linjc16/ctgov huggingface dataset:
Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.

Detailed Description
-----------------
The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery, namely children undergoing selective rhizotomy for treatment of medically refractory spasticity.

Official Title
-----------------
Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases

Conditions
-----------------
Spasticity

Intervention / Treatment
-----------------
* Procedure: Rhizotomy for children with spasticity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children over the age of 3 and younger than 17 years Children who have failed appropriate medical therapy and are recommended for selective rhizotomy to treat spasticity by the pediatric neurosurgeon Children who would normally undergo electrodiagnostic testing including EMG monitoring for physiologic testing during surgery Surgery must be performed at the Vanderbilt University Children's Hospital Exclusion Criteria: Patients in which a segment of the nerve (up to 2cm) cannot likely be identified at the time of surgery as determined by the pediatric neurosurgeon Children not undergoing routine selective rhizotomy for medically refractory spasticity as determined by the pediatric neurosurgeon Children who are medically unstable to tolerate an additional 20 minutes of experimental testing during the surgery Women who are pregnant will be excluded from this study

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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 |
| --- | --- |
| Rhizotomy for children with spasticity<br>Children with spasticity needing Rhizotomy surgery | Procedure: Rhizotomy for children with spasticity<br>* Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity, rhizotomy, surgery
A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)

Study Overview
=================
Brief Summary
-----------------
This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.

Official Title
-----------------
A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: voclosporin ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG Schirmer's I Test ≥ 10mm/5 minutes with anesthesia Corrected Snellen acuity of 20/40 or better in both eyes Exclusion Criteria: Subjects diagnosed with any ocular disease other than refraction error Subjects with intraocular pressure >21 mmHg Use of a contact lens within 7 days prior to administration of the first dose Subjects with history of ocular surgery Subjects with a history of laser refractive surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LX214 0.02%<br>LX214 ophthalmic solution 0.02% | Drug: voclosporin ophthalmic solution<br>* 0.02%, 0.2% t.i.d. or b.i.d.<br>|
| Experimental: LX214 0.2%<br> | Drug: voclosporin ophthalmic solution<br>* 0.02%, 0.2% t.i.d. or b.i.d.<br>|
| Placebo Comparator: placebo<br>placebo | Drug: voclosporin ophthalmic solution<br>* 0.02%, 0.2% t.i.d. or b.i.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular irritation |  | 12 hours |
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.

Detailed Description
-----------------
The frequency of EWS scores, number of automated notifications and serious events performed on a general ward is contingent on the quality and frequency of vital signs measurement like respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and more frequent scoring. We examine the influence of different respiration rate sensor concepts and measurements on scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.

Official Title
-----------------
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III

Conditions
-----------------
Cardiac Arrest, Renal Failure, Respiration Failure, Myocardial Infarction, Severe Sepsis

Intervention / Treatment
-----------------
* Device: Automatic RR Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to the study units during the period of data collection Exclusion Criteria: palliative patients

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 |
| --- | --- |
| Manual Respiration Rate Measurement<br>Patients with manually measured respiratory rate | |
| Automatic Respiration Rate Measurement<br>Patients with automatically measured respiratory rate | Device: Automatic RR Measurement<br>* Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of NEWS Scores |  | 8-12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NEWS, early warning scoring, respiration rate, acute care teams, CREWS
Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

Study Overview
=================
Brief Summary
-----------------
The prevalence of overweight children has increased dramatically over the last decade, and many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a naturally occurring dietary fatty acid, has shown promising results in reducing body fat among adults, and we propose to test the efficacy of CLA supplementation on body fat accretion in 6 to 10 year old children who are overweight or at risk of overweight.

Official Title
-----------------
Effect of CLA Supplementation on Body Fat Accretion Among Children Who Are Overweight or at Risk of Overweight

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Conjugated linoleic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 6 to 10 years body mass index greater than 85th percentile Tanner stage I Exclusion Criteria: medical condition dairy allergy

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Dietary Supplement: Conjugated linoleic acid<br>* 3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)<br>|
| Placebo Comparator: B<br> | Dietary Supplement: Conjugated linoleic acid<br>* 3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition using DXA |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conjugated linoleic acid, body fat, children, overweight
Bone Mineral Density in Israeli Female Vegans and Omnivores

Study Overview
=================
Brief Summary
-----------------
A vegan diet is more and more prevalent in the general population in Israel in recent years. There have been some concerens that a vegan diet may lack in bone-health related nutrients (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral density. The study aims to compare bome mineral density and other biochemical bone health parameters in vegan and omnivore non-menopausal Israely females.

