linjc16/ctgov huggingface dataset:
Changes in Central Arterial Pressure When Comparing Nifedipine/Labetalol for Routine Hypertension Control in Pregnancy

Study Overview
=================
Brief Summary
-----------------
To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.

Detailed Description
-----------------
Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study. Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so. Their participation will be complete after the 4 hour assessment is complete.

Official Title
-----------------
Changes in Central Arterial Pressure When Comparing Nifedipine and Labetalol for Routine Hypertension Control in Pregnancy

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

Intervention / Treatment
-----------------
* Other: Nifedipine
* Other: Labetalol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol Exclusion Criteria: Multiple pregnancy Currently on multiple anti-hypertension medications Narcotic use Irregular heart rhythms or arrhythmias Peripheral arterial disease, leg artery disease Reynaud's phenomena Intense cold/hypothermia If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment Known sensitivity to labetalol or nifedipine Severe tachycardia (>120) Greater than 1st degree heart block Severe asthma Congestive heart failure or heart disease Lupus Inability to adequately monitor BP Currently receiving magnesium sulfate

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 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 |
| --- | --- |
| Nifedipine<br>patients will be assigned to antihypertensive medications by their physicians in the course of their routine care | Other: Nifedipine<br>* patients will be assigned to antihypertensive medications by their physicians in the course of their routine care<br>|
| Labetalol<br>patients will be assigned to antihypertensive medications by their physicians in the course of their routine care | Other: Labetalol<br>* patients will be assigned to antihypertensive medications by their physicians in the course of their routine care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central blood pressure changes |  | every 30 min for 4 hours |
Molecular and Genetic Analysis of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Investigators use a genome-wide approach within a case-control design to identify SNPs that show evidence of association with lung cancer risk and survival.

Detailed Description
-----------------
Investigators also investigate how genetic variants may affect cancer treatment, at various stages of disease development, in order to determine prognostic and predictive factors for survival.

Official Title
-----------------
Molecular and Genetic Analysis of Lung Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy controls: participants without evidence of any cancer cases: pathology proven primary lung cancer Exclusion Criteria: younger than 18 years old

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival among patients at different stages of lung cancer and treatment will be measured using questionnaires along with medical chart data to monitor treatment and disease progression | Study lung cancer development in a case control study. We will look at three separate outcome measures specified below | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Measurement from time of diagnosis to death will be obtained | 20 years | 
| Progression-free survival | Time of diagnosis to disease progression (measured by metastasis) | 20 years | 
| Treatment toxicities | Effects on ECOG and physical sequelae from treatment (radiation, chemotherapy and other treatment modalities will be analyzed) | 20 years |
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-104 medium concentration
* Drug: DE-104 high concentration
* Drug: Placebo
* Drug: 0.005% latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided signed, written informed consent. 18 years of age and older. Diagnosed with primary open-angle glaucoma or ocular hypertension. If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

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 |
| --- | --- |
| Experimental: 1<br> | Drug: DE-104 medium concentration<br>* Topical ocular application<br>|
| Experimental: 2<br> | Drug: DE-104 high concentration<br>* Topical ocular application<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Topical ocular application<br>|
| Active Comparator: 4<br> | Drug: 0.005% latanoprost<br>* Topical ocular application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. |  | 15 days |
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient

Study Overview
=================
Brief Summary
-----------------
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient

Official Title
-----------------
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient

Conditions
-----------------
Haemodialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 patient under haemodialysis treatment patient not objecting to study Exclusion Criteria: Patient with known cardiac arrythmias

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 |
| --- | --- | --- |
| Description of all the cardiologic abnormalities |  | 3 days |
The Effect of Colonoscopy on Intralocular Pressure

Study Overview
=================
Brief Summary
-----------------
Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed and treated properly. The major risk factor for the development and progression of glaucoma is increased intraocular pressure. Colonoscopy is one of the most preformed world wide screening exam. It is used to detect colon cancer at its early stages. As part of this examination, the examiner inflates the inspected colon with air in order to increase the colon lumen for better visualization of the colon. As a consequence of the insufflation the intrabdominal pressure increases as well. the increase in intrabdominal pressure could increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure increase while preforming colonoscopy.

Official Title
-----------------
The Effect of Colonoscopy on Intralocular Pressure

Conditions
-----------------
Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18. Patients referred by a gastroenterologist for a colonoscopy examination. Patients the are interested in participating in this study and who are able to sign an informed consent. Exclusion Criteria: Family history of Glaucoma - first degree relatives. Patients with known ocular disease, excluding refraction. Patients receiving eye pharmacologic treatment. Patients with known allergies to Oxybuprocaine Hydrochloride drops.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of Intraocular pressure |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy
Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection

Study Overview
=================
Brief Summary
-----------------
The main purpose of this pre-approval access program (PAAP) is to provide rilpivirine Long Acting (RPV LA) injectable suspension for the treatment of human immunodeficiency virus (HIV)-1 infection as single patient request to individuals who have no available treatment alternatives and/or limited treatment options (for example, who are unable to participate in the Phase III clinical studies or do not qualify). RPV LA can only be provided if participants are also eligible for cabotegravir Long Acting injections.

