linjc16/ctgov huggingface dataset:
Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
clinical trial to assess the efficacy of Acetyl-L-carnitine

Detailed Description
-----------------
A multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Acetyl-L-carnitine in patient with Alzheimer's disease

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Acetyl-L-Carnitine
* Drug: Placebo of Acetyl-L-Carnitine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 50 Years probable Alzheimer disease according to DSM-IV and NINCDS-ADRDA standard 12≤K-MMSE(screening)≤26 be able to perform examinations Patient taking donepezil(5mg or 10mg/day) more than 3 months be able to visit to hospital with caregiver Exclusion Criteria: possible or probable or definite vascular dementia according to NINDS-AIREN standard CNS disease(Cerebrovascular diseases, Epilepsy etc) to cause dementia Illiteracy Patient taking galantamine, memantine, rivastigmine within three months Patient taking brain enhancer, thyroid hormone within 4 weeks Patient taking Central nervous system stimulant, Antipsychotic agent, anticholinergic agent within 2 weeks at screenig blood test: AST, ALT≥ 3 X upper limit of normal range or Hb≤8g/dL or platelet<100,000/mm3 or Serum creatinine ≥ 3 X upper limit of normal range Abnormal result of Vit.B12, Syphilis serology, TSH Severe Depression, Schizophrenia, Alcoholism, Drug addiction Parkinson's disease (need to drug therapy) Angina, Myocardial infarction, ischemia within six months Head injury with sense of loss within six months Patient taking other IP within three months Hypersensitivity to IP Sever Hearing problems or Visual impairment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Acetyl-L-carnitine (DongA ST) | Drug: Acetyl-L-Carnitine<br>* TID<br>* Other names: Nicetile;|
| Placebo Comparator: placebo<br>Placebo of Acetyl-L-carnitine (DongA ST) | Drug: Placebo of Acetyl-L-Carnitine<br>* TID<br>* Other names: Placebo of Nicetile;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog |  | 24week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-MMSE |  | 12week, 24week |
Text Message Support to Prevent Smoking Relapse

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to test a text message intervention for people who are beginning an attempt to quit smoking. The intervention seeks to teach people to think about their cravings to smoke in more helpful ways. The investigators expect that participants receiving the text message craving program will be less likely to begin smoking again compared to participants in a control condition.

Official Title
-----------------
Text Message Support to Prevent Smoking Relapse in Community Treatment Settings

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Text Message Craving Program
* Behavioral: Self-Help Manual Plus Control Texts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. During the first visit smoking status will be verified by a Carbon Monoxide level of at least 8 parts per million. Have a mobile phone and use text messaging at least monthly Be planning to quit smoking without pharmacological help. Exclusion Criteria: Significant cognitive impairment Current therapy or pharmacological intervention for smoking or nicotine cravings Inability to read English

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text Message Craving Program<br>Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day. | Behavioral: Text Message Craving Program<br>* Text messages targeting cravings delivered 2-3 times per day.<br>|
| Active Comparator: Self-Help Manual Plus Control Texts<br>A print, self-help manual plus general motivational text messages delivered 2-3 times per day. | Behavioral: Self-Help Manual Plus Control Texts<br>* Self-help manual plus motivational text messages delivered 2-3 times per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Day Point Prevalence Abstinence | Point prevalence abstinence is defined as the prevalence of not experiencing a full relapse in the period immediately preceding measurement. A full relapse will be defined as 7 continuous days of smoking or smoking ≥ 1 day(s) per week for the two consecutive weeks preceding the time of measurement. Self-reported abstinence will be verified by a Carbon Monoxide assay of breath samples and will override self-report in the direction of smoking. | End of Treatment (6-week) Follow-Up |
Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

Study Overview
=================
Brief Summary
-----------------
The objective of the proposed study is to assess bone health and determinants of bone health among select subpopulations of rheumatoid arthritis patients.

Detailed Description
-----------------
The overall hypothesis of this study is that osteopenia and/or osteoporosis are common among African Americans and men with rheumatoid arthritis and there are identifiable genetic and environmental factors contributing to the pathogenesis of bone loss in these groups. The Specific Aims of the study are to: Determine baseline hip and lumbar spine bone density (BMD) values and osteopenia/osteoporosis prevalence among African American men and women with early RA and among male veterans with established RA. Identify environmental factors and candidate alleles, which confer increased risk of reduced baseline BMD loss over time among African American men and women with early RA and among male veterans with established RA.

Official Title
-----------------
RA Comorbidity: Bone Health in Men and African Americans

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of rheumatoid arthritis per ACR guidelines Exclusion Criteria: Patients with diagnosis > 2yrs (CLEAR study)

Ages Eligible for Study
-----------------
Minimum Age: 19 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 CLEAR participants - African Americans with early rheumatoid arthritis<br>CLEAR enrollees include African American patients with early rheumatoid arthritis, as defined using ACR criteria | |
| 2 VARA participants - male veterans with established rheumatoid arthritis<br>VARA enrollees will include male veterans with established RA diagnosed using ACR criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Bone mineral density (BMD) test measures calcium and other minerals in bone. Bones containing more minerals are denser, so they tend to be stronger and less likely to break. | baseline and at 5 years disease | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, African Americans, osteopenia, osteoporosis, bone mineral density
Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from patients with Wilms tumor.

