linjc16/ctgov huggingface dataset:
EC50 of Anesthetics During Microelectric Recording

Study Overview
=================
Brief Summary
-----------------
The investigators determine the half maximum effective concentration (EC50) of the Cet value of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for the maintenance of general anesthesia during microelectrode recording in the deep brain surgery in patients with Parkinson's disease.

Detailed Description
-----------------
General anesthesia is sometimes required for DBS (deep brain stimulation) surgery in those with excessive fear, anxiety, reduced cooperation, or severe movements due to ' off drug' state. Dexmedetomidine and propofol are both used individually in the sedation for DBS surgery, and were reported to affect the MER (microelectrode recording) to some extent, especially in the higher zone of the dose range. In this study, the investigators plan to use the combination of dexmedetomidine and propofol for the maintenance of general anesthesia in patients with Parkinson's disease. In this study, dexmedetomidine is given with a loading dose of 0.5 mcg/Kg, and continuous infusion with the dose of 0.4 mcg/Kg/hr. Propofol is given within 0.8 1.8 mcg/Kg during the MER recording (based on institutional guideline). MER recording will be observed and correlated wtih the dose of propofol. The Dixon up-and-down sequential allocation method was used to determine the EC50 of the value of Cet of propofol. The study aims to determine the dose that is adequate for maintaining general anesthesia with endotracheal intubation and least interference with the MER recording.

Official Title
-----------------
Determination of EC50 of Anesthetics During Microelectric Recording in Patients Receiving Deep Brain Stimulation Under Anesthesia

Conditions
-----------------
Deep Brain Stimulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 20-85 Clinical diagnosis of Parkinson's disease Scheduled for deep brain stimulation surgery under general anesthesia Exclusion Criteria: Allergic history to dexmedetomidine and propofol Clinical diagnosis of congestive heart failure Clinical diagnosis of liver cirrhosis Clinical diagnosis of third degree A-V block

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Cet of propofol | concentration of propofol used during microelectrode recording | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
effective concentration
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet

Detailed Description
-----------------
We propose to conduct a randomized double-blind, placebo-controlled crossover trial in 149 individuals with celiac disease proven by biopsy (or other medically documented confirmation of CD, e.g. TTG counts > 10 times the upper limit of normal on two occasions) at least 12 months before study entry, and who are following a gluten-free diet but continue to have recurrent symptoms. AGY is designed to neutralize the hidden gliadin in food, thus preventing gliadin absorption and gliadin induced pathogenesis. The study will test whether AGY is safe and effective in the study population, versus placebo. Primary Objective: The primary objective will be to evaluate the effect of AGY on celiac symptoms using the daily Celiac Symptom Index (CSI). Secondary objectives: Secondary objectives will be to evaluate product safety and the effect of AGY on quality of life, autoantibodies, and gut permeability.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: AGY
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of CD experience periodic celiac related symptoms following a gluten free diet for at least 12 months Exclusion Criteria: severe complications of CD or chronic active GI disease type 1 diabetic pregnant or breast feeding daily ASA/NSAID use any condition that in the opinion of the investigator, would preclude safe participation

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 65 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: Crossover Assignment
Interventional Model Description: randomized double-blind, placebo-controlled crossover trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGY<br>capsule containing egg yolk with AGY | Dietary Supplement: AGY<br>* oral AGY taken prior to meals<br>|
| Placebo Comparator: placebo<br>capsule containing plain egg yolk | Other: placebo<br>* oral placebo taken prior to meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms | celiac related symptoms | 14 weeks |
Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. The purpose of this study is to explore the accuracy of the two diagnostic criteria of EASL-CLIF and APASL ACLF in assessing the survival rate of patients with liver cirrhosis after LT.

Detailed Description
-----------------
A retrospective collection and analysis of the preoperative conditions of patients with LT due to cirrhosis in a single center from January 2015 to June 2020 would be conducted, including epidemiological characteristics, etiology, clinical indicators, and short-term (28 days, 90 days) and long-term (1 year, 3 years) survival after LT.

Official Title
-----------------
Liver Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study to Evaluate Different Criterion in Predicting Post-transplant Outcomes

Conditions
-----------------
Acute-On-Chronic Liver Failure, Liver Cirrhosis, Liver Transplant; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent liver transplantation for cirrhosis The diagnosis of ACLF followed APASL and EASL-CLIF definition. Exclusion Criteria: Patients with malignant tumor or underwent living donor liver transplantation (LDLT) were excluded.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EASL-CLIF ACLF patients<br> | |
| APASL ACLF patients<br> | |
| Non-ACLF patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 years overall survival |  | Up to  3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute-On-Chronic Liver Failure, EASL-CLIF criteria, APASL criteria
Effect of Roux-en-Y Gastric Bypass Versus Laparoscopic Adjustable Gastric Band Operations on Resistin, Apelin and Visfatin Peptides

Study Overview
=================
Brief Summary
-----------------
This study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent to RYGBP, LAGB and their relation with obesity.

