linjc16/ctgov huggingface dataset:
Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in ART-Naive & First Switch Patients

Study Overview
=================
Brief Summary
-----------------
Hypotension does not occur with Maraviroc at a dose of 600 mg/day

Detailed Description
-----------------
A qualitative description of orthostatic hypotension in patients receiving once daily Maraviroc at 600 mg with Epzicom measured by a validated questionnaire

Official Title
-----------------
Observational Study of the Safety and Efficacy of Nucleoside Reverse Transcriptase Inhibitor Backbones With Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in Antiretroviral Therapy-Naive Patients and First-Switch Subjects

Conditions
-----------------
Drug-induced Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epzicom Maraviroc once daily dosing Exclusion Criteria: Maraviroc with any other back bone

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- |
| Patients on once daily Maraviroc<br>Maraviroc tablet 600 mg once daily 48 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension related to once daily Maraviroc dosing | Blood pressure lowering secondary to Maraviroc 600 mg once daily dosing | 48 Weeks |
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Official Title
-----------------
A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)

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

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate (+) metformin hydrochloride
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has type 2 diabetes mellitus Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months Patient is a male, or a female who is unlikely to conceive Exclusion Criteria: Patient has type 1 diabetes mellitus or history of ketoacidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: drug | Drug: sitagliptin phosphate (+) metformin hydrochloride<br>* sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.<br>* Other names: Janumet™;|
| Active Comparator: 2<br>Arm 2: active comparator | Drug: metformin<br>* metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 18 | A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | Baseline and Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With A1C < 7.0% at Week 18 |  | Week 18 | 
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL. | Baseline and Week 18 |
Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis. All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.

Detailed Description
-----------------
All patients with acute pancreatitis are evaluated according to modified Atlanta classification acute pancreatitis severity scores. Blood serum, urine and DNA samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours. CT is performed in al patients to evaluate necrosis of pancreas Day 5-7 since hospital admission. If necrosis is not present follow-up is stopped.

Official Title
-----------------
Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Diagnostic Test: CT Scan Day 5-7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no prior diagnosis of acute pancreatitis admission to the hospital within 2 days since the clinical symptoms confirmed diagnosis of acute pancreatitis Exclusion Criteria: chronic pancreatitis pancreatic cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute pancreatitis<br>First time acute pancreatitis. No later than 2 days since the clinical symptoms started. | Diagnostic Test: CT Scan Day 5-7<br>* Computed Tomography on Day 5-7 according to a clinical protocol.<br>|
| Healthy<br>No major systemic illness | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings | Different molecular weight Heat Shock proteins role while developing acute pancreatitis. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure pancreas cells activity while applying Heat Shock Protein inhibitors | To establish a mechanism explaining the potential use of heat shock proteins inhibitors/ activators for treatment of acute pancreatitis | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heat Shock Proteins, early diagnosis
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)

Study Overview
=================
Brief Summary
-----------------
To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.

Official Title
-----------------
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Procedure: complete repair
* Procedure: partial repair of the abdominal wall


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent from the patient or his/her legal representative Incisional hernia requiring elective surgical repair Exclusion Criteria: No written informed consent Emergency surgery (incarcerated hernia) All incisional or parastomal hernias not originating at the midline All recurrent hernias All patients with mesh placed intra-abdominally during surgery have to be withdrawn

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: complete repair|nan|
|Procedure: partial repair of the abdominal wall|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative morbidity rate |  |  | 
| Postoperative pain |  |  | 
| Long term complication rate |  |  | 
| Recurrence rate |  | 3 years |
Prediction of Response to IUCD Associated Menorrhagia Using Doppler

Study Overview
=================
Brief Summary
-----------------
Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia

Official Title
-----------------
Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia

Conditions
-----------------
Women's Health: Amenorrhea/Dysmenorrhea

Intervention / Treatment
-----------------
* Device: Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD copper T 380 A insertion Exclusion Criteria: history of bleeding tendency history of abnormal uterine bleeding due to other causes history of active liver disease history of antiplatelet or anticoagulant intake in the last month history of thyroid disease history of endometritis history of allergy to NSAIDs Adenomyosis women having contraindications to use NSAIDs e.g. peptic ulcer Insulin dependant diabetes mellitus

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm clinical trial<br> | Device: Doppler<br>* Doing doppler for women having IUCD associated menorrhagia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia) | Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters | 1 year |
Nosocomial Influenza Surveillance 2018 - 2022

Study Overview
=================
Brief Summary
-----------------
Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals. The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset. The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds

Official Title
-----------------
Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.

