linjc16/ctgov huggingface dataset:
Difference Between Patient Vaccine Hesitancy and Perception by Their Family Physician of Their Vaccine Hesitancy

Study Overview
=================
Brief Summary
-----------------
The investigators will ask to a patient and his/her family physician to complete in parallel a brief questionnaire at the beginning of the consultation: for the patient: self-evaluation of his/her vaccine hesitancy (with a 0-100 scale) for the physician: evaluation of this patient vaccine hesitancy (on the same 0-100 scale) Each of these 2 questionnaires should be filled blindly from the other.

Detailed Description
-----------------
The investigators will ask to a patient and his/her family physician to complete in parallel a brief questionnaire at the beginning of the consultation: for the patient: self-evaluation of his/her vaccine hesitancy (with a 0-100 scale) for the physician: evaluation of this patient vaccine hesitancy (on the same 0-100 scale) Each of these 2 questionnaires should be filled blindly from the other. The investigators will recruit 400 to 500 patients in 20 medical practices of general practioners.

Official Title
-----------------
Difference Between Patient Vaccine Hesitancy and Perception by Their Family Physician of Their Vaccine Hesitancy

Conditions
-----------------
Vaccine Hesitancy

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: visiting the family physician accepting the study after information Exclusion Criteria: none apart from the reverse of inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| unique group<br>patients visiting their family physician | Other: questionnaire<br>* no intervention at all apart from filling a brief questionnaire<br>* Other names: no intervention at all apart from filling a brief questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between patient's vaccine hesitancy and perception by his/her family physician of his/her vaccine hesitancy. | Each participant will evaluate hi/her vaccine hesitancy on a 0-100 scale; his/her family physician will also evaluate the vaccine hesitancy of this participant on the same 0-100 scale. The outcome 1 is the difference between patient's vaccine hesitancy and perception by his/her family physician of his/her vaccine hesitancy (on this 0-100 scale). These are arbitrary units. | one day |
Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the change in muscle activity during gait with the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.

Detailed Description
-----------------
A small group of children with hemiplegic cerebral palsy is investigated by 3D instrumented gait analysis. Muscle activity is measured by surface electromyography (sEMG) of selected lower limb muscle groups. Kinematic, Kinetic, and sEMG data are compared between both lower limbs walking with and without an ankle foot orthosis. Data are also compared with those of an healthy control group.

Official Title
-----------------
Muscle Activity With the Use of Ankle Foot Orthoses in Cerebral Palsy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of spastic hemiplegic cerebral palsy age between 8 and 18 years must have an equinus barefoot gait pattern must have a heel-toe gait pattern with ankle foot orthosis no prior operations Exclusion Criteria: no Botulinumtoxin treatment for at least 6 months prior to investigation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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
-----------------
gait analysis, cerebral palsy, ankle foot orthosis, emg, surface electromyography
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma

Study Overview
=================
Brief Summary
-----------------
Serum samples of asthmatic patients will be screened for serum biomarkers

Official Title
-----------------
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma

Conditions
-----------------
Asthma, Biomarkers

Intervention / Treatment
-----------------
* Diagnostic Test: Serum biomarker testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 65 years physician-diagnosed asthma Exclusion Criteria: No clear asthma phenotype Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis) > 15 pack years No sputum available Respiratory infection Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Asthmatics<br>Asthmatic group from which serum samples will be collected for analysis | Diagnostic Test: Serum biomarker testing<br>* Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calprotectin | Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum calprotectin | Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay | Day 1 |
Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate predictors of response to antipsychotic medication in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI, genetics and neuropsychological profile. Two groups of treatment will be compared: first generation antipsychotics vs. second generation antipsychotics. Participants will be randomized to one of the groups. Trial duration: 12 weeks.

Official Title
-----------------
Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia

Conditions
-----------------
Schizophrenia or Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Antipsychotics
* Drug: Antipsychotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia or schizoaffective disorder Age: 18-45 years olde Less than 10 years of diagnosis Acute exacerbation of psychotic symptoms Exclusion Criteria: Use of clozapine Clinical unstable disease Delirium and cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Active Comparator: First generation antipsychotic<br>Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine. | Drug: Antipsychotics<br>* Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.<br>|
| Experimental: Second generation antipsychotics<br>Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone | Drug: Antipsychotics<br>* Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg<br>* Other names: Seroquel, Geodon, Zyprexa, Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % responders to first generation antipsychotics vs. % responders to second generation antipsychotics |  | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of treatment abandon and respective causes |  | 8-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, predictors of response, antipsychotics, 18-45 years old, non-refractory
Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth

Study Overview
=================
Brief Summary
-----------------
This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.

Official Title
-----------------
Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth

Conditions
-----------------
Substance Use, Unprotected Sex

Intervention / Treatment
-----------------
* Behavioral: AWARE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking. Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AWARE condition<br>AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback. | Behavioral: AWARE<br>* AWARE consists of four group sessions. The AWARE curriculum involves sharing basic information on sexually transmitted diseases; providing condom use skills training; providing normative feedback on substance use and sexual risk behavior among young adults; discussing unrealistic beliefs about substance use and sexual risk; discussing potential benefits of both cutting down and stopping risky behaviors; and discussing risky situations and coping strategies.<br>|
| No Intervention: Standard Care condition<br>Participants in the Standard Care condition have access to usual care at the drop-in center where the study is being conducted. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use | frequency and quantity of alcohol and drug use | 12 months | 
| Unprotected sex | proportion of condom-unprotected sexual events | 12 months |
The ARIC MRI Study

Study Overview
=================
Brief Summary
-----------------
To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in Communities (ARIC) magnetic resonance imaging subcohort.

