linjc16/ctgov huggingface dataset:
Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.

Official Title
-----------------
An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Ziprasidone
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients newly treated for schizophrenia and those receiving continuing treatment will be eligible if the treating psychiatrist is ready to initiate a new antipsychotic medication, and would consider using either ziprasidone or olanzapine as an appropriate therapy. Male and female patients who meet all criteria listed below are eligible to be enrolled in this study: Diagnosed with schizophrenia Willing to provide information on at least one alternate contact person for study staff to contact regarding patient's whereabouts, should the patient be lost-to-follow-up over the course of the study Exclusion Criteria: Progressive fatal disease of a life expectancy which prohibits them from participating in a one year research study Previously randomized to study medication and enrolled in this 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ziprasidone|nan|
|Drug: Olanzapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause mortality, mortality due to suicide, cardiovascular mortality, mortality due to sudden death |  | During the year observation period | 
| To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause hospitalization, hospitalization for arrhythmia, myocardial infarction, or diabetic ketoacidosis |  | During the year observation period | 
| The rate of discontinuation of randomized treatment. |  | During the year observation period |
Registry for Chronic Obstructive Pulmonary Disease With Anxiety and Depression in China

Study Overview
=================
Brief Summary
-----------------
Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. The study aim to investigate the prevalence and long-term outcome of anxiety and depression in COPD.

Official Title
-----------------
The Early Detection, Clinical Course and Prognosis of Anxiety and Depression in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD, Anxiety, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable chronic obstructive pulmonary disease (COPD) patients Exclusion Criteria: Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months Patients with tumor history during past 5 years Patients with COPD exacerbations during past 4 weeks Participants in clinical trials Patients in pregnancy or breastfeeding Patients unable to complete questionaire independently Patients older than 80 years old Patients receiving long-term domiciliary oxygen therapy

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |
| moderate and severe COPD exacerbations | total times | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | mortality in % | 3 years |
Effect of General Anesthesia on Enterocyte Damage

Study Overview
=================
Brief Summary
-----------------
During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.

Detailed Description
-----------------
Inclusion criteria Indication of non-urgent surgery General anesthesia protocol using propofol and remifentanyl One half of the patients have a history of ischemic arteriopathy One half of the patients have no history of ischemic arteriopathy Exclusion criteria Age < 18 years old Pregnant Primary objective Is there a significant elevation of I-FABP between the pre-anesthesic period and 11 minutes after induction of general anesthesia ? Secondary objectives Is I-FABP elevation higher among patients with history of patent arteriopathy ? Is I-FABP elevation higher among patients presenting with hypotension during anesthesia ?

Official Title
-----------------
Impact of General Anesthesia on Enterocyte Damage

Conditions
-----------------
General Anesthesia, Non-urgent Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Indication of non-urgent surgery General anesthesia protocol using propofol and remifentanyl One half of the patients have a history of ischemic arteriopathy One half of the patients have no history of ischemic arteriopathy Exclusion criteria Age < 18 years old Pregnant

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 |
| --- | --- | --- |
| I-FABP elevation after induction of general anesthesia | Primary measure of plasma I-FABP before induction of general anesthesia. Second measure of plasma I-FABP concentration 11 minutes after induction of general anesthesia using a protocol of propofol and remifentanyl with monitoring of bispectral index. | 11 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-urgent surgery, General anesthesia, Enterocyte damage, Intestinal fatty acid-binding protein
Alpha-1 Research Registry

Study Overview
=================
Brief Summary
-----------------
The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers. The Registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1.

Detailed Description
-----------------
The purpose and goal of the Alpha-1 Research Registry (Registry, or group of patients) will be to obtain uniform, longitudinal (over the course of time), complete and accurate data that can be organized, and made available for the public to query. The collective number of Registry members enables investigators to enroll sufficient subjects to carry out their studies. The community benefits from having more research and potential therapies performed in their disease. Regular updates from patients will give objective data-points to measure the progression of disease.

