linjc16/ctgov huggingface dataset:
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis. To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis, Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: rhIL-11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented, signed informed consent to participate in this study Age greater than or equal to 18 years Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy Exclusion Criteria: Crohn's disease Ulcerative proctitis Ulcerative colitis extending beyond the splenic flexure

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rhIL-11|nan|

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
-----------------
Left-Sided, Ulcerative, Colitis
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease

Official Title
-----------------
Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: donepezil hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria; Patients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Patients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5. Exclusion criteria; Patients who used Aricept within 3 months prior to dosing. Patients registered this survey before. Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

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 |
| --- | --- |
| Donepezil Hydrochloride<br> | Drug: donepezil hydrochloride<br>* Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Jcog (test of cognitive function) |  | 36 month (12 weeks and every 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events/adverse drug reactions |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donepezil hydrochloride, Alzheimer's Disease
Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a prospective study to determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in 138 patients with hilar cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.

Detailed Description
-----------------
Objective: To determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in patients with hilar cholangiocarcinoma (HC). Summary Background Data: For HC treated with hepatectomy, the extent of liver resection remains controversial despite extensive studies. Methods: From January 2000 to December 2007, we prospectively studied patients who received surgical treatment for HC. Of the 187 patients who were surgically treated, 138 (73.8%) underwent resection with a curative intent. Minor hepatectomy was carried out in 93 patients who had Bismuth-Corlette types I, II and III HC without hepatic artery/portal vein invasion; and major hepatectomy in 45 patients who had type III HC with hepatic artery/portal vein invasion, or type IV HC.

Official Title
-----------------
Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?

Conditions
-----------------
Cholangiocarcinoma, Surgical Treatment, Hepatectomy

Intervention / Treatment
-----------------
* Procedure: Minor or Major Liver Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria for resectability were absence of peritoneal or liver metastases, tumor extension to beyond secondary biliary branches bilaterally, tumor extension to secondary portal venous branches bilaterally Exclusion Criteria: not in accordance with the above criteria

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 72 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 |
| --- | --- |
| No Intervention: Control group<br> | Procedure: Minor or Major Liver Resection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On multivariate analysis, prognostic factors significantly impacted on long-term survival were UICC tumor stage and histopathologic grade. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minor Liver Resection, Major Liver Resection, Hilar
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia

Study Overview
=================
Brief Summary
-----------------
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.

Official Title
-----------------
Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia

Conditions
-----------------
Falls, Balance, Insomnia, Aging

Intervention / Treatment
-----------------
* Behavioral: White light exposure
* Behavioral: Dim white light exposure
* Behavioral: Very dim white light exposure
* Behavioral: Dim orange light exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 55-85 Stable health Normal color vision Exclusion Criteria: Alcohol abuse Depression Sleep disorders Smoking Use of illegal drugs

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Interventional Model Description: The order of the interventions were randomized to the four visits.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>13 minutes of light at night (2 hours after bedtime) | Behavioral: White light exposure<br>*  200 lux of broad spectrum white light<br>Behavioral: Dim white light exposure<br>*  28 lux of broad spectrum white light<br>Behavioral: Very dim white light exposure<br>* <0.5 lux of broad spectrum white light<br>Behavioral: Dim orange light exposure<br>*  28 lux of orange light<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Balance | Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling. | 13 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postural Balance, Sleep Initiation and Maintenance Disorders
Smartphone Addiction and Physical Activity

Study Overview
=================
Brief Summary
-----------------
This study aimed to determine the effect of smartphone addiction on physical activity level in healthy individuals. A total of 300 (134 female) healthy university students were included in this study. The mean age of the subjects was 21.36 ± 2.33 year.

Detailed Description
-----------------
This study aimed to determine the effect of smartphone addiction on physical activity level in healthy individuals. A total of 300 (134 female) healthy university students were included in this study. The mean age of the subjects was 21.36 ± 2.33 year. The universe of the study consisted of volunteer students (Coaching Education, Physical Education and Sports Teaching, Sports Management, Recreation Departments) at the Faculty of Sport Sciences. Participants' demographic information was obtained and their physical activity levels were questioned with International Physical Activity Questionnaires (IPAQ) and smartphone addictions with the Smartphone Addiction Scale- Short Verison (SAS-SV).

Official Title
-----------------
The Effect of Smartphone Addiction on Physical Activity Level

Conditions
-----------------
Sports Physical Therapy

Intervention / Treatment
-----------------
* Other: addiction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be 18-35 old years Exclusion Criteria: not to be sports science students

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Addiction<br>problematic addiction | Other: addiction<br>* questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | International Physical Activity Questionnaires: The higher score obtained from this questionnaire indicated that participant have a high physical activity level. Physically inactive (<600 MET-min / week), low level of physical activity (600 - 3000 MET minutes / week) and the adequate level of physical activity (beneficial to health) (> 3000 MET minutes / week). | This questionnaire is used during baseline assessment | 
| Scale | Smartphone Addiction Scale- Short Verison: The higher score obtained from this scale indicated that participant have smartphone addiction. Cut-off score was 31 for male and 33 for female | This scale is used during baseline assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Addiction, Healthy individuals, Physical activity, Smartphone, Sport science
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction

Study Overview
=================
Brief Summary
-----------------
The neuromolecular and metabolic underpinnings of Anorexia Nervosa (AN) are studied using multi-modal molecular (positron emission tomography with two different radioligands) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Subjects with AN and normal weight adolescents will be studied with PET and MRI and followed for five years.

