linjc16/ctgov huggingface dataset:
Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.

Detailed Description
-----------------
Despite the established benefits of beta-blockers, their use is limited by their side effect profile and by a perception of reduced efficacy in certain populations such as African Americans (Amudha, 2003). This is a double-blind, randomized, placebo and active-controlled, multi-center, parallel group, forced titration study. Patients will be stratified across all treatment arms by age, gender, and diabetes status (history of diabetes mellitus vs no history of diabetes mellitus). The study consists of 3 periods: screening run-in, double-blind, randomized, forced titration and double-blind, washout period (only for patients who complete the double-blind, forced titration period and who are not participating in the long-term follow-up study). After a 14-28 day, single-blind, placebo controlled, run-in period, which includes washout (if applicable), eligible patients will be randomized to one of 3 treatment regimens for approximately 12 weeks. This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension.

Official Title
-----------------
A Double-Blind, Randomized, Placebo- and Active-Controlled, Forced Titration Study Evaluating the Effects of Nebivolol on Blood Pressure and Heart Rate in African American Patients With Hypertension

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

Intervention / Treatment
-----------------
* Drug: Nebivolol and Atenolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African Americans with stage 1-2 hypertension Exclusion Criteria: Recent myocardial infarction or stroke Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy

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

| Intervention/Treatment |
| --- |
|Drug: Nebivolol and Atenolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  | 
| Heart Rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol
Drinking Habits of Glaucoma Patients and Age Matched Controls

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if a chronic dehydration is a risk factor for the developement or progression of some forms of glaucoma.

Detailed Description
-----------------
Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment are asked about their drinking habits. Objective evaluation of hydration status is assessed with the Body Composition Monitor (Fresenius). Retinal Vessel Analysis and Laser Doppler Flowmetry are investigated in subgroups. The control group are also hospitalized patients who do not suffer from glaucoma.

Official Title
-----------------
Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls

Conditions
-----------------
Dehydration, Glaucoma

Intervention / Treatment
-----------------
* Behavioral: alter drinking habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma patients controls Exclusion Criteria: psychiatric disease, epilepsy, pregnancy, nutritional disorder, malfunction of blood clotting and wound healing, pacemaker, metallic stents

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glaucoma<br>hospitalized glaucoma patients | Behavioral: alter drinking habits<br>* if dehydration is apparent, more fluid intake is recommended<br>|
| controls<br>hospitalized patients without glaucoma | Behavioral: alter drinking habits<br>* if dehydration is apparent, more fluid intake is recommended<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dehydration | The composition of a patient's body, in particular a patient's water content are determined with bioimpedance spectroscopy (Body Composition Monitor, FRESENIUS) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microvascular changes | To investigate differences in retinal vessel diameters measured with the Retinal Vessel Analyzer (RVA, IMEDOS) in glaucoma patients and controls | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dehydration, risk factor, glaucoma, Controls
Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland

Study Overview
=================
Brief Summary
-----------------
The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.

Official Title
-----------------
Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS

Conditions
-----------------
ARDS

Intervention / Treatment
-----------------
* Device: Doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: 18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours - Exclusion Criteria: Patients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too. -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Doppler ultrasound|Pulmonary artery pressure and right heart function will be assessed using Doppler ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland |  | 20/11/2021-20/12/2022 | 
| ICU mortality ICU mortality | Mortality during treatment in ICU | 20/11/2021-20/12/2022 | 
| 28-days mortality rate | Mortality at 28 days of hospitalization | 20/11/2021-20/12/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator time | Ventilator time in ICU | 20/11/2021-20/12/2022 | 
| Hospital length of stay | Total length of stay in hospital | 20/11/2021-20/12/2022 |
Pediatric Intubation During CPR

Study Overview
=================
Brief Summary
-----------------
We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of two video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with uninterrupted chest compressions using an child manikin.

Official Title
-----------------
Comparison of the Atmos Scope, the Coopdech and the AirTraq in Pediatric Patients During Resuscitation. Randomized Crossover Manikin Trial

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: ATMOS Scope
* Device: COOPDECH
* Device: AirTraq


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Give voluntary consent to participate in the study minimum 1 year of work experience in emergency medicine experienced emergency medical personnel (physicians, nurses, paramedics) Exclusion Criteria: Not meet the above criteria Wrist or Low back diseases

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubation during chest compression<br>Intubation during mannequin chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control, Redmond, WA, USA). | Device: ATMOS Scope<br>* Video-laryngoscopy 1<br>* Other names: ATMOS Scope Flexible Videoendoscope;Device: COOPDECH<br>* Video-laryngoscopy-1<br>* Other names: COOPDECH Video Laryngoscope Portable VLP-100;Device: AirTraq<br>* Optical-laryngoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of intubation | effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants using two intubation devices | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | time in seconds required for a successful intubation attempt | 1 day | 
| POGO score | self-reported percentage of glottis opening (POGO) score | 1 day | 
| Cormack-Lehane grading | self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, child, resuscitation, simulation, Endotracheal
Varicella Vaccination With Pulmicort

