linjc16/ctgov huggingface dataset:
Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure

Official Title
-----------------
A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure

Conditions
-----------------
Diastolic Dysfunction, Symptomatic Heart Failure

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic diastolic heart failure Breathlessness with physical exertion Exclusion Criteria: Uncontrolled hypertension Asthma, COPD, or abnormal lung function History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Allergy to valsartan Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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: valsartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline exercise test after 15-42 days and 14 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen consumption during the exercise test |  |  | 
| Exercise test blood pressure |  |  | 
| Borg score of breathlessness |  |  | 
| 6-minute walk test at baseline and after 14 weeks |  |  | 
| Quality of life assessment at baseline and after 14 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diastolic dysfunction, heart failure, exercise tolerance, valsartan
Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Study Overview
=================
Brief Summary
-----------------
The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Detailed Description
-----------------
Information will be collected. Images will be taken.

Official Title
-----------------
Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Conditions
-----------------
Colon Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Presenting for surveillance, screening or diagnostic colonoscopy Willingness to provide informed consent Exclusion Criteria: Inability to provided informed consent Pregnancy Known inflammatory bowel disease Personal or family history of polyposis or nonpolyposis syndrome Emergency colonoscopy/endoscopy Coagulopathy or thrombocytopenia preventing polypectomy Procedure indication for acute bleeding or active colitis

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 |
| --- | --- | --- |
| Accuracy of In Vivo determination of colorectal polyps histopathology | Compare accuracy of current colonoscope to improved colonoscope for discrimination of polyps as neoplastic versus non-neoplastic. The accuracies of the two approaches will be compared via logistic regression model with the significance of the difference in the accuracies assessed via generalized estimating equation approach to take account of the possible dependence introduced by inclusion of mulitple polyps per patient. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes. | Estimate the sensitivity and specificity in high definition mode for distinguishing neoplastic from none neoplastic lesions. Sensitivity and specificity will be estimated using the logistic regression approach as above; 95% confidence intervals will be obtained by transforming confidence intervals on the logs odds scale. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Colon Polyps
Tolerance and Development of Healthy, Term Infants

Study Overview
=================
Brief Summary
-----------------
To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Official Title
-----------------
Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Alternate protein infant formula
* Other: Standard infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term infants; Age 0-8 days of age; Exclusively formula fed; No use of vitamin/mineral supplements. Exclusion Criteria: Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 8 Days

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein formula<br>Feed as per HCP direction | Other: Alternate protein infant formula<br>* Feed as per HCP directions<br>|
| Active Comparator: Standard infant formula<br>Feed as per HCP instructions | Other: Standard infant formula<br>* Feed as per HCP directions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean rank stool consistency at 14 days of age |  | 14 days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy infants
Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
Transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are at risk for preterm delivery. A shortened cervical length has been associated with an increased risk of preterm delivery. Dynamic cervical change is visible shortening(>6mm) of the cervix seen during the ultrasound examination. Prior studies have shown that the presence of dynamic change in patients with a shortened cervical length(<3cm) is not independently predictive of preterm delivery. However, a subset of patients with normal initial cervical length(>3cm) and dynamic change did demonstrate an increased rate of preterm delivery. Because this was a small sub-group, the present study was designed to obtain a larger sample size for further evaluation. The second focus of this study involves patients with a dilated cervix and whether cervical length adds predictive value to gestational age at delivery. Patients presenting to with symptomatic preterm labor(vaginal pressure or uterine contractions), who consent to the study, will undergo the standard evaluation for preterm labor(described in detail below.) The only additional evaluation is a prolonged transvaginal ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during a contraction. Null hypothesis: Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit dynamic cervical change deliver at a gestational age equal to those without dynamic change. Alternative hypothesis: Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit dynamic cervical change deliver at an earlier gestational age than those without dynamic change.

Conditions
-----------------
Dynamic Cervical Change in Preterm Labor Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between the ages of 18 and 45 years. Intrauterine pregnancy with gestational age between 22 0/7 and 34 6/7 weeks gestation. Presenting with symptomatic preterm labor (e.g. Regular uterine contractions, uterine cramping, or pelvic pressure). Exclusion Criteria: Cervical cerclage Ruptured membranes noted on initial speculum examination Cervical os dilation >4 cm noted on initial digital examination Known HIV-positive or active HSV(to minimize the risk of perinatal exposure) Presence of multiple genital warts Patients under extreme duress from their uterine contractions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
preterm labor, transvaginal ultrasound, dynamic cervical change
A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).

Official Title
-----------------
A Prospective Randomized Trial Comparing Qam With Qpm Daily Dosing in Assisted Reproductive Technologies

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between 21-42 undergoing IVF Exclusion Criteria: women > 45, women with one ovary, donor egg, surrogacy, FET cycles, uterine problems, large fibroids

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 42 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 |
| --- | --- |
| morning dose<br>women undergoing IVF/ICSi taking their gonadotropin dose in the am | |
| evening dose<br>Women undergoing IVF/ICSI taking their gonadotropin in the evening | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, ICSI, gonadotropin, am dose, pm dose, pregnancy, implantation, live birth
Crossed Leg Sign and it's Correlation With Significant Pathology

Study Overview
=================
Brief Summary
-----------------
By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology.

