linjc16/ctgov huggingface dataset:
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987517<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-046)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy

Study Overview
=================
Brief Summary
-----------------
Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.

Conditions
-----------------
Pediatrics

Intervention / Treatment
-----------------
* Drug: remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy Exclusion Criteria: cardiovascular, renal, liver disease or growth retardation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>Group S (n = 15): saline | Drug: remifentanil<br>* During surgery, 3 different dose of remifentanil or placebo was infused.<br>|
| Experimental: remifentanil 0.3 mcg/kg/min<br>Group 0.3 (n = 15): remifentanil 0.3 mcg/kg/min | Drug: remifentanil<br>* During surgery, 3 different dose of remifentanil or placebo was infused.<br>|
| Experimental: remifentanil 0.6 mcg/kg/min<br>Group 0.6 (n = 15): remifentanil 0.6 mcg/kg/min | Drug: remifentanil<br>* During surgery, 3 different dose of remifentanil or placebo was infused.<br>|
| Experimental: remifentanil 0.9 mcg/kg/min<br>Group 0.9 (n = 15): remifentanil 0.9 mcg/kg/min | Drug: remifentanil<br>* During surgery, 3 different dose of remifentanil or placebo was infused.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fentanyl consumption for IV-PCA |  | 24 h and 48 h after surgery | 
| Postoperative pain score |  | during 48 h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric patients (ASA physical status I or II) aged between
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Official Title
-----------------
A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

Conditions
-----------------
Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: BMS-663513


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good activity level Life expectancy of ≥ 6 months Solid tumor malignancy for which paclitaxel and carboplatin are appropriate Exclusion Criteria: Major surgery within 4 weeks Any concurrent cancer History of autoimmune diseases Symptomatic bowel obstruction Continued use of steroids Symptomatic brain metastases Current nerve damage in fingers/toes Positive for HIV, hepatitis B/C White blood cells < 3,000 Hemoglobin < 9 Platelets < 100,000 ALT/AST and/or alkaline phosphatase >= 2.5 x ULN Creatine > 1.5 Prior BMS-663513

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose escalation<br> | Drug: BMS-663513<br>* mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers. |  | throughout the study | 
| Describe anti-tumor activity |  | throughout the study | 
| Obtain tissue or ascites for exploratory research |  | throughout the study |
CIRculating CANcer MAster-Protocol

Study Overview
=================
Brief Summary
-----------------
This exploratory study will focus on the development of the analyses of blood biomarkers to better understand the circulating biomarkers associated with cancer diagnosis, treatment efficacy and progressive disease

Official Title
-----------------
MAster Protocol Studying the Impact of Blood Biopsy on Screening, Diagnosis, Diagnostic and Follow-up of Solid Cancer in Adult

Conditions
-----------------
Adult With Solid Cancer

Intervention / Treatment
-----------------
* Biological: Blood sampling for biomarker analysis (microRNA, circulating DNA…)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18y) Owing a social security insurance Any solid cancer diagnosed by histopathology or cytology Patient with blood sampling required as per standard of care Informed consent signed Exclusion Criteria: Refusal to participate No blood sampling required as per standard of care Hemoglobin < 7g/dl (< 9g/dl if respiratory or cardiovascular disease history) Heterologous blood transfusion in the last 48 hours Weight under 20 kg

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 |
| --- | --- |
| Adult with solid cancer. No intervention.<br> | Biological: Blood sampling for biomarker analysis (microRNA, circulating DNA…)<br>* From one to four blood samplings: at diagnosis, after the first cycle of treatment, end of treatment, progressive disease (or end of study).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liquid biopsy analyses | Extraction of circulating DNA or circulating RNA followed by a tumoral cells extraction. | Day 0 | 
| Standard technics of disease assessment | Genetic and transcriptomic explorations with immunofluorescence technique. Marking with specific markers of the tumor pathology. And enumaration of tumoral cells. | Week 16 | 
| Correlation between outcome 1 and outcome 2 | Building a biological collection of blood samples and following, diagnosis and prediction of adult solid cancer. | year 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liquid biopsy, solid cancer
Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
Patients will be randomized into 2 groups: Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses Control group: Vitamin E will not be applied Postoperative pain will be assessed 24 hours after surgery.

Detailed Description
-----------------
Patients will be randomized into 2 groups: Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass. Control group: Vitamin E will not be applied Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).

Official Title
-----------------
Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Vitamine E Acetate
* Drug: No application of vitamin E acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >40 Kg/m2 or >35 Kg/m2 associated to obesity-related comorbidities Patients undergoing Roux-en-Y gastric bypass as bariatric procedure Patients accepting to participate in the study and signing and Informed Consent form Exclusion Criteria: Patients undergoing other bariatric techniques Patients undergoing Roux-en-Y gastric bypass as revisional 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E acetate<br>Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass | Drug: Vitamine E Acetate<br>* Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass<br>* Other names: Vitamin E acetate ointment;|
| Sham Comparator: Control group<br>No ointment will be applied | Drug: No application of vitamin E acetate<br>* Vitamin E acetate ointment will not be applied in this group<br>* Other names: No application of vitamin E acetate oinment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain) | 24 hours after surgery |
Activity Counseling Trial (ACT)

Study Overview
=================
Brief Summary
-----------------
To develop and evaluate the effectiveness of various intervention approaches, delivered in primary health-care settings, in increasing and maintaining habitual physical activity and cardiorespiratory fitness among sedentary men and women patients.

