linjc16/ctgov huggingface dataset:
Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

Study Overview
=================
Brief Summary
-----------------
The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.

Official Title
-----------------
Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

Conditions
-----------------
Bipolar Disorder, Subsyndromal Depressive Phase, Heart Rate Variability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar group: DSM-IV bipolar disorder Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10 Clinical Global Impression severity (CGI-S) for last one month : ≤ 3 Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist. Exclusion Criteria: Psychiatric disorder except bipolar disorder Neurological symptoms or signs History of head trauma History of cardiovascular diseases Any medication except psychiatric medication.
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 |
| --- | --- |
| Control group<br>Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist. | |
| Bipolar group<br>individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale score of 10 or less and Clinical Global Impression severity of 3 or less for last one month. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) | Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (The variance of NN intervals over the temporal segment), VLF(Power in very low frequency range; <0.04 Hz), LF(Power in low frequency range; 0.04 0.15 Hz), HF(Power in high frequency range; 0.15 0.4 Hz) | at baseline |
Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

Study Overview
=================
Brief Summary
-----------------
This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and internationally. The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing with a reference standard test. Subjects will be patients who present with symptoms consistent with dengue infection, such as fever and myalgia. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. The first will be collected within the first 7 days of symptoms onset, and the second will be collected at least 7 days later, between the 10th and 21st days post-onset of symptoms. ELISA and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.

Official Title
-----------------
Determination of Estimated Sensitivity for Dengue NS1 ELISAs

Conditions
-----------------
Infectious Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All age groups and both sexes. Initial serum samples must be collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection. Information must be available about symptoms, age, and sex of patient from which samples are collected. The location of sample collection must be recorded. Archived samples that have been sent to reference labs for dengue or flavivirus testing should be considered for inclusion as test specimens in this study. If these specimens are included in this study, then they must have a documented history that the specimen was obtained within the first 7 days of onset of subject symptoms consistent with dengue infection. Exclusion Criteria: Archived samples with linked personal identifiers or any sample for which personal information can be discovered. Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent. Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.
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 |
| --- | --- | --- |
| number of subjects with positive result |  | 1 day |
Observational Research on Use of Immunoprop Supplement in Chronic Fatigue Syndrome

Study Overview
=================
Brief Summary
-----------------
Observational study regarding the use of supplements in chronic fatigue syndrome patients

Detailed Description
-----------------
Detailed questionnaire regarding the diagnosis of an onset of chronic fatigue syndrome and 100 patients. using Karnofsky scale before and after use of supplements patient scores are compared in a double blind trial.

Official Title
-----------------
Observational Research on Use of Immunoprop Supplement in Chronic Fatigue Syndrome

Conditions
-----------------
Chronic Fatigue Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection Exclusion Criteria: non inclusion in the above criteria

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Karnovsky score comparison | Review of Karnofsky score over prior to diagnosis and subsequent to patients having taken supplements | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic fatigue syndrome, Karnofsky score, supplements
A Trial of Two On-Line Interventions for Child Brain Injury

Study Overview
=================
Brief Summary
-----------------
The primary aims of this project are to examine the feasibility and relative efficacy of two models of on-line intervention for families of children with traumatic brain injury: one, a model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing linking families to resources and providing professionally-moderated peer support.

Detailed Description
-----------------
The feasibility of the two interventions will be evaluated by examining family utilization of on-line materials and satisfaction with receiving services this way. Previous studies suggest the longer-term effects of TBI often create significant stress for both child and family and the need for psychological services.

Official Title
-----------------
A Trial of Two On-Line Interventions for Child Brain Injury

Conditions
-----------------
Traumatic Brain Injury, Depression, Anxiety Disorders

Intervention / Treatment
-----------------
* Behavioral: Case management and problem solving therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child between 5 and 17 years old who experienced a TBI in the past 12 months

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Case management and problem solving therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Previous investigations using problem solving therapy have documented large effect sizes on measures of problem solving and depression. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Similarly, the single previous controlled intervention following pediatric traumatic brain injury (TBI) demonstrated a large effect on self-report measures of depression and anxiety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tbi, intervention, depression, anxiety
DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.

Detailed Description
-----------------
Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).