Official Title
-----------------
Effect of Roux-en-Y Gastric Bypass Versus Laparoscopic Adjustable Gastric Band Operations on Resistin, Apelin and Visfatin Peptides

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of morbid obesity Being underwent LAGB or RYGBP Exclusion Criteria: Having prior abdominal surgery history
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RYGBP<br>Patients underwent Roux-en-Y Gastric Bypass for morbid obesity. | |
| LAGB<br>Patients underwent Laparoscopic Adjustable Gastric Banding for morbid obesity. | |

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
-----------------
Visfatin, Resistin, Apelin, roux-en-y gastric bypass, laparoscopic adjustable gastric banding, morbid obesity
The Crnic Institute Human Trisome Project Biobank

Study Overview
=================
Brief Summary
-----------------
The Human Trisome Project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions. Its biobank will provide de-identified samples to research.

Detailed Description
-----------------
The purpose of this study is to provide qualified and approved researchers with access to biological samples and health information to answer specific research questions. This project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions such as Alzheimer's disease, congenital heart defects, autoimmune disorders, autism, and some forms of leukemia. Participation includes a blood draw, a mouth swab, and allowing researchers to look at your health information yearly for the next 5 years. Optional procedures include providing a urine and/or stool sample and taking part in the study for a longer time frame.

Official Title
-----------------
Research to Develop the Human Trisome Project Biobank

Conditions
-----------------
Down Syndrome, Trisomy 21

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone 6 months to 89 years old who: has Down syndrome (any type) does not have Down syndrome Exclusion Criteria: Prisoners Wards of the state

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 89 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 |
| --- | --- |
| Those with trisomy 21<br>People aged 6 months to 89 years old who have some form of trisomy 21. | |
| Controls<br>People aged 6 months to 89 years old who do not have trisomy 21. These persons can be related to someone with some form of trisomy 21 but do not have to be related. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants and Controls Enrolled in Biobank | Create biobank of blood cells and plasma, saliva, mouth swab, urine, stool, and induced pluripotent stem cells (iPSC) cells for use in approved research projects. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Clinical Records Available for Approved Research Purposes | Create a database of clinical information to pair with biological samples listed above. | 5 years | 
| Multidimensional Sample Characterization | Characterize biological samples with multidimensional cellular and molecular analyses to generate the most thoroughly characterized set of samples from individuals with Down syndrome in the world. | 5 years |
A Study of Why People With Early Memory Problems Fall or Almost Fall

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia.

Detailed Description
-----------------
The specific objectives of this six month study are to: characterize falls and near-falls in community dwelling older adults with early-stage dementia; determine which potentially modifiable physical fall risk factors contribute to falls and near-falls in older adults with early-stage dementia; examine the relationship between dementia sub-type, medical and neuropsychological factors, balance and gait, and falls and near-falls in community dwelling older adults with early-stage dementia.

Official Title
-----------------
Factors Associated With Falls and Near-Falls in Community Dwelling Older Adults With Early-Stage Dementia

Conditions
-----------------
Falls, Dementia, Near-Falls

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females over the age of 50 with early-stage dementia as described by Global Deterioration Scale levels 2,3,4 or 5. Exclusion Criteria: subjects who have a medical condition that significantly predispose them to falls (Meneire's disease or Parkinson's disease) subjects without a caregiver/spouse to assist with the completion of a Fall Diary subjects unable to stand independently or safely walk a short distance either unaided or with the support of an assistive device subjects unable to safely complete the balance and gait evaluations.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Memory problems | |
| 2<br>No memory problems | |

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
-----------------
dementia, falls, risk factors
A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study

Study Overview
=================
Brief Summary
-----------------
Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.

Conditions
-----------------
Biopsy, Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy, Operative Link on Gastric Intestinal Metaplasia

Intervention / Treatment
-----------------
* Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later
* Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 40 years or older with Helicobacter pylori infection; Histologically verified GIM, atrophic gastritis or dysplasia. Exclusion Criteria: Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium; Pregnancy or breastfeeding; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>Patients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later | Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later<br> <br> |
| Active Comparator: goup 2<br>patients in Group 2 will receive WLE at first and pCLE 2 months later. | Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE. |  | 9 months | 
| the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall detection rate of GIM by pCLE. |  | 9 months | 
| the overall detection rate of GIM by WLE. |  | 9 months |
NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.

Official Title
-----------------
An Open-Label, Multi Center, Clinical Trial: External Continuous Subcutaneous Infusion of Insulin Using Insulin Aspart (NovoLog®) in Subjects With Type 1 and Insulin Requiring Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with Type I or Type II Diabetes 18 Years or Older.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction with insulin pump therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  |  | 
| Insulin dose |  |  | 
| Overall glycemic control |  |  | 
| number and types of infusion sets used. |  |  | 
| infusion set in-use times |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Diabetes
A Study of RO4989991 in Patients With Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.

Official Title
-----------------
A Multi-center, Randomized, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO4989991


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18-65 years of age, inclusively A history of allergic rhinitis diagnosed by a physician, but otherwise healthy A positive skin prick test to at least one standardized allergen at screening A body mass index (BMI) between 18 and 32 kg/m2, inclusively Exclusion Criteria: History or presence of any respiratory disease or condition other than allergic rhinitis Use of prescription medication or herbal remedies within 14 days of dosing the study drug Use of over-the-counter (OTC) medications within 7 days of dosing the study drug Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection Positive test for human immunodeficiency virus (HIV) or hepatitis B or C

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

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: RO4989991<br>* Subcutaneous repeated dose<br>|
| Experimental: 2<br> | Drug: RO4989991<br>* Subcutaneous repeated dose<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Subcutaneous repeated dose<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Subcutaneous repeated dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety and tolerability of RO4989991 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetics |  | 24 weeks |