linjc16/ctgov huggingface dataset:
Study of Having a Female Friend as Labor Support

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group). The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.

Detailed Description
-----------------
The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

Official Title
-----------------
Evaluation of Continuous Support in Labor

Conditions
-----------------
Pregnancy, Delivery, Obstetric

Intervention / Treatment
-----------------
* Behavioral: doula training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous (never given birth before) Singleton pregnancy Vertex presentation Low risk pregnancy Has a female friend willing to be a doula Exclusion Criteria: Placenta previa Abruptio placenta Multiple pregnancy Breech presentation Planned operative delivery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: doula training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of labor |  |  | 
| type of delivery |  |  | 
| type and timing of analgesia/anesthesia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight |  |  | 
| neonatal Apgar score at 1 and 5 minutes after birth |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
doula, caregivers, labor support, being with woman, continuous labor support, maternal outcomes, Parturition
Angio-Seal Evolution Device Registry

Study Overview
=================
Brief Summary
-----------------
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.

Detailed Description
-----------------
This multi-center clinical registry is designed to collect data on the use of the Angio-Seal Evolution Device in patients who have had diagnostic and/or interventional procedures through femoral artery access. Data will be collected on a patient's initial screening through hospital discharge and 30 days post-procedure to evaluate major and minor vascular complications as defined in the protocol.

Official Title
-----------------
Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

Conditions
-----------------
Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease, Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is having a diagnostic and/or interventional procedure via femoral artery access. Exclusion Criteria: Patients who are unable to provide written informed consent.

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 |
| --- | --- | --- |
| Collect major vascular complications |  | 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess time artery stops bleeding |  | Immediately following procedure | 
| Collect minor vascular complications |  | 30 days post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angio-Seal, Peripheral vascular disease, Vascular closure device, Arterial closure, Coronary artery disease, Arterial hemostasis, Coronary cardiac catheterization, Percutaneous coronary intervention, Interventional catheterization, Diagnostic catheterization, Common femoral artery, Manual compression, Vascular intervention, Angiogram, Coronary intervention, Coronary angioplasty, Angiography, Arteriotomy, Vascular access
Dermal Photo Allergic Skin Reaction

Study Overview
=================
Brief Summary
-----------------
A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design

Official Title
-----------------
A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design

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

Intervention / Treatment
-----------------
* Drug: FMX-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female who were 18 years of age or older Had uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II or III Exclusion Criteria: Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfigurations of the test site

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMX-101<br> | Drug: FMX-101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of photoallergic skin reactions (numerical equivalent scoring of erythema and edema) after periodic exposure to IP on irradiated and non-irradiated skin |  | 6 weeks |
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic, well-compensated stable liver Hypercholesterolemia Exclusion Criteria: Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score > 5 History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Pravastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum LDL-C |  | at week 12 | 
| ALT value |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HDL-C, TC and TG |  | at week 12 | 
| clinical symptoms related to acute hepatic injury |  |  |
Sexually Transmitted Infections Among African American Women Who Have Sex With Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine rates of sexually transmitted infections (STIs) among African American women who have sex with women (AAWSW). In addition, the study is interested in better understanding the types of risk behaviors that place AAWSW at risk for STIs. The investigators hypothesis is that AAWSW experience high rates of STIs, similar to heterosexual African American women. Knowledge gained from this study will guide development of interventions to reduce women's risk for these types of infections and will improve how AAWSW are screened for STIs.

Detailed Description
-----------------
The objectives of this study are (1) To determine the prevalence of bacterial vaginosis, trichomoniasis, Chlamydia, gonorrhea, Mycoplasma genitalium, HIV, genital herpes, and syphilis and associated risk behaviors in a cohort of African American women who have sex with women (AAWSW) in Birmingham, Alabama; (2) To compare exclusive AAWSW (during the past 12 months) to African American women who have sex with women and men (AAWSWM) in terms of socio-demographic characteristics, sexual risk behavior characteristics, and STI prevalence; and(3) To perform an exploratory prospective study of an age-matched (± 2 years) sub-group of exclusive AAWSW and AAWSWM over a 12 month time period to obtain data on differences in STI risk behaviors and STI incidence rates.

Official Title
-----------------
Sexually Transmitted Infections Among African American Women Who Have Sex With Women

Conditions
-----------------
Sexually Transmitted Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female gender, self-identification as African American Age of 16 years or older, self report of sexual contact (oral, vaginal, or anal) with another female within the past 12 months English speaking The ability to give written informed consent. For the sub-groups of women being followed prospectively, they have to have at least one active female sexual partner (AAWSW group) or at least one active female and male sexual partner (AAWSWM group) at the time of enrollment into the study. Exclusion Criteria: Pregnant or nursing and the inability or unwillingness to give written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AAWSW/AAWSWM<br>African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexually Transmitted Infection Diagnosis |  | 1 year |
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.

Detailed Description
-----------------
The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease. Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations. Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed. In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.

Official Title
-----------------
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis

Conditions
-----------------
Food (Shrimp) Allergy

Intervention / Treatment
-----------------
* Procedure: shrimp challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a history of shrimp allergy Exclusion Criteria: severe anaphylactic reaction from seafood pregnancy underlying diseases such as cardiovascular, hepatobiliary, and renal diseases on systemic corticosteroid or β-blocking agents

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shrim<br> | Procedure: shrimp challenge<br>* Patients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group<br>* Other names: open food challenge;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Serum tryptases |  | baseline and 60 minutes after the onset of symptoms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tryptases, anaphylaxis, shrimp allergy
Golgi Protein for HCC Diagnosis

Study Overview
=================
Brief Summary
-----------------
This case-control study was conducted on 90 patients who were equally divided into two groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using ELISA technique

Official Title
-----------------
Golgi Protein 73 for Diagnosis of HCC in Egyptian Patients

Conditions
-----------------
Screening for Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Serum Golgi Protein 73


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients were older than 18 years. Exclusion Criteria: patients with hepatic focal lesions not due to HCC such as Hemangioma, Hepatic cyst, and liver metastases; patients infected with HIV; patients with any autoimmune disease; or patients with metastatic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| HCC<br> | Diagnostic Test: Serum Golgi Protein 73<br>* Serum test<br>|
| liver cirrhosis No HCC<br> | Diagnostic Test: Serum Golgi Protein 73<br>* Serum test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Golgi protein correlated with presence of HCC |  | within one year |
Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use

Study Overview
=================
Brief Summary
-----------------
This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.

Official Title
-----------------
A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus Prescribed Saxagliptin by patient's attending physician Exclusion Criteria: Known allergic or serious adverse reaction to Saxagliptin Pregnant or breastfeeding patients

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 |
| --- | --- | --- |
| Adverse events observed during the treatment duration |  | Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up | 
| Clinical Response determined by cure rate |  | Up to three (3) months after initiation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saxagliptin, type 2 diabetes, clinical practice
Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

Study Overview
=================
Brief Summary
-----------------
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

Detailed Description
-----------------
The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

Official Title
-----------------
Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination

Conditions
-----------------
HIV, Rabies

Intervention / Treatment
-----------------
* Biological: rabies vaccines on day 0 and 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected patients 18-60 years of age Ever received primary rabies immunization Exclusion Criteria: currently have any active opportunistic infections have received blood or blood product within previous 3 months history of allergy to vaccine or any vaccine components currently received anti-malarial drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rabies vaccines on day 0 and 3<br>Cell culture Rabies vaccines on day 0 and 3 | Biological: rabies vaccines on day 0 and 3<br>* All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies Neutralizing Antibody Titers | Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year. | Day 360 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rabies, HIV, booster, immune response