Conditions
-----------------
Hospital-Acquired Infection, Influenza

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients and health-care workers in a participating unit in the study, more than 18 years old, volunteers, who present an influenza-like illness defined by fever > 37,8°C or/and cough or sore throat. Exclusion Criteria: -Everyone who does not present the inclusion criteria.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Influenza-like illness group<br> | Other: Questionnaire<br>* An interview to collect some informations will be done: demographic informations, medical history, vaccination against influenza status, symptoms and virological informations. Then, a nasal swab was performed in order to identified the influenza virus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients and health-care workers who present an influenza illness. | An interview to collect some informations will be done to evaluate if participants present symptoms of an inflenza illness (fever > 37,8°C or/and cough or sore throat). Then, a nasal swab will be performed in order to identified the influenza virus. | 5 days maximum |
Functional Review of Distal Biceps Re-Insertion

Study Overview
=================
Brief Summary
-----------------
This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps successfully restores elbow function.

Conditions
-----------------
Distal Biceps Ruptures

Intervention / Treatment
-----------------
* Procedure: Distal Biceps Re-Insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary distal biceps repair with endobutton at least two years from date of surgery Exclusion Criteria: any ipsilateral wrist, forearm, or elbow condition any contraindication to having an MRI

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endobutton<br> | Procedure: Distal Biceps Re-Insertion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
We identify all patients who had undergone primary total knee arthroplsty(TKA) from April 1, 2015, to March 30, 2016. Patients are grouped by uric acid level. The knee society score(KSS score) and the hospital for special surgery knee score (HSS score) before the surgery and 6 years after the surgery will be collected. Also the clinical data will be collected.

Official Title
-----------------
Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty

Conditions
-----------------
Arthritis Knee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had undergone primary TKA from April 1, 2015, to March 30, 2016 Exclusion Criteria: (1) infection, (2) rheumatoid arthritis, (3) ankylosing spondylitis, (4) revision surgery, (5) patients with unicondylar knee replacement, (6) patients who have been diagnosed with gout or previous gouty symptoms, and (7) patients combined with preoperative redness or swelling.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| patients with normal uric acid level<br>The uric acid level is below 420 μmol/L in men and 360 μmol/L in women | |
| patients with high uric acid level<br>The uric acid level is higher than 420 μmol/L in men and 360 μmol/L in women. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP | C-reactive protein | within 7 days after surgery | 
| temperature | The nurses measured the body temperature by Non-contact Ear Thermometer. The temperatures were measured at 6 am, 14 pm, and 18 pm every day, and the patients were kept admitted till day 5. The highest one was chosen for analysis. | within 7 days after surgery | 
| HSS score | the hospital for special surgery knee score | 6 years after surgery | 
| KSS scores | knee society score | 6 years after surgery |
The Expression of Matrix Metalloproteinase 13, Tissue Inhibitor of Metalloproteinases 3, and Calcium-sensing Receptor in Human Trabecular Meshwork

Study Overview
=================
Brief Summary
-----------------
This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining method and western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and Eosin staining.

Official Title
-----------------
The Expression of Matrix Metalloproteinase 13（MMP13）, Tissue Inhibitor of Metalloproteinases 3（TIMP13）, and Calcium-sensing Receptor（CaSR） in Human Trabecular Meshwork

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Procedure: trabeculectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intraocular pressure greater than 22 mmHg with two or more medications wide anterior chamber angle glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry Exclusion Criteria: the presence of any secondary form of glaucoma including exfoliation syndrome or a history of ocular trauma, etc

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trabeculectomy<br> | Procedure: trabeculectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the expressions of matrix metalloproteinase 13 and calcium-sensing receptor |  | one hour after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological changes of trabecular meshwork |  | one hour after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3, calcium-sensing receptor, trabecular meshwork, open-angle glaucoma
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers

Study Overview
=================
Brief Summary
-----------------
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.

Official Title
-----------------
A Phase II, Open-label, Randomised, Dose-finding Study to Compare the Efficacy (in Terms of Clearance of RhD-positive RBCs) and Safety of LFB-R593, a Monoclonal Anti-RhD Antibody vs a Polyclonal Anti-RhD Immunoglobulin in Healthy RhD Negative Volunteers

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

Intervention / Treatment
-----------------
* Drug: polyclonal anti-D immunoglobulin
* Drug: monoclonal anti-D immunoglobulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy RhD-negative volunteers Males and definitively sterile females No prior sensitization to RhD antigen Exclusion Criteria: Healthy RhD-positive volunteers

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polyclonal anti-D immunoglobulin<br> | Drug: polyclonal anti-D immunoglobulin<br>* single injection of 300 µg<br>|
| Experimental: Monoclonal anti-D immunoglobulin<br> | Drug: monoclonal anti-D immunoglobulin<br>* Comparison of different dosages of LFB-R593<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of RhD-positive red blood cells |  | within 2 weeks after RBC injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of foeto-maternal allo-immunisation