linjc16/ctgov huggingface dataset:
Adherence in Adolescents and Children Treated on Quetiapine

Study Overview
=================
Brief Summary
-----------------
Observational study aimed to describe the adherence in a population of adolescents and children treated on quetiapine from a first psychotic episode whose more important secondary objective is to identify possible predictive factors influencing the adherence to treatment with Quetiapine

Official Title
-----------------
Adherence in Adolescents and Children Treated on Quetiapine

Conditions
-----------------
Psychosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one psychotic symptom (delusions or hallucinations) before age 18. Start of treatment in a maximum period of 2 years after the onset of first psychotic symptom Written informed consent by parents or guardians and patients. Exclusion Criteria: Pregnancy or lactancy High risk of aggression or suicidal behaviour Alcohol dependence

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival analysis of rate of adherence to treatment on quetiapine |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival analysis of rate of adherence to treatment on quetiapine |  | 12 months | 
| Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence |  | 0, 6, 12 months | 
| Tolerability profile (UKU) possibly influencing adherence |  | 0, 6, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychosis, adolescents, adherence, quetiapine
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)

Study Overview
=================
Brief Summary
-----------------
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.

Conditions
-----------------
Peripheral Artery Disease With Intermittent Claudication

Intervention / Treatment
-----------------
* Drug: Olmesartan
* Drug: other anti-hypertensive drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 20 and 85 years at visit 1 Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed) Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment Exclusion Criteria: Blood pressure of more than 180/110 mmHg Patients taking ARBs or ACE inhibitors treatment for at least 6 months before Patients taking aldosterone receptor antagonists at least 6 months before Patients with serum creatinine of more than 3 mg/dL serum potassium (K+) > 5.5mg/dl History of bilateral renal artery stenosis History of acute coronary syndrome or heart failure hospitalization within 6 months Peripheral arterial revascularization planned within 1 month Critical limb ischemia Patients with impaired cognition (e.g. dementia) pregnancy or women at age of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: olmesartan group<br>olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg) | Drug: Olmesartan<br> <br> |
| Active Comparator: other group<br>other anti-hypertensive drug (titrating BP <140/90 mmHg) | Drug: other anti-hypertensive drug<br>* CCB, diuretics, alpha blocker, direct vasodilator, beta blocker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free maximum walking distance and time | Effect of olmesartan in maximum, pain free walking distance & time | 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by questionnaires | Effect of olmesartan in quality of life (WIQ, SF-36) | 24th week |
Genetic Contribution of Pain and Inflammation in IBS

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome.

Detailed Description
-----------------
Stored and de-linked blood or DNA from subjects with IBS will be utilized for analysis for possible polymorphisms at predetermined genetic loci located in chosen genes.

Official Title
-----------------
Genetic Contribution of Pain and Inflammation in Irritable Bowel Syndrome.

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with IBS and previously stored samples Exclusion Criteria: Subjects without IBS and no previously stored samples
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 |
| --- | --- | --- |
| Polymorphisms | The goal of the study isd to identify possible polymorphisms on the loci of canidate genes that may be involved in modulation of pain and inflammation in irritable Bowel Syndrome. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS
Implementation of a Tool on Alimentary Empowerment in New-born Baby

Study Overview
=================
Brief Summary
-----------------
The alimentation of the premature newborn children is one of main thing concerning of nurses and pediatricians in neonatology. The absence of common tool of evaluation of the children cause a great discrepancy in prescriptions and the practices of the nursing.The aim of this study is to estimate the improvement of the food empowerment of the premature newborn children after the introduction of a help tool at the food progress which allows to fit the prescription of food(supply) to the capacities of the newborn child.

Detailed Description
-----------------
If the importance of feeding premature newborns is a central concern during their management, the absence of an evaluation tool leads to a great disparity in their implementation (particularly marked by at regular times by the care teams), which can eventually lead to oral disorders. The possibility of an assessment of the newborn's skills could allow a homogenization of therapeutic proposals and thus a potentially faster progression of dietary independence of the newborn. This method could also encourage parental involvement in feeding care. The objective of the study is to evaluate the impact of a tool to help food progression on food autonomy.

Official Title
-----------------
Implementation of a Tool on Alimentary Empowerment in New-born Baby

Conditions
-----------------
Neonatal Feeding Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born before 37 weeks of pregnancy hospitalized in GHPSJ neonatology Predictable duration of hospitalization of at least 7 days Exclusion Criteria: parents not speaking french language new borm with complication du to his prematurity

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Days

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 |
| --- | --- | --- |
| Age of prematurity of the newborn child | It's an estimation between the real age of the premature baby (i.e number of weeks of pregnancy) and the normal date of delivery. | delivery date |
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.