Detailed Description
-----------------
BACKGROUND: Although the clinical manifestations of cerebrovascular disease (CVD) typically appear acutely, the deleterious effects of CVD on brain structure and function likely begin in a presymptomatic fashion at a younger age than clinical strokes. In an effort to characterize the prevalence, risk factors, and cognitive correlates of subclinical CVD, the Atherosclerosis Risk in Communities (ARIC) Study funded by the National Heart, Lung, and Blood Institute performed cerebral magnetic resonance imaging (MRI) and cognitive assessments on a large, bi-racial sample of middle-aged and young-elderly adults. Results from the ARIC MRI baseline study revealed a remarkably high prevalence of subclinical CVD including silent cerebral infarctions, white matter hyperintensities, and brain atrophy. Moreover, these subclinical abnormalities were found to be associated with reduced cognitive functioning and with clinical CVD outcomes such as incident stroke. Surprisingly little is known about risk factors related to the incidence or progression of subclinical CVD or how progression of these markers may relate to clinical outcomes such as stroke or neurocognitive decline. DESIGN NARRATIVE: This is a follow-up study of the ARIC MRI cohort, with repeated semiquantitative MR imaging and cognitive assessments. The study will also take advantage of recent advances in MR imaging and obtain volumetric measurements of selected brain regions and expand upon the baseline cognitive assessment to further characterize neurocognitive functioning. The longitudinal design of the proposed study will fill salient gaps in current understanding of subclinical CVD. Moreover, conducting this study within ARIC takes advantage of ARIC's baseline MRI data, unique African American population, and extensive vascular risk factor data (including new genetic and biochemical factors as well as subclinical markers of both large and small vessel disease), making an efficient study to provide new insights into the incidence, progression, and outcomes associated with subclinical CVD.

Official Title
-----------------
The ARIC Neurocognitive Longitudinal Study

Conditions
-----------------
Cardiovascular Diseases, Cerebrovascular Disorders, Cerebrovascular Accident

Participation Criteria
=================
Eligibility Criteria
-----------------
Participated in the baseline ARIC MRI study.
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 |
| --- | --- | --- |
Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth

Study Overview
=================
Brief Summary
-----------------
Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy treatment in human primary molars.

Official Title
-----------------
Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth.

Conditions
-----------------
Effectiveness of Biodentine® in Pulpotomies Primary Teeth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or more primary teeth which requires pulpotomy. Exclusion Criteria: not healthy patients, patients with teeth which requires pulpectomy.

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| formocresol<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the primary molar pulpotomy |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulpotomy, primary teeth, Biodentine®, formocresol
The Association Between Overweight and Oocyte Diameter in Women Undergoing Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
We believe that there is an association between BMI and oocyte diameter in women undergoing IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF. One group will have BMI 20-25 and the other group will have BMI above 30.

Conditions
-----------------
Infertility, Obesity

Intervention / Treatment
-----------------
* Other: Oocyte Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF treated patients BMI between 20-25 or over 30 Exclusion Criteria: Everyone else

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BMI over 30<br>Women undergoing IVF with BMI over 30 | Other: Oocyte Measurement<br> <br> |
| BMI 20-25<br>Women undergoing IVF treatments with BMI between 20-25 | Other: Oocyte Measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Larger Size of Oocyte Diameter | Oocyte will be measured in women undergoing IVF treatment | One year |
Juice Preference in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
ED patients who are able to drink juice will be approached and asked their beverage preference.

Detailed Description
-----------------
Once per week for 26 weeks, patients will be enrolled during a randomly selected 1-hour block. The random blocks will be assigned using STATA. During these enrollment periods, all current ED patients will be screened by the treating physicians and research associates, excluding patients in the Special Care unit, where most patients are intoxicated with alcohol. Eligibility for oral consumption of water and juice will be determined by treating physicians. Patients who are deemed eligible to drink water or juice will be approached and asked their beverage preferences. Their response will be recorded, and the beverage will be procured for them.

Official Title
-----------------
Journey to Understand and Interpret Juice Preference in the Emergency Department

Conditions
-----------------
All Eligible ED Patients (Not Limited to a Particular Condition)

Intervention / Treatment
-----------------
* Other: Beverage procurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference. Patients are only enrolled during randomly selected 1-hour blocks once per week for 26 weeks. Exclusion Criteria: Previously enrolled in the study Patients who are placed in the special care unit of the Emergency Department, which generally cares for intoxicated patients.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ED patients<br>All ED patients who are able to drink water/juice, and be able to communicate juice preference. | Other: Beverage procurement<br>* All Emergency Department patients will be approached to ask their beverage preferences in a randomly permuted data collection form. If they would like juice, the flavor will be recorded and the juice (and/or water) will be procured by a research assistant if the patient would like that, though the actual procurement of the juice is not part of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Juice preference | Cranberry, apple, orange, or grape | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beverage preference | Water, juice, or both | 1 hour | 
| Ice preference | Yes or no (in any beverage) | 1 hour | 
| Alternate juice preference | For those requesting juice, they will be asked if there is an unavailable alternate flavor that he/she would prefer | 1 hour |
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: KAD-1229
* Drug: Placebo
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0% Exclusion Criteria: Type 1 Diabetes Mellitus Patients with serious diabetic complications and other serious complications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KAD-1229/KAD-1229<br>Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. | Drug: KAD-1229<br> <br> Drug: Insulin<br> <br> |
| Other: Placebo/KAD-1229<br>Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. | Drug: KAD-1229<br> <br> Drug: Placebo<br> <br> Drug: Insulin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, HbA1c