linjc16/ctgov huggingface dataset:
Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.

Official Title
-----------------
Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression

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

Intervention / Treatment
-----------------
* Drug: Prilosec OTC (omeprazole-magnesium)
* Drug: Prevacid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal subjects who are age 18-65 generally healthy non-childbearing potential females or those using birth control Exclusion Criteria: history of significant GI disease any significant medical illness history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or other proton pump inhibitors currently using GI medications GI disorder or surgery leading to impaired drug absorption

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Prilosec OTC | Drug: Prilosec OTC (omeprazole-magnesium)<br>* Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast<br>|
| Active Comparator: B<br>Prevacid | Drug: Prevacid<br>* Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Time That Gastric pH > 4.0 on Day 5 | for 24 hours starting Day 5 for each period | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal Healthy Subject Population
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.

Official Title
-----------------
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

Conditions
-----------------
Fluid Loss

Intervention / Treatment
-----------------
* Device: CM-1600


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written consent Ability and willingness to comply with the study procedures and duration requirements 18 years of age or older Consented and eligible to undergo a single unit whole blood donation Exclusion Criteria: Females who are pregnant or breastfeeding Undergone an amputation of any upper extremity Diagnosed with dextrocardia Subjects who have a pacemaker Subjects with body hair density which prevents adequate application of device electrodes

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Loss<br> | Device: CM-1600<br>* Subjects undergoing blood donation will be connected to the CM-1600 device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity and sensitivity of minor blood loss detection | To determine the specificity and sensitivity of the CM-1600 Device in detecting minor blood loss as compared to standard physiological parameters | 15 - 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right vs left antecubital blood donation | Characterize the differences in the relative changes in right vs left antecubital blood donations | 15 - 60 minutes | 
| Correlation between physiological parameters and relative index | Investigate any possible correlations between adverse events, subject demographics, changes in the Relative Index, and timing of when the events occurred | 15 - 60 minutes |
Physical Activity, Body Composition, and Prevalent Asthma

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship of childhood lifestyle and physical characteristics to prevalent asthma.

Detailed Description
-----------------
BACKGROUND: Morbidity and mortality from pediatric asthma have been increasing in developed countries over the past three decades, making asthma the most common chronic disease of children. A joint session at the American Thoracic Society meeting in May 2000 was titled Childhood Asthma: Is Change in Lifestyle the Key? During this session, the hypothesis was advanced that a lack of physical exercise and higher levels of childhood obesity may be contributing to an increased incidence of asthma among United States children. DESIGN NARRATIVE: Data from physician diagnosed pediatric asthma were assessed for relationships with the potential risk factors body mass index, percent fat and lean tissue, obesity, and physical activity. The data pertained to a large population-based multi-ethnic cohort of school children (n=826) from the Detroit area for whom, using dual-energy x-ray absorptiometry, precise measurements of whole body bone mass, and soft tissue composition were collected along with height and weight measurements in 1992-1993, when the children were nine years old. Detailed data on physical activity, collected with consultation with an exercise physiologist, and prevalent asthma diagnosis and symptoms, collected under the direction of a respiratory disease/pediatric epidemiologist and a pediatric allergist, were obtained at the same time. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
Think FAST Research Study

Study Overview
=================
Brief Summary
-----------------
To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. The investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).

Official Title
-----------------
Prolonged Nightly Fasting (PNF) in Older Adults With Age-related Cognitive Decline: A Pilot Study Exploring Changes in Neurocognitive Function (Public Name:Think FAST)

Conditions
-----------------
Age-related Cognitive Decline

Intervention / Treatment
-----------------
* Other: PNF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 or older Self-identified age-related cognitive decline (ARCD) Has a text capable phone and access to wifi Exclusion Criteria: Diagnosed with an eating disorder in the past 20 years Works a night shift Cannot participate in a 14 hour fast Has diabetes