Official Title
-----------------
A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Conditions
-----------------
Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Device: Dexamethasone drug delivery system (DDS-25)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older with macular edema resulting from retinal vein occlusion Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) Visual acuity in other eye no worse than 20/200 Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months History of glaucoma or current high eye pressure requiring more than 1 medication Diabetic retinopathy Uncontrolled systemic disease Known steroid-responder Use of systemic steroids Use of warfarin/heparin

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
Interventional Model Description: intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DDS-25<br>Intravitreal injection of DDS-25(Dexamethasone drug delivery system ) | Device: Dexamethasone drug delivery system (DDS-25)<br>* 350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (BCVA) |  | Day 0 - Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central foveal thickness at 48 weeks |  | 1 day to 48 weeks |
Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India

Study Overview
=================
Brief Summary
-----------------
The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.

Official Title
-----------------
A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult who is a known Type 2 diabetic as per the ADA 2010 criteria OR controlled diabetic (taking any antidiabetic medication) Patients in the study will have been on lipid lowering drugs at a stable dose for the last three months before the designated study visit. Exclusion Criteria: Type 1 diabetic patients Patients with a history of hepatic or renal diseases Hypertension due to organic diseases

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 |
| --- | --- | --- |
| Proportion of type 2 diabetic dyslipidemia patients achieving the target LDL goal according to ADA 2010. These patients should be on stable dose of Lipid Lowering Drugs(LDL) for at least 3 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender |  |  | 
| Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination |  |  | 
| Control of dyslipidemia by all commercial available brands hypolipidemics drugs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Management of dyslipidemia in Type 2 Diabetes Mellitus adult patients in India, Dyslipidemia control rates in Type 2 diabetic Mellitus patients
Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Study Overview
=================
Brief Summary
-----------------
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.

Official Title
-----------------
Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Conditions
-----------------
Myeloma Multiple

Intervention / Treatment
-----------------
* Biological: Descartes 08


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years of age or older at the time of enrollment High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs). Exclusion Criteria: Patients who are pregnant or lactating. Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.

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: Descartes 08<br> | Biological: Descartes 08<br>* Car T-cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stringent complete response |  | 2 years |
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

Study Overview
=================
Brief Summary
-----------------
In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC. UCVA,BCVA, refractory error after the operation and the number of endothelial cells before and after the surgery would be compared in 6 months.

Official Title
-----------------
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: Mitomycin C 0.02%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 < age < 60 Refractory error stabled for at least one year No corneal pathology -3 < bilateral myopia and astigmatism < -5 with no difference more than 0.75 between 2 eyes Exclusion criteria: Keratoconus Ectatic corneal disease Glaucoma Corneal dystrophy Lens changes affecting the visual acuity Anterior or posterior uveitis Corneal scar

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mitomycin c 0.02%<br> | Drug: Mitomycin C 0.02%<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Testing Radon Com Methods: Clinical Trial Smartphone App vs Print Brochures

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare the effectiveness of radon information delivered via the radon app vs. a traditional approach (printed brochure). The prevalence of exceptionally high levels of residential radon in ND, coupled with public's poor understanding of this hazard, is a critical public health problem.

Official Title
-----------------
Testing Radon Com Methods: Clinical Trial Smartphone App vs Print Brochures

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

Intervention / Treatment
-----------------
* Other: The radon app
* Other: Print brochure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The principal eligibility criterion is that participants own a smartphone. Exclusion Criteria: The principal exclusion criterion is previous testing for radon within the past two years.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Print brochures<br>Participants assigned to the print brochure group will receive three educational print brochures about radon published by EPA via postal mails for three months (one per each month). | Other: Print brochure<br>* Participants will receive print brochures.<br>|
| Experimental: The radon app<br>Participants assigned to the radon app group will be asked to use the radon app for three months where they will be exposed to mobile friendly educational content that is repurposed from educational print brochures about radon published by EPA. | Other: The radon app<br>* Participants will be asked to use the radon app.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ordering a free radon test kit | The rate at which participants order a free radon test kit | Through the study completion - 3 months | 
| Using the radon test kit | The rate at which participants use the radon test kit to test their houses | Through the study completion - 3 months | 
| Change from baseline radon knowledge at 3 months | Participants' knowledge about radon and its dangers, how to protect themselves from radon, etc. | Change from baseline knowledge level to the completion of study at 3 months |