linjc16/ctgov huggingface dataset:
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per §67(6)AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Atrovent® inhalets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both gender, older than 40 years, who suffer from chronic obstructive Pulmonary disease Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion Exclusion Criteria: • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhalets

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Chronic Obstructive Pulmonary Disease<br> | Drug: Atrovent® inhalets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of improvement of the clinical picture rated on a 6-point symptom profile |  | Up to 4 weeks after first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 4-point scale |  | Up to 4 weeks after first drug administration | 
| Assessment of efficacy by patient on a 4-point scale |  | Up to 4 weeks after first drug administration | 
| Assessment of tolerability by investigator on a 4-point scale |  | Up to 4 weeks after first drug administration | 
| Assessment of tolerability by patient on a 4-point scale |  | Up to 4 weeks after first drug administration | 
| Number of patients with adverse drug reactions |  | Up to 4 weeks after first drug administration |
Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure

Study Overview
=================
Brief Summary
-----------------
After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).

Official Title
-----------------
Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study

Conditions
-----------------
Cirrhosis, Acute Liver Failure, Chronic Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure). Age > 18years Exclusion Criteria: Previous liver transplantation. Patients who died within 8 hours of ICU (Intensive Care Unit) admission. Acute liver failure Lack of consent Patient on steroids/ or any other immunosuppressive medication

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhotics/ Acute on chronic liver failure admitted to ICU<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within 1 month during ICU (Intensive Care Unit) stay. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days stayed in ICU (Intensive Care Unit). |  | 30 days | 
| Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc |  | 30 days | 
| Proportion of patients with organ failure. |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute on Chronic Liver Failure (ACLF),Cirrhosis,, Institute of Liver & Biliary Sciences (ILBS)
Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal cystine accumulation. II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00 unit when treated with this regimen.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, multicenter study Patients are randomized to receive the current formulation of cysteamine hydrochloride as drops in one eye and the new formulation of cysteamine hydrochloride as drops in the other eye. Patients receive the two formulations of cysteamine hydrochloride in their assigned eyes every hour during waking hours daily for 6 months (safety study) or for 1 year (efficacy study).

Conditions
-----------------
Cystinosis

Intervention / Treatment
-----------------
* Drug: cysteamine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of cystinosis with more than 2 nmole half-cystine/mg protein in leukocytes OR presence of corneal crystals consistent with cystinosis and distributed in corneal stroma observed by slit lamp biomicroscopy Clinical history consistent with cystinosis Safety study: History of adherence with current eye drop and follow-up schedule on protocol #86-El-0062 Any crystal density score, including zero, on photographs, that has been stable or improved over the past year Efficacy study: Crystal density score at least 1.00 on photographs Concurrently on cysteamine for at least the past 6 months --Prior/Concurrent Therapy-- No prior cysteamine drops (efficacy study) --Patient Characteristics-- Age: 1 to 50 (safety study) 2 to 12 (efficacy study) Other: Willingness and ability to tolerate corneal photographs

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cysteamine hydrochloride|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
-----------------
cystinosis, rare disease, renal and genitourinary disorders
Nutritional Supplements on Blood Pressure 2008

Study Overview
=================
Brief Summary
-----------------
Three different supplements will be used in the study (fruits and vegetable powders, whey protein and calcium) for patients with hypertension. The null hypothesis was that the supplements had no effects on participants' blood pressure.

Detailed Description
-----------------
Hypertensive participants will be randomly assigned into three groups. The first group of participants will take the fruits and vegetable powders mixed with water. The second group takes whey protein and the third group takes calcium pills. Blood pressure and heart rate variability will be measured every two weeks for three months.

Official Title
-----------------
Effects of Nutritional Supplements on Blood Pressure and Heart Rate Variability

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

Intervention / Treatment
-----------------
* Dietary Supplement: NanoGreens
* Dietary Supplement: Whey protein
* Dietary Supplement: Calcium pills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-70 Hypertensive male and female subjects. Exclusion Criteria: Severe cardiovascular and renal conditions. Pregnancies and taking medications.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruit and vegetables<br>Fruits and vegetables | Dietary Supplement: NanoGreens<br>* fruits and vegetables<br>|
| Active Comparator: Whey protein<br>Whey protein | Dietary Supplement: Whey protein<br>* Whey<br>* Other names: NanoPro;|
| Active Comparator: Ca<br>Calcium pills | Dietary Supplement: Calcium pills<br>* CA<br>* Other names: CA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure and HRV |  | every two weeks for three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, supplement, HRV
Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm

Study Overview
=================
Brief Summary
-----------------
Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.

