linjc16/ctgov huggingface dataset:
Pushing Behaviors in Individuals Post-stroke

Study Overview
=================
Brief Summary
-----------------
Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground. The investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.

Detailed Description
-----------------
The study population of interest is primarily individuals in inpatient rehabilitation.

Official Title
-----------------
Inpatient Rehabilitation Treatments and Effect on Pushing Behaviors in Individuals Post-stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Sitting in wheel chair
* Other: Gait training on treadmill
* Other: Gait training overground


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: score >0 in each subsection of the Scale for Contraversive Pushing admitted to the Rehabilitation Institute of Chicago inpatient rehabilitation setting stroke within previous 180 days consent to participate in the study ambulating greater than 150' at a time prior to stroke Exclusion Criteria: other neurologic diagnoses weight bearing precautions, orthopedic injuries, or other medical co-morbidities that prevent adherence to the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Other: wheelchair, walking on treadmill, walking overground<br>Sitting in wheel chair Gait training on treadmill Gait training overground | Other: Sitting in wheel chair<br>* Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes<br>Other: Gait training on treadmill<br>* Walking on a treadmill with or without body weight support during 30 minute treatment<br>Other: Gait training overground<br>* Walking overground with or without body weight support during 30 minute treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burke Lateropulsion Scale | Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session. | Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Pusher Syndrome, Lateropulsion, Pushing Behaviors, Burke Lateropulsion Scale
Isoflavones and Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing

Official Title
-----------------
Effects of Isoflavones on Hypertension, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Dietary Supplement: soy isoflavone
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35 Exclusion Criteria: infections inflammatory diseases liver diseases Clinical diagnosis of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet

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 |
| --- | --- |
| Active Comparator: isoflavone<br>100 mg soy isoflavone (as 2 tablets) | Dietary Supplement: soy isoflavone<br>* 100 mg soy isoflavone (as 2 tablets)<br>|
| Placebo Comparator: control<br>2 tablets of placebo | Other: control<br>* 2 tablets of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose | Serum concentrations of glucose | 8 weeks | 
| fructoseamine | Serum concentrations of fructoseamine | 8 weeks | 
| carboxymethyl lysine | Serum concentrations of carboxymethyl lysine | 8 weeks | 
| pentosidine | Serum concentrations of pentosidine | 8 weeks | 
| Systolic blood pressure | Systolic blood pressure | 8 weeks | 
| Diastolic blood pressure | Diastolic blood pressure | 8 weeks |
Biomarkers, Neurodevelopment and Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.

Official Title
-----------------
Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

Conditions
-----------------
Preterm, Neurodevelopmental Disorder, Epigenetic Changes

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <32 weeks gestation Born at Weiler Division of Montefiore Exclusion Criteria: Intraventricular hemorrhage Chromosomal abnormalities Congenital viral conditions

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Preterm infants <32 weeks gestational age | Other: Observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain white matter development | Brain MRI | 38-42 weeks adjusted age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopment | Administration of NICU Neonatal Neurobehavioral Scale | 38-42 weeks adjusted age | 
| Neurodevelopment | Administration of Bayley Scales of Infant and Toddler Development, 3rd edition | 18-24 months adjusted age |
Rehabilitative Training for Older People With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of a rehabilitation program called Functional Adaptation Skills Training (FAST) in treating older patients with schizophrenia.

Detailed Description
-----------------
People with schizophrenia often have problems functioning in everyday life. As people with schizophrenia get older, resources for effective health care and social services may become more limited. There is a need to develop effective rehabilitation programs that are sensitive to the special needs of older persons with schizophrenia. Patients are randomly assigned to either 1 of 2 groups. The FAST group will involve 24 sessions of group intervention designed to enhance daily functioning of older patients with schizophrenia. The placebo group will involve participation in a psychosocial support group for an equivalent amount of time. Treatment is followed by 6 monthly maintenance sessions. Patients will be assessed at 6, 12, and 18 months after the study start. Assessments include clinical and functional measures.

