linjc16/ctgov huggingface dataset:
A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

Official Title
-----------------
A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease

Conditions
-----------------
Atherosclerotic Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Lp(a) Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent History of ASCVD Exclusion Criteria: Participants known to be currently receiving investigational drug in a clinical study Participants with a diagnosis of end-stage renal disease or requiring dialysis Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with history of ASCVD<br>Participants with history of ASCVD with known or unknown Lp(a) values. | Other: Lp(a) Screening<br>* Participants will provide demographic information and have a blood draw for Lp(a) levels if they are unknown.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with elevated Lp(a) with documented history of ASCVD |  | Up to approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lp(a) Levels | Blood sampling will be performed in cases where Lp(a) values are not available at enrollment. In cases where Lp(a) values are available, data will be collected retrospectively. | Up to approximately 2 weeks | 
| Lp(a) Levels stratified by demographics and region |  | Up to approximately 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerotic Cardiovascular Disease, Lipoprotein(a)
Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group). .

Detailed Description
-----------------
The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group). Materials and methods 200 obese patients 4 groups. had been monitored in a private clinic, each group 50 patients number, with 35 females and 15 males who were already on treatment.

Official Title
-----------------
Combination of Topiramate(Conviban) and Empagliflozin(Jardiance) is Considered a Good Option for the Treatment of Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: The intervention being studied


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable weight in the previous 6 months. a sedentary lifestyle. no history of diabetes mellitus. taking medication that affects appetite, or weight within the past 6 months Exclusion Criteria: severe anemia hypothyroidism and hyperthyroidism Diabetes mellitus moderate to severe liver or kidney disease body mass index less than 30

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 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 |
| --- | --- |
| on topiramate<br>topiramate, conviban® group vs no treatment ( control group). | Drug: The intervention being studied<br>* Intervention Other Names have not been specified<br>* Other names: topiramate, conviban®;|
| on empagliflozine<br>empagliflozine, jardiance® vs no treatment ( control group). | Drug: The intervention being studied<br>* Intervention Other Names have not been specified<br>* Other names: topiramate, conviban®;|
| on topiramate plus empagliflozine<br>all patients' vs no treatment ( control group). | Drug: The intervention being studied<br>* Intervention Other Names have not been specified<br>* Other names: topiramate, conviban®;|
| no treatment<br>all patients' vs no treatment ( control group). | Drug: The intervention being studied<br>* Intervention Other Names have not been specified<br>* Other names: topiramate, conviban®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight | weight measurement | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, drug combination, empagliflozin(jardiance), topiramate(conviban)
Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.

Official Title
-----------------
Open Label, Multi-center, Phase 2 Study of KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) Previously Treated With First-Line Chemotherapy

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: KOS-1584


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV. Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC. Good performance status. Exclusion Criteria: Prior treatment with an epothilone. Known central nervous system (CNS) metastases. Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.

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 |
| --- | --- |
| Experimental: Single Arm 25mg/m2<br>KOS-1584 25mg/m2 | Drug: KOS-1584<br>* 25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.<br>* Other names: BMS-878271;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate of KOS-1584 |  | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584. |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
MRI Repository for Acute Stroke Clinical and Research Applications

Study Overview
=================
Brief Summary
-----------------
Stroke is one of the leading causes of death and long-term disability. A major unresolved problem in MRI-based stroke assessment is to relate image features to brain function in a way that can properly guide stratification for treatment and rehabilitation. This requires extracting meaningful and reproducible models of brain function from stroke images, a daunting task severely hindered by the great variability of lesion frequency and pattern. Large datasets are imperative to uncover possible lesion-function relationships. In this project the investigators will create a large database of acute strokes MRIs. The investigators will retrospectively archive an estimated 3,000 MRIs of patients with acute stroke, acquired at the Johns Hopkins Hospital, 2009-2019. This dataset will include 1.5 and 3 Tesla scans, diverse protocols and sequences (e.g., diffusion and perfusion weighted images (DWI/b0, PWI), T1, T2, FLAIR, susceptibility weighted images), with typical clinical low voxel resolution (4-7 mm3). Lesions will be initially delineated on DWI/b0, the most informative MRI sequence for acute stroke. After anonymization and defacing, two trained evaluators will perform the manual lesion segmentation. Two expert neuroradiologists will create consensual structured radiological reports with information about stroke type and location according to different criteria (e.g., 34 brain structures and 11 vascular territories). The investigators will also archive structured information from discharge (demographics, laboratory, and neurological evaluation of patients, including NIH stroke scale and modified Rankin scale, mRS), as well as the 90-days follow-up mRS.

Official Title
-----------------
MRI Repository for Acute Stroke Clinical and Research Applications

Conditions
-----------------
Stroke, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted at Hopkins Stroke center with the diagnosis of acute brain stroke Exclusion Criteria: Not performed MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Demographic and clinical data obtained via chart review | This is a hospital based retrospective collection of data for acute stroke from a ten-year period retrospective review of participant charts. | 1 year |
Failed/Difficult Colonoscopy Outcomes

Study Overview
=================
Brief Summary
-----------------
Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this removal is also known as polypectomy. Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a tertiary centre with extensive experience in difficult colonoscopy or have an alternative test such as CT scan. The investigators unit has accumulated significant experience related to previously failed colonoscopy and anecdotally appears to have a high success rate in completing the procedure. The purpose of this project is to describe the investigators technical approach to management of patients with previously failed colonoscopy. There is no additional intervention and the project is observational in nature. The investigators will collect data on patient characteristics, the reason for the failure and what technique was used to overcome the difficulty. The investigators will also note whether the final outcome of the technique had any impact on the overall management of the patient.

