linjc16/ctgov huggingface dataset:
Coronary Artery Disease (CAD) in Patients HIV-infected

Study Overview
=================
Brief Summary
-----------------
HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

Official Title
-----------------
ROLE OF IMMUNE ACTIVATION PROFILES IN CORONARY ATHEROTHROMBOSIS IN PATIENTS HIV-1-INFECTED ON EFFECTIVE ANTIRETROVIRAL THERAPY

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

Intervention / Treatment
-----------------
* Other: coronary computed tomographic angiographic (CCTA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected patients >= 45 years with 2 or more CV risk factors currently on ART HIV-RNA < 50 copies >= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months Exclusion Criteria: Sign of coronary pathology (chest pain, syncope, dyspnea). ATCD of allergy to IV contrast agents Chronic inflammatory disease other than HIV Subject to a measure for the protection of justice

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| HIV-1 patients and treated effectively for more than 12 months<br>X-ray examination with contrast by a 64-slice CT coronary angiography. | Other: coronary computed tomographic angiographic (CCTA)<br>* x-ray examination with contrast by a 64-slice CT coronary angiography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between a particular profile of immune activation in patients HIV under treatment presenting cardiovascular risk factors and the presence of coronary atheromatous plaques | Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the bacterial populations constituting the intestinal microbiota in patients infected with HIV and look for a microbiotic signature in patients with subclinical atherothrombosis. | microbial translocation (16S DNA) | 24 months |
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is a 15-month study with two phases. During the first 12-month phase of this study, patients will be randomly assigned to receive either active study drug or placebo (approximately half of all patients will be on active study drug, the other half on placebo). The second phase is a 3-month randomized withdrawal period. For this phase approximately 10% of the patients will remain on the active drug.

Detailed Description
-----------------
This is a placebo-controlled, parallel-groups, 12 month, double-blind study, followed by a 3-month, double-blind, randomized withdrawal period to evaluate the efficacy and safety of an investigational drug (currently approved for other indications) to slow the progression of symptoms of AD. Patients with probable AD according to NINCDS-ADRDA criteria who have a Mini Mental State Examination (MMSE) score between 13 and 26 inclusive will be eligible for participation in the study. Patients on stable doses of marketed cholinesterase inhibitors approved for the treatment of AD (except for tacrine) for at least 3 months are eligible for study entry. Use of NSAIDs (except aspirin 81 mg per day) is not allowed during the study.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Investigational drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or female and at least 50 years of age or older Female patients must be postmenopausal or surgically sterilized Clinical diagnosis of AD Patient must be in good health except for AD diagnosis Patient must have informant/caregiver who can monitor and assist patient during the study Exclusion Criteria: Patient is living in a nursing home or skilled nursing facility Women will be ineligible if not postmenopausal or surgically sterilized Site physician or Sponsor may exclude patients with serious medical problems such as cancer, cardiovascular disease, major neurological or psychiatric illness, thyroid disease, or major head trauma

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Investigational drug|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Investigational Drug
Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.

Detailed Description
-----------------
Please see brief summary above.

Official Title
-----------------
Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Conditions
-----------------
Tobacco Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smokers must be over the age of 18, Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group. Must smoke at least 10 cigarettes per day Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22. Exclusion Criteria: Those unable to give informed consent. Psychotic disorders other than schizophrenia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-psychiatric smokers<br>Smokers not meeting criteria for Schizophrenia or Schizoaffective Disorder | |
| Smokers with Schizophrenia<br>Smokers meeting criteria for schizophrenia or schizoaffective disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mirror-tracing Persistence (in Seconds) | Number of seconds participants continued working on a mirror tracing task before giving up. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence as a Prospective Predictor of Smoking Cessation | Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables. | 6 months |
Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM

Study Overview
=================
Brief Summary
-----------------
This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

Detailed Description
-----------------
Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety. Primary endpoint - HbA1c change after 24 weeks treatment Secondary endpoint Average rate of change in HbA1c after baseline Ratio of subjects with HbA1c<7% after 24 weeks Ratio of subjects with HbA1c<6.5% after 24 weeks Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease Safety endpoint : Adverse Event

Official Title
-----------------
A Non-interventional, Single Group, Open-label, Multicenter Observational Study to Evaluate the Efficacy and Safety of Anagliptin in Type 2 Diabetic Patients With Other DPP4is as Mono or Combination Therapy With Insufficient Glucose Control

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

Intervention / Treatment
-----------------
* Drug: Anagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years of age at the time of consenting Understands and is willing to sign an informed consent form (ICF) HbA1c≥7.0% within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks Exclusion Criteria: Prior exposure to Anagliptin

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anagliptin|Anagliptin treatment for 24weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1C |  | after 24weeks treatment |
ESWT for Shoulder Pain in Patients With Brain Damage

Study Overview
=================
Brief Summary
-----------------
This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

