linjc16/ctgov huggingface dataset:
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.

Official Title
-----------------
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No self-reported history of diabetes or pre-diabetes defined as per ADA criteria Age greater than 18 years Scheduled to receive HbA1c in participating clinic Able and willing to give legally effective consent Able and willing to participate in patient questionnaires(attached) Exclusion Criteria: Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded. Baseline HbA1c level above 5.7 Severe Anemia (defined as Hb less than 8gm/dL) Patients with hemoglobinopathies Pregnancy Polycystic ovarian disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low risk group<br>Patients will be stratified based on risk factors significantly contributing to diabetes type 2. | |
| Intermediate risk group<br> | |
| High risk group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the rate of change of HbA1c in normal population with known risk factors of diabetes |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes prediction model based on the rate of change in HbA1c | To develop a mathematical model which will predict the onset of type 2 dm based on the rate of change in HbA1c valued leading to development of pre-diabetes | one year |
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children

Study Overview
=================
Brief Summary
-----------------
Poverty is a common experience for many children and families in developing countries. Living in a poor or low-income household has been linked to poor health and increased risk for mental health problems than the general population. Previous studies link psychological well-being with yoga in adolescents and children. This study investigated the effects of a structured yoga program on psychological well-being in low-income school children.

Official Title
-----------------
Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial

Conditions
-----------------
Psychological Disturbance, Anxiety Disorder of Childhood

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low income Group Parental consent to participate in study Exclusion Criteria: Disabilities Substance abuse Living outside the school areas

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga in School Group<br>30-mins yoga sessions were conducted in schools for 8-weeks | Other: Yoga<br>* 30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.<br>|
| No Intervention: Control Group<br>Usual Activities in school | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety score was measured through State and Trait Anxiety Inventory | Change from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression Score was measured through Beck Depression Inventory | Changes from baseline to 8 weeks | 
| Self Esteem | Self Esteem was measured through Rosenberg Self-esteem scale | Changes from baseline to 8 weeks |
Multimodal MRI in Multiple Sclerosis (MS): Reliability and Follow Up

Study Overview
=================
Brief Summary
-----------------
To determine wether multimodal MRI (conventinal T1 and T2 sequences, diffusion, magnetization transfer, spectroscopy) is reproducible; to follow up a cohort of patients with early remmittent MS after treatment with interferon.

Official Title
-----------------
Follow Up by Multimodal MRI of a Cohort of Patients With Early Remitting Multiple Sclerosis (REPROMMS Study).

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MS patients according to Poser's criteria Remitting evolution (less than two years of evolution) Aged 18-50 Immunomodulatory treatment indicated Exclusion Criteria: Unable to perform MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
-----------------
aged 18-50, remitting evolution, less than two years of evolution, MS patients
To Compare the Octopus 311 and the Humphrey Field Analyzer 700 Series

Study Overview
=================
Brief Summary
-----------------
To compare the Octopus 311 and the HFA 700 series

Detailed Description
-----------------
To compare the Octopus 311 and the HFA 700 series to evaluate reliability, reproducibility, test duration, patient preference and technician preference.

Official Title
-----------------
To Compare the Octopus 311 and the Humphrey Field Analyzer 700 Series With Respect to Reliability, Reproducibility, Test Duration, Patient Preference, Technician Preference.

Conditions
-----------------
Visual Field

Intervention / Treatment
-----------------
* Device: Visual Field (Octopus 311 and the HFA 700 series)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior Visual Field Exclusion Criteria: Scotopic pupil less than 3 mm

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

| Intervention/Treatment |
| --- |
|Device: Visual Field (Octopus 311 and the HFA 700 series)|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
-----------------
Perimetry, Visual Field, Octopus
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

Official Title
-----------------
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: preservative free inactivated split influenza vaccine using the strain composition 2006/2007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged >18 years Exclusion Criteria: serious chronic diseases or significant acute infections requiring systemic antibiotic treatment history of any anaphylaxis, serious vaccine reactions hypersensitivity against vaccine components history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected impairment/alteration of immune function more than one injection of influenza vaccine received or laboratory confirmed influenza disease within last 6 months: influenza vaccination received

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: preservative free inactivated split influenza vaccine using the strain composition 2006/2007|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, influenza
Losartan and HCTZ and Amlodipine vs Atenolol and Amlodipine (0954A-309)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the effects of combination losartan versus combination atenolol in patients with ambulatory systolic hypertension.

