linjc16/ctgov huggingface dataset:
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors

Study Overview
=================
Brief Summary
-----------------
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.

Official Title
-----------------
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Nevirapine and Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy African American men and women. 18-55 years of age. Willing and able to provide written informed consent. Exclusion Criteria: Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes. Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance. Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >1.5 X upper limit of normal. Positive pregnancy test in women of childbearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nevirapine and Efavirenz|single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single dose nevirapine and single dose efavirenz |  | 5-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nevirapine, Efavirenz, pharmacokinetics, healthy, CYP2B6, HIV/AIDS
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

Study Overview
=================
Brief Summary
-----------------
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.

Detailed Description
-----------------
Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile root of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in  50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Official Title
-----------------
Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia

Conditions
-----------------
Biliary Atresia

Intervention / Treatment
-----------------
* Drug: prednisolone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biliary atresia Exclusion Criteria: <100 days at portoenterostomy no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome) anu contra-indications to corticosteroids

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>oral corticosteroids | Drug: prednisolone<br>* 2 mg/kg /day from post-op day 7 - day 21 1 mg/kg /day from post-op day 22 - day 30<br>|
| Placebo Comparator: B<br>as for active regimen | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance of jaundice (<20 umol/L) |  | 1 year | 
| Proportion transplanted or died |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical indices of liver function |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biliary atresia, Kasai portoenterostomy, corticosteroids
Evaluation of a Simulation Training Tool to Identify Lesions Requiring Further Screening for Melanoma

Study Overview
=================
Brief Summary
-----------------
The investigators will design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents. This requires having a skin simulation model that presents a range of lesions from benign nevus to atypical nevus to melanoma in a distribution and density that mimics the clinical findings of those with 2 skin tones: fair-skin non- Hispanic white and Hispanic.

Official Title
-----------------
Development and Evaluation of a Simulation Training Module to Identify Lesions Requiring Further Visual Screen or Skin Biopsy for Melanoma

Conditions
-----------------
Skin Simulation Model, Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy

Intervention / Treatment
-----------------
* Other: Simulation teaching session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical student in his primary care clerkship at Northwestern University Exclusion Criteria: Not a medical student in his primary care clerkship at Northwestern University

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Students<br>3rd year medical students during their primary care clerkship | Other: Simulation teaching session<br>* Simulation-based, mastery learning educational intervention in visual screening for melanoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulation curriculum for screening for melanoma | To design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in melanoma detection skills | To measure changes in medical student and resident skills before and after the intervention, and determine if students achieve the zero error rate in recognizing the melanomas, namely no false negatives. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Simulation Training, Medical Students
Sleep and Cerebral Responses to High Altitude

Study Overview
=================
Brief Summary
-----------------
Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on one hand and cerebral perturbations on teh other hand may be key mechanisms. The investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days in order to better describe sleep and cerebral responses. The investigators hypothesized that sleep and cerebral disturbances play a critical role for the developement of acute mountain sickness and for exercise performance limitation during acute high-altitude exposure.

Official Title
-----------------
Intolerance Mechanisms and Exercise Performance Limitation During a High Altitude Stay: Investigation of Sleep and Cerebral Responses

Conditions
-----------------
Acute Mountain Sickness, High Altitude Pulmonary Edema, High Altitude Cerebral Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 50 yrs old Male Exclusion Criteria: Respiratory, cardiac, metabolic or neuromuscular diseases History of severe acute mountain sickness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxia, Exercise, Sleep, Brain, Neuromuscular function, Heart
EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal inflammation by: improving clinical periodontal parameters and, improving the salivary SOD levels.

Official Title
-----------------
EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).

Conditions
-----------------
Etoricoxib, Cyclooxygenase Two Inhibitors, Periodontitis, Superoxide Dismutase, Saliva

Intervention / Treatment
-----------------
* Drug: Etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Forty patients with chronic generalized periodontitis - Exclusion Criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib<br>Etoricoxib 60 mg once daily | Drug: Etoricoxib<br> <br> * Other names: Arcoxia;|
| Placebo Comparator: matching placebo<br>matching placebo once daily | Drug: Etoricoxib<br> <br> * Other names: Arcoxia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in salivary SOD level |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontitis, Cyclooxygenase two inhibitors, Etoricoxib, Superoxide dismutase, Saliva
sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
This study aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.

Official Title
-----------------
sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Blood sampling and bone marrow analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will only be included in the study if they meet all of the following criteria: Patients who have given informed consent Patients at least 18 years old Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma. Exclusion Criteria: Patients will not be included in the study if one of the following criteria applies: Patients who cannot communicate reliably with the investigator Patients who are unlikely to cooperate with the requirements of the study Patients at increased risk of death from a pre-existing concurrent illness Patients who participated already in part I of this study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinically Suspected or Pathologically Confirmed Multiple Myeloma.<br>Patients with a clinically suspected or pathologically confirmed multiple myeloma. | Other: Blood sampling and bone marrow analysis<br>* Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. | Reporting of the relative amount of patients for whom such sdAb could be successfully obtained | Within 2 years after study completion | 
| Amount of Paraprotein-targeting sdAbs Generated Per Patient | Absolute amount of unique sdAbs obtained per patient | Within 2 years after study completion |
Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy.

Conditions
-----------------
Effects of Recruitment Maneuver During Intraoperative and Postoperative Period

Intervention / Treatment
-----------------
* Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 80 yr American Society of Anesthesiologists physical status 1 or 2 scheduled for elective robotic assisted radical prostatectomy Exclusion Criteria: heavy smoker severe respiratory or cardiac disease hepatic or renal function impairment neurologic disease BMI > 31kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: recruitment maneuver and PEEP<br>apply recruitment maneuver and positive end expiratory pressure (PEEP) 5 centimeter of water (cmH2O) after induction of anesthesia | Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only<br>* application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group<br>|
| Active Comparator: PEEP<br>apply positive end expiratory pressure (PEEP) 5 cmH2O after induction of anesthesia | Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only<br>* application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of perioperative complication | check the rate of perioperative complication( desaturation during operation and postoperative atelectasis in each groups | perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory index | static & dynamic compliance, results of arterial blood gas analysis | intraoperative respiratory index |
Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk.

Official Title
-----------------
Compartmental Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no history of malignancy at the time of image acquisition fasting glucose measured immediately prior to PET/CT Exclusion Criteria: history of neck cancer, radiation therapy, and/or surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 91 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 |
| --- | --- |
| All subjects<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of specific neck compartments to cardiovascular risk | Cardiovascular risk measures were obtained within one year of CT imaging of the neck. | 1 year between PET/CT and cardiometabolic marker measures |
T2Bacteria Panel Pivotal Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood clinical samples.

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them. Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only). Subject is between 18-95 years of age. Exclusion Criteria: Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study. Subject has had previous specimens tested by the T2Bacteria Panel with valid results. Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Prospective Arm<br> | |
| Contrived Arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bacteria detections of contrived clinical samples. | Up to 19 hours post blood collection | 
| Specificity | The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative contrived clinical samples. | Up to 19 hours post blood collection |