Detailed Description
-----------------
6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range) on subscapularis and lesser and greater tuberlces of humerus to reduce pain in patients with brain damage

Official Title
-----------------
The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage

Conditions
-----------------
Brain Damage, Hypoxic, Stroke, Brain Tumor, ICH

Intervention / Treatment
-----------------
* Device: Extracorporeal shockwave therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brain damaged patient confirmed in the brain image 1 month after brain damage Pain in hemiplegic shoulder areas more than 4 points on the numerical scale (NRS) Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE) Age: 20 and older Person who has agreed in writing to decide his or her participation and comply with the precautions Exclusion Criteria: Pain due to trauma Injection treatments two weeks before participating in the study Severe coagulopathy (excluding antiplatelet use) Impaired cognition

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range | Device: Extracorporeal shockwave therapy<br>* Extracorporeal shockwave therapy 6 times during 2 weeks<br>|
| Sham Comparator: Control group<br>Sham therapy | Device: Extracorporeal shockwave therapy<br>* Extracorporeal shockwave therapy 6 times during 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | Pain intensity (0-10, ordinal scale) | Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index (SPADI) | Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst) | Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal shockwave therapy, Brain damage, Pain
A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Parallel Group Study of Uridine 5'-Triphosphate (UTP) Solution for Inhalation as an Adjunct in the Diagnosis of Lung Cancer by Sputum Cytology

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy have FEV1 greater than or equal to 40% predicted normal for age and height Exclusion Criteria: have obtained a confirmed diagnosis for the current suspicious lung tumor have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing

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: Uridine 5'-Triphosphate (UTP) Solution for Inhalation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of lung cancers (malignancies) diagnosed by sputum cytology |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology; |  |  | 
| Proportion of small and large lung cancers diagnosed by sputum cytology; |  |  | 
| Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology; |  |  | 
| Wet weight of sputum expectorated; |  |  | 
| Macrophage content of sputum |  |  |
Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy

Study Overview
=================
Brief Summary
-----------------
In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

Detailed Description
-----------------
Outcome Measures : VAS score Use of analgesics during operation and postoperative period

Official Title
-----------------
Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, During Gynecological Laparoscopic Surgery

Conditions
-----------------
Gynecological Laparoscopy

Intervention / Treatment
-----------------
* Drug: 10 mLRopivacaine 1%
* Drug: Water for injection
* Drug: 10 mL Ropivacaine 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy Patient not participating in other medical study at present or during the last 30 days Patient is capable of reading, understanding and signing on an informed consent Age 18 years and above ASA physical status grade 1-2 Exclusion Criteria: Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol Acute pelvic inflammatory disease Coumadin or aspirin treatment Significant arrythmias Analgesic treatment for chronic pain BMI>35

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br> | Drug: 10 mLRopivacaine 1%<br>* Intraperitoneal nebulization of 10 mL Ropivacaine 1%<br>Drug: 10 mL Ropivacaine 1%<br>* Intraperitoneal nebulization of 10 mL Ropivacaine 1%<br>|
| Placebo Comparator: Water for injection<br> | Drug: Water for injection<br>* Intraperitoneal nebulization of 10 mL water for injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score (VAS) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Analgesics |  | 24 hours |
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

Study Overview
=================
Brief Summary
-----------------
The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.

Official Title
-----------------
Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction

Conditions
-----------------
Meibomian Gland Dysfunction

Intervention / Treatment
-----------------
* Drug: Systane Balance
* Drug: Optive Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schein symptom score (all 6 questions) of greater than 5, evidence of MGD changes in both eyes (i.e., lower eyelid secretion quality score greater than 1.0 (0 - 3 scale) OR gland dropout score greater than 1.0 (i.e., greater than 25% of entire lower eyelid) as demonstrated by meiboscopy, and corneal staining of grade 4.0 or greater (0 - 20 scale). Exclusion Criteria: contact lens wear, use of topical ocular medication other than artificial tears (use of Restasis is specifically excluded), unstable systemic medication use (i.e., anti-histamines, steroids, etc.), recent (within 6 months of study start) ocular trauma or surgery, diabetes, aqueous deficient dry eye (defined as a Schirmer I value (without anesthetic) of < 5 mm of wetting in 5 minutes in either eye), and use of punctal plugs. -Subjects taking omega 3 fatty acid supplements for dry eye can be included so long as their intake is stable for the prior six months and they meet the inclusion criteria above. -

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Balance<br>Artificial tear emulsion | Drug: Systane Balance<br>* Artificial tear emulsion drop<br>|
| Active Comparator: Optive Lubricant Eye Drops<br>Artificial tear | Drug: Optive Lubricant Eye Drops<br>* Artificial tear eye drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Film Breakup Time | time in seconds to observer a dark spot in the tear film | Measured 2 hours after in-office administration of a single drop of test solution | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, meibomian gland dysfunction, tear film break up time