Detailed Description
-----------------
OBJECTIVES: To determine whether Wilms Tumor (WT) patients without WT1-associated congenital anomalies or syndromes, but with end-stage renal disease (ESRD) unrelated to progressive bilateral tumors, carry germline WT1 mutations. To determine whether non-syndromic WT1 germline mutation carriers have a substantially higher incidence of ESRD than do WT patients who do not harbor WT1 mutations. OUTLINE: Archived blood and tumor tissue specimens (or DNA isolated from these samples) are analyzed for WT1 mutations by gene sequencing and PCR.

Official Title
-----------------
Pilot Case-Control Study of WT1 Mutations in Wilms Tumor Patients Who Develop ESRD

Conditions
-----------------
Kidney Cancer, Renal Failure

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of Wilms Tumor (WT) Patients who participated in the NWTS-5 protocol Non-syndromic patients who developed end-stage renal disease (ESRD) during 5-10 years for reasons other than progressive bilateral WT Matched control patients who had not developed ESRD by the time (since WT onset) of ESRD diagnosis Blood and tumor tissue samples available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: mutation analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, stage I Wilms tumor, renal failure
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications

Study Overview
=================
Brief Summary
-----------------
Endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy. Different classifications have been proposed to predict histology depending on the endoscopic aspect. Thus, the aspect of the shape of the lesion is described in the Paris classification, the aspect of the mucosal pattern in Kudo's classification and the vascular pattern in Sano's one. Recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the NICE classification or even more recently the Japanese JNET classification. However, although the interest in combining the Paris, Sano and Kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria. We have created a synthetic classification called CONECCT grouping the different criteria for an initial educational purpose. We have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files. Nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published. To validate this CONECCT classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.

Official Title
-----------------
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts.

Conditions
-----------------
Colorectal Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participants were gastroenterologist doctors (experts, general or internal). Lesions presented were resected endoscopically after completion of a picture file. Pathology available for presented lesions. Participants signed informed consent and voluntarily participated in the characterization of these 206 lesions. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Evaluation of the interobserver Concordance of the CONECCT classification compared to the 6 other existing ones |  | 1 year |
Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
• To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.

Conditions
-----------------
HBV-related Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: Aged between 18-75 years (inclusive). Male or female. Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B. The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study. Exclusion Criteria: Subjects meeting any of the following criteria must not be enrolled in the study Subjects with non-HBV cirrhosis Co-infection with HAV/HCV/HDV/ HIV Subjects who take nucleosides within 6 months Kidney injury due to non-HBV factors Inability to comply with study requirements as determined by the study investigator Patients with very low GFR, who may need dialysis or renal transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antiviral drug<br>Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients. | Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir<br>* investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.<br>* Other names: no.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks | No. | May 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks | No. | May 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tebivudine eGFR non-Tebivudine
Impact of Arterial Cannulation Site on Vasopressor Requirement in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.

Official Title
-----------------
Impact of Arterial Cannulation Site on Vasopressor Requirement During Cardiac Surgery: a Monocentric Prospective Cohort Study

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Device: Choice of arterial cannulation site at the beginning of the surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Scheduled for cardiac surgery with cardiopulmonary bypass Exclusion Criteria: More than one arterial cannula at the beginning of the surgery

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 |
| --- | --- |
| Radial artery cannulation<br>Patients whom radial artery was cannulated at the beginning of the surgery. | |
| Aortic cannulation (brachial or femoral artery)<br>Patients whom femoral or brachial artery was cannulated at the beginning of the surgery. Active comparator | Device: Choice of arterial cannulation site at the beginning of the surgery<br>* Choice of arterial cannulation site at the beginning of the surgery is at the discretion of the anesthesia physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative vasopressor requirement | Mean intraoperative dosage of Norepinephrine (µg.kg-1.min-1) | end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac surgery, Aortic to radial arterial pressure gradient, Vasopressor
Eva-Hip, Evaluation of Rehabilitation After Hip-fracture

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity.

Official Title
-----------------
The Effect on Gait and Activity Level of a Physiotherapy Intervention Aimed at Improving Mediolateral Stability 4 Months After a Hip Fracture

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Procedure: physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Home dwelling prior to fracture age>70yr able to walk 10m Exclusion Criteria: expected life expectancies <3 months exercises contraindicated due to medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physiotherapy<br>exercises | Procedure: physiotherapy<br>* exercises, 20 sessions over 10 weeks<br>|
| No Intervention: conventional treatment<br>care as usual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in gait speed |  | 4,6 and 12 months postfracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in activity level |  | 4,6 and 12 month postfracture |