linjc16/ctgov huggingface dataset:
Metoclopramide for Migraine: A Dose Finding Study

Study Overview
=================
Brief Summary
-----------------
Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.

Detailed Description
-----------------
Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Official Title
-----------------
Metoclopramide for Acute Migraine: A Dose Finding Study

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: metoclopramide
* Drug: metoclopramide
* Drug: metoclopramide
* Drug: Diphenhydramine 25mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute migraine Exclusion Criteria: secondary cause of headache lumbar puncture allergy or intolerance to study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes | Drug: metoclopramide<br>* metoclopramide 10 mg<br>Drug: Diphenhydramine 25mg<br>* Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes<br>|
| Experimental: 2<br>metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes. | Drug: metoclopramide<br>* metoclopramide 20 mg<br>Drug: Diphenhydramine 25mg<br>* Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes<br>|
| Experimental: 3<br>metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes. | Drug: metoclopramide<br>* metoclopramide 40 mg<br>Drug: Diphenhydramine 25mg<br>* Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Score | Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10. | Baseline, 60 minutes |
Neural Mechanisms of Motor and Cognitive Networks

Study Overview
=================
Brief Summary
-----------------
This study investigates the neural mechanisms of motor and cognitive networks using cognitive assessment, reaction time measurement, high-density EEG and fMRI.

Official Title
-----------------
Neural Mechanisms of Motor and Cognitive Networks

Conditions
-----------------
Motor Disorders, Normal Volunteers, Cognition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (for healthy people): right handed, no history of psychological/psychotic problems, no history of important diseases. Exclusion Criteria (for healthy people): Being Pregnant or breast feeding having any non-MRI compatible conditions Inclusion Criteria (for patients): right handed in a stable condition ability to follow complex commands Exclusion Criteria (for patients): having any non-MRI compatible conditions inability to perform required tasks

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 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 |
| --- | --- |
| Normal<br>healthy subjects | |
| CogImpair<br>persons with cognitive impairments | |
| MotorDeficits<br>persons with motor deficits | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive assessment scores |  | within one week |
Efficacy of Dark Chocolate in Achalasia Patients

Study Overview
=================
Brief Summary
-----------------
Flavanols, present in dark chocolate, were shown to induce Nitric Oxide synthesis. Since Nitric Oxide facilitates smooth muscle relaxation, it might ease the relaxation of the LES (lower esophageal sphincter)as well. The objective of the present study is to evaluate tha efficacy of dark chocolate in improving LES relaxation in achalasia patients.

Official Title
-----------------
Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Dietary Supplement: dark chocolate
* Dietary Supplement: placebo chocolate with crossover to dark chocolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of achalasia Achalasia diagnosis during manometry at day 1 of the study. Exclusion Criteria: pregnancy pseudoachalasia consumption of GI-motility modifiers durin 72 hours preceding the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate | Dietary Supplement: dark chocolate<br>* 21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.<br>* Other names: FruiBel chocolate, Belgium.;|
| Other: 2<br>placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks. | Dietary Supplement: placebo chocolate with crossover to dark chocolate<br>* Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.<br>* Other names: FruiBel chocolate, Belgium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| achalasia symptoms before and during dark-chocolate consumption |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols
Comparison of PRS According to Inhalation Agent During LDLT

Study Overview
=================
Brief Summary
-----------------
The investigators tried to evaluate the effect of desflurane on the incidence of postreperfusion syndrome during living donor liver transplantation surgery. The investigators used sevoflurane as a comparison.

Conditions
-----------------
Liver Transplantation, Postreperfusion Syndrome

Intervention / Treatment
-----------------
* Drug: sevoflurane
* Drug: Desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective LDLT Exclusion Criteria: age < 18, age > 65 patient refusal re-transplantation

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>Performing liver transplantation under general anesthesia using sevoflurane | Drug: sevoflurane<br> <br> |
| Experimental: Desflurane<br>Performing liver transplantation under general anesthesia using desflurane | Drug: Desflurane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of PRS | reperfusion syndrome occurs, if it occurs, immediately after reperfusion. Therefore, the primary outcome, reperfusion syndrome, can only be assessed immediately after reperfusion. | immediately after reperfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | after LT until the patient is transferred to the ward |
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

Study Overview
=================
Brief Summary
-----------------
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

Detailed Description
-----------------
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Official Title
-----------------
Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23

Conditions
-----------------
Infections, Streptococcal

Intervention / Treatment
-----------------
* Biological: Pneumococcal vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine. Exclusion: children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs; children having received any additional pneumococcal vaccine than in the primary study; children with any disease that affect the immune system and history of seizures and/or allergic disease.

Ages Eligible for Study
-----------------
Minimum Age: 11 Months
Maximum Age: 14 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pneumococcal vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody concentrations against pneumococcal serotypes 1 month post-booster |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity pre and post-booster and safety (follow up of SAEs) |  |  |
Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear

Study Overview
=================
Brief Summary
-----------------
Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays are divergent, forming a cone. As a result, this technique is less irradiating that the scanner. The purpose of this exploratory study is to compare the performance of the scanner and the cone beam in the detection of anatomical structures of the ear.

