linjc16/ctgov huggingface dataset:
Single Dose of Atorvastatin and Circulating Endothelial Microparticles

Study Overview
=================
Brief Summary
-----------------
Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating endothelial microparticles and flow-mediated vasodilation in the brachial artery by ultrasound at different time points.

Official Title
-----------------
The Effect of Single Dose of Atorvastatin on Change of Circulating Endothelial Microparticles

Conditions
-----------------
Endothelium, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy youth Exclusion Criteria: acute pathologies familial history of cardiovascular disease smoking or drinking alcohol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atorvastatin<br>atorvastatin 20mg tablet, single dose of 80mg by mouth | Drug: atorvastatin<br> <br> * Other names: Liptor;|
| Placebo Comparator: placebo<br>placebo 20mg tablet, single dose of 80mg by mouth | Drug: placebo<br> <br> * Other names: sugar pill manufactured to mimic atorvastatin 20mg tablet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of circulating endothelial microparticles |  | from 1h to 24h after taking atorvastatin |
Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Study Overview
=================
Brief Summary
-----------------
Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Detailed Description
-----------------
Five patients who are on treatment of imatinib and deriving clinical benefit after CAMN107DBR01 study termination and written informed consent obtained will enter the trial, all five patients will receive Glivec (8oomg per day) treatment until tumor progression [by RECIST guidelines, version 1.0], unacceptable toxicity, death or withdrawal of consent.

Official Title
-----------------
Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Conditions
-----------------
Gastrointestinal Stromal Tumor

Intervention / Treatment
-----------------
* Drug: Glivec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Five patients who are on treatment of imatinib and deriving clinical benefit after CAMN107DBR01 study termination and written informed consent obtained. Exclusion Criteria: N/A.

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 |
| --- |
|Drug: Glivec|800 mg per day|

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
-----------------
Gastrointestinal Stromal Tumor, GIST
Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Detailed Description
-----------------
Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Official Title
-----------------
Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine

Conditions
-----------------
In Vitro Fertilization, Infertility

Intervention / Treatment
-----------------
* Other: Medium with no human serum albumine added
* Other: Conventional medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples seeking IVF/ICSI. Female under 38 years of age. No more than two previous IVF/ICSI treatments without pregnancy. Regular menstruation periods. No endocrine disease that requires treatment in the female. BMI below 30 in the female. At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI. Written informed consent. Exclusion Criteria: Low responders to FSH. Females in danger of developing OHSS. Sperm sample below ICSI-quality.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Medium with no human serum albumine added | Other: Medium with no human serum albumine added<br>* See above<br>|
| Active Comparator: 2<br>Conventional medium | Other: Conventional medium<br>* See above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization |  | 24 hours | 
| Cleavage |  | 48 hours | 
| Embryo score |  | 48 hours | 
| Embryos used |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cell Culture Techniques
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Detailed Description
-----------------
The study will compare the effectiveness of providing HCV education by providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Official Title
-----------------
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Educational Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study population includes Faculty Medical Center obstetrics and postpartum patients enrolled in the HOPE program who are 18 years old or older. The study will include patients with and without a Hepatitis C diagnosis. Patients will be recruited at their routine office visits and/or during any admissions to the hospital. Exclusion Criteria: Patients who do not speak and understand English.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pamphlets plus Review with Expert Educator<br>Educational Intervention includes Pamphlets plus Review with Expert Educator | Other: Educational Intervention<br>* Patients will be randomized to a group that receives the pamphlets only and a group that receives the pamphlets and has an expert educator review that pamphlets with them and answer questions.<br>|
| Other: Pamphlets only<br>Educational Intervention includes Pamphlets only | Other: Educational Intervention<br>* Patients will be randomized to a group that receives the pamphlets only and a group that receives the pamphlets and has an expert educator review that pamphlets with them and answer questions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Questions Scored Correct on the Hepatitis C Knowledge Survey | Number of questions scored correct on the Hepatitis C knowledge survey | 2-8 weeks after study intervention |
Safety Study of HPP593 in Subjects During and After Limb Immobilization

Study Overview
=================
Brief Summary
-----------------
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization

Conditions
-----------------
Hypodynamia, Muscle Atrophy

Intervention / Treatment
-----------------
* Drug: HPP593
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking. Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results. Not restricted to a wheel-chair or confined to a bed. Weight ≥ 50.0 kg. BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening. Exclusion Criteria: Any of the following abnormalities at Screening Visit and Baseline: Fasting glucose > 110 mg/dL (Screening visit only). Serum creatinine > 1.5 mg/dL. If serum creatinine is >1.5 mg/dL and creatinine clearance is >60 mL/min, the subject need not be excluded Troponin I level above the upper limit of normal (ULN) Liver function tests (LFTs) > 1.5x ULN Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension) Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit. Has received HPP593 in a previous clinical trial. Smoking within 6 month prior to Day -1. Michigan Alcohol Screening Test score greater than 2.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPP593<br> | Drug: HPP593<br>* Oral, twice a day.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral, twice a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation | Number and severity of adverse events across trial period | Baseline to Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle Strength |  | Day 1 to Day 42 | 
| Changes on Muscle Related Biomarkers |  | Day 1 to Day 29 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle Atrophy
Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

Study Overview
=================
Brief Summary
-----------------
This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

Detailed Description
-----------------
We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.

