linjc16/ctgov huggingface dataset:
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

Study Overview
=================
Brief Summary
-----------------
In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.

Official Title
-----------------
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

Conditions
-----------------
Hypercholesterolemia, Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-risk patients with and without evident CHD who had LDL-C > 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin. Patients were aged >18 years and <70 years (men) and < 75 years (women). Exclusion Criteria: Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin

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?
-----------------
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
-----------------
cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia
Lay-Led Smoking Cessation Approach for Southeast Asian Men

Study Overview
=================
Brief Summary
-----------------
To develop a scientifically valid and ethnically approved, lay-led smoking cessation intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam.

Detailed Description
-----------------
BACKGROUND: Economically disadvantaged Southeast Asian men were targeted because of their higher than average smoking prevalence rate, their extraordinary increased numbers, and the relative paucity of strategies to reach this hard-to-reach group. DESIGN NARRATIVE: Trained, lay S.E. Asian counselors (cadre) were the primary agents for this study's assessment, intervention, and follow -up of smoking cessation behaviors. Seven reasons for using this approach were cited, including the potential generalization of this approach to other populations. Over the six year demonstration and education research study period, the investigators: collected baseline data on smoking and smoking cessation behaviors; designed ethnically approved strategies for the cessation and maintenance of smoking cessation behaviors based upon findings from the baseline assessment; implemented ethnically approved strategies for smoking cessation; maintained smoking cessation after initial quitting; and evaluated the effectiveness of the intervention. On the macro level, an equal number of randomly selected subjects (E1) allocated equally among the three ethnic groups in one county were compared to an equal number of control subjects in geographically separate counties. On the micro level, E1 subjects were also compared to control subjects (C1) in the intervention county. All subjects were longitudinally followed. The standard for successful cessation was biochemically verified through salivary cotinine tests at one year of self-reported abstinence. Among the study's features were the community-based (versus academic or clinical) nature of lay change agents, the deliberate integration of baseline data and scientific principles with ethnic values in the intervention approach, and a research design that allowed for both macro and micro comparisons of the intervention with control conditions.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Study Overview
=================
Brief Summary
-----------------
To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.

Detailed Description
-----------------
Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.

Official Title
-----------------
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Other: Seprafilm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gastric cancer Operable Exclusion Criteria: Withdrew consent Pregnant Ascites Distant metastasis Liver dysfunction (serum total bilirubin >2.0 mg/dL) Renal failure (serum creatinine >1.5 mg/dL) A past history of small bowel obstruction.

Ages Eligible for Study
-----------------
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>no Seprafilm | Other: Seprafilm<br>* two sheets per body<br>|
| Active Comparator: Seprafilm<br> | Other: Seprafilm<br>* two sheets per body<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of small bowel obstruction |  | 3 years, more than 6 months after gastrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative and postoperative morbidity and mortality. |  | 3 years |
Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders

Study Overview
=================
Brief Summary
-----------------
Impact of stigma on the empathy and quality of life of people with schizophrenic disorders and their siblings.

Official Title
-----------------
Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders

Conditions
-----------------
The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their Siblings

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria for the Person with Schizophrenic Disorder Aged between 18 and 35. Medical follow-up in progress DSM-5 diagnosis of Schizophrenia Spectrum Disorder Reading and understanding the information and non-opposition form Person affiliated to a social protection scheme or beneficiary of State Medical Aid Volunteer mastering the French language Exclusion Criteria: Non-inclusion criteria for the person with schizophrenic disorders: 1. Clinical condition incompatible with testing 2. Current or less than one month's commitment to another research protocol 3. A person who is subject to a safeguard measure of justice 4 A person of full age under guardianship 5. Minor patients with mental disorders 6. Pregnant or breastfeeding women Version 1.2 date 19-05-2020 7. A person in situations of social fragility (persons deprived of liberty by a judicial or administrative decision, hospitalized persons) 8. Persons incapable or unable to give consent Inclusion Criteria: Inclusion criteria for a sibling member: Age of 16 years or older Volunteer with a sibling included in the study with a diagnosis of schizophrenia according to DSM-5. Reading and understanding the information and non-opposition form Volunteer affiliated to a social protection scheme or beneficiary of State Medical Aid Volunteer mastering the French language Criteria for non-inclusion of siblings: Clinical condition incompatible with testing Current or less than one month's commitment to another research protocol Brother or sister subject to a measure of safeguard of justice 4 Brother or sister under curatorship 5. Brother or sister with mental health problems 6. Minor siblings under 16 years of age 7. A pregnant or nursing sister 8. Brother or sister in situations of social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons) 9.Brother or sister incapable or unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| Internalized Stigma of Mental Illness Scale | for people with schizophrenic disorders | 1 hour and half |
Assessment of a Modified Minimally Invasive Esophagectomy

Study Overview
=================
Brief Summary
-----------------
This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.

Official Title
-----------------
Assessment of a Modified Minimally Invasive Esophagectomy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: Fully minimally invasive esophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with primary esophageal cancer of any cell type underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons Exclusion Criteria: non-elective procedure less than 90 days of post-discharge follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Cases<br>Patients who underwent minimally invasive esophagectomy with this novel procedure at Kaiser Permanente, Northern California, Oakland Medical Center | Procedure: Fully minimally invasive esophagectomy<br>* Esophagectomy using a novel fully minimally invasive approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Hospital length of stay | Through study completion, an average of 2.9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit length of stay | Intensive care unit length of stay | Through study completion, an average of 2.9 years | 
| Feeding tube placement | Feeding tube placement | Intra-operatively | 
| Number of patients with inpatient mortality | Number of patients with inpatient mortality | Through study completion, an average of 2.9 years | 
| 90-day total mortality | 90-day total mortality | 90 days post discharge | 
| Number of patients with hospital readmission within 30 days | Number of patients with hospital readmission within 30 days | 30 days post discharge | 
| Number of patients with complications | Number of patients with medical and surgical complications both inpatient and post-discharge | Hospital stay and 30 days post discharge |
To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.

