linjc16/ctgov huggingface dataset:
Genetic Assessment of Early to Late Macular Degeneration Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or GA) in patients with early AMD (soft confluent drusen>120 microns ) in the study eye, and with either early AMD or advanced AMD in the non-study eye.

Detailed Description
-----------------
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. To date, two major polymorphisms on the HTRA1 and CFH genes have been associated with AMD. Progression and vision loss need to be followed and treated promptly in order to preserve vision. This study will provide more information on the genetics of disease progression and may lead to future guidelines for patient follow-up and treatment. This study consists of a blood draw and observation of eye conditions. Consented, enrolled patients will come in every four months as per standard of care. At each visit, visual acuity measurement, slit lamp exam, indirect ophthalmoscopy, fundus photos, and spectral domain optical coherence tomography will be performed. Every 8 months, or per standard of care, fluoroscein angiography will be performed. DNA extraction and genotyping will be performed, and correlations between HTRA1 and CFH genotypes and the progression to bilateral advanced AMD will be analyzed.

Official Title
-----------------
Genetic Assessment of Early to Late macuLar dEgeneration studY 2

Conditions
-----------------
Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 45 years Disease related considerations Subjects with a diagnosis of advanced AMD in one eye (either CNV or geographic atrophy) and soft confluent drusen in the study eye OR subjects with bilateral large soft drusen. Exclusion Criteria: Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye. |  | 5 years |
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: JR-131


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients being treated with erythropoiesis stimulating agent. Exclusion Criteria: Patients having complication or history of a cardiovascular / lung / brain infarction. Patients having a pronounced hemorrhagic lesion.

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

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

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

Design Details

Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JR-131<br> | Drug: JR-131<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure adverse events |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  | 52 weeks |
Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease

Study Overview
=================
Brief Summary
-----------------
Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.

Official Title
-----------------
Characterization of Adipose Derived Regenerative Cells (ADRCs) From Excess Tissue and Cells Designated for Discard From Patients With Chronic Heart Disease

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Adipose-Derived Regenerative Cells (ADRCs)- Cell Characterization | Cells will be evaluated regarding cell composition by flow cytometric assays. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADRCs, cell characterization
Chewing Gum and Gastric Emptying of Water

Study Overview
=================
Brief Summary
-----------------
The aims of this prospective cross over study was to compare the gastric emptying of 250 ml water in fasting volunteers, in two situations : without chewing gum or while chewing gum during 45 min

Conditions
-----------------
Comparison of Gastric Emptying Rate of Water When Chewing Gum or Not

Intervention / Treatment
-----------------
* Behavioral: 1 chewing gum over 45 minutes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 or 2 volunteers Exclusion Criteria: digestive diseases, gastroparesis Smokers Pregnancy Diabetes Mellitus Medication affecting gastric motility Previous gastrointestinal surgery

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controle<br>The volunteer does not chew gum during the study period | |
| Experimental: Chewing gum<br>The volunteer chews gum during the first 45 min after ingestion of 250 ml water | Behavioral: 1 chewing gum over 45 minutes<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the rate of gastric emptying of 250 ml water when chewing or not chewing gum, as assessed by the ultrasound measurement of antral area performed each 20 min |  | every 20 minutes during 120 min |
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

Study Overview
=================
Brief Summary
-----------------
Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP level are in the top quintile will be offered participation in this study. Participants will be randomised to receive either spironolactone or placebo for three years. Participants will then be monitored for indications of heart failure. It is anticipated that the medication will reduce the development of heart failure in this group.

Official Title
-----------------
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Was recruited to SCREEN-HF Has provided informed consent Exclusion Criteria: Uncorrected hyperkalaemia eGFR < 30 ml/min

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: Spironolactone<br>* 25 mg tablets (placed in capsules for blinding) once daily.<br>|
| Placebo Comparator: Group B<br> | Drug: Placebo<br>* Placebo (lactose in capsules for blinding) once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Spironolactone in preventing heart failure |  | 1 year and 3 year | 
| Cost effectiveness of Spironolactone prevention |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of evidence of LV dysfunction, either systolic or diastolic, on echocardiography and/or symptomatic heart failure |  | 1 year and 3 year | 
| Change in 6 minute walk test between the two groups |  | 1 year and 3 years | 
| Change in quality of life between the two groups |  | 1 year and 3 year | 
| Change in left ventricular remodelling parameters |  | 1 year and 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of heart failure in individuals at high risk
Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

