linjc16/ctgov huggingface dataset:
Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.

Official Title
-----------------
6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients

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

Intervention / Treatment
-----------------
* Drug: exenatide (Byetta)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes subjects 40 to 80 years body mass index (BMI) between 25 and 40 kg/m² baseline glycated haemoglobin (HbA1c) > 7.0 %, despite a maximally-tolerated combined oral therapy with a BCF stimulant (sulfonylurea or repaglinide) plus metformin Exclusion Criteria: previous or current use of glitazone previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine previous exposure to GLP-1 receptor agonist or DPP-4 inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exenatide (Byetta)|all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in HbA1c |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T2DM, exenatide, HbA1c, weight, waist circumference, insulin sensitivity, beta-cell function
Long-term Clinical Outcomes in Patients With FFR Guided-Deferred Coronary Lesions, Assessed by IVUS Analysis

Study Overview
=================
Brief Summary
-----------------
This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.

Detailed Description
-----------------
From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included. Target patient screening The database will select patients who meet the selection and exclusion criteria. target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record. coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter. intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).

Official Title
-----------------
Long-term Clinical Outcomes in Patients With FFR GuidEd-DeFERred CoRonAry Lesions, Assessed by IVUS Analysis

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject over 19 years old Patients with mild or moderate stenosis lesions on coronary angiography Patients with lesions with FFR values greater than 0.80 Patients with analytical intravascular ultrasound images Exclusion Criteria: Left main lesion History of coronary artery bypass grafting Patients with lower left ventricular ejection fraction (<25%)

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| patient-oriented composite outcome | all-cause death, myocardial infarction and any revascularization | during 5-year |
Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Tadalafil may lower the pulmonary artery pressure in patients with Chronic Obstructive Lung Disease and secondary pulmonary hypertension and thereby improve patients quality of life.

Detailed Description
-----------------
Twenty outpatients with Chronic Obstructive Lung Disease (COPD) and secondary pulmonary hypertension are treated in a cross-over design with Tadalafil or placebo for 4 weeks. Primary effect parameter is 6 min. walking test.

Official Title
-----------------
Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Lung Disease

Intervention / Treatment
-----------------
* Drug: Tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Chronic obstructive lung disease Exclusion Criteria Patients with asthma

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil treatment 40 mg<br> | Drug: Tadalafil<br>* 40 mg tablet<br>* Other names: PDE5 inhibitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 min. walking test |  | 6 months |
Nutritional Risk Factors for Hip Fracture: a Case Control Study

Study Overview
=================
Brief Summary
-----------------
Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the low BMI per se that increases risk of hip fracture or if specific micro-nutrients contribute. The investigators want to elucidate this aspect in a case control study studying micronutrients in serum and bone turnover markers of hip fracture patients compared with controls of the same age.

Official Title
-----------------
Nutritional Risk Factors for Hip Fracture: a Case Control Study

Conditions
-----------------
Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture. Exclusion Criteria: Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable. Regarded as moribund at admittance. Absence of a valid informed consent or assent.
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 |
| --- | --- |
| Cases<br>Hip fracture patients participating in a randomised controlled trial (RCT) of orthogeriatric care (ClinicalTrials.gov NCT01009268) | |
| Controls<br>A group of voluntary elderly persons without a history of hip fracture, recruited specifically for this purpose | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| micronutrient association with increased risk of hip fracture | Blood was drawn for micronutrient analysis in hip fracture patients and in controls | At admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Are micronutrients related to bone turnover markers | Blood was drawn for bone turnover analysis. Correlation analysis with micronutrients was performed | At admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture, risk factors, vitamin K1, vitamin D, bone turnover markers, osteocalcin, undercarboxylated osteocalcin, bone specific alkaline phosphatase (BALP), insulin like growth factor 1 (IGF1), parathyroid hormone (PTH)
Effect of Accelerated RTH in Squamous Cell Carcinoma in Head and Neck

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy of the accelerated radiotherapy in squamous cell carcinoma of head and neck

Detailed Description
-----------------
HNSCC is the sixth most common cancer worldwide, with 890.000 new cases and 450.000 deaths in 2018. The incidence of HNSCC continues to rise and is anticipated to increase by 30% (that is, 1.08 million new cases annually) by 2030. Squamous cell carcinoma constitutes 90% of all head and neck cancers and it predominates in males. Risk factors such as cigarette consumption and alcohol consumption, are well established. Treatment decisions are guided by clinic-pathologic factors such as age and stage. Treatment of the majority of patients with HNSCC requires multimodality approaches. Radiotherapy or surgery alone can be considered as the standard treatment modality for patients having early head and neck squamous cell carcinoma. When conventionally fractionated radiotherapy is used, long-term tumor control can be achieved in less than 30% of patients with advanced head and neck carcinomas.