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>8 week 14 hour prolonged nightly fasting intervention. | Other: PNF<br>* PNF Participants will engage in 8 weeks of 14 hours per night fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory and Attention Phone Screener (MAPS) | Cognitive Function and Performance Test. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid Eating Assessment for Participants Scale (REAPS) | Scale to asses eating behaviors. The scale has a minimum of 13 and a maximum of 39. Higher scores indicate higher diet quality. | 8 weeks | 
| Insomnia Severity Index (ISI) | Scale to asses insomnia symptoms. The scale has a minimum of zero and maximum of 28 where zero would be absence of insomnia and 28 would be severe insomnia. | 8 weeks | 
| Mindful Eating Scale (MES) | Scale to asses behaviors related to mindful eating. Each item has a minimum of zero and a maximum of 4 where 4 means less eating awareness. | 8 weeks | 
| Creature of Habit Scale (COHS) | Scale to asses routine habits. Each item has a minimum of zero and a maximum of 4 where 4 means a more habitual nature. | 8 weeks | 
| Salivary Cortisol | Measure of cortisol via participant saliva samples. | 8 weeks | 
| Body Mass Index (BMI) | Self-reported body measurements . | 8 weeks |
New CSF Biomarkers for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Today, the Alzheimer's disease (AD) diagnosis is founded not only on clinical criteria but also on complementary examinations to confirm a physiopathological process of AD. In complex cases, lumbar punction could be necessary in order to measure Aβ peptides and Total and phosphorylated Tau but new biomarkers could be useful. The main objective of this project is to conserve these cerebrospinal fluids, collected in usual practice in order to validate new biomarkers for diagnosis, prognosis or therapeutic following of Alzheimer's disease and other dementia.

Official Title
-----------------
New Diagnosis or Prognosis Biomarkers for Alzheimer's Disease: Biobank of CSF Collected as Part of Differential Diagnosis of Dementia

Conditions
-----------------
Alzheimer Disease, Dementia, Neurodegenerative Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lumbar punction collected in usual practice in the context of dementia diagnosis Exclusion Criteria: Absence of consent
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 |
| --- | --- | --- |
| CSF collection constitution to have samples available for assessing new Alzheimer's biomarker | Each CSF collected in the context of dementia diagnosis were conserved to be used in other studies on Alzheimer's or dementia biomarkers. Futre studies that will use collected CSF to assess new biomarkers will be conduced under a new protocol describing scientific contexte, specific aims and time frame necessary to achieve them. | 50 years |
Medium Dose of Cytarabine and Mitoxantrone

Study Overview
=================
Brief Summary
-----------------
By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM.

Detailed Description
-----------------
The patients of AML in shenzhen people's hospital were randomly divided into two therapy groups.One group was treated by High dose of cytarabine ,and the other was HAM.Evaluate the two chemotherapy schemes by bone marrow suppression time and patient survival time.

Official Title
-----------------
The Clinical Observationg on HAM for Acute Myeloid Leukemia

Conditions
-----------------
Acute Myelogenous Leukemia, Chemotherapy

Intervention / Treatment
-----------------
* Device: Flow Cytometer
* Drug: Mitoxantrone
* Drug: Cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people diagnosed as AML Exclusion Criteria: acute promyeloytic leukemia

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 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 |
| --- | --- |
| high dose of cytarabine<br>high dose of cytarabine | Device: Flow Cytometer<br>* high dose<br>Drug: Mitoxantrone<br>* high dose<br>Drug: Cytarabine<br>* high dose<br>|
| HAM<br>medium dose of cytarabine and mitoxantrone | Device: Flow Cytometer<br>* high dose<br>Drug: Mitoxantrone<br>* high dose<br>Drug: Cytarabine<br>* high dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone marrow suppression time | time of agranulocytosis | one month | 
| patient survival time | disease free survival | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML HAM
Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.