Official Title
-----------------
Alpha-1 Research Registry Protocol

Conditions
-----------------
Alpha 1-Antitrypsin Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Alpha-1 Antitrypsin Deficiency (PiZZ, PiZNull, PiSZ etc.) Alpha-1 carriers (PiMZ, PiMS etc.) Exclusion Criteria: Failure to provide informed consent Normal healthy individuals (MM)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alpha-1 Diagnosed Individuals<br>Larger patient cohorts are needed to support the clinical trials coming in the next 3-5 years. Despite widespread invitations to the Alpha-1 community from the Alpha-1 Foundation Research Registry, it is estimated that the Alpha-1 Foundation Research Registry now contains <40% of the identified PiZZ individuals in the US. | |
| Carriers of Alpha-1<br>Larger patient cohorts are needed to support the clinical trials coming in the next 3-5 years. Despite widespread invitations to the Alpha-1 community from the Alpha-1 Foundation Research Registry, it is estimated that the Alpha-1 Foundation Research Registry now contains <40% of the identified PiZZ individuals in the US. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the Alpha-1 Research Registry using REDCap | To gather accurate patient data for longitudinal prospective follow up/analysis of Alpha-1 progression. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AATTD, ALPHA 1, COPD, AAT, ZZ, MZ, CARRIER, MM, MS, PiZZ
Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

Study Overview
=================
Brief Summary
-----------------
In this study, we aim at evaluating the effect of electroacupuncture in diabetic patients with gastroparesis. Patient-based symptom severity measure, serum parameters and solid-phase gastric emptying time are measured to evaluate the effectiveness of electroacupuncture.

Detailed Description
-----------------
Initially, we will collect 30 patients with type 2 diabetes with a ≧ 3-month history of dyspeptic symptoms. An upper GI endocopy will be obtained to rule out possibility of organic obstruction. Cardiac arrhythmia and pregnancy will be excluded. None of them ever received abdominal surgery. Patients are then randomized to one of two treatment arms. Arm I: 15 patients received EA stimulation on acupoints St-36 (Zusanli) and Li-4 (Hegu). Arm II: 15 subjected to EA stimulation on non-acupoints around St-36 and Li-4 with the same electrical pulse and amplitude. Gastroparesis Cardinal Symptom Index (GCSI) and solid-phase gastric emptying time will be measured on baseline and after EA. In addition, serum gastrin, motilin, human pancreatic polypeptide, fasting blood sugar, and postprandial glucose levels will be also monitored.

Conditions
-----------------
Diabetes Mellitus, Gastroparesis

Intervention / Treatment
-----------------
* Device: Electroacupuncture (device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Dyspetic symptoms for more than 3 months Symptoms include nausea, vomiting, upper abdominal discomfort, early satiety, bloating and anorexia Exclusion Criteria: Organic gastrointestinal obstruction Previous surgery of gastrointestinal tract Cardiac arrhythmia Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Device: Electroacupuncture (device)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, gastroparesis, electroacupuncture
Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.

Conditions
-----------------
Contact Lens Wear

Intervention / Treatment
-----------------
* Device: OPTI-FREE RepleniSH
* Device: ReNu MultiPlus MPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful contact lens wear on a daily wear basis Wear contact lenses at least 8 hours/day Vision correctable to at least 20/30 Normal Eyes Other protocol-defined inclusion criteria may apply Exclusion: Topical ocular medication use Other protocol-defined inclusion criteria may apply

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: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opti Free RepliniSH<br>Opti Free RepliniSH | Device: OPTI-FREE RepleniSH<br>* Multi-Purpose Solution for soft contact lenses<br>|
| Active Comparator: ReNu Multi-Plus<br>ReNu Multi-Plus | Device: ReNu MultiPlus MPS<br>* Multi-Purpose Solution for soft contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confocal microscopy analysis of Corneal Epithelium |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort |  | 2 weeks | 
| Corneal Staining |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lens wear, multi-purpose solution, corneal staining
Online Health Survey of Patients With Vitiligo Vulgaris/ Online Survey of Pediatric Patients With Vitiligo

Study Overview
=================
Brief Summary
-----------------
The study is an on-line survey posted on survey monkey that addresses some demographic and environmental issues that could potentially relate to vitiligo vulgaris onset or disease exacerbation.

