRS) reported with the results of multi-gene panel testing affects the breast cancer risk management recommendations healthcare providers make to their patients. The PRS is a score based on small genetic changes, clinical history, and family history. The PRS is used to estimate remaining lifetime risk of developing breast cancer for patients with no personal history of breast cancer and an overall negative result from MGPT.

Official Title
-----------------
Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer: Impact on Risk Estimates, Management Recommendations, Clinical Outcomes, and Patient Perception

Conditions
-----------------
Breast Cancer Risk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, age ≥ 18 years Willing and able to provide meaningful informed consent Willing and able to complete study procedures as described in this protocol Electing to undergo multi-gene panel testing for hereditary breast cancer for clinical purposes at the time of consent No personal history of cancer (except non-melanoma skin cancer) and meets NCCN guidelines for BRCA1/2 testing based on family history of breast and/or ovarian cancer Meets Ambry criteria for clinical reporting of PRS score Exclusion Criteria: Prior germline BRCA1/2 testing Not willing to receive PRS Personal history of cancer, except non-melanoma skin cancer Personal history of allogenic bone marrow/stem cell transplant

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

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

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 |
| --- | --- | --- |
| Change in Breast Cancer Risk Management Recommendations | Breast Cancer Risk Management Recommendations are recorded at two separate times; first recommendations will be recorded by the investigator or his/her designee based on the results of MGPT only. After these recommendations are recorded, the complete report including the PRS will be released. Then the healthcare provider will record recommendations again based on the results of MGPT and PRS. The difference between these recommendations will be used as a measure of the effect a PRS has on breast cancer risk management recommendations made by healthcare providers. | First recommendations will be made within 45 days of the initial study visit. Second recommendations will be made within 75 days of the initial study visit. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Breast Neoplasm, Genetic Testing, Breast Cancer Risk, Cancer Risk, Risk Score, Genetic Risk Score, Polygenic Risk Score, Personalized Risk Score
Gender Differences in Familial Risk

Study Overview
=================
Brief Summary
-----------------
To develop, test, and apply comprehensive mathematical models for the interaction of genetic and environmental effect on cardiovascular risk with gender differences.

Detailed Description
-----------------
DESIGN NARRATIVE: Models were developed which allowed for sex difference in the expression of autosomal polygenes, differences in the impact of the paternal and maternal environment on male and female offspring, and for the complex consequences of assortative mating on the correlations among loci and between genes and environment. Computer simulations were used to decide which kinds of gender-dependent effects could be resolved with particular constellations of relatives, and to address problems of power and bias resulting from errors of model-specification. The methods developed were applied to data from extensive data already gathered from twins and their relatives to determine the importance of sex differences in genetic and environmental causes of variation in measured aspects of cardiovascular risk including weight, body-mass index, family history of CV disease, smoking, alcohol consumption, exercise, diet, psychosocial variables and lifestyle.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

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

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 |
| --- | --- | --- |
Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.

Official Title
-----------------
Prediction of Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease After Cardiac Surgery

Conditions
-----------------
Fluid Responsiveness

Intervention / Treatment
-----------------
* Procedure: TFU(transfontanel ultrasound)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing cardiac surgery Exclusion Criteria: preterm closure of anterior fontanelle anatomical abnormalities on aortic arch (ex, patent ductus arteriosus) presence of intracardiac and extracardiac shunt

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypovolemia<br>patients with hypovolemic signs including hypotension, decreased central venous pressure (less than 5mmHg), and decreased urine output | Procedure: TFU(transfontanel ultrasound)<br>* The respiratory variation of the carotid artery blood flow peak velocity was measured using TFU before and after the fluid administration (10ml/kg for 20 min.)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in respiratory variation of carotid artery blood flow peak velocity after volume expansion |  | before and after fluid administration (20min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cardiac index after volume expansion |  | before and after fluid administration (20min) | 
| change in pleth variability index after volume expansion |  | before and after fluid administration (20min) | 
| change in respiratory variation of aorta flow blood flow peak velocity after volume expansion |  | before and after fluid administration (20min) |
Taste Test of a New Formulation of Sildenafil (Revatio)