Official Title
-----------------
Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm

Conditions
-----------------
Arteriovenous Malformations, Intracranial Aneurysm, Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients between the ages of 18 and 89 that are having open surgical resection of an AVM or clipping of an aneurysm will be included Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AVM Patients<br>Patients receiving surgical intervention for an intracranial arterial-venous malformation. | |
| Ruptured Aneurysm<br>Patients receiving surgical intervention for a ruptured intracranial aneurysm. | |
| Unruptured Aneurysm<br>Patients receiving surgical intervention for an unruptured intracranial aneurysm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk gene expression | The samples will be frozen after collection and then analyzed. | Within one week of sample collection. |
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy

Study Overview
=================
Brief Summary
-----------------
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Official Title
-----------------
Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)

Conditions
-----------------
Refractory Epilepsy

Intervention / Treatment
-----------------
* Device: PINS Vagus Nerve Stimualtor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3-6 At least 6 seizure per month Refractory Epilepsy In good health except epilepsy Patients or his(her) familyscould understand this method and sign the informed consent Patients with good compliance and could complete postoperative follow-up Exclusion Criteria: Results of MRI remind epilepsy caused by intracranial space-occupying lesions The vagus nerve lesion and damage Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication Cann't write the epilepsy diary Participating other clinical trial Cann't complate the operation Complete the postoperative follow-up Cann't complete the promgramming

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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: Experimental<br>Subjects'Vagus Nerve stimulator is on always | Device: PINS Vagus Nerve Stimualtor<br>* PINS Vagus Nerve Stimualtor<br>|
| Sham Comparator: Control<br>Subjects'Vagus Nerve stimulator is off from enrollment to 3 month | Device: PINS Vagus Nerve Stimualtor<br>* PINS Vagus Nerve Stimualtor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency |  | 12 weeks of stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency |  | 6、12、24 weeks of stimulation | 
| Engel scale description |  | 6、12、24 weeks of stimulation | 
| Changes in the Number of Anti-epileptic Drugs |  | 6、12、24 weeks of stimulation | 
| GESELL mental development scales |  | 12、24 weeks of stimulation |
A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age

Study Overview
=================
Brief Summary
-----------------
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.

Official Title
-----------------
A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients

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

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =>95th PERCENTILE FOR AGE/GENDER/HEIGHT CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED Exclusion Criteria: BLOOD PESSURE IS =>5% HIGHER THAN 99th PERCENTILE FOR AGE SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS Other protocol-defined inclusion/exclusion criteria will also apply.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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: valsartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic blood pressure after 2 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks |  |  | 
| Change from baseline systolic blood pressure after 4 weeks |  |  | 
| Change from baseline diastolic blood pressure after 2 weeks |  |  | 
| Change in diastolic blood pressure after 2 weeks to 4 weeks |  |  | 
| Change from baseline diastolic blood pressure after 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEDIATRIC HYPERTENSION, PEDIATRIC, VALSARTAN
Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China

Study Overview
=================
Brief Summary
-----------------
The data of patients undergo extracorporeal cardiopulmonary resuscitation (eCPR) will be collected and analyzed. This study will provide useful information about the indication, the start time and others to improve the outcome of ECPR.

Official Title
-----------------
Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China

Conditions
-----------------
Cardiopulmonary Arrest, Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
-----------------
* Device: extracorporeal membrane oxygenation (ECMO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18y Cardiac arrested patients accept ECPR treatment Exclusion Criteria: No

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: extracorporeal membrane oxygenation (ECMO)|ECMO under ongoing cardiopulmonary resuscitation (eCPR) in patients with refractory cardiac arrest|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | the death rate of the patients | 28 days |
The Impact of Opioids in Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for heart attack. An impact of opioid medications on coronary heart disease is hypothesised (MIOP). In addition, all patients with coronary angiography should be consulted twice (after 3 and 6 months) to find out how many of these patients have developed a refractory angina pectoris (TRAPS).

Official Title
-----------------
Evaluation of Past Medications in Patients With Coronary Heart Disease and Patients Hospitalized for a Non-cardiac Reason

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years or older written informed consent Exclusion Criteria: currently cancer cognitive limitations

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Patients with coronary heart disease<br>coronary angiography with finding coronary heart disease currently no cancer 40 years or older | |
| control patients<br>coronary angiography with exclusion coronary heart disease or other patients with non-cardiac diseases currently no cancer 40 years or older | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with opioid treatment (WHO II/ WHO III) within the last 10 years before present hospitalization, Interview with standardized CRF | Standardized assessment of opioid medications taken before hospital admission to evaluate the impact of opioids in coronary heart disease. Exact doses, substances and intake habits are inquired. | 20 minutes | 
| Number of patients with refractory angina pectoris, Interview with standardized CRF | Standardized assessment of angina pectoris symptoms and treatments to evaluate a refractory angina pectoris. Changes of their medications are inquired twice. | 30 minutes |