Official Title
-----------------
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had symptoms of SUI for at least 3 months prior to study entry. Have urine leakage most often associated with activity (such as coughing, sneezing, exercise). Ambulatory and able to use a toilet independently and without difficulty. - Exclusion Criteria: Subjects who participated or were discontinued from any previous studies investigating duloxetine. Use of excluded medications within 14 days prior to study entry or at any time during the study. Subjects who currently have or have had a history of urogenital cancer.

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

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

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: Duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire. |  |  |
Automated Caries Detection Using a 3D Intraoral Scanner. An in Vivo Validation Study.

Study Overview
=================
Brief Summary
-----------------
This in vivo study with in vitro validation assessed four different algorithms (ALG1-ALG4) implemented in the intraoral scanner system for automated caries detection and classification. 3D scans of the examined teeth were obtained both in vivo and vitro, i.e. before and after tooth extraction, in order to assess any possible differences in the performance of the algorithms at different conditions. The latter could potentially help drawing some conclusions regarding i) the validity of the in vitro studies assessing fluorescence method for caries detection, and ii) the in vivo applicability of in vitro results obtained in the past and the future. Additionally, visual-tactile examination using the ICDAS (ICDAS II) criteria19 was conducted on the same teeth in vivo and histological assessment was used as reference test in vitro.

Official Title
-----------------
Assessment of the Difference of Fluoresce of the TRIOS 4 Intraoral Scanner of the Same Surface at In Vivo and In Vitro Conditions

Conditions
-----------------
Healthy Patients

Intervention / Treatment
-----------------
* Diagnostic Test: Trios4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with permanent molars / premolars, Sound teeth or with caries lesions on the occlusal surfaces. Exclusion Criteria: Front teeth / deciduous teeth Teeth with fillings Teeth with broken crown Teeth with extensive lesions on the lateral surfaces.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Teeth<br>Occlusal examination | Diagnostic Test: Trios4<br>* Examination of occlusal surfaces with 3D scanner and optical criteria<br>* Other names: ICDAS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of In vivo validation with in vitro caries detection | To assess the difference in vivo and in vitro the fluorescence emitted of the TRIOS FLUO intraoral scanner from occlusal surface from 3rd molar before and after extraction | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caries detection, in vivo, intraoral scanner, ICDAS, histology
Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema

Study Overview
=================
Brief Summary
-----------------
Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The purpose of this study is to test whether this effect can be retrieved in other patients.

Detailed Description
-----------------
Dandelion juice has been used in herbal medicine for at least 1000 years. One case report has shown a beneficial effect of this herbal remedy on dyshidrotic hand eczema, and the purpose of this pilot study is to test whether this effect can be retrieved in other patients. The patients are recruited from our out-patient clinic. Only patients with negative patch tests to Compositae are offered treatment with dandelion juice for 20-30 days.

Official Title
-----------------
Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema

Conditions
-----------------
Vesicular Palmoplantar Eczema, Pompholyx

Intervention / Treatment
-----------------
* Drug: dandelion juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with dyshidrotic eczema for at least 1 year and negative patch test reactions to Compositae (tested within the last 3 years) and normal renal and hepatic blood tests. Exclusion Criteria: Treatment with systemic steroids or other immunosuppressive/-modulating drugs, including UV therapy, within the last 3 months. Pregnancy, lactation. Compositae contact allergy. Liver or gall bladder disease. Abnormal renal or hepatic blood tests.

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 |
| --- | --- |
| Other: 10 ml of dandelion juice twice daily<br> | Drug: dandelion juice<br>* 10 ml bid for 20-30 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in dyshidrotic hand eczema in the study period assessed by HECSI score. |  | 3-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in dyshidrotic eczema in the study period assessed by the patient (Visual Analog Scale). |  | 3-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dandelion, herbal remedy, hand eczema, Compositae
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

Study Overview
=================
Brief Summary
-----------------
The investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status.

Detailed Description
-----------------
Refraction measurement will be done by the investigator in all 161 children. Visual acuity is checked, initial and after correction with proper correction. Vitamin D level is dosed from all the children in order to make correlations with the visual acuity, refractive status and risk for visual impairment.

Official Title
-----------------
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

Conditions
-----------------
Child, Only

Intervention / Treatment
-----------------
* Other: Refraction measurement with auto-ref-keratometer Canon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with disabilities and healthy children Exclusion Criteria: children diagnosed with another chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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 |
| --- | --- |
| cohort group<br>80 children with disabilities like autism, ADHD, Down syndrome, deafness, phocomelia, dyslexia, different motor problems | Other: Refraction measurement with auto-ref-keratometer Canon<br>* Refractive measurement and vitamin D level dosing<br>|
| control group<br>81 healthy children, not known or diagnosed with a chronic disease of any kind | Other: Refraction measurement with auto-ref-keratometer Canon<br>* Refractive measurement and vitamin D level dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive disorders in children with disabilities | Prevalence of refractive disorders in children with disabilities | 1 January 2019-31 August 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disability, healthy