Detailed Description
-----------------
The survey is designed to look at some issues that are pertinent to individuals with vitiligo, including access to care, severity of disease, under-reported disease activity, causative and exacerbating factors and co-morbid illnesses.

Official Title
-----------------
Online Health Survey of Patients With Vitiligo Vulgaris/ Online Survey of Pediatric Patients With Vitiligo

Conditions
-----------------
Vitiligo Vulgaris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to complete survey Exclusion Criteria: Inability to complete survey
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 |
| --- | --- |
| Vitiligo Patients<br>patients with vitiligo vulgaris | |
| Controls<br>Individuals without vitiligo vulgaris | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Disease State in Vitiligo with Clinical and Psychological Measures |  | Self-reported retrospective single survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitiligo Vulgaris, Autoimmunity, Thyroid Disease
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

Study Overview
=================
Brief Summary
-----------------
Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. The purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.

Official Title
-----------------
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Gastric bypass
* Behavioral: Caloric restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥30 kg/m2 Exclusion Criteria: Marked weight reduction in the last 2 years (>5% of initial body weight) Recent extreme fasting (during the last month) Manifest eating disorders (assignment to a specialist for eating disorders) Severe psychiatric disorders requiring treatment Pregnancy, lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gastric bypass<br>Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate. | Procedure: Gastric bypass<br>* Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.<br>|
| Other: Caloric restriction<br>Caloric restriction calculated by an online weight management program (based on subject's starting weight, start BMI, age, target weight and time span). Subjects are followed-up in regard to resting metabolic rate. | Behavioral: Caloric restriction<br>* Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting metabolic rate |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (muscle mass, fat mass) |  | 24 weeks | 
| Body Mass Index |  | 24 weeks | 
| Caloric restriction |  | 24 weeks | 
| Weight loss |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caloric restriction, Obesity, Gastric bypass, Resting metabolic rate
NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya

Study Overview
=================
Brief Summary
-----------------
Near infrared spectroscpy is a validated method of evaluating cerebral blood flow. The aim in this pilot study to explore its use in children with moyamoya disease.

Detailed Description
-----------------
Moyamoya disease is a cerebrovascular condition in which there is chronic brain hypoperfusion. As surgery can possibly augment brain blood flow, a method for evalutaing cerebrovascualr reserve would be helpful in selecting patients for intervention. Near infrared spectroscopy (NIRS) is a validated non-invasive method of evaluating cerebral blood flow. We aim to investigate the feasibility and tolerability of using NIRS haemodynamic reserve in children with moyamoya and controls by evaluating cerebral blood flow in the baseline state and after breath-holding. Feasibility will be assessed by how many successful studies are carried out. Tolerability will be assessed by asking children some simple questions about their experience.

Official Title
-----------------
NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya

Conditions
-----------------
Moyamoya

Intervention / Treatment
-----------------
* Device: near infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moyamoya and unaffected healthy controls - Exclusion Criteria: age <6 -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: patients and controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patient<br>child with moyamoya | Device: near infrared spectroscopy<br>* evaluate cerebral blood flow with and without breatholding<br>|
| Active Comparator: control<br>unaffected control | Device: near infrared spectroscopy<br>* evaluate cerebral blood flow with and without breatholding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of NIRS studies that can be completed in moyamoya patients | how many studies can be completed | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaire to evaluate children's experience of NIRS in moyamoya | ask children re their experience | 2years |