linjc16/ctgov huggingface dataset:
Sun Protection Factor Assay (316/2016)

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: BAY 987516
* Drug: SPF Control


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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<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: BAY 987516<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: Z46-100)<br>Drug: SPF Control<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.<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 |
RCT Assessing the Impact of Online Training on Doctors' Prescribing for Older Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess, by means of a randomized controlled trial, the impact of an online educational tool, on doctors' knowledge and confidence with regards to prescribing for older patients.

Detailed Description
-----------------
Both control and intervention groups will complete assessments at baseline, 4 weeks post intervention and 8 weeks post intervention. Differences in mean test scores will be the primary outcome measure. Qualitative information exploring doctors' attitudes and confidence, pre and post intervention will also be collected and will be a secondary outcome

Official Title
-----------------
A Randomized Controlled Trial Assessing the Impact of an Online Educational Tool on Doctors' Knowledge and Confidence With Regards to Prescribing for Older Patients

Conditions
-----------------
Appropriateness of Prescribing in Older Patients

Intervention / Treatment
-----------------
* Other: SCRIPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered non-consultant hospital doctor working in one of the hospitals approved by the ethics board Exclusion Criteria: Currently working as a consultant Having previously worked as a pharmacist
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>These participants will not receive the educational intervention | |
| Experimental: Intervention<br>These participants will receive the online educational intervention SCRIPT | Other: SCRIPT<br>* An online tool designed to train doctors in all areas of prescribing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean test scores | test scores pre and post intervention compared | At baseline, 4 weeks post intervention and 8 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doctors' confidence with regards to prescribing for older patients | doctors answer a questionnaire as part of each assessment to determine their overall confidence with regards to prescribing for older patients | At baseline, 4 weeks post intervention and 8 weeks post intervention |
Sarah Cannon Outcomes Registry

Study Overview
=================
Brief Summary
-----------------
This is an investigational multi-site outcomes registry intended to collect information about a patient's cancer care. Patients may enter the Registry at any time during the patient's current stage in the continuum of care. The registries main objectives will be to measure and evaluate the effects of patient care throughout the care continuum, resulting in the identification of the most effective treatment options. Objectives will encompass evaluations and analytics around safety, effectiveness, and improved efficiencies.

Detailed Description
-----------------
Q

Official Title
-----------------
Sarah Cannon Outcomes Registry

Conditions
-----------------
Oncology

Intervention / Treatment
-----------------
* Other: Patient registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older Patients that have been diagnosed with/ or are thought to have any form of cancer at any stage in the continuum of their care from screening through survivorship. Patient must have the ability to understand the nature of the trial and give written informed consent Exclusion Criteria: There are no exclusion criteria for this Outcomes Registry

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 |
| --- |
|Other: Patient registry|Oncology data registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality improvement |  | 10 yrs | 
| Treatment patterns and utilization |  | 5 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humanistic and economic outcomes |  | 10 yrs |
Ropivacaine After Sternotomy

Study Overview
=================
Brief Summary
-----------------
Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.

Detailed Description
-----------------
A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.

Official Title
-----------------
Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery

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

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective CABG or heart valve surgery patients Exclusion Criteria: Psychic disorders Sleep apnea syndrome Diabetes mellitus (insulin dependent) Obesity, body mass index (BMI) ≥ 35 Cardiac insufficiency, ejection fraction (EF) ≤ 30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine<br>Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours | Drug: Ropivacaine<br> <br> |
| Placebo Comparator: Placebo<br>Saline infusion 4 ml/h for 48 hours | Drug: Ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative oxycodone consumption | postoperative PCA administered oxycodone | 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured with Visual Analog Scale | pain measured with VAS at rest and on movement | 48 postoperative hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Requirement of postoperative pain medication
Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a new MR pulse sequence is accurate in determining how much iron is in the liver.

Detailed Description
-----------------
Quantification of liver iron requires liver biopsy and histological assessment. New rapid MR techniques allow determination of liver relaxation times that can be altered with increasing iron deposition. The purpose of this study is to compare the results obtained with MRI to liver biopsy and iron quantification in patients undergoing liver biopsy in the setting of hemochromatosis.