Study Overview
=================
Brief Summary
-----------------
taste of formulation

Detailed Description
-----------------
taste test None

Official Title
-----------------
A Single-Blind Study In Healthy Adult Volunteers To Investigate The Palatability Of Different Oral Suspension Formulations Of Revatio®

Conditions
-----------------
None Volunteer

Intervention / Treatment
-----------------
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: History of hypersensitivity to test compounds or excipients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| 1. Taste test<br> | Drug: sildenafil<br>* Oral suspension of sildenafil.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| palatability (aroma, flavour texture and mouth feel) |  | Duration of study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
taste test
Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI

Study Overview
=================
Brief Summary
-----------------
Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. The purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type VI.

Conditions
-----------------
Brittle Cornea Syndrome, Ehlers-Danlos Syndrome Type 6

Intervention / Treatment
-----------------
* Drug: Riboflavin
* Device: Kera-X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patient with: Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and Either: Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma Exclusion Criteria: Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Riboflavin|0.1%, applied every 5 minutes for 60 minutes|
|Device: Kera-X|3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI |  | 3 Months |
Package of Interventions After Recovering From Moderate Acute Malnutrition

Study Overview
=================
Brief Summary
-----------------
Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.

Official Title
-----------------
Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Lipid Nutrient Supplement
* Drug: Sulfadoxine-pyrimethamine
* Drug: Albendazole
* Drug: Zinc
* Other: Insecticide-treated bednet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm Exclusion Criteria: not permanent resident in vicinity of site severe chronic illness receiving other supplementary food or participating in other research

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention<br>No specific intervention given after recovery from moderate acute malnutrition. | |
| Experimental: Package of interventions<br>Package of interventions given after recovery from moderate acute malnutrition -- includes lipid-nutrient supplement for 2 months, malaria chemoprophylaxis for 3 months during malaria season, an insecticide-treated bed net, a one-time albendazole treatment, and 14 days of zinc. | Dietary Supplement: Lipid Nutrient Supplement<br> <br> Drug: Sulfadoxine-pyrimethamine<br> <br> Drug: Albendazole<br> <br> Drug: Zinc<br> <br> Other: Insecticide-treated bednet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema) | Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate Acute Malnutrition
Occupational Performance Coaching in Mothers of Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on self-efficacy and occupational performance with mothers of children with cerebral palsy. Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be employed to data collection. The sample size was determined for each group of 15 people. The participants conveniently and according to inclusion and exclusion criteria will be randomized into the groups. Participants in the intervention group will be participated in 10 sessions of OPC. At the end the questionnaires will be completed by both groups.

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: occupational performance coaching
* Behavioral: standard OT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mothers: being literate 25 to 25 caring nobody disabled other than her child children: 5 to 12 cerebral palsy Exclusion Criteria: children: others problems that affect on communication

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OT<br>standard OT | Behavioral: standard OT<br> <br> |
| Experimental: OT+OPC<br>occupational performance coaching | Behavioral: occupational performance coaching<br> <br> Behavioral: standard OT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure | It is a questionnaire. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sherer general self-efficacy | It is a questionnaire. | 10 weeks |
A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.

Conditions
-----------------
Complication

Intervention / Treatment
-----------------
* Procedure: trans-rectal to perform the prostate biopsy
* Procedure: trans-perineal to perform the prostate biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate-specific antigen > 4ng/ml Palpation is positive Exclusion Criteria: older than 80y prostate-specific antigen > 100 ng/ml

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trans-rectal<br>trans-rectal to perform the prostate biopsy | Procedure: trans-rectal to perform the prostate biopsy<br>* the puncture points are at the rectal<br>|
| Experimental: trans-perineal<br>trans-perineal to perform the prostate biopsy | Procedure: trans-perineal to perform the prostate biopsy<br>* the puncture points are at the perineal<br>* Other names: the puncture points are at the perineal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of positive detections |  | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rate of each complication |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rate of positive detection