Official Title
-----------------
Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method

Conditions
-----------------
Locally Advanced Rectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: pelvic MR examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically proved rectal cancer locally advanced rectal cancer (≥T3 or N+) a distance less than 12cm between the lower edge of tumor and the anal margin no evidence of distant metastases no prior anti-cancer therapy before treatment scheduled to receive preoperative CRT Exclusion Criteria: history or concurrent of other malignancy incomplete preoperative CRT failed to receive surgery or unavailable pCR assessment poor quality of MR images for measurement patient quit
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LARC-CRT<br>LARC patients who will receive neoadjuvant CRT before surgical resection. | Diagnostic Test: pelvic MR examination<br>* All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response(pCR) | Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes. | within one week after surgery |
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

Study Overview
=================
Brief Summary
-----------------
to evaluate the effect of subcutaneous irrigation on wound complications

Detailed Description
-----------------
Cesarean section is the most common abdominal operation performed worldwide. As with every other surgical procedure, it is sometimes accompanied by surgical complications. Wound complications are encountered in approximately 5% of women that undergo CS and include haematomas, seromas and infection. To evaluate the effects and benefits of subcutaneous irrigation during cesarean section we decide to conduct this randomized study.

Official Title
-----------------
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

Conditions
-----------------
Cesarean Section; Complications, Wound, Hematoma

Intervention / Treatment
-----------------
* Other: subcutaneous saline irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-40, undergoing cesarean section Exclusion Criteria: patients with systemical disease, body mass index>30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization will be performed by an online software. Randomized cards will be in sealed envelopes and will be open by surgeon at the time of surgery.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcutaneous irrigaton<br>Patients will receive 200 cc subcutaneous saline irrigation before skin incision closure. | Other: subcutaneous saline irrigation<br>* 200 cc saline irrigation<br>|
| No Intervention: Subcutaneous no irrigation<br>Patients will not receive subcutaneous saline irrigation before skin incision closure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound complications | wound complications will be evaluated 1 week after the surgery. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound, infection, cesarean section
A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered alone in health male volunteers.

Official Title
-----------------
A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone in Healthy Male Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DP-R207
* Drug: Rosuvastatin
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects age between 19 and 55 signed informed consent Exclusion Criteria: subjects have an allergy reaction of this drug

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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: A group<br>DP-R207 >> rosuvastatin+ezetimibe | Drug: DP-R207<br> <br> Drug: Rosuvastatin<br> <br> Drug: Ezetimibe<br> <br> |
| Active Comparator: B group<br>rosuvastatin+ezetimibe >> DP-R207 | Drug: DP-R207<br> <br> Drug: Rosuvastatin<br> <br> Drug: Ezetimibe<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | 0-72hr | 
| Peak Plasma Concentration (Cmax) |  | 0-72hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R207, Rosuvastatin, Ezetimibe
BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED

Study Overview
=================
Brief Summary
-----------------
Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).

Detailed Description
-----------------
Dyspneic patients 65 years were enrolled in a randomized, controlled trial; hemodynamically unstable patients were excluded. BNP (Biosite assay) levels were measured prior to physician assessment with randomization in 1:1 ratio to either BNP 1) level reported or 2) level not reported. ED physicians made triage decisions guided by clinical judgment and nomogram to aid in interpretation of BNP level. Primary outcome was mean total hospital cost per subject. Secondary outcomes included admission rate, service assignment, discharge diagnosis and length of stay. Differences between groups were compared by t-test with bootstrap. Costs reflect 2005 constant dollars.

Official Title
-----------------
BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project

Conditions
-----------------
Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath. Exclusion Criteria: hemodynamically unstability

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| A<br>BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition. | |
| B<br>BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean total hospital cost per subject |  | spans from ED eval through hospitalization discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Included admission rate, service assignment, discharge diagnosis, and length of stay. |  | from ED evaluation through hospitalization discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congestive heart failure, Brain naturietic peptide, hospital utilization cost