linjc16/ctgov huggingface dataset:
Simulation in Teaching Vaginal Examination

Study Overview
=================
Brief Summary
-----------------
Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.

Official Title
-----------------
The Benefits of Simulation in Teaching Vaginal Examination for Women During Labor: a Randomized Controlled Study

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

Intervention / Treatment
-----------------
* Procedure: vaginal examination simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Interns who finished their study in faculty of medicine Interns who never performed VE before Interns who accept to participate in the study Exclusion Criteria: Interns who refuse to participate in the study
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: simulation group<br>Interns will carry out 10 VE on a simulator | Procedure: vaginal examination simulator<br> <br> |
| No Intervention: Control group<br>Interns who will not perform any simulated VE | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement of vaginal examination accuracy score after practical training on simulators |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
teaching vaginal examination
Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery

Study Overview
=================
Brief Summary
-----------------
Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study is to use a single cell flow cytometry approach to characterize the cellular and molecular mechanisms involved in the inflammatory response to surgical trauma.

Official Title
-----------------
Detection of Immune Changes as a Result of Surgical Trauma in Human Back Surgery Subjects: Optimization of CyTOF Analysis

Conditions
-----------------
Surgical Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 - 90 Men and women Undergo back surgery Exclusion Criteria: Any systemic disease that might compromise the immune system (e.g. lupus) Current diagnosis of cancer Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant. Unwilling to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Back surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells | This is an exploratory study. | Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge |
Clinical Application and Outcome of Non-invasive Ventilation in Different Chest Diseases

Study Overview
=================
Brief Summary
-----------------
Noninvasive ventilation is increasingly used method of respiratory management in both the emergency room and critical care. Noninvasive ventilation delivers mechanically assisted breaths without the placement of an artificial airway and has become an important mechanism of ventilator support inside and outside the intensive care unit. Noninvasive ventilation is further subdivided into negative pressure ventilation which is the iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to provide negative pressure during inspiration and positive pressure during expiration. Noninvasive positive pressure ventilation can be used as continuous positive airway pressure or bi-level positive airway pressure.

Official Title
-----------------
Clinical Application and Outcome of Non-invasive Ventilation in Different Chest Diseases

Conditions
-----------------
Chest--Diseases

Intervention / Treatment
-----------------
* Device: Non-invasive mechanical ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstructive sleep apnea syndrome acute exacerbation Chronic obstructive pulmonary disease pneumonia interstitial lung diseases Exclusion Criteria: Patients refuse Non invasive ventilation Patients with absolute indication for Mechanical ventilator (in respiratory arrest or unstable cardiorespiratory status, trauma or burns involving the face, or gastric surgery, reduced consciousness, Pneumothorax Patients with contraindication to Non invasive ventilation

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 |
| --- |
|Device: Non-invasive mechanical ventilator|mechanical assisted breaths without the placement of an artificial way|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients need mechanical ventilation | the number of patients without improvement on non-invasive ventilator and require transfer to mechanical ventilator | 1-48 hours |
Role of CD7 in Skin Inflammation and Psoriasis

Study Overview
=================
Brief Summary
-----------------
Role of CD7 in skin inflammation and psoriasis

Detailed Description
-----------------
Psoriasis is a debilitating, chronic inflammatory skin disorder characterized by scaly skin patches caused by infiltration of inflammatory cells into the dermis and epidermis, with secondary epidermal cell (keratinocyte) hyperproliferation. Psoriasis is a complex disease and a combination of genetic and environmental factors are likely to be causative. T-cell-mediated immune process, including cytokines (eg. IFN-γ) and chemokines, play an essential role in psoriasis. Susceptibility genes for psoriasis map to PSORS1 in the HLA region at chromosome 6p21, PSORS2 in the chromosome 17q24-q25, and others. Recently our colleagues in the Academia Sinica and we performed a genome-wide linkage analysis with polymorphic microsatellites in one five-generation affected psoriasis kindred, and the result revealed a close linkage at D17S928, close to CD7. CD7+ T cells produce IFN-γ when activated, and have been located in skin inflammatory lesions. Therefore, in this study we first want to examine the role of CD7 in skin inflammations conditions. CD7+ cells will be stimulated by a variety of methods, and will be used to treat keratinocyte cultures or be injected intradermally to mice. We will watch for skin inflammation and possible proliferation and changes in keratinocytes. Possible changes in CD7 function in patients with psoriasis will be explored, for example, polymorphisms of the CD7 gene may predispose skin inflammation and abnormal interaction with the keratinocytes. CD7- T cells, which could be derived from CD7+ cells and are enriched in skin inflammation lesions, secrete the Th2 cytokine IL-5. We are also interested in the mechanism and the consequences of this CD7 shift. We hope this study will be helpful in the understanding and management of skin inflammation conditions, including psoriasis.