Study Overview
=================
Brief Summary
-----------------
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine

Official Title
-----------------
Rates of Seroconversion Following Varicella Vaccination of Asthmatic Children Between the Ages of One and Eight Years Treated With Pulmicort Respules® Versus Non-Steroidal Conventional Asthma Therapy

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide
* Drug: varicella zoster virus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the age of 10 months and 8 years, have asthma or shown recent signs suggesting asthma, have a parent or guardian willing to comply with study requirements Exclusion Criteria: Varicella zoster immune globulin (VZIG) within 5 months prior to immunization, Previous varicella immunization, an immunization or allergy immunotherapy 4 weeks prior to immunization, Severe asthma, have another persistent lung disease, have a planned hospitalization for the duration of study

Ages Eligible for Study
-----------------
Minimum Age: 10 Months
Maximum Age: 8 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pulmicort | Drug: budesonide<br> <br> * Other names: Pulmicort;|
| Active Comparator: 2<br>Varivax | Drug: varicella zoster virus<br> <br> * Other names: Varivax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion level |  | Week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Children, Varivax, varicella, Pulmicort, budesonide
Alopecia Areata Registry

Study Overview
=================
Brief Summary
-----------------
Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata.

Detailed Description
-----------------
Alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. It is thought to be an autoimmune disease and in some cases the disease is hereditary. The Alopecia Areata Registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). This will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). Information from these patients will be used to search the human genome for disease-associated loci and/or genes. Researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question. Patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. Patients will fill out an information form online (alopeciaareataregistry.org). Patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn.

Official Title
-----------------
Alopecia Areata Registry and Immunogenetic Mechanisms

Conditions
-----------------
Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Autoimmune Hair Loss, Alopecia Partialis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosed with alopecia areata by a dermatologist United States resident Accepts Health Volunteers: Non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient.
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 |
| --- | --- | --- |
| Alopecia Areata Registry | Database registration of participants via collection of participant epidemiology data. | Registration on-going | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Baldness, Autoimmunity, Hair, Alopecia Areata, Alopecia Partialis, Alopecia Totalis, Alopecia Universalis, Autoimmune Hair Loss
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.

Official Title
-----------------
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)

Conditions
-----------------
Chronic Myelogenous Leukemia in Chronic Phase

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase Previously untreated with Interferon-alpha Performance status is normal or capable of only limited self-care Exclusion Criteria: Patients who are pregnant or possibly pregnant Significant hepatic diseases Chronic Myelogenous Leukemia in advanced phase Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 74 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imatinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 years overall survival |  |  | 
| Duration of remaining in chronic phase |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib, |  |  | 
| Adverse event |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Myelogenous Leukemia, Imatinib, CML
Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the cardiovascular risks of growth hormone deficient young adult males who have completed growth hormone therapy to healthy young adult males.

Detailed Description
-----------------
Adults with growth hormone deficiency are at risk for cardiovascular disease. What age this begins is not known. The objectives of this study are to compare the following measurements between growth hormone deficient young males 3-7 years post completion of growth hormone treatment and age related healthy controls: Carotid artery imaging Metabolic and cardiac parameters Body composition measurements

Official Title
-----------------
Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy.

Conditions
-----------------
Growth Hormone Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Growth Hormone Deficient Inclusion Criteria: Males, 18-25 years old Completed growth hormone therapy approximately 3-5 years prior to study enrollment History of multiple pituitary hormone deficiencies or growth hormone stimulation test <7 at initiation of growth hormone therapy Healthy Control Inclusion Criteria: Males, 18-25 years old No confirmed endocrine diagnosis including Diabetes and thyroid disorders BMI - z-score within 2 SD of mean Exclusion Criteria: Known risk factors for cardiovascular disease (eg tobacco use, hypertension, diabetes) Family history of early cardiovascular disease (myocardial infarction or stroke <55years of age) in first degree family members Any implanted device Medication known to interfere with glucose or lipid metabolism or to influence blood pressure Chronic organ illness (eg severe asthma, hepatic or nephritic conditions)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>18-25 year old males, growth hormone deficient, who completed growth hormone treatment 3-5 years prior to enrollment in study | |
| 2<br>18-25 year old males, healthy, never treated with growth hormones. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare carotid artery intima medial thickness |  | During study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare metabolic parameters and body composition measurements |  | During study visit |
Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients

Study Overview
=================
Brief Summary
-----------------
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.

Detailed Description
-----------------
All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness > 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: sofosbuvir and daclatasvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart Exclusion Criteria: Heart rate < 50/min, Taking amiodarone

Ages Eligible for Study
-----------------
Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects will receive sofosbuvir and daclatasvir | Drug: sofosbuvir and daclatasvir<br>* A fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks.<br>* Other names: Sovodak;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sustained viral response rate | Qualitative hepatitis C virus RNA polymerase chain reaction | 12 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug events | Questionnaire | weeks 2, 4, 8, 12 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, sofosbuvir, daclatasvir