Official Title
-----------------
Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Inhaled treprostinil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligible subjects must: Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed), Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use. Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening. Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled treprostinil<br> | Drug: Inhaled treprostinil<br>* 0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* placebo inhalation solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical worsening |  | 1 day to 2.5 years. |
An Open Label Comparing the Short Term Efficacy of Lacrisert

Study Overview
=================
Brief Summary
-----------------
To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.

Official Title
-----------------
An Open Label Comparing the Short Term Efficacy of Lacrisert

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Lacrisert, 5 Mg Ophthalmic Insert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of >6 Exclusion Criteria: Concurrent involvement in any other clinical trial Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant Active ocular infection, uveitis or non-KCS inflammation History of recurrent herpes keratitis or active disease within the last six months Topical ophthalmic medications during the study Temporary collagen punctal plugs within one week prior to study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open label<br> | Drug: Lacrisert, 5 Mg Ophthalmic Insert<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye disease measured by OSDI questionnaire |  | 10 days | 
| Dry eye disease measured by Corneal Staining |  | 10 days | 
| Dry eye disease measured by topographic results |  | 10 days |
Initiation of Insulin Aspart in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects with type 2 diabetes.

Official Title
-----------------
Evaluation of the Initiation of Insulin Treatment Using Insulin Aspart on Blood Glucose Profile in Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 3 years HbA1c greater than 8.0% Body Mass Index (BMI) below 40.0 kg/m2 Inadequate treatment with diet and OADs Never received treatment with insulin Exclusion Criteria: Type 1 diabetes Known or suspected allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 30 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: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose value |  | at 5 pm in a daytime blood glucose cycle profile | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of 24-hour blood glucose cycle |  |  | 
| HbA1c |  |  | 
| Hypoglycaemic episodes |  |  |
Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration

Study Overview
=================
Brief Summary
-----------------
A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration. One of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods. The purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.

Official Title
-----------------
Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration

Conditions
-----------------
The Sweat Alcohol Concentration

Intervention / Treatment
-----------------
* Other: oral dose of alcohol
* Device: alcotest
* Biological: blood samples
* Device: Transdermal monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18-40 years, age-matched (+ 3 years) Caucasian BMI: 19 to 28 kg/m2 No smoking or light smoker (<5 cig/d) Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience Exclusion Criteria: Subjects with addiction to toxic or alcohol (MINI Questionnaire) Positive individuals in search of drugs and toxic Anxiety or depressive subjects (IASTA Questionnaires and BDI)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteers<br> | Other: oral dose of alcohol<br> <br> Device: alcotest<br> <br> Biological: blood samples<br> <br> Device: Transdermal monitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The determination of ethanol in the plasma | blood samples | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures in the exhaled air | Assessed with the device Alcotest® | 6 months | 
| sweat alcohol concentration | assessed with a Transdermal monitor | 6 months |
French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

Detailed Description
-----------------
Collection of epidemiological data on non-high-risk APL patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, Performance status…). Documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk APL patients. Documentation of Minimal Residual Disease (MRD). Correlation of clinical outcomes with the chosen therapy. Validation of published prognostic factors and identification of new prognostic factors

Official Title
-----------------
The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

Conditions
-----------------
Acute Promyelocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly-diagnosed APL (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript PML/RARα. Non-high-risk APL (White Blood Count < 10000/μl at presentation) Age ≤ 70 years Exclusion Criteria: Relapsed APL Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation) Age > 70 years

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- |
| ATRA-chimio<br>according to usual practice center | |
| ATRA-ATO<br>according to usual practice center | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | events are: no achievement of haematological complete remission after induction therapy; no achievement of molecular remission after the consolidation courses; relapse; death including early death | From date of induction until the date of first documented event, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hematological complete remission | from date of inclusion until end of induction therapy | up to 30 days | 
| Rate of overall survival |  | at 5 years |