Detailed Description
-----------------
It has already been known for a long time that cancer is a genetic disorder and that the development of the illness is a very complex interaction between genetic and surrounding factors. Also the response on therapy and the development and seriousness of side effects is stipulated by this complicated collaboration of genetic and surrounding factors. Moreover it is not only the DNA that plays an important role but also the systems of control at protein level. At this moment a lot of questions remain to be answered because up till now the studies were of rather restricted statistic strength with frequently inconsistent dates and moreover retrospective. Major retrospective studies are necessary to distinguish the relationship between DNA/protein patterns and clinical relevant endpoints like prognosis and toxicity in which an as broad as possible patient group is being monitored. For this reason we want to take blood samples in MAASTRO clinic of all patients with lung cancer and to store it encrypted so that we can perform DNA and protein analyses in future and to correlate the results with survival and toxicity of the treatment.

Official Title
-----------------
Storing Blood for Analysis of DNA and Protein of Patients With Cancer in MAASTRO Clinic

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer Exclusion Criteria: not able to comply with follow-up

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, genomics, proteomics
Effect of Viscous Soluble Fibers on Serum Cholesterol Levels

Study Overview
=================
Brief Summary
-----------------
Research over the past several decades have linked the intake of dietary fiber with lower blood cholesterol levels. The distinction between soluble and insoluble fiber fractions emerged shortly after and there is now a general consensus that soluble fiber possesses the capacity to lower cholesterol. Since the discovery of the cholesterol lowering effects of soluble dietary fiber, there has been much debate as to the degree of cholesterol reduction from these fibers. In order to handle the inconsistencies a full and systematic review of the published literature was conducted by Brown et. al (1999). Results from this meta-analysis, concluded that 'increasing soluble fiber can make only a small contribution to lowering cholesterol.' Research is constantly progressing and new research findings may not always be consistent with older data. For example, results from new research are now challenging the previously approved health claims for soy foods and fatty acids. This is a major public health concern because if clinical evidence is not reliable, it could lead to harm. Since the publication of the meta-analysis by Brown et. al (1999) over a decade ago, scientists have continued to research the effects of soluble fiber on cholesterol levels with new technology and trial designs, therefore it is crucial to revisit the question and update the literature on the effect of viscous soluble dietary fibers on serum cholesterol levels. A series of meta-analyses will be performed to assess the link between viscous dietary fibers and serum cholesterol levels. Nutritionists now consider fiber to be an integral part of diet and disease. Results from these meta-analyses help address the question of whether viscous soluble fibers have a role lowering serum cholesterol levels.

Official Title
-----------------
Effect of Viscous Soluble Fibers on Serum Cholesterol Levels: A Series of Systematic Reviews and Meta-analyses

Conditions
-----------------
LDL Cholesterol

Intervention / Treatment
-----------------
* Dietary Supplement: Soluble Fibre


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized Controlled Trials Paralell or Crossover Design Duration: >3 weeks
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Soluble Fibre|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LDL Cholesterol Level |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Non-HDL Cholesterol Level |  | 3 weeks | 
| Serum Apolipoprotein B Level |  | 3 weeks |
Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.

Official Title
-----------------
Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

Conditions
-----------------
Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies

Intervention / Treatment
-----------------
* Drug: Anti-PD-1 or anti-PD-L1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Electronic patient file DxCare at the University Hospitals of Montpellier Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records Exclusion Criteria: No mention of % eosinophilia in the patient file
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>Patients in the University Hospitals of Montpellier system who have received anti-PD-1 and/or anti-PD-L1 | Drug: Anti-PD-1 or anti-PD-L1<br>* Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1 |  | Before treatment (before day 0) versus after (15 days) | 
| Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1 |  | Before treatment (before day 0) versus after (1 month) | 
| Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1 |  | Before treatment (before day 0) versus after (3 months) | 
| Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1 |  | Before treatment (before day 0) versus after (6 months) | 
| Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1 |  | Before treatment (before day 0) versus after (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies | Name of pathology | Day 0 | 
| Age (years) |  | Day 0 | 
| Sex (male/female) |  | Day 0 |