Official Title
-----------------
Antihypertensive Effects of a Fixed-dose Combination of Losartan and Hydrochlorothiazide Plus Amlodipine Versus a Hydrochlorothiazide and Atenolol Combination Plus Amlodipine in Subjects With Ambulatory Systolic Hypertension.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: MK0954, losartan potassium/Duration of Treatment: 18 weeks
* Drug: Comparator: losartan, HCTZ, amlodipine, atenolol/Duration of Treatment: 18 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females at least 18 years of age who have ambulatory systolic hypertension.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0954, losartan potassium/Duration of Treatment: 18 weeks|nan|
|Drug: Comparator: losartan, HCTZ, amlodipine, atenolol/Duration of Treatment: 18 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daytime ambulatory systolic blood pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory BP |  |  | 
| Pulse pressure |  |  | 
| Trough sitting BP |  |  | 
| Percentage of patients who reach goal ambulatory systolic BP |  |  |
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Detailed Description
-----------------
As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Official Title
-----------------
Extended Release (ER) / Long-acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Assessment 5.1: Surveillance of Emergency Department Visits and Hospitalizations for Opioid Overdose and Poisoning Events

Conditions
-----------------
Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse

Intervention / Treatment
-----------------
* Other: Retrospective database review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one dispensing of an ER/LA opioid after 01 July 2010 At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period Exclusion Criteria: Missing or implausible values for age Missing or implausible values for gender
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All commercially insured patients in the HIRD<br> | Other: Retrospective database review<br> <br> |
| All Medicaid patients in a participating state Medicaid plan<br> | Other: Retrospective database review<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ED visits for opioid overdose/poisoning and mortality |  | Retrospective review over period from July 2010 through December 2014 | 
| Number of hospitalizations for opioid overdose/poisoning and mortality |  | Retrospective review over period from July 2010 through December 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | Retrospective review over period from July 2010 through December 2014 |
Intraoperative Imaging With ICG Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to monitor the rate of recurrence in patients who undergo cancer surgery.

Detailed Description
-----------------
Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance. In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Official Title
-----------------
Intraoperative Imaging With ICG Registry

Conditions
-----------------
Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of Recurrence

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclkusion Criteria Adult patients >= 18 years of age Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence. Good operative candidate as determined by the treating physician and/or multidisciplinary team Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects registered |  | 2 years |
Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)

Study Overview
=================
Brief Summary
-----------------
Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.

Official Title
-----------------
Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: SCH 527123
* Drug: SCH 527123
* Drug: SCH 527123
* Drug: SCH 527123


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race. Exclusion Criteria: Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose SCH 527123<br> | Drug: SCH 527123<br>* Low dose<br>|
| Experimental: Medium dose SCH 527123<br> | Drug: SCH 527123<br>* Medium dose<br>|
| Experimental: High dose SCH 527123<br> | Drug: SCH 527123<br>* High dose<br>|
| Placebo Comparator: Placebo<br> | Drug: SCH 527123<br>* Placebo to match SCH 527123<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe asthma exacerbations, pulmonary function test data, and a change in symptoms |  | Measured over the duration of the trial. |
Factors Associated With Pregnancy Loss in IVF Women

Study Overview
=================
Brief Summary
-----------------
Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.

Detailed Description
-----------------
Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy. Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.

Official Title
-----------------
Factors Associated With Second-Trimester Pregnancy Loss in Women With Normal Uterine Anatomy Undergoing In Vitro Fertilization

Conditions
-----------------
Invitro Fertilization

Intervention / Treatment
-----------------
* Other: follow up antenatal care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation) Exclusion Criteria: abnormal uterine cavity induced abortion for medical problem

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aborted women<br>women who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring | Other: follow up antenatal care<br>* ultrasound follow up of pregnancy<br>|
| continued women<br>women who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring | Other: follow up antenatal care<br>* ultrasound follow up of pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| second trimester abortion |  | between 12 1/7 and 23 6/7 weeks of gestation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
second trimesteric pregnancy loss