Official Title
-----------------
Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration

Conditions
-----------------
Hemochromatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing liver biopsy for suspected or known hemochromatosis Undergoing liver biopsy for living-related liver donation evaluation Exclusion Criteria: Contraindication to MRI

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemochromatosis<br>Hemochromatosis | |
| Living-related liver donation<br>Living-related liver donation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of MR in quantifying liver iron |  | one time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemochromatosis, liver cirrhosis, liver diseases
Analysis of Immune Response In Bacterial Infection of Obese Subject

Study Overview
=================
Brief Summary
-----------------
Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude

Official Title
-----------------
Analysis of Immune Response In Bacterial Infection of Obese Subject

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Biological: blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between18 and 80 years obesity: BMI > 30 presumed bacterial infection: pneumonitis (documented or probably) pyelonephritis / acute prostatitis soft tissue / skin infection (except for bedsore) cholecystitis / angiocholitis meningitis clostridium colitis surgical site infection signed consent Exclusion Criteria: patients with viral, parasitic or mycotic documented infection patients with bacterial infection with treatment> 4 weeks (ex. endocarditis; osteo- articular infections) patients with prior antibiotic treatment (< 14 days) intensive care unit patients patients with a history of cancer or malignant hematological disease within the 5 previous years that is currently clinically significant (non metastatic prostatic and basocellular malignancy are excluded) patients with systemic disease Known diagnosis of human immunodeficiency infection (DICV, HIV…) immunosuppression treatment during last month including corticotherapy pregnancy 3 months follow up not possible non signed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: investigational<br>Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later | Biological: blood analysis<br>* Pilot study, single center, interventional including 15 obese subjects with acute sepsis. Inflammatory and immunological tests during acute phase and one month later after a presumed return parameters at baseline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis (normal) situation | Standard inflammatory markers; immunological markers (cytokines, leptine, lymphocyte phenotype) | T 0 and at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sepsis; correlation with inflammatory and immunological parameters |  | T 0 and at 1 month | 
| Analysis of leptine polymorphism |  | 1 month |
Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

Study Overview
=================
Brief Summary
-----------------
SDB has been identified as an important risk factor for insulin resistance and the metabolic syndrome. In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c). In children, there are only 3 studies that have examined the relations between SDB, obesity and the metabolic syndrome. In order to further understand the relative contribution of SDB to the development of impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence and severity of SDB in children with T2DM compared to obese children without T2DM. The investigators hypothesize that SDB will be more prevalent and more severe among obese children with T2DM compared with the general obese pediatric population.

Official Title
-----------------
Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

Conditions
-----------------
SDB, T2DM, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with T2DM obese Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 20 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 |
| --- | --- |
| T2DM<br>Children 6-20 years old diagnosed with T2DM | |
| Obesity<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children. |  | In 6 months | 
| To measure markers of inflammation and oxidative stress known to be associated with cardiovascular morbidity in children with T2DM and SDB compared to non-diabetic obese children. |  | In 6 months | 
| To examine changes in metabolic measures and markers of inflammation and oxidative stress in response to treatment for SDB (adenotonsillectomy) in children with T2DM compared to obese children without T2DM. |  | In 6 months |
Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse

Study Overview
=================
Brief Summary
-----------------
This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.

Official Title
-----------------
Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

Conditions
-----------------
Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor, Osteosarcomas, Neuroblastomas, Medulloblastomas

Intervention / Treatment
-----------------
* Drug: Vinorelbine, cyclofosfamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 12 months and < 25 years Measurable disease Score of Lansky > 30 or World Health Organization (WHO) score < 2 Life expectancy > 2 months Satisfactory hematologic conditions: Polynuclear neutrophiles > 1 X 10^9/l. Platelets > 100 X 10^9/l or > 50 X 10^9 in the event of medullary invasion. Creatinine < 1.5 of normal for age or clearance > 70 ml/min/1.73 m2 Normal hepatic function: Bilirubin < 3 N ASAT and ALAT < 2,5 N). Absence of toxicity of bodies (Rank > 2 according to coding National Cancer Institute-Common Toxicity Criteria [NCI-CTC] version 2.0) Absence of antecedent of hematuric cystitis to repetition Written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects Exclusion Criteria: Does not satisfy the criteria of eligibility

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 25 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: Vinorelbine, cyclofosfamide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the hematologic tolerance of this association |  |  | 
| To evaluate the pharmacokinetics of injectable Vinorelbine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft parts tissue
The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Study Overview
=================
Brief Summary
-----------------
Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel. Determine the relationship between conducting a GBS test in pregnant women and EOGBSD in Israel.

Detailed Description
-----------------
There have been few studies in recent years, which has prompted us to undertake this study. Our aim was to examine the current colonization rates and attack rates in the Israeli population. Our secondary aim was to evaluate the need to readjust recommendations towards universal screening.

Official Title
-----------------
The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Conditions
-----------------
Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women with term pregnancies from 2015 to 2016 (until 20/9/16) insured by Maccabi Healthcare Services (MHS) Exclusion Criteria: repeat pregnancies occurring in the same woman during the time period multiple pregnancies gestational age greater than 42 weeks due to probability of data inaccuracy women with missing information
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women screened for GBS<br>All women who were pregnant during 2015-2016 and delivery was between 37-42 weeks who were screened for GBS during pregnancy | |
| Women not screened for GBS<br>All women who were pregnant during 2015-2016 and delivery was between 37-42 weeks who were not screened for GBS during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attack rate of early-onset GBS disease (EOGBSD) | Attack rate of (EOGBSD) | 2015-2016 |