Detailed Description
-----------------
By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology. Therefore, by determining the sensitivity and specificity of this physical exam finding, the clinician would have a better idea of the patients clinical management, including diagnostic testing and ultimate treatment of the patient. Crossed Leg Sign will be defined in this study as: any patient observed in the Emergency Department with sustained crossed legs. To my knowledge, crossed legs have never been evaluated in regards to it's correlation with significant pathology. This could potentially add another physical exam finding to be used by the clinician.

Official Title
-----------------
Crossed Leg Sign and it's Correlation With Significant Pathology

Conditions
-----------------
Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient observed in the Emergency Department with sustained crossed legs. Exclusion Criteria: Any patient not observed to have sustained crossed legs and is not being used as a control.
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 |
| --- | --- | --- |
Dysphagia Handicap Index: A Structured Translation From English to German

Study Overview
=================
Brief Summary
-----------------
Establishment of a questionnaire in German to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.

Official Title
-----------------
Dysphagia Handicap Index: A Structured Translation From English to German of a Quality of Life Questionnaire Relating to Swallowing

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Procedure: Pretest and validation of a translated questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients with dysphagia Exclusion criteria: Inability to fill in the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pretest and validation of a translated questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients able to fully understand and fill out the german translation of the questionnaire. | Establishment of a questionnaire in german to determine in a structured and quantifiable manner the quality of life of patients with dysphagia. | Patients suffering from dysphagia for at least half a year will be asked to answer the questionnaire at the time of enrolment. |
Cranberry Juice in the Prevention of Urinary Tract Infections in Children

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Detailed Description
-----------------
Five percent of children have at least one UTI episode and 30% of these episodes recur. Recurrences and the risk of renal damage are indications for long term antimicrobial prophylaxis, but emerging antimicrobial resistance underlines the need for alternatives. The bacteria causing urinary tract infection arise from the stools. Dietary changes can alter the balance of faecal bacteria. Vaccinium berries and products containing lactobacilli have been shown to act against the coliform bacteria that cause most urinary tract infections. In our previous study cranberry juice was effective in preventing symptomatic recurrences of urinary tract infections in women. The objective of our study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Official Title
-----------------
The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Biological: Cranberry juice
* Biological: Placebo juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urinary Tract Infection 0-2 months priorly Exclusion Criteria: Antibiotic Prophylaxis

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Cranberry juice | Biological: Cranberry juice<br>* 5 ml/kg up to 300 ml, 1-2 doses daily for six months<br>|
| Placebo Comparator: B<br>Placebo juice | Biological: Placebo juice<br>* 5 ml/kg up to 300 ml, 1-2 doses daily for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of the first recurrence |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of UTI episodes and use of antimicrobials |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Tract Infections, Cranberry, Prevention
Probiotics and Recovery From Surgery

Study Overview
=================
Brief Summary
-----------------
The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.

Detailed Description
-----------------
Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.

Official Title
-----------------
Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings.

Conditions
-----------------
Major Abdominal Operation

Intervention / Treatment
-----------------
* Dietary Supplement: VSL #3 BID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All elective major GI surgical patients Exclusion Criteria: • Current episode of acute pancreatitis as defined by clinician Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSL #3<br>probiotics given orally BID | Dietary Supplement: VSL #3 BID<br> <br> |
| Other: placebo<br>Near-identically appearing placebo | Dietary Supplement: VSL #3 BID<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day postsurgical outcome including death, infection, readmission |  | within 30 days after surgery |
Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the long-term safety of DTX401 following a single intravenous (IV) dose in adults with GSDIa.

Detailed Description
-----------------
Only participants who received DTX401 in study 401GSDIA01 (NCT03517085) are eligible to participate in study 401GSDIA02. No investigational product will be administered during study 401GSDIA02.

Official Title
-----------------
A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of Adeno Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Glucose-6-Phosphatase (G6Pase) in Adults With Glycogen Storage Disease Type Ia (GSDIa)

Conditions
-----------------
Glycogen Storage Disease Type IA, Von Gierke's Disease (GSD Type Ia)

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received DTX401 in study 401GSDIA01. Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures being performed. Willing and able to comply with all scheduled study visits, procedures, and requirements. Exclusion Criteria: Planned or current participation in any other interventional clinical study that may confound the safety or efficacy evaluation of DTX401 during this study. Presence or history of any condition that, in the view of the Investigator, poses a risk to subject safety or places the subject at high risk of poor compliance or not completing the study or that would significantly affect the interpretation of study results.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>All participants enrolled in study 401GSDIA02 will have received a single IV dose of DTX401 during their participation in study 401GSDIA01 (NCT03517085). | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs), Serious AEs and Discontinuations Due to AEs |  | Up to 312 weeks following DTX401 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time to First Hypoglycemic Event During a Controlled Fasting Challenge from Day 0 (Study 401GSDIA01) to 312 weeks |  | Up to 312 weeks following DTX401 administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AAV, gene therapy, glucose metabolism disorder, carbohydrate metabolism, inborn errors, genetic diseases, Inborn Metabolic Diseases