Official Title
-----------------
Bone Mineral Density in Israeli Female Vegans and Omnivores

Conditions
-----------------
Bone Mineral Density, Vegan Diet

Intervention / Treatment
-----------------
* Other: bone mineral density test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: generaly healthy vegan group: vegan diet for the past 3 years omnivore group: comsumption of animal products at least 3 times a week Exclusion Criteria: pragnent / breastfeeding women amenorrhea (absence of a menstrual period) for more than 3 months amenorrhea in the past significant underweight in the present/past (BMI < 17.5) taking medicine that affect bone density hypo/hyper thyroidism hypo/hyper parathyroidism smokimg in the past 10 years over consumption of alcohol (more than 7 units a week)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vegans<br>a vegan diet in the last 3 years | Other: bone mineral density test<br> <br> |
| omnivores<br>aminal-based diet, comsumption of aminal products at least 3 times a week | Other: bone mineral density test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density |  | 1 day |
Association Study of Gene Polymorphisms With Cardiac Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether polymorphisms in G protein subunits, namely Galphas and Galphaq, are associated with altered cardiac performance in heart failure patients.

Detailed Description
-----------------
G Protein pathways plays a pivotal role in mediating positive inotropy and cardiac hypertrophy by transducing signals of neurohormones in cardiomyocytes. Single nucleotide polymorphisms (SNPs) in the G protein subunits Galphas and Galphaq have been shown to result in altered protein expression. We now want to examine whether G Protein polymorphisms alter NYHA functional class, and hemodynamic variables in patients with coronary artery disease scheduled for coronary artery bypass grafting .

Official Title
-----------------
Observational Association Study of G Protein Polymorphisms With Cardiac Performance in Coronary Artery Disease Patients Undergoing Coronary Artery Bypass Grafting

Conditions
-----------------
Genetic Polymorphism, Coronary Artery Disease, Hemodynamics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of coronary artery disease patients scheduled for coronary artery bypass grafting Exclusion Criteria: emergency operation combined vitium

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| genotype dependent change of hemodynamic variables |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 60 days |
Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop a validated French version of the HAQ-II questionnaire for rheumatoid arthritis.

Detailed Description
-----------------
The HAQ is the original Health Assessment Questionnaire used in rheumatology. It is available in more than 60 languages and includes 42 items. However the questionnaire is not easy to use in the clinic : complicated questions, long to answer for the patient and not easy to score for the doctor. The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as the HAQ and is simpler to administer and score. It includes 5 items already translated in English and 5 new items not yet translated. The aim of the study is the validation of the French version of the HAQ-II for rheumatoid arthritis.

Official Title
-----------------
Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Patient with rheumatoid arthritis 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal validity, scale HAQ-II |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HAQ-II, Rheumatoid arthritis
Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women fulfilled two out of three diagnostic criteria for PCOS Exclusion Criteria: Pre-existing secondary endocrine disorders History of hypertension, diabetes mellitus or cardiovascular disorders Pharmacologic treatment in the last 6 months before entering the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS patients<br> | |
| Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean platelet volume |  |  | 
| Thromboxane A2 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, cardiovascular disorders
Prenatal Yoga for Pregnancy Related Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.

Official Title
-----------------
Prenatal Yoga for Pregnancy Related Back Pain

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Behavioral: yoga
* Behavioral: support group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uncomplicated pregnancies starting at 12-26 weeks of gestation pregnant women with and without back pain who had no regular yoga practice. Exclusion Criteria: significant back pathology pregnancy complications non-English speaking otherwise were not able to participate (eg. transportation, scheduling issues)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: yoga<br>weekly prenatal yoga group class | Behavioral: yoga<br>* once weekly group yoga class for 12 weeks<br>|
| Active Comparator: support<br>weekly group support class | Behavioral: support group<br>* once weekly group support class for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of recruitment | recruitment rate | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| back pain disability | Roland Morris Disability Questionnaire (range 0-24), lower better | baseline, 4, 8, 12 weeks | 
| back pain severity | Back Pain Severity Visual Analogue Scale (rage 0-10), lower better | baseline, 4, 8, 12 weeks | 
| pregnancy symptoms | Pregnancy Symptom Inventory (range 0-123), lower better | baseline, 4, 8, 12 weeks | 
| depression | Edinburgh Postnatal Depression Scale (range 0-30), lower better | baseline, 4, 8, 12 weeks | 
| quality of lfe | Short Form-12 (range 12-56), higher better | baseline, 4, 8, 12 weeks | 
| childbirth experience | Childbirth Experience (range 19-76), higher better | postpartum visit | 
| mobility lab- speed | instrumented gait speed | baseline, 4, 8, 12 weeks | 
| acceptability | class attendance | 4,8, 12 weeks, postpartum | 
| mobility lab- double support | double support time | baseline, 4, 8, 12 weeks | 
| mobility lab- TUG | timed up and go time | baseline, 4, 8, 12 weeks | 
| mobility lab- turn | turn time | baseline, 4, 8, 12 weeks |
Generalization of Training in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study examines whether patients with schizophrenia can benefit from a problem-solving training intervention and whether a work-related social skills training intervention leads to improvements in the patient's performance at work.

Official Title
-----------------
Generalization of Training in Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: Problem-Solving Training
* Behavioral: Work-Related Social Skills Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans with schizophrenia or schizoaffective disorder

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Problem-Solving Training|nan|
|Behavioral: Work-Related Social Skills Training|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
-----------------
Schizophrenia, vocational rehabilitation, neuropsychology