Official Title
-----------------
Retrospective Study of Effect of Accelerated Radiation Therapy , Six Fractions Per Week , for Squamous Cell Carcinoma of Head and Neck.

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of (18 up to 75 years of age) Performance status of 0-2 according to ECOG scale. Patients with no prior chemotherapy, radiotherapy or surgery except for biopsy. Exclusion Criteria: Patients with previous irradiation to head and neck. Pregnant or lactating women. Patients with impaired heart or lung diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine progression-free survival rate | Determine the toxicity and loco-regional control by using accelerated RTH in squamous cell carcinoma in head and neck | Baseline |
Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Study Overview
=================
Brief Summary
-----------------
This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.

Official Title
-----------------
Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Conditions
-----------------
Axial Spondyloarthritis, Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: secukinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years. Diagnosed with axSpA or PsA. Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection. Had at least 3 months follow up from first bDMARD administration. Patients with EHRs. Exclusion Criteria: • Receiving bDMARD within a clinical trial from January 2018 to data collection.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axial Spondyloarthritis Patients<br>Patients with Axial Spondyloarthritis | Drug: secukinumab<br>* all patients who received secukinumab<br>|
| Psoriatic Arthritis Patients<br>Patients with Psoriatic Arthritis | Drug: secukinumab<br>* all patients who received secukinumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment | Disease control was defined as: For Axial Spondyloarthritis (axSpA) population: Bath Ankylosing Spondylitis Functional Index (BASDAI) score < 4. If BASDAI was not available, Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 was used. For Psoriatic Arthritis (PsA) population: Disease Activity in PSoriatic Arthritis (DAPSA) score < 14. If DAPSA was not available, Disease activity score 28 (DAS-28) < 3.2 was used. | month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axial spondyloarthritis;, Psoriatic Arthritis;, electronic health records;, natural language processing;, artificial intelligence
Prediction Model for Minimizing the Risk of Median Nerve Puncture

Study Overview
=================
Brief Summary
-----------------
The main aim of this study was to correlate anthropometric measures of the forearm in healthy subjects with the ultrasound pronator teres depth to determine the needle length in order to avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional study, was carried out in order to perform a predictive model for the median nerve depth into the pronator teres muscle using a decision tree analysis algorithm.

Official Title
-----------------
Ultrasound and Anthropometric Prediction Model for Minimizing the Risk of Median Nerve Puncture With Dry Needling Approach Into the Pronator Teres Muscle

Conditions
-----------------
Pronator Teres Nerve Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asinthomatic subjets Exclusion Criteria: Pain in the 3 moths before in the forearm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asinthomatic<br>The only group evaluated | Diagnostic Test: Ultrasound<br>* Ultrasound and Anthropometric meassures<br>* Other names: Anthropometric meassures;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle thicknesses | With ultrasound | 10 minutes | 
| Median Nerve depth | With ultrasound | 5 minutes | 
| Forearm Perimeter | in cm | 2 minutes | 
| Forearm Longitude | in cm | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry needling, median nerve, Pronator Teres
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.

Detailed Description
-----------------
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.

Official Title
-----------------
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Rectus muscle approximation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who will undergo first elective cesarean section Singleton pregnancy Exclusion Criteria: Previous abdominal or pelvic surgery Medical or psychiatric disease Previous pelvic inflammatory disease Obesity Allergy to analgesics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectus muscle approximation<br>Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section. | Procedure: Rectus muscle approximation<br>* The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.<br>|
| No Intervention: Control<br>No approximation for the rectus muscle will be done for the control group in cesarean section. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early pain score | Early pain score will be assessed by an investigator for patients | 24 hours after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late pain score | Late pain score will be assessed by an investigator for patients | 48 hours after cesarean section |
The Surgical Gastrointestinal Diseases Registry Protocol

Study Overview
=================
Brief Summary
-----------------
By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.

Detailed Description
-----------------
Researchers are asking for past, current and future medical record information.

Official Title
-----------------
The Surgical Gastrointestinal Diseases Registry Protocol

Conditions
-----------------
Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Other: Research Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects being seen by the University of Pittsburgh Medical Center for gastrointestinal diseases

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 |
| --- |
|Other: Research Registry|We are asking for permission to allow us to place subject's past, current and future medical record information into a Surgical Gastrointestinal Disease Registry. By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allow researchers to review and study the medical records of many individuals to answer questions about their disease and its treatment. |  | 1-N/A | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It will help researchers identify and recruit subjects who are eligible for participation in future research studies. |  | 1-N/A |