linjc16/ctgov huggingface dataset:
Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig). The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.

Official Title
-----------------
Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study

Conditions
-----------------
Surgical Training

Intervention / Treatment
-----------------
* Other: Robotic assistance
* Other: Pelvic Trainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics) Exclusion Criteria: The intern refuses to participate in the study The internal is not available for training and/or evaluation
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic Trainer without robotic assistance<br>Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart. Intervention: Pelvic Trainer | Other: Pelvic Trainer<br>* The standard Pelvic Trainer simulator for surgical training.<br>|
| Experimental: Pelvic Trainer with robotic assistance<br>Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart but with robotic assistance. Intervention: Robotic assistance Intervention: Pelvic Trainer | Other: Robotic assistance<br>* Robotic assistance will be implemented during Pelvic Trainer training sessions.<br>Other: Pelvic Trainer<br>* The standard Pelvic Trainer simulator for surgical training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig). |  | 6 months (3 months after a second training session on the Pelvic Trainer) |
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

Study Overview
=================
Brief Summary
-----------------
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.

Official Title
-----------------
An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Saxagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women (not of childbearing potential) of Chinese ethnicity Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2 Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant. Exclusion Criteria: History of clinically significant hypoglycaemia (low blood sugar levels) Women who are pregnant or breastfeeding

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saxagliptin|Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin |  | Multiple timepoints during 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin |  | Multiple time points during 9 days | 
| Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin |  | Multiple time points during 10 days (including measurements before dosing) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DPP-4 inhibitors, HBA1c, Incretins, Pharmacokinetics
Food Effect Study of CTP-543 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Detailed Description
-----------------
This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

Official Title
-----------------
A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: CTP-543


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults between 18 and 55 years of age, inclusive Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening Exclusion Criteria: History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening Urinalysis positive for greater than trace blood, protein or glucose History of drug or alcohol abuse within 6 months of screening History of tobacco product use within 3 months prior to the study Inability to comply with dietary restrictions during study participation Blood donation or collection within 8 week prior to dosing Positive pregnancy test

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Period 1: CTP-543 with meal Period 2: CTP-543 without meal | Drug: CTP-543<br>* Once daily dosing<br>|
| Experimental: Sequence 2<br>Period 1: CTP-543 without meal Period 2: CTP-543 with meal | Drug: CTP-543<br>* Once daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of CTP-543 in plasma under fed and fasted conditions |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Bioavailability, Pharmacokinetics
Adapting the HOPE Online Support Intervention to Increase Uptake of Medications for Opioid Use Disorder

Study Overview
=================
Brief Summary
-----------------
In a randomized controlled trial, with 3, 6-month and 1-year follow-up, this application aims to explore whether and how the HOPE intervention can be adapted to increase MOUD uptake among OUD patients, assess the effectiveness of using HOPE to increase MOUD requests, and analyze online community data to improve future intervention implementation and sustainability.

Official Title
-----------------
Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients

Conditions
-----------------
Opioid-use Disorder

Intervention / Treatment
-----------------
* Other: Behavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age; Resident of CA, NV, AZ, OR, WA; English speakers only; Has moderate to severe OUD; Is not currently prescribed MOUD; Reports using social media at least 2x per week; Has, or is willing to create a Facebook/social media account and accept a friend request and group invite from our study social media page Exclusion Criteria: -

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>HOPE intervention peer-led online community | Other: Behavioral Intervention<br>* Peer leaders/role models will be trained in HOPE intervention fundamentals and assigned to online community groups with participants.<br>|
| No Intervention: Control<br>Online community without HOPE intervention psychological components | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of requests to receive a resource on medications that can be used to treat opioid use disorder | Participants will be invited to request an informational resource on medications for opioid use disorder as well as to ask for assistance scheduling an appointment with a provider on this topic. We will count the number of participants making this request | request during the course of the 12-week community | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
online community
Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

Study Overview
=================
Brief Summary
-----------------
The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.

Official Title
-----------------
Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Enbrel (etanercept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria · Patients with rheumatoid arthritis [only those refractory to the previous treatment]

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enbrel (etanercept)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up

Study Overview
=================
Brief Summary
-----------------
patients 6-25 years old upon diagnostic evaluation will be recruited . study population will comprise of two groups: newly diagnosed IBD patients/ Celiac disease and healthy controls. upon enrollment, subjects will fill out sleeping habits questioners, demographic data, medical history. blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal biopsies will be snap frozen for clock gene extraction and amplification only for patients with IBD.

