linjc16/ctgov huggingface dataset:
The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.

Detailed Description
-----------------
Patients are randomized to 1 of 3 groups for 12 months of treatment. Group 1 receives MK-639 plus AZT. Group 2 receives MK-639 alone. Group 3 receives AZT alone. Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels. If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639.

Official Title
-----------------
Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of MK-639 and Zidovudine (AZT) Administered Concomitantly to MK-639 Alone and Zidovudine (AZT) Alone

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

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV seropositivity. Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart. Note: Patients with known hemophilia may be enrolled at the discretion of the investigator. Prior Medication: Excluded: Any protease inhibitor. Significant prior use (greater than 2 weeks) of nucleoside analogues. Chronic therapy for an active opportunistic infection. (Allowed: Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid). Investigational agents or immunomodulators within 30 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute hepatitis. Lymphoma. Visceral Kaposi's sarcoma. Invasive cervical cancer. Active infection. Concurrent Medication: Excluded: Anticipated immunosuppressive therapy.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Zidovudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
QT Variability Pre and Post Cardioversion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.

Detailed Description
-----------------
Atrial Fibrillation variably activates the renin-angiotensin-aldosterone system (RAAS), stimulates the sympathetic nervous system, generates oxidant stress, produces natriuretic peptides, and increases ventricular rate. These are interrelated responses and the extent to which these or other pathophysiologic responses determine QT interval during and after Atrial Fibrillation (AF) is unknown. In this study, the QT variability is related to those potential markers in patients with AF undergoing elective DC-cardioversion.

Official Title
-----------------
QT Variability Pre & Post Cardioversion in Patient's With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 21 years of age Scheduled to undergo an elective DC-Cardioversion of atrial fibrillation or atrial flutter at Vanderbilt University Medical Center Exclusion Criteria: Undergoing emergent DC-Cardioversion of atrial fibrillation for hemodynamic instability Undergoing DC-Cardioversion for post-cardiac surgery Dual chamber pacemakers

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| QT variability before and after direct current cardioversion |  | 1.5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QT Interval, Atrial Fibrillation, Cardioversion, Direct Current Cardioversion
Hyzaar Asia HEAALTH (0954A-950)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.

Official Title
-----------------
An Open Label Study to Assess the Efficacy of Losartan/HCTZ Combination Therapy in Patients With Essential Hypertension Who Were Inadequately Controlled on Current Antihypertensive Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: losartan potassium (+) hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or female and = 18 years of age Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal Exclusion Criteria: History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study Previous history of severe essential hypertension History of stroke or myocardial infarction (heart attack) Evidence of renal or liver disease Uncontrolled diabetes mellitus Any known bleeding disorder Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide) Other antihypertensive medications or medications that may affect blood pressure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Losartan/HCTZ | Drug: losartan potassium (+) hydrochlorothiazide<br>* Patients took losartan 50 mg /HCTZ 12.5 mg orally once daily for 13 weeks. At Weeks 0, 4 and 8 if the blood pressure goal was not reached then the losartan/HCTZ combination will be titrated upwards according to the following scheme: losartan 50/HCTZ 12.5 to losartan 100/HCTZ 12.5 to losartan 100/HCTZ 25.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching a blood pressure goal (diastolic <90mm Hg for non-diabetics; <80mm Hg for diabetics) after 8 weeks of treatment |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 13 Weeks |
Metabiomics Colon Cancer Clinical Research Study

Study Overview
=================
Brief Summary
-----------------
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.

Detailed Description
-----------------
The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.

Official Title
-----------------
Metabiomics Colon Cancer Clinical Research Study

Conditions
-----------------
Colonic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy Male or female, Age: 18-95 years, Able to comprehend, sign, and date the written informed consent form (ICF), Able to give informed consent in English Women and minorities will be included. Exclusion Criteria: History of Inflammatory Bowel Disease Antibiotics within 2 weeks of sample collection. Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection Any radiation therapy

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 |
| --- | --- |
| Diagnosed colon cancer patients<br>Patients undergoing colectomy for colonic adenocarcinoma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate of test for colon cancer | The False Negative Rate is calculated as (100*False Negative) /(True Positive + False Negative). | immediately post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonic Neoplasms, Colon Cancer, Microbiome
A Study to Improve the FAST Ultrasound Exam

Study Overview
=================
Brief Summary
-----------------
This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients with bleeding.