Conditions
-----------------
Ear Diseases

Intervention / Treatment
-----------------
* Device: Cone-beam CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Indication of a CT scan of the ear Written and signed informed consent by the patient to participate in the study Exclusion Criteria: Pregnancy Breast feeding Patient under a legal protection procedure Lack of affiliation to a social security system

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eligible patients for cone-beam CT<br>A cone-beam CT will be offered to the patient undergoing a CT scan of the middle ear | Device: Cone-beam CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the cone-beam CT vs CT scan | Correlation coefficient measuring the concordance for a given radiologist, between the number of anatomical structures of the ear viewed by the cone beam CT and the CT scanner on a total of 24 studied structures | 1 minute |
World Bleeding Disorders Registry Pilot Study

Study Overview
=================
Brief Summary
-----------------
The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international, observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the feasibility of conducting an expanded WBDR to more centres with a more comprehensive case report form, around the world.

Detailed Description
-----------------
The pilot phase of the WBDR is an observational disease registry of patients with hemophilia. Forty hemophilia treatment centres (HTCs), of varying levels of economic development (emerging, mid-level and established), that have data entry capabilities and the ability to obtain the required data on patients in English, were invited to participate in the pilot phase. Participating HTCs will complete a Minimal Data Set (MDS) of data on approximately 10 patients each. A series of performance indicators have been identified by the Steering committee and will be used to assess the feasibility of expanding the pilot phase to the WBDR. The performance indicators include: proportion of HTCs invited that are willing to participate; proportion of participating HTCs who successfully obtain necessary regulatory approvals; proportion of patients approached who consent to participate; proportion of enrolled patients on which data collection and database entry is successful.

Official Title
-----------------
World Bleeding Disorders Registry Pilot Phase

Conditions
-----------------
Hemophilia A and B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of participating Hemophilia Treatment Centres with Hemophilia A or B. Ability to provide data in English Exclusion Criteria: none
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 |
| --- | --- | --- |
| Proportion of HTCs which agree to participate in the pilot phase of the WBDR | This is be measured by the number of HTCs who agree to participate, divided by the number of HTCs invited. | 6 months | 
| Proportion of participating HTCs who successfully obtain necessary regulatory approval | This will be measured by the number of HTCs who obtain approval, divided by the number of HTCs who have agreed to participate in the pilot phase of the WBDR. | 6 months | 
| Proportion of patients who agree to participate in this pilot phase of the WBDR. | This will be measured by the number of patients who provided consent to participate, divided by the number of patients who were approached to participate. | 6 months | 
| Proportion of enrolled patients on which data collection and database entry is successful. | This will be measured by the number of patients on who data is collected and entered successfully into the database, divided by the number of patients who are enrolled in the pilot phase of the WBDR. | 6 months |
Improving Metabolism With HDL Cholesterol

Study Overview
=================
Brief Summary
-----------------
High levels of good cholesterol (HDL) in our blood decreases our chance of having a heart attack. This relates in part to the role good cholesterol plays in reducing build up of fat in the arteries. However, good cholesterol has many other protective effects. We have recently identified three enzymes (proteins) activated by HDL in cells lining the blood vessels, which may be responsible for some of HDL's protective actions.

Official Title
-----------------
A Novel Mechanism Mediating Anti-atherosclerotic and Metabolic Actions of HDL Cholesterol

Conditions
-----------------
Heart Disease, Diabetes

Intervention / Treatment
-----------------
* Drug: rHDL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 - 65 years Free of overt coronary disease Body mass index <35 kg.m-2 Fasting plasma glucose > 7 mmol/L-1 No major illness Exclusion Criteria: Unable to give informed consent Smokers Abnormal LFT, U&E, FBE or creatinine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameters |  |  |
Evaluate EGFR Mutation Status and Impact Factors in North China

Study Overview
=================
Brief Summary
-----------------
Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.

Detailed Description
-----------------
Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.

Official Title
-----------------
A Retrospective Study on Real-world EGFR Mutation Testing Practice Status and Impact Factors in Patients With Advanced NSCLC in North China

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmed NSCLC; Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014; Researchers should collect the records of consecutive NSCLC patients in each site. Exclusion Criteria: Any patients without NSCLC diagnosis; Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non interventional study<br>The patients with advanced NSCLC who have the medical records from Jan 1st 2014 to Dec 31st 2014 will be recruited . | Other: Non interventional study<br>* Non interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test |  | 2014.01.01-2014.12.31 |
ABF Tourette's Disorder Post Marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).

Detailed Description
-----------------
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Official Title
-----------------
Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the New Drug Re-Examination

Conditions
-----------------
Tourette's Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients 6 to 18 years of age with Tourette's Disorder Patients who are prescribed Abilify® treatment as per investigator's medical judgment. Patients who gave written authorization to use their personal and health data Patients starting Abilify® treatment after agreement is in place Exclusion Criteria: Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify® Patients who have been treated with Abilify® Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S Patients participating in other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aripiprazole (Abilify® Tablets/Abilify® ODT)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency (n) of Subjects With Adverse Event | Frequency (n) and Percentage(%) of subjects with Adverse event | Follow-up at least once from baseline to 6 weeks and at least 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment *TS-CGI scale 0=Not assessed Normal, not at all ill Borderline ill Mildly ill Moderately ill Markedly ill Severely ill Extremely ill | at least 6, 12 weeks interval from baseline |