Official Title
-----------------
Rilpivirine Long Acting Single Patient Requests

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: Rilpivirine Long Acting (RPV LA)


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rilpivirine Long Acting (RPV LA)|Participants will receive RPV LA injectable suspension containing 300 milligram per milliliter (mg/mL) of RPV by intramuscular (IM) injection. A starting dose of 900 milligram (mg) RPV LA (3 milliliter [mL] suspension) will be administered with subsequent doses of 600 mg RPV given at 4-week intervals.|

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
-----------------
HIV, Rilpivirine, Long Acting Rilpivirine Injection, Rilpivirine Expanded Access, Rilpivirine Single Patient Request
The Effect of Parental Presence on Pain and Anxiety Levels During Peripheral Intravenous Catheterization in Infants

Study Overview
=================
Brief Summary
-----------------
Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. It is extremely important that parents are with their children during painful procedures. Research; parents during peripheral intravenous catheterization in infancy It was planned to determine the effect of inclusion on pain and anxiety.

Detailed Description
-----------------
This randomized controlled trial included data from 120 cases in the Pediatric Health and Diseases Department of Istanbul, during March 2020-August 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). Information form, State-Trait Anxiety Inventory and FLACC scale were used to collect data.

Official Title
-----------------
Pediatric Nursing in Bagcilar Training and Research Hospital

Conditions
-----------------
Family Centered Care

Intervention / Treatment
-----------------
* Other: not interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children within the age group of 1-24 months Parents know Turkish language Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 24 Months

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 |
| --- | --- |
| parental involvement group<br>n=46 | |
| parental presence group<br>n=42 | |
| parental absence group<br>control group, n=32 | Other: not interventional<br>* This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypothesis 0 | There is no difference between the pain and anxiety levels of the children whose parents were included in the procedure during peripheral intravenous catheterization and the pain and anxiety levels of the children whose parents were only with the child during the procedure and who were not with the child during the procedure. | March 2020-August 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
family centered care
Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment

Study Overview
=================
Brief Summary
-----------------
Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. The most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. In clinical examination, both can appear very thin and transparent. Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.

Official Title
-----------------
Use of Spectral Domain Optical Coherence Tomography to Differentiate and Follow-up Senile Retinoschisis and Retinal Detachment

Conditions
-----------------
Retinoschisis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age. Ophthalmoscopic evidence of RS or RD Written informed consent has been obtained. Exclusion Criteria: Progression of retinal detachment or retinoschisis requiring surgical treatment Contraindication to pupil dilation, known allergy.

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 |
| --- | --- |
| 1<br>At all study visits a complete ophthalmic examination, visual acuity and refractive error, Spectralis OCT, Cirrus OCT, Topcon OCT, PS-OCT, Optomap Fundus photography will be performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up |  | Baseline | 
| Change or progression of disease measured in optical coherence tomography |  | 2 years |
Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke

Study Overview
=================
Brief Summary
-----------------
Cognitive disorders are common early after stroke but can be overseen in patients with mild stroke who seem to be functionally recovered but are at risk to experience difficulties in advanced daily activities affecting social, vocational and family responsibilities. Acute stroke units admit a large number of patients and adequate referral to rehabilitation services is essential in terms of quality of care. A self-evaluation tool to evaluate cognitive function was developed by the occupational therapy department. Patients with mild strokes and pre-stroke independent for instrumental daily activities fill out this self-evaluation tool, which is a paperwork task. Semi-structured interpretation is performed by physician and may result in referral to the occupational therapist for comprehensive evaluation. In this study the validity and reliability of the self-evaluation tool will be examined.

Official Title
-----------------
Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke

Conditions
-----------------
Stroke, Acute, Cognitive Dysfunction

Intervention / Treatment
-----------------
* Other: Self evaluation tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnose of stroke written consent age 18 years or older less than 1 week after stroke onset Exclusion Criteria: not able to write/read not able to understand Dutch unilateral motor deficit in upper limb (NIHSS score for upper limb +2) referred to stroke unit with Transcient Ischemic Attack

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: Self evaluation tool|This self-evaluation tool to evaluate cognitive function, developed by the occupational therapy department, is a paperwork task with guidelines for semi-structured interpretation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-evaluation tool | cognitive screening tool | within one week after stroke onset | 
| Oxford Cognitive Screen | cognitive measure | within one week after stroke onset | 
| Montreal Cognitive Assessement | cognitive measure | within one week after stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Occupational therapy, Evaluation tool
Characteristics of Plant Sterols Consumers in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the cardiovascular risk profile in subjects who consume a marketed drinkable low fat fermented milk enriched with plant sterol. Investigations are lead prospectively and retrospectively among adults enrolled from general practitioners' database.

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female aged 18-70 years, regular visits to GP (at least once every six months within the past 2 years), agreeing to a written informed consent Exclusion Criteria: any clinical, psychological or language problem that would prevent from completing the questionaires or communicating with GP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| group 1<br>group 1 = consumers of marketed drinkable low fat fermented milk enriched with plant sterol | |
| group 2<br>group 2 = non-consumers of marketed drinkable low fat fermented milk enriched with plant sterol | |

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
-----------------
cardiovascular risk, dairy enriched product with plant sterols, general practitioners, adults followed by general practitioners