Official Title
-----------------
Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination

Conditions
-----------------
Hemoperitoneum

Intervention / Treatment
-----------------
* Procedure: Fast exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All trauma patients who present as a Trauma Activation with clinical history or physical signs of blunt abdominal trauma. Exclusion Criteria: Pregnant females Prisoners Patients with prohibitive right sided chest trauma Patients in extremis undergoing salvage maneuvers (chest compressions or emergent surgical intervention) which prevents performance of an ultrasound examination Patient who leave against medical advice or are otherwise removed from the medical system before their work up has been completed

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAST examination after Right sided roll (FASTeR)<br>Subjects will have a standard FAST exam, and will then be rolled onto their right side and the FAST exam will be repeated. | Procedure: Fast exam<br>* Positional change before Fast exam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects screening positive for blood around the abdominal organs (hemoperitoneum) after trauma, as assessed by focused assessment with sonography for trauma (FAST), a rapid bedside ultrasound examination. |  | 24 hours |
Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study

Study Overview
=================
Brief Summary
-----------------
The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.

Conditions
-----------------
Bioresorbable Scaffolds

Intervention / Treatment
-----------------
* Device: Absorb scaffold
* Device: Xience stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for implanting an Absorb scaffold: age < 55 years OR lesion length > 24mm OR multiple lesions to be treated
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Absorb scaffold<br>Bioresorbable vascular scaffold implanted in coronary arteries, which are completely resorbed over a period of approximately two years | Device: Absorb scaffold<br> <br> |
| Xience stent<br>Second generation drug-eluting stent to treat coronary artery lesions | Device: Xience stent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse post-stenting results | Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary vessels, coronary stenosis, percutaneous transluminal angioplasty, stents, drug-eluting stents, bioresorbable scaffolds, optical coherence tomography
Dietary Factors and Risk of Gallbladder Carcinoma in China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how people's diets, other aspects of their lifestyles affect their chances of getting gallbladder carcinoma in China. This survey will enroll 100 patients who have had gallbladder carcinoma，as well as controls with gallstones. The investigators will compare these two groups of subjects to see what factors may lead to gallbladder carcinoma.

Detailed Description
-----------------
The investigators will conduct a case-control study in 10 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. There will be 100 cases with gallbladder carcinoma, 100 controls. The investigators will interview participants about known and potential risk factors for gallbladder carcinoma and obtain information on diet. The investigators will obtain the blood and urine samples for further analysis of metabolomics studies. The investigators will use logistic regression to determine odds ratios for disease with various exposures.

Official Title
-----------------
Dietary Factors and Risk of Gallbladder Carcinoma in China

Conditions
-----------------
Dietary Habits

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls) Exclusion Criteria: The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
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 |
| --- | --- | --- |
| the The demographic, reproductive, and lifestyle characteristics | Cases and controls were interviewed by one of three research assistants with a standard questionnaire to elicit information about demographic, reproductive, and lifestyle characteristics. | 2017-2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary Exposure, gallbladder carcinoma
Effectiveness Study of the Guardian RT in Type 1 Diabetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.

Detailed Description
-----------------
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.

Official Title
-----------------
The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Guardian RT Telemetered Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes for at least 12 months HbA1c must be 8.1% or above at study entry Intensive Insulin Therapy 3 months prior to study entry Exclusion Criteria: Impaired hearing or vision (must see screens and hear alarms) Unable to comply with protocol Chronic debilitating or psychiatric disturbances

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 59 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

| Intervention/Treatment |
| --- |
|Device: Guardian RT Telemetered Glucose Monitoring System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Change in A1c (%) between continuous use of CGM and control |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in A1c (%) between biweekly use of CGM and control |  | 12 weeks | 
| Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Glycemic Control, Continuous Glucose Monitoring
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

Detailed Description
-----------------
This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section. Outcomes will include fever, wound infection, and urinary tract infection.

Official Title
-----------------
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study

Conditions
-----------------
Emergency Cesarean Section, Infection Wound

Intervention / Treatment
-----------------
* Drug: Cefepime
* Drug: Cefuroxime plus Metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intrapartum caesarean section Exclusion Criteria: evidence of infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cefepime , Maxipime® 1 gm<br>Patient will receive Cefepime ,Maxipime® 1 gm IV during cesarean section just before skin incision | Drug: Cefepime<br>* Antibiotic prophylaxis<br>* Other names: Maxipime;|
| Active Comparator: Cefuroxime, Zinnat® 1gm plus metronidazoleFlagyl® 500<br>Patient will receive Cefuroxime, Zinnat® 1gm ,and metronidazoleFlagyl® 500 IV; just before skin incision for emergency cesarean section | Drug: Cefuroxime plus Metronidazole<br>* Antibiotic prophylaxis<br>* Other names: Zinnat plus Flagyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site wound infection | Examining the wound after one week of the surgery to detect any infection | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum