linjc16/ctgov huggingface dataset:
Forearm Position in Subpectoral Biceps Tenodesis

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to compare two different forearm positions, extension-pronation (EP) or neutral, for fixation of the long head of the biceps tendon (LHB) in biceps tenodesis.

Detailed Description
-----------------
Long head of biceps pathologies have been regarded as a source of anterior shoulder pain and disability. Tenodesis is preferable surgical choice for especially young patients to to eliminate anterior shoulder pain. The optimal position of the elbow and forearm during tenodesis is a debated topic. The investigators aimed to evaluate pain and strength loss after biceps tenodesis fixed at extension-pronation (EP) and neutral positions. The investigators aimed to find the most appropriate and anatomical arm position that gives better clinical and functional results.

Official Title
-----------------
Does Forearm Position Matter in Subpectoral Biceps Tenodesis? A Randomised Controlled Trial

Conditions
-----------------
Biceps Tendon Disorder

Intervention / Treatment
-----------------
* Procedure: Fixation while forearm in extension-pronation position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Participants with diagnosis of chronic biceps tendinitis Exclusion Criteria: - Participants who had undergone rotator cuff repair surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Fixated in the EP position<br>Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the extension-pronation (EP) position | Procedure: Fixation while forearm in extension-pronation position<br>* Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.<br>|
| No Intervention: Fixated in the neutral position<br>Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the neutral position (elbow 90 degrees flexed and hands positioned with the thump pointing up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the two groups in terms of functional score | The investigators evaluated the functional results of the patients with the Ases score. 100 points is the best result in 17 questions. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biceps, tenodesis, forearm, shoulder arthroscopy, position
Proteomic Analysis of Human Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma.

Official Title
-----------------
Proteomic Analysis of Human Hepatocellular Carcinoma Associated With Portal Vein Thrombosis

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Procedure: Operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arm A: Hepatocellular carcinoma with vessel invasion: hepatocellular carcionoma, pathologic diagnosed. image documented vessel invasion, including portal vein thrombosis eligible for surgical intervension. Arm B: hepatocellular carcinoma without vessel invasion: hepatocellular carcinoma, pathologic diagnosed or clinical diagnosed according to EASL criteria. no vessel invasion on image. Arm C: Healthy hepatitis carrier: patients age >18 years old with hepatitis B or C normal liver function.

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Operation|Operation for clinically evaluated resectable hepatocelluar carcinoma. Compare the different expression of protein between tumor, non-tumor and tumor with vascular invasion part.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Evidence of clinically definite vascular invasion of hepatocellular carcinoma. Confirmed by operation. Compare the proteomic expression of tumor, non-tumor ans tumor tissue in vascular part. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, hepatocellular, Portal vein, Proteomics
A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Study Overview
=================
Brief Summary
-----------------
Bloom Technologies is developing a wearable device for monitoring pregnancy. In this study, Bloom Technologies wants to investigate the reliability of this new technology. For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.

Official Title
-----------------
A Cross-sectional, Interventional, Exploratory Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Device: Biopotentials measurement with gtec device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman ≥ 18 years old Gestational age ≥ 30 weeks and 0 days Singleton pregnancy Ability to read and understand English or Spanish Willingness to participate in the study Exclusion Criteria: Implanted pacemaker or any other implanted electrical device History of allergies to skin adhesives Irritated or lesioned skin at the electrodes locations

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gtec<br> | Device: Biopotentials measurement with gtec device<br>* A measurement of 40 minutes is performed with the gtec g.Hlamp to collect biopotential signals. 32 electrodes are attached to the body (abdomen, thorax and back).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability in fetal heart rate extraction | Percentage of a recording with a fetal heart rate signal extracted | 40 minutes | 
| Reliability in maternal heart rate extraction | Percentage of a recording with a maternal heart rate signal extracted | 40 minutes |
Proteomic Assessment of Preterm Birth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.

Official Title
-----------------
Proteomic Assessment of Preterm Birth

Conditions
-----------------
Preterm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years or older. Subject has a singleton pregnancy. Subject is able to provide consent. Exclusion Criteria: Subject is pregnant with more than one fetus. There is a known or suspected fetal anomaly.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with preterm delivery<br> | |
| Women without preterm delivery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous Preterm Birth |  | August 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm Birth, Proteomics
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxcarbazepine or any comparable or similar product.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxcarbazepine then Trileptal<br>600 mg suspension | Drug: Oxcarbazepine<br> <br> * Other names: Trileptal;|
| Active Comparator: Trileptal then Oxcarbazepine<br>600 mg suspension | Drug: Oxcarbazepine<br> <br> * Other names: Trileptal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax | Blood sampling taken during specified time points to determine bioequivalence | 10 days |
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

Study Overview
=================
Brief Summary
-----------------
The goals of this study are: To assess the impact of genetic testing based on how it alters behaviors, to assess the utility of serum biomarker measurement in combination with genetic testing, to assess the utility of genetic counseling in personal analysis of risk for age-related macular degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal neovascularization (CNV).

