linjc16/ctgov huggingface dataset:
Letigen® and Cardiovascular Morbidity

Study Overview
=================
Brief Summary
-----------------
Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for this was a number of spontaneous reports about patients that died during treatment with Letigen®. The causal relation has never been addressed. There are only sparse data from randomised studies and the above-mentioned reports are not conclusive. We propose a controlled study based on data from Statistics Denmark that hold a complete copy of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge Register. The aim of the study would be to determine whether there is an excess frequency of deaths and serious cardiovascular events that can not be explained by particular characteristics of users of the drug. A well-known problem in such observational studies is a fundamental incomparability between users and non-users of drugs. In the present setting, it should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse, type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding serious cardiovascular events will probably show an excess frequency that can not necessarily be attributed to the drug. This problem can be addressed by a special epidemiological technique - the case-crossover design - which is particularly robust to such comparability problems. In brief, only cases should be included. Controls are the same persons at an earlier time, , where the case-defining disease has not yet developed. The exposure of cases will be compared with the exposure of the same persons' case history. To account for the effect of chronic exposure, we also perform, as a secondary analysis, a conventional case-control study nested within the cohort of Letigen users, and employing a risk-set sampling technique.

Official Title
-----------------
Letigen® and Cardiovascular Morbidity. A Register-Based Epidemiological Study

Conditions
-----------------
Stroke, Myocardial Infarctions, Sudden Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of letigen TM within the period Jan 1995 - Dec 2001 The occurrence of a case-defining event Exclusion Criteria: A cancer diagnosis other than non-melanoma skin cancer Age outside the range 18-70

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
Genetic Findings in a Chinese Family With Axenfeld-Rieger Syndrom

Study Overview
=================
Brief Summary
-----------------
Axenfeld-Rieger syndrome (ARS) is a rare autosomal dominant disorder, characterized by anterior segment abnormalities and systemic abnormalities. To date,two major genes, forkhead box C1 (FOXC1) on chromosome 6p25 and pituitary homeobox 2 (PITX2) on chromosome 4q25, have been demonstrated to cause ARS. In this study, we performed complete ophthalmologic examinations and analysis of FOXC1 and PITX2 of a Chinese family with ARS.

Detailed Description
-----------------
Two genetions of a Chinese family with ARS were recruited to Aier Eye Hospital of Changsha. Clinical evaluations: We performed full ophthalmologic examinations of all subjects, including: visual acuity, intraocular pressure measurements (Goldman), slit lamp, anterior segment photography, visual field test (Humphrey 750, Carl Zeiss, Germany), Anterior segment OCT (Carl Zeiss, Germany). If the refractive medium is clear, we also performed funduscopy, gonioscopic and retinal nerve fiber layer (RNFL) thickness measurements (Carl Zeiss, Germany). Mutation analysis: About 2 ml of venous blood sampled from each subject and collected in Vacutainer tubes (Sanjiu Medical Technology Co., Ltd., Liuyang, China) containing EDTA. Genomic DNA was extracted from each blood using a genomic DNA mini kit for blood (Life Technologies), All coding exons, with flanking intronic regions, of FOXC1 and PITX2 were amplified using PCR with primers. The amplifed DNA was purifed by agarose gel electrophoresis and sequenced on a 3730/3700xl automated DNA sequencer (Applied Biosystems).

Official Title
-----------------
Genetic Findings in a Chinese Family With Axenfeld-Rieger Syndrom

Conditions
-----------------
Genetic Findings in a Chinese Family With ARS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a Chinese family with ARS Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pedigree of the family with ARS<br>Nine members of the same family with ARS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Novel genetic findings in a Chinese family with Axenfeld-Rieger syndrom |  | Dec 1, 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axenfeld-Rieger syndrom, genetic findings
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.

Official Title
-----------------
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles. Assessment of Efficiency of Botulinum Toxin on Spasticity in Agonist and Antagonist Muscles Using Clinical Assessment and Gait Analysis in Cerebral Palsy Children: Rectus Femoris and Semitendinosus

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: Botulinum toxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 7 to 17 years old Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis. Patients with functional status allowing the use of botulinum toxin on target muscles. Exclusion Criteria: Patients under 7 years old Patients up to 17 years old Patients in whom botulinum toxin is contra-indicated Patients who received botulinum toxin within a 6 month period before the beginning of the study

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of the passive range of motion of the lower limbs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test |  |  | 
| Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy children, Botulinum toxin
Young Blind Child Melatonin Treatment Study

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.

Detailed Description
-----------------
Subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. Melatonin will be measured in urine, for children under the age of 3. Sleep and behavioral questionnaires will be completed by parents and/or teachers. This study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. A second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.