Official Title
-----------------
Functional Skills Training for Late Life Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Functional Adaptation Skills Training (FAST)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have schizophrenia or schizoaffective disorder

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Functional Adaptation Skills Training (FAST)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5

Official Title
-----------------
Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: D961H
* Drug: D961H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese Classified as homo-EM Negative for HIV, Hepatitis B, Hepatitis C and syphilis Exclusion Criteria: Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D961H 40 mg gelatin capsule<br>2 way crossover | Drug: D961H<br>* Oral gelatin capsule<br>|
| Experimental: D961H 40 mg HPMC capsule<br>2 way crossover | Drug: D961H<br>* Oral HPMC capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5 |  | PK sample at Day 5 of treatment period 1 and treatment period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5 |  | PK sample on Day 5 of treatment period 1 and treatment period 2 | 
| Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs. |  | Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer, Japanese males, homo-EM, Bioequivalence study
The Mechanism and Prognosis of Pulmonary Circulation Dysfunction

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Transcriptomics and cytokine antibody array are also used to find new biomarkers of VTE's early diagnosis, severity and prognosis.

Official Title
-----------------
The Mechanism and Prognosis of Pulmonary Circulation Dysfunction in Pulmonary Injury and Recovery

Conditions
-----------------
VTE

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese Han population older than 14 years old Acute VTE patients diagnosed in 1 month With informed consent Exclusion Criteria: Patients with psychosis Patients with contraindications for computed tomographic pulmonary angiography (CTPA) Chronic VTE Recurrence of chronic VTE

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | death | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism (VTE) recurrence | VTE recurrence detected by echocardiography or CTPA scan | 6months | 
| chronic thromboembolism pulmonary hypertension(CTEPH) | newly developed CTEPH detected by pulmonary angiography | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VTE, SNP, biomarkers
ReActiv8 Post Market Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.

Official Title
-----------------
ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: ReActiv8 Implantable Stimulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the Indications for ReActiv8 Willing to sign the Informed Consent for the Registry Age ≥ 18 years Exclusion Criteria: 1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

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 |
| --- |
|Device: ReActiv8 Implantable Stimulation System|Implantable electrical stimulation system.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Back Pain - NRS | Change in NRS compared to Baseline | 90 days, 180 days, 1 year, 2 years post Activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Effects |  | Through 2 years post Activation |
Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients

Study Overview
=================
Brief Summary
-----------------
Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device. Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment. The patients will attend 4 visits.

Official Title
-----------------
Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: NAABAK eyedrops
* Drug: Saline eyedrops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 years old Patients with dry eye syndrome in allergic conjunctivitis Exclusion Criteria: Severe dry eye syndrome Severe ocular pathology

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Naaga in ABAK system<br> | Drug: NAABAK eyedrops<br> <br> |
| Placebo Comparator: Saline solution<br> | Drug: Saline eyedrops<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
In this study, measurements of central macular thickness using optical coherence tomography along with examination of visual acuity by Snellen's chart in diabetic hypertensive patients will be done .

Detailed Description
-----------------
correlate relationship between optical coherence tomography changes and visual acuity in patients with type 2 diabetes and hypertension

Official Title
-----------------
Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients in Sohag City

Conditions
-----------------
Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients with hypertension . Exclusion Criteria: Patients with type 1 diabetes mellitus . Ocular disease ( such as high myopia , glaucoma ) . Patients with opacities in the media ( corneal opacities , dense cataract , vitreous hemorrhage ) . Systemic medication (Tamoxifen , Chloroquine , Canthaxanthine ) to avoid its effect on macular thickness . Central visual field defect that prevents fixation on OCT . Intraocular inflammation such as anterior or posterior uveitis . Refractive error greater than 6 diopter .

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| macular thickness and visual acuity<br>optical coherence tomography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness in diabetic hypertensive patients | measurement of central macular thickness by optical coherence tomography | June 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular thickness and visual acuity