Conditions
-----------------
Psoriasis, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of psoriasis Exclusion Criteria: -
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
-----------------
Psoriasis, T cell, inflammation, CD7, cytokine
MK0767 Glipizide Comparator Cardiac Safety Study (0767-018)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the cardiac and metabolic effects of MK0767 in patients with Type 2 Diabetes. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You are taking at least one medication for high blood sugar Age 21 to 80 Exclusion Criteria: History of Type 1 Diabetes Mellitus Currently on estrogen replacement therapy regimen Currently on a weight loss program with ongoing weight loss or taking medications for weight loss Having surgery 30 days before starting the study Have taken any other investigational drug in the past 90 days Have Hepatitis B or C Active liver or gallbladder disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Primary Care iSBIRT to Reduce Serious Teen Health Risks

Study Overview
=================
Brief Summary
-----------------
The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.

Detailed Description
-----------------
We have previously developed and tested a computerized substance use screening and feedback program for adolescents. We will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop Technological Extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.

Official Title
-----------------
Primary Care Internet/Intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) System to Reduce Serious Teen Health Risks

Conditions
-----------------
Substance-related Disorders, Depression, High-risk Sex

Intervention / Treatment
-----------------
* Behavioral: iSBIRT
* Behavioral: iSBIRT/TE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-21 years old arriving for non-urgent care provide informed assent/consent Exclusion Criteria: less than 6th grade reading level unavailable for follow-up questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iSBIRT<br>Participants will complete the iSBIRT system. | Behavioral: iSBIRT<br>* Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.<br>* Other names: SBIRT;|
| Experimental: iSBIRT/TE<br>Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders | Behavioral: iSBIRT/TE<br>* Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system along with technological extenders<br>* Other names: SBIRT;|
| No Intervention: TAU<br>Participants will receive Treatment as Usual from their primary care provider. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of substance use and other risk behaviors |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco, alcohol, marijuana, drug use, seat-belt, weapons, depression, suicidality, sexual risk behaviors
A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)

Study Overview
=================
Brief Summary
-----------------
Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.

Official Title
-----------------
A Double-Blind, Randomized, Multicenter, Active-Comparative, 12-Week Study to Assess the Efficacy and Safety of the Drug in Conjunction With Another Drug in Korean Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholerolemia

Intervention / Treatment
-----------------
* Drug: MK0653; ezetimibe / Duration of Treatment: 12 weeks
* Drug: Comparator: simvastatin / Duration of Treatment: 12 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean males or females at least 18 years of age with hypercholesterolemia

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653; ezetimibe / Duration of Treatment: 12 weeks|nan|
|Drug: Comparator: simvastatin / Duration of Treatment: 12 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio |  |  |
UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: UFT/LV
* Procedure: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metastatic breast cancer objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy time period between the end of chemotherapy and randomization < 4 weeks age over 18 years Performance status (OMS) < 2. Life expectancy > 3 months Biological criteria before randomization: Neutrophiles > 1.5 x 109 G/L; Pl. > 100 x 109 G/L; Hb > 10 g/dl; Creatininemia < 1,5 UNL; Bili. < 2 UNL; Transaminases < 2,5 UNL; Alcalines Phosphatases < 2,5 UNL Signed written informed consent Exclusion Criteria: Metastatic breast cancer having received more than one chemotherapy line. Tumor progression under chemotherapy Free interval between primary tumor and metastases > 5 years, with estrogen receptors and without visceral metastases Free interval between primary tumor and metastases < 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization Concomitant hormonotherapy Other cancer Symptomatic brain metastases Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF < 50% or coronary insufficiency Psychiatric disorder Other concomitant trial Male patient Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) History of high dose chemotherapy with bone marrow transplantation

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: UFT/LV|nan|
|Procedure: Observation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nevirapine Levels and Fluconazole

Study Overview
=================
Brief Summary
-----------------
Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.

Official Title
-----------------
Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy and Fluconazole

Conditions
-----------------
Nevirapine, Fluconazole, Adverse Event

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected patients >15 years of age, naïve to antiretroviral therapy, were initiated with a NVP-based ART regimen, used NVP 200-mg once-daily lead-in dose, prior to escalation to 200 mg twice daily. Exclusion Criteria: creatinine level was higher than 2.0 mg/ml liver aminotransferase enzyme was higher than five times of upper normal limit receiving a medication that has drug-drug interactions with NVP or FLU

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
Expanded Use of Cannabidiol Oral Solution

Study Overview
=================
Brief Summary
-----------------
To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.

Detailed Description
-----------------
To allow subjects who have completed Insys 030 extension study (A multicenter, open-label, flexible dose study to assess the long-term safety of pharmaceutical Cannabidiol Oral Solution as an adjunctive treatment for pediatric subjects with a treatment-resistant seizure disorder who complete INS011-14-029 or Part A of INS011-15-054) to continue to take Cannabidiol oral solution.

Official Title
-----------------
A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054

Conditions
-----------------
Refractory Epilepsy

Intervention / Treatment
-----------------
* Drug: Cannabidiol oral solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the Insys 030 protocol Compliant in drug study procedures Non-pregnant females of child bearing age, willing to utilize a double-barrier method of birth control during treatment and for 30 days after treatment has ended Exclusion Criteria: Failure to follow study procedures in Insys 030 Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cannabidiol oral solution|Cannabidiol; Pharmacological class of drug|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |