linjc16/ctgov huggingface dataset:
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema

Study Overview
=================
Brief Summary
-----------------
This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy

Official Title
-----------------
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema

Conditions
-----------------
Oedema, Neuropathy

Intervention / Treatment
-----------------
* Device: electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and over Be a non-responder to the geko MK1&2 device Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form. Able and willing to follow the protocol requirements. Exclusion Criteria: Has a pacemaker Pregnancy. Is contraindicated for the MK1&2 device and/or the Digitimer DS7A Recently diagnosed or suspected DVT

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digitimer stimulation<br> | Device: electrical stimulation<br> <br> * Other names: Digitimer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observable foot twitch in response to stimulation with Digitimer DS7A | Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured | up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Any adverse events recorded during the study will be recorded | up to 2 hours | 
| oedema | oedema will be measured to classify the level of swelling in the participants leg | up to 2 hours | 
| patient rated tolerability questionnaire | Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire | up to 2 hours |
Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The current study is designed to estimate the effect of rifampin (600 mg orally every 24 hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy volunteers

Official Title
-----------------
A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Tasocitinib (CP-690,550) plus Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects (of non-childbearing potential) Exclusion Criteria: Clinically significant disease or condition Recent serious infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tasocitinib (CP-690,550) plus Rifampin<br> | Drug: Tasocitinib (CP-690,550) plus Rifampin<br>* Period 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of tasocitinib (CP-690,550) |  | 9 days | 
| Cmax of tasocitinib (CP-690,550) |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Tmax, t1/2 of tasocitinib (CP-690,550) |  | 9 days | 
| Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate). |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-Drug Interaction, Tasocitinib (CP-690, 550), Rifampin, Healthy Volunteers
How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?

Study Overview
=================
Brief Summary
-----------------
Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. The purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.

Detailed Description
-----------------
Four tubes of blood will be taken from 100 people. Of those, half will have primary open angle glaucoma (POAG) and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.

Official Title
-----------------
Nuclear Genetic and Mitochondrial Influences in Glaucoma

Conditions
-----------------
Primary Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 yrs Caucasian or African American Male or female with POAG, PACG, PXFG, Normal Exclusion Criteria: Other ophthamic co-morbidities Other ethnic groups Unable to understand and give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| 1<br>Primary Open Angle Glaucoma (POAG) | |
| 2<br>Controls (Normals, patients without glaucoma) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators will quantify the spectrum of changes in mitochondrial respiration, relative mitochondrial DNA content, and oxidative stress associated with different types of glaucoma. |  | one blood draw | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary open angle glaucoma, Nuclear Genetics, Mitochondrial DNA, POAG
Yoga in School Sports - a Pilot Study in Germany

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for school sports to evaluate potential effects in stress reduction and concomitant psychological parameters.

Official Title
-----------------
Yoga in School Sports - a Non-randomized Controlled Pilot Study in Germany

Conditions
-----------------
Yoga, Stress

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students of Berlin Oberstufenzentrum (OSZ) aged 17-27 years Written consent (with parents at underage (17 years) Exclusion Criteria: Severe chronic or acute diseases Pregnancy or lactation Immobility or restriction for gymnastic exercises because of orthopedic, neurological or other medical reasons Participation in another study

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 27 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Students have 10 weeks yoga instead of school sport. | Other: Yoga<br> <br> |
| Active Comparator: School sport<br>Students have 10 weeks regular school sport. | Other: School sport<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen Perceived Stress Scale (CPS) |  | Change in CPS from Baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen Perceived Stress Scale (CPS) |  | Change in CPS from Baseline to 6 months | 
| WHO-5 questionaire (quality of life) |  | Baseline, 10 weeks, 6 months | 
| Hospital Anxiety and Depression (HADS) |  | Baseline, 10 weeks, 6 months | 
| Profile of Mood States (POMS) |  | Baseline, 10 weeks, 6 months | 
| Visual analogue scales (VAS) for general pain, headache, shoulder and neck tension, fatigue, sleep quality |  | Baseline, 10 weeks, 6 months | 
| D2 Test of Attention | The d2 Test of Attention is a neuropsychological paper-and-pencil test of selective and sustained attention. Participants have to cross out any letter d with two marks around above it or below it in any order. Surrounding distractors are similar to the target stimulus, e.g. a p with two marks. | Baseline, 10 weeks, 6 months | 
| Yoga Self-Efficacy Scale |  | Baseline, 10 weeks, 6 months | 
| Overall assessment of efficacy and tolerability (Likert scales) |  | Baseline, 10 weeks, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga, Stress, Adolescents, School, Children
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular function

Official Title
-----------------
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Preserved Left Ventricular Systolic Function

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Candesartan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 or above Congestive Heart Failure with symptoms for more than 4 weeks before starting study Provision of informed consent Exclusion Criteria: Current low blood pressure with symptoms Liver disease considered significant by the study doctor Pregnant or lactating females

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Candesartan<br> <br> * Other names: Atacand;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality or hospitalisation due to congestive heart failure |  | , 4, 6 weeks, 6 months, every 4 months thereafter until 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI |  | Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Atacand, Candesartan
Dose, Effects and Characteristics of Pilocarpine

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation, in which pilocarpine was given in repeated doses, was to evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients to pilocarpine 2% when given once, twice and four daily. In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

Detailed Description
-----------------
In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

Official Title
-----------------
Dose, Effects and Characteristics of Pilocarpine

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Pilocarpine Concentration
* Drug: Pilocarpine Frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open-angle glaucoma Primary open-angle glaucoma suspect

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilocarpine Concentration<br>Varying concentration 0.5 to 8% - 22 patients were examined regarding: visual acuity, iris color, pupil size, chamber angle, C/D ratio, visual field (VF), coefficient of aqueous outflow and Goldmann tonometry. After a one month washout period, pilocarpine was used 4 times daily, in concentrations from 0.5 to 8%. The amount of IOP change was compared with various clinical findings | Drug: Pilocarpine Concentration<br>* Varying concentration 0.5 to 8%<br>|
| Experimental: Pilocarpine Frequency<br>Varying frequency, once to four times daily - 15 patients were included in a crossover study: IOP was checked daily for 3 days and for 9 hours on fourth day. Pilocarpine was started on day 5 once daily OD and BID OS; on day 9 once daily OD and QID OS; on day 12 QID OD and once daily OS; on day 16 once daily OD and QID OS; and on day 19 QID OD and once daily OS. No medications were used on days 23-25. IOP was measured on days 4, 8, 11, 15, 18, 22 and 25. | Drug: Pilocarpine Frequency<br>* 1 to 4 times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure |  | 25 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Concentration, Pilocarpine, POAG, IOP, Frequency, Primary open-angle glaucoma, Primary open-angle glaucoma suspect
Consequences of Intensified Handwash and Hand Disinfection Among Children During the COVID19 Pandemic

Study Overview
=================
Brief Summary
-----------------
During the COVID-19 pandemic after reopening of the country, school, kindergarten and daycare, children have been obligated to do frequent handwash. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare facilities electronic platforms.

Detailed Description
-----------------
During the COVID-19 pandemic Denmark closed down, including schools, kindergartens and daycare. After reopening of the country 5 weeks later obligatory frequent handwash was a requirement from the government and routines has been implemented at all reopened schools, kindergartens and daycare. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. Also the study group wished to investigate if frequency or use of hand disinfection mattered. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare electronic platforms. The questionnaire included 20 questions on demographics, frequency of hand wash and use of disinfectants, current and previous symptoms of eczema, atopic dermatitis and dispositions.

Official Title
-----------------
Re-opening of the Country and Dermal Consequences of Mandatory Intensified Handwash and Hand Disinfection Among a Danish Pediatric Population During the COVID19 Pandemic

Conditions
-----------------
Hand Eczema, Hand Dermatitis, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children returned to daycare, kindergarten or school after covid19 close down of the country Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 13 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal reaction to frequent hand wash and disinfection in children | Dermal symptoms as a result of frequent hand wash and disinfection among children | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermatitis, Hand wash, Hand disinfection, Children, Pediatric
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. The treatment will be conducted as individual therapy or group therapy.

Official Title
-----------------
Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.

Conditions
-----------------
Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral therapy (individual)
* Behavioral: Cognitive behavioral therapy (group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, DSM-IV criteria Exclusion Criteria: Pervasive Developmental Disorder Psychotic symptoms Intelligence score < 70 Use of medications with anxiety reducing effects during treatment Neither parent competent in Norwegian language

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Individual CBT | Behavioral: Cognitive behavioral therapy (individual)<br>* The Coping Cat program, 12 weekly sessions, two additional parent meetings<br>|
| Experimental: B<br>Group CBT | Behavioral: Cognitive behavioral therapy (group)<br>* The Coping Cat program, 12 weekly sessions, two additional parent meetings<br>|
| No Intervention: C<br>Waiting-list control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth |  | post-treatment and 2 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score on the MASC |  | post-treatment and 2 year follow-up | 
| CGAS |  | post-treatment and 2 year follow-up |
Autonomic Dysfunction in Patients With Pectus Excavatum.

Study Overview
=================
Brief Summary
-----------------
Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.

Detailed Description
-----------------
Since pectus excavatum can cause cardiac arrhythmia, the cardiac autonomic function in participants with pectus excavatum might be impaired. However, to our knowledge, there is no any study to evaluate the cardiac autonomic function in participants with pectus excavatum.

Official Title
-----------------
Autonomic Dysfunction in Patients With Pectus Excavatum.

Conditions
-----------------
Pectus Excavatum, Autonomic Dysfunction, Surgery

Intervention / Treatment
-----------------
* Procedure: Nuss surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pectus excavatum Agree to receive Nuss surgery to correct pectus excavatum Exclusion criteria: Major medical disease (asthma, heart failure, renal disease) Known psychiatric disease Known sleep-disordered breathing Skeletal disease Major surgery within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 45 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 |
| --- | --- |
| Study group<br>patients with pectus excavatum | Procedure: Nuss surgery<br>* surgical correction for pectus excacatum<br>|
| Control group<br>healthy subjects without pectus excavatum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of Nuss surgery on HRV in patients with pectus excavatum | If Nuss surgery can improve HRV in different stress in patients with pectus excavatum? | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pectus excavatum, heart rate variability