Official Title
-----------------
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

Conditions
-----------------
Age-Related Macular Degeneration, Choroidal Neovascularization, Genetic Counseling

Intervention / Treatment
-----------------
* Behavioral: Early disclosure
* Behavioral: Late disclosure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary. Exclusion Criteria: Individuals with a personal history of AMD are not eligible. Non-caucasian individuals are not eligible. Employees of the Moran Eye Center are not eligible. Individuals with a personal history of previous AMD genetic risk testing are not eligible. Individuals with a major psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early disclosure<br>Early disclosure group receives results of genetic testing at Week 4 | Behavioral: Early disclosure<br> <br> |
| Active Comparator: Late disclosure<br>Late disclosure group receives results of genetic testing at final study visit (Month 12) | Behavioral: Late disclosure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in carotenoid levels in the skin | Carotenoid levels in the skin are measured non-invasively at baseline and again at 12 months. Carotenoid levels are a biomarker of fruit and vegetable intake. | Twelve months | 
| Change in carotenoid levels in the eyes | Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months. | Twelve months |
France PCI Registry : National Observatory of Interventional Cardiology

Study Overview
=================
Brief Summary
-----------------
Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014. CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.

Official Title
-----------------
France PCI Registry : National Observatory of Interventional Cardiology

Conditions
-----------------
STEMI, Interventional, Cardiology, Angioplasty, Coronary, Database

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age =>18 years at enrollment Patient who have had a coronary angiogram or angioplasty Exclusion Criteria: Patient who didn't want to participated

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 |
| --- | --- | --- |
| Census of interventional cardiology activity | Census, follow-up and monitoring of patients during 1 year, after a coronary angioplasty | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of STEMI patient care time | Manage STEMI < H24 patients, record and monitor time intervals from first pain to first medical contact in order to achieve and maintain the quality of care | Less than 24 hours |
St. Jude Medical Angio-Seal VIP Vascular Closure Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.

Official Title
-----------------
Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

Conditions
-----------------
Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure

Intervention / Treatment
-----------------
* Device: Angio-Seal VIP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access. Patient is of legal age. Patient has given written informed consent for participation prior to the procedure. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements. Exclusion Criteria: Patient is unable to provide written informed consent. Patient has an inability or is unwilling to adhere to data collection and follow-up requirements. Patients who are pregnant or lactating. Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).

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 |
| --- | --- |
| Other: Angio-Seal VIP<br> | Device: Angio-Seal VIP<br>* Vascular Closure Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device deployment characteristics and performance | Device Deployment Success and rationale for non-deployment, procedural circumstances present during deployment such as type of procedure and procedure duration, Time to hemostasis, and assessment of vascular complications prior to leaving the cath lab. Data will be summarized using descriptive statistics in addition to listings or summary data tables being provided. | At procedure | 
| Adverse events (vascular complications) | Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure. | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis |  | The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes. | 
| Rate of minor vascular complications |  | Ongoing |
Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

Study Overview
=================
Brief Summary
-----------------
Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.

Detailed Description
-----------------
In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.

Official Title
-----------------
Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days

Conditions
-----------------
Helicobacter Infections

Intervention / Treatment
-----------------
* Drug: Sequential therapy
* Drug: Triple therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Helicobacter pylori infection in biopsy Eradication required Exclusion Criteria: Antibiotic received two weeks prior Previous treatment for H pylori infection Allergy to any of the treatment drugs Smoking > 5 cigarettes daily.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential therapy<br>Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days | Drug: Sequential therapy<br>* Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days<br>* Other names: Omeprazole-Amoxicillin-Clarithromycin-Metronidazole;|
| Active Comparator: Triple therapy<br>Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days | Drug: Triple therapy<br>* Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days<br>* Other names: Omeprazole-Clarithromycin-Metronidazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication | Helicobacter pylori in gastric biopsy | 6 to 8 week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Nausea, vomiting, stomach ache | two weeks after beginning of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sequential therapy, Triple therapy, Eradication