Official Title
-----------------
Clock Gene Disruption May be an Initial Manifestation of IBD and Celiac .

Conditions
-----------------
Inflammatory Bowel Diseases, Circadian Dysregulation

Intervention / Treatment
-----------------
* Other: no intervention performed- observational only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBD or celiac patients with a confirmed diagnosis, recruited upon diagnosis. Both male and female Age 6-25 years Medically treated for IBD in our institute. Exclusion Criteria: Genetic disorder. Known primary or secondary immunodeficiency . Pregnancy or lactating

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 25 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 |
| --- | --- |
| IBD patients<br> | Other: no intervention performed- observational only<br>* no intervention performed- observational only<br>|
| Healthy controls<br> | Other: no intervention performed- observational only<br>* no intervention performed- observational only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clock gene expression levels in intestinal mucosal samples and WBC peripheral blood. | PCR amplification levels | 4 years |
Impact of Non-Commercialism Policy in Seattle Schools

Study Overview
=================
Brief Summary
-----------------
This pilot study on the impact of a non-commercialism policy in Seattle schools will assess and evaluate obesity-related health outcomes of a real-life policy decision, recently voted on and adopted by the Seattle School Board. The policy reduces the exposure to advertising and other marketing pressures, including those from commercial food vendors.

Official Title
-----------------
Impact of Non-Commercialism Policy in Seattle Schools

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

Intervention / Treatment
-----------------
* Procedure: reducing exposure to marketing pressures


Participation Criteria
=================
Eligibility Criteria
-----------------
no restrictions

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: reducing exposure to marketing pressures|nan|

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
-----------------
obesity in school aged children
COVID-19 Stroke Apical Lung Examination Study

Study Overview
=================
Brief Summary
-----------------
Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker.

Detailed Description
-----------------
Diagnosis of coronavirus disease 2019 (COVID-19) relies on clinical features and reverse-transcriptase polymerase chain reaction (RT-PCR) testing. The latter is constrained by limited sensitivity and a timescale of hours to yield results, with no point-of-care test widely available. A dedicated computed tomography study of the chest is likely to be more sensitive than RT-PCR for COVID-19. Carotid computed tomography angiography (CTA) is a routine acute stroke investigation and includes the lung apices. We aim to assess the lung apices on CTA for ground glass opacification and compare this with COVID-19 RT-PCR test results and clinical outcome measures.

Official Title
-----------------
COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study

Conditions
-----------------
Covid19, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients presenting with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation. Exclusion Criteria: Poor image quality. No radiologist report available. Computed tomography angiography performed in a non-acute setting.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test | Defined by sensitivity, specificity, positive and negative predictive values | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value of the computed tomography biomarker | Defined by its relationship with 30 day mortality and modified rankin scale following treatment | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID, stroke, CT, CTA
The Effects of Coffee

Study Overview
=================
Brief Summary
-----------------
In this study, participants will be eligible to participate in a paid research study that will examine the effects of regular coffee drinking. The study takes approximately 2 hours total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink only coffee provided to them during the study.

Detailed Description
-----------------
The purpose of the experiment is to evaluate how coffee affects different individuals while completing computer tasks. If an individual agrees to participate, particpants will be asked to come to the laboratory to drink coffee on 2 days. During each visit, participants will be asked to drink coffee, complete forms, and perform computer tasks. To be eligible to participate, participants must be medically healthy.

Official Title
-----------------
The Effects of Coffee

Conditions
-----------------
Healthy Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be regular coffee drinkers. For more information or to set up an appointment, please send a contact number (and a convenient time to call) via e-mail and a BPHP laboratory member will contact you or call the BPHP laboratory at the number listed below.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coffee, caffeine, healthy subjects
Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.

Official Title
-----------------
Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac

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

Intervention / Treatment
-----------------
* Drug: ropivacaine and ketorolac
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for total hip arthroplasty Patients > 18 years of age Signed written informed consent Spinal anaesthesia Exclusion Criteria: Allergy towards study drugs Rheumatoid arthritis Body Mass Index > 35 (severe obesity) Pregnancy or nursing women Regular opioid use Patients who can not read or understand danish

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RK-group<br> | Drug: ropivacaine and ketorolac<br>* The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively<br>|
| Active Comparator: K-group<br> | Drug: Ketorolac<br>* The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Cummulative morphine comsumption postoperatively | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity measured on the visual analog scale (VAS) at rest and during walking | 24 hours postoperatively | 
| Postoperative nausea | Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe) | 24 hours postoperatively |