Official Title
-----------------
Outcomes of Patients With Failed or Difficult Colonoscopy at a Tertiary Referral Centre

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Procedure: Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously failed colonoscopy Referred to Westmead Endoscopy Unit for a complete colonoscopy 18 years or older Exclusion Criteria: Younger than 18 years Previously successful colonoscopy No previous colonoscopy attempted

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Failed/Difficult Colonoscopy<br>Patients referred for colonoscopy because of previously failed attempt at complete caecal intubation. | Procedure: Colonoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of reasons for failure of colonoscopy. | Listing and making note of techniques used to perform successful and complete colonoscopy. | 60 days |
Ambulatory Anesthesia and Light Therapy

Study Overview
=================
Brief Summary
-----------------
We previously evidenced in both animal models and patients that a short duration ambulatory anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3 days. The light is the main, natural synchronisateur, of the biological cerebral clock, and is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of the sleep (Alzheimer disease for example). We would like to test for a simple and safe strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase of the light intensity at a still physiological level during the initial phase of recovery from anesthesia by using a particular artificial light of color spectrum similar to natural sun daylight.

Official Title
-----------------
A Role for Light Therapy at Immediate Recovery From Short Duration Ambulatory Anesthesia to Prevent Dysregulation of Circadian Rest-Activity Rhythm in Patients Submitted to Colonoscopy.

Conditions
-----------------
Colonoscopy, Anesthesia

Intervention / Treatment
-----------------
* Other: light therapy (1500 lux)
* Other: standard light (100 LUX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I & II ambulatory anesthesia for colonoscopy on Monday or Tuesday social security Exclusion Criteria: treatment for cancer hypnotics, beta-bloquers pregnancy legal supervision trans 5 meridian travel in the last two months

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - Light therapy<br>Light therapy (1500 lux) | Other: light therapy (1500 lux)<br>* light therapy (1500 lux) for 90 minutes<br>|
| Placebo Comparator: B - identical control lamp<br>identical control lamp | Other: standard light (100 LUX)<br>* standard light (100 LUX) for 90 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of on parametric analysis of circadian rhythm of rest-activity post anesthesia as compared to reference period (within factor) ; between factor : light intensity group |  | Within the first 5 days after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of gene period 3 phenotype on the effect of anesthesia |  | Blood sample taken the day of the anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia propofol ambulatory rhythm
Comparison of Cardiovascular Outcomes of Pioglitazone and Metformin in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
The study aims to see if there is any significant difference in the cardiovascular outcomes in type 2 diabetes patients who are treated with pioglitazone or Metformin

Official Title
-----------------
A Randomised Pilot Study to Compare the Effect of Pioglitazone and Metformin on Cardiovascular Morbidity and Mortality in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Pioglitazone vs Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed (less than six months since diagnosis and not controlled on dietary modifications) type 2 diabetic patients of both sexes aged 25-60 years. Ready to give written informed consent Exclusion Criteria: Presence of ketonuria Severe concurrent, infection or illness History of hypersensitivity to any study drug Impaired renal function Pulmonary insufficiency with hypoxemia Severe hepatic disease Congestive heart failure History of myocardial infarction or angina(stable/unstable) History of alcohol or drug abuse Pregnant or lactating women -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Metformin | Drug: Pioglitazone vs Metformin<br> <br> |
| Experimental: Experimental<br>Pioglitazone | Drug: Pioglitazone vs Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.

Official Title
-----------------
A Multi-center, Open Label Study to Evaluate the Efficacy and Safety of Azithromycin Microspheres in Subjects Identified as Having Low Risk Community Acquired Pneumonia (CAP)

Conditions
-----------------
Community-Acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: Azithromycin microspheres 2.0 single dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated. Diagnosis of CAP as manifested by at least 3 or more of the following: cough, pleuritic chest pain, fever (temperature of >37.8 C to <40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC> 10,000/mm3 or greater than 15% immature neutrophils (bands) Exclusion Criteria: Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides. Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count < 1,000/mm3, HIV positive subjects with CD4 count < 200 cells/mm3, any immunoglobin or neutrophil disorder.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin microspheres 2.0 single dose|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess bacteriological efficacy of 2.0 g single dose of azithromycin microspheres. To assess the safety and tolerability of 2.0 g single dose of azithromycin microspheres. |  |  |
Stratus Versus Cirrus OCT in AMD

Study Overview
=================
Brief Summary
-----------------
The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected

Official Title
-----------------
Reliability of Threshold Algorithm in Age-Related Macular Degeneration: Stratus Versus Cirrus OCT

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>55 years Age-related macular degeneration Exclusion Criteria: Not consented patients

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| 1<br>retinal thickness program Stratus OCT software 4.0 | |
| 2<br>retinal cube 200x200 program of Cirrus OCT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of algorithm failures assessed by Stratus OCT versus Cirrus OCT in the horizontal central line |  | only 1 examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of algorrithm failures in Stratus versus Cirrus OCT assessed in the whole scan |  | 1 examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-related macular degeneration, choroidal neovascularization, Stratus OCT, Cirrus OCT