Detailed Description
-----------------
BACKGROUND: A conference on physical activity sponsored by the National Heart, Lung, and Blood Institute (NHLBI) in August 1991 recommended that one priority area for research should be the development and evaluation of interventions for adoption and maintenance of physical activity including interventions that can be incorporated into primary care practice. The 1992 NHLBI Working Group Report on Primary Prevention of Hypertension identified physical inactivity as a risk factor for hypertension. Intervention research applicable to health-care settings is particularly important in light of national recommendations advising health-care professionals to intervene, including Healthy People 2000, the U.S. Preventive Services Task Force reports, and the American Heart Association. DESIGN NARRATIVE: Randomized, multicenter, demonstration and education study. Men and women primary care patients at three sites in Dallas, Palo Alto, and Memphis were randomized to two patient education intervention groups or to a standard care control group of physician advice. Intervention continued for two years for all participants. The primary outcomes were cardiorespiratory fitness and physical activity. Other outcomes were effects on blood pressure, lipoproteins, and weight; the long-term maintenance of these effects; and the cost-effectiveness of various intervention approaches. Recruitment took 15 months and has been completed with the accrual of 874 subjects. The National Institute on Aging participated in the ACT through the addition of a measurement of arterial stiffness involving approximately 700 patients. The NIA tested the hypothesis that increases in physical activity resulting from educational interventions could reduce arterial stiffness.

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

Intervention / Treatment
-----------------
* Behavioral: health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Sedentary men and women, free of coronary heart disease, who were patients in primary care settings.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: health education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients

Study Overview
=================
Brief Summary
-----------------
The optimal amount caloric intake were still controversy in critically ill patients in literature. There were no significant outcome difference with different caloric intake in acute lung injury patients. In order to identify the optimal amount caloric intake in acute lung injury patients, we conduct a prospectively observational study to see whether the caloric differences influence hospital mortality.

Detailed Description
-----------------
The is a prospectively observational study. The data including basic demographic data, daily PN/EN caloric intake, days of ICU stay, days of hospital stay, hospital mortality, days of ventilator use.. will be collected. Statistic analysis included chi-square, student t test, logistic regression and ROC curve will be applied to analyze the different characteristics between survived and died patients. Also we can figure out the optimal cut value of caloric intake with best outcome by ROC curve analysis. We plan enrolled 200 participants within study period.

Official Title
-----------------
The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients

Conditions
-----------------
ARDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS (2012 Berlin Criteria) Exclusion Criteria: Expected ICU stay less than 72 hours

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Hospital mortality |  | through study completion, an average of 1 year |
Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

Study Overview
=================
Brief Summary
-----------------
Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.

Official Title
-----------------
The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla

Conditions
-----------------
Visualisation and Evaluation of Ampulla of Vater

Intervention / Treatment
-----------------
* Device: Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication of Esophagogastroduodenoscopy independent from the study Written informed Age ≥ 18 years Exclusion Criteria: Absence of written informed consent Contraindication or absence of informed consent regarding sedation with Propofol Postoperativ changes of the upper GI-tract Intention of endoscopic intervention Suspicion of upper GI-bleeding Suspicion of stenosis of the esophagus Stent in the papilla duodeni major ASA (American Society of Anesthesiologists) classification ≥ 3

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard Esophagogastroduodenoscopy<br>standard Esophagogastroduodenoscopy | |
| Experimental: cap assisted Esophagogastroduodenoscopy<br>cap assisted Esophagogastroduodenoscopy | Device: Cap<br>* cap assisted esophagogastroduodenoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete visualisation of papilla duodeni major | visualisation: none, incomplete, complete | 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield in the upper GI-tract | All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc) | up to 10 minutes | 
| time of investigation | Duration of Esophagogastroduodenoscopy | up to 10 minutes | 
| complication rate | Any complications related to the examination within one week would be reported. | up to one week |
Prolift Versus IVS for Pelvic Floor Prolapse

Study Overview
=================
Brief Summary
-----------------
Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be enrolled. Their data will be collected from the files. Comparison between two groups will be carried our: Those who underwent a posterior IVS and those who underwent posterior prolift procedure. The data will be obtained by questionaires by a telephone interview by a physician who did not participate in the surgery. Follow-up physical examination data will also be obtained.

Official Title
-----------------
Postoperative Comparison Between Posterior Prolift Mesh Placement and Posterior IVS Sling Placement

Conditions
-----------------
Pelvic Floor Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who previously underwent surgery for pelvic floor prolapse at least a year before Exclusion Criteria: Women who did not have surgery for pelvic floor prolapse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Pelvic floor prolapse<br>Those who underwent prolift and those who underwent IVS | |

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
-----------------
Surgery, pelvic floor prolapse, prolift, IVS