Official Title
-----------------
Identification of Free-Running Rhythms in Blind Children

Conditions
-----------------
Blindness

Intervention / Treatment
-----------------
* Biological: Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-20 years Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health. Exclusion Criteria: Abnormal heart, lung, kidney, liver disease or a primary sleep disorder, Significant clinical abnormalities (other than blindness), Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy. | Biological: Melatonin<br>* 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling. |  | every 2-4 weeks throughout the entire study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography (Sleep Assessment) |  | 1 12-hour assessment any time during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin, circadian rhythms, sleep, sleep disorders
The Genetic Basis of the Influence of Dairy Product Intake on Body Measures in Children

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to explore the genetic basis of the influence of dairy product intake on body measures in children. The investigators assume that the effect of dairy products intake on children body measures is affected by genetic polymorphisms.

Conditions
-----------------
Body Mass Index

Intervention / Treatment
-----------------
* Other: Blood samples will be taken for gene sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children Exclusion Criteria: Sick children Chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| Childrens' Milk Intake<br>The milk intake of children will be reconciled with body measurement index and blood samples will be taken for gene sequencing | Other: Blood samples will be taken for gene sequencing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body indexes measurements | Body indexes measurements including height and weight in correlation with milk intake and gene sequences. | One year |
Application of AI in Polypectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess the performance of AI system in polypectomy

Official Title
-----------------
Application of Artificial Intelligence in Colorectal Polypectomy

Conditions
-----------------
Colonic Polyp

Intervention / Treatment
-----------------
* Other: AI system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to undergo colorectal polypectomy; agree to give written informed consent Exclusion Criteria: patients with the contraindications to colorectal polypectomy; patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery; patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC; patients refused to participate in the trial; the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool; the procedure have to be terminated due to complications of anaesthesia.

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI-aided group<br> | Other: AI system<br>* The real-time assistance of AI system<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polypectomy time | the time for detection in polypectomy | 12 months |
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Study Overview
=================
Brief Summary
-----------------
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.

Official Title
-----------------
A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b
* Drug: Lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening. Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease. Exclusion criteria: Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b|nan|
|Drug: Lamivudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBeAg seroconversion to anti-HBe |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of alanine aminotransferase (ALT) |  |  | 
| Undetectable HBV DNA |  |  | 
| Histologic improvement |  |  | 
| Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBeAg-positive, chronic, Hepatitis B, lamivudine, seroconversion, Chronic Hepatitis B
Retrospective Study of the Linear™ Hip

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use and efficacy of the Encore Linear™ Hip System in a group of 200 patients for whom data has already been collected.

Official Title
-----------------
Post-Market Study of the Linear™ Hip System

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Femoral Fracture, Correction of a Functional Deformity, Avascular Necrosis

Intervention / Treatment
-----------------
* Device: Encore Linear™ Hip System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have hip joint disease related to one or more of the following osteoarthritis rheumatoid arthritis femoral fracture correction of a functional deformity avascular necrosis of the natural femoral head Skeletal maturity Patient is likely to be available for evaluation for the duration of the study Able and willing to sign the informed consent and follow study procedures Patient is not pregnant No infection present No known materials sensitivity Patient is over 18 years of age Exclusion Criteria: Skeletal immaturity Infection or sepsis Insufficient bone quality that may affect the stability of the implant Muscular, neurologic or vascular deficiencies which compromise the affected extremity Alcoholism or other addictions Prisoners High levels of physical activity Patient is pregnant Loss of ligamentous structures Materials sensitivity Patient is under 18 years of age

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Linear Hip<br>Encore Linear Hip System | Device: Encore Linear™ Hip System<br>* Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use and efficacy of the Encore Linear™ Hip System |  | 2 year |
Predictive Values of Serotonergic Alterations for Outcome - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the predictive value of serotonergic alterations for outcome.

Official Title
-----------------
Predictive Values of Serotonergic Alterations for Outcome

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Fenfluramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Neuroendocrine changes |  |  | 
| Psychological changes |  |  | 
| Craving |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients

Official Title
-----------------
Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Conditions
-----------------
Upper Gastrointestinal Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract Written informed consent provided prior the start of participation in the study. Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with acute upper gastrointestinal bleeding | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of patients with drug-induced upper gastrointestinal bleeding |  | About 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding |  | About 1 year | 
| Number and percentage of patients with concomitant diseases contributing to drug-induced upper gastrointestinal bleeding and those who receive NSAIDs, antiplatelet agents, anticoagulants, steroids or combination therapy |  | About 1 year | 
| Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy |  | About 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute upper gastrointestinal bleeding, patients with drug-induced upper gastrointestinal bleeding, routine management