Detailed Description
-----------------
A total of sixty females (30 with AN, 30 healthy controls) are recruited into this prospective study. The subjects will undergo physical examination, body tissue composition measurement, functional and structural MRI of the brain and body, and positron emission tomography (PET) with ligands [18F]-FDG, and [11C]carfentanil. Subjects' weight and physical condition will be followed up for 5 years. The study will start in August 2020 and end in the fall of 2028.

Official Title
-----------------
Anorexia Nervosa and it's Effects on Brain Function, Body Metabolism and Their Interaction

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for AN: Female sex Age 18-32 3 years BMI < 17.5 kg/m2 Currently fulfilling modified DSM-IV diagnosis of AN with or without amenorrhea, onset age before 25 years Diagnosed less than 2 years ago For controls: Female sex Age 18-32 3 years BMI 19 20-25 kg/m2 No lifetime history of obesity (BMI ≥> 30) or eating disorders Exclusion Criteria: Any chronic disease or medication that could affect glucose metabolism or neurotransmission History of psychiatric disorders (excl. AN for the corresponding study group) Smoking of tobacco, taking of snuffs, or use of narcotics Abusive use of alcohol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients and controls<br>AN patients and controls are recruited, studied using imaging and followed for 5 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in brain reward system and metabolism in AN patients | AN patients and controls are studied using fMRI and PET imaging and followed 10 years. Reward system function is measured using functional MRI and metabolism using 18F-fluorodeoxy glucose and PETCT imaging | 10 years | 
| Predictive value of baseline body mass index (BMI), functional brain activation and metabolism in AN | Results from baseline are combined with follow updata | 10 y | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia nervosa, metabolism, functional imaging, PET
Effect of Concept Mapping Teaching Method on Critical Thinking Skills of Medical Students

Study Overview
=================
Brief Summary
-----------------
effect of concept map in teaching critical thinking was done with randomized study

Detailed Description
-----------------
This quasi-experimental study with two groups design and pre-posttest method was conducted at Ahvaz University of Medical Sciences in 2014. About 100 Medical Students of in their third semester were recruited for the study based on census. Participants were divided into two intervention and control groups by using random sampling and Random Number Table List. Students in the control group were lectured in Anatomy using traditional lecture method. Whereas, students in the experimental group were taught Anatomy using concept map teaching method. Student's critical thinking was evaluated by examining Standard California Critical Thinking Skills Questionnaire

Official Title
-----------------
Effect of Concept Mapping Teaching Method on Critical Thinking Skills of Medical Students

Conditions
-----------------
Education

Intervention / Treatment
-----------------
* Other: concept map teaching
* Other: traditional teaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any student at 1st semester of medicine who accept participation in study Exclusion Criteria: do not accepting to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>teaching anatomy by concept map | Other: concept map teaching<br>* teaching anatomy using concept map to improve critical thinking<br>|
| Sham Comparator: placebo<br>teaching anatomy by traditional method | Other: traditional teaching<br>* teaching anatomy using lecture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard California Critical Thinking Skills Questionnaire score | score which was got from questionnaire pre and post intervention | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| student satisfaction | questionnaire for satisfaction | 4 months | 
| anatomy score | scores of anatomy in same exam at final | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Concept Map, critical thinking, medical student teaching
ParentLink: Better and Safer Emergency Care for Children

Study Overview
=================
Brief Summary
-----------------
The emergency department (ED) constitutes a high-risk environment for errors and poor quality of care. Pediatric patients are at increased risk of medical errors. We postulate that implementation of a patient-centered health information technology - ParentLink - can address system-level deficiencies and the unique just-in-time information needs of ED physicians and the parents of ill children. The proposed work delivers an innovative product - an electronic interface linked to a pediatric knowledge base that integrates parent-derived data with best practices for safe and effective emergency care across common pediatric disease conditions: otitis media, urinary tract infections, asthma, and head trauma. The study has two aims, the first of which addresses critical gaps in data capture: to evaluate the completeness and accuracy of information on symptoms, disease condition, medications and allergies generated by parents using ParentLink versus information documented by ED physicians and nurses, using structured telephone interviews as a gold standard. The second aim measures the ParentLink's impact on ED patient safety and quality, specifically: a) the error rate for ordering and prescribing of medications during ED care, and b) the percent of ED visits that adhere to national evidence-based guidelines. Parentlink will be rigorously evaluated in a clinical trial at two diverse ED sites and will use a sequential, non-randomized observational design with two intervention and two control periods to measure the effects of ParentLink on data capture and safety and quality of patient care.

Official Title
-----------------
ParentLink: Better and Safer Emergency Care for Children

Conditions
-----------------
Otitis Media, Urinary Tract Infection, Asthma, Head Injury

Intervention / Treatment
-----------------
* Procedure: patient-driven health IT product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age less than 12 years with head trauma Age less than 12 years with ear pain Ages less than 12 years with concern for UTI 1 year - 12 years with asthma history and respiratory chief complaint 3 months - 2 years with fever Parent speaks English or Spanish Triage status is non-emergent

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: patient-driven health IT product|nan|

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
-----------------
information technology, emergency department, medication error, quality of care, patient-centered care
IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

Official Title
-----------------
A Phase I, Multi-center, Open-label Study of IMGN529 Administered Intravenously in Adult Patients With Relapsed or Refractory Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Conditions
-----------------
Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: IMGN529


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL). Adequate organ function ECOG ≤ 2 Recovered or stabilized from prior treatments. Exclusion Criteria: Allogeneic stem cell transplantation Pregnant or lactating females Known central nervous system, meningeal or epidural disease including brain metastases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMGN529<br>Dose escalation study, dosing done every 3 weeks. | Drug: IMGN529<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of dose limiting toxicities |  | During study |