Official Title
-----------------
A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function

Conditions
-----------------
Renal Impairment, Healthy

Intervention / Treatment
-----------------
* Drug: Sotagliflozin
* Drug: Sotagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female subjects ≥18 to ≤75 years of age Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD Control group of matched healthy subjects Willing and able to provide written informed consent Exclusion Criteria: Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin History of any major surgery within 6 months History of hepatic disease, or significantly abnormal liver function test Women who are breastfeeding or are planning to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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: Group 1<br>Subjects with normal renal function | Drug: Sotagliflozin<br>* Single dose<br>|
| Experimental: Group 2<br>Subjects with mild renal impairment | Drug: Sotagliflozin<br>* Single dose<br>|
| Experimental: Group 3<br>Subjects with moderate renal impairment | Drug: Sotagliflozin<br>* Single dose<br>|
| Experimental: Group 4<br>Subjects with severe renal impairment | Drug: Sotagliflozin<br>* Single dose<br>|
| Experimental: Group 5<br>Subjects with ESRD requiring HD | Drug: Sotagliflozin<br>* 2 single doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events |  | Day 1 to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of sotaglifozin to evaluate AUC |  | Day 1 |
Post Study Continuation of C7 for G1D

Study Overview
=================
Brief Summary
-----------------
This protocol provides ongoing access to triheptanoin for patients who did complete an initial pilot protocol, and provides the opportunity to collect long-term safety data from patients treated with triheptanoin.

Detailed Description
-----------------
Only patients who completed the initial pilot study were eligible. The study is ongoing with these patients only.

Official Title
-----------------
Post Study Continuation of C7 for G1D

Conditions
-----------------
Glut1 Deficiency Syndrome, Glucose Transporter Type 1 Deficiency Syndrome

Intervention / Treatment
-----------------
* Drug: Triheptanoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in the pilot trial (UTSW 122010-186) Exclusion Criteria: Subjects who did not complete the pilot trial (UTSW 122010-186)

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 28 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triheptanoin|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
-----------------
G1D, Glut1 Deficiency, Glucose Transporter Type 1 Deficiency, Glucose Transporter Type I Deficiency
Reflection and Feedback in Clinical Reasoning

Study Overview
=================
Brief Summary
-----------------
Medical students' abilities to diagnose skin lesions after dermatology electives often remain unsatisfactory despite a dermatology elective being one of the most effective ways to improve their clinical reasoning. Feedback and reflection are two basic teaching methods used in clinical settings. This study aimed to investigate the effectiveness of structured reflection and immediate feedback in improving of medical students' evaluation of skin lesions.

Official Title
-----------------
Effects of Structured Reflection and Immediate Feedback in Improving of Medical Students' Evaluation of Skin Lesions

Conditions
-----------------
Educational Problems

Intervention / Treatment
-----------------
* Other: Reflection and feedback
* Other: Lecture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fourth-year medical students at Seoul National University College of Medicine Students taking 2-week dermatology elective courses Exclusion Criteria: Students who do not complete the whole course
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>2-hour training based on reflection and feedback | Other: Reflection and feedback<br>* 2-hour training involving 10 written clinical cases to encourage students to practice thinking like a dermatologist in their clinical reasoning, and to help students build adequate illness scripts of skin diseases<br>|
| Active Comparator: Lecture group<br>1-hour lecture | Other: Lecture<br>* Traditional didactic lecture which uses the same clinical cases<br>|
| No Intervention: Control group<br>The remaining students only attending dermatology electives | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy in the training set | Mean score of the training set (number of correct answers) | At the end of a 2-week dermatology elective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy in the control set | Mean score of the control set (number of correct answers) | At the end of a 2-week dermatology elective |
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients. The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.

Official Title
-----------------
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: PET-MR 18f-FACBC
* Procedure: histology (gold standard)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer) Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection) Exclusion Criteria: Previous treatment (for example TURP or hormone therapy) Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)
Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| Experimental: PET-MR 18F-FACBC<br> | Procedure: PET-MR 18f-FACBC<br> <br> Procedure: histology (gold standard)<br>* histopathological classification of co-located dissected lymph nodes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases | Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid
JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple sclerosis (MS) participants.

Detailed Description
-----------------
This is a cross-sectional, multi-center, multi-national, epidemiological study to estimate the prevalence of anti-JCV antibody in MS participants. This study will provide an estimate of the prevalence of anti-JCV antibody in the MS population and will investigate inter-country differences.

Official Title
-----------------
Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: All candidates for this study must have the ability to understand the purpose of the study and provide signed and dated informed consent. All patients with a diagnosis of Multiple Sclerosis (MS) of any type, irrespective of their treatment, are eligible to participate once. Key Exclusion Criteria: None NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
| --- | --- | --- |
| Prevalence of anti-JCV antibodies | Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated. | Single timepoint (Day 1) |
Cocaine in Parotid Saliva, Blood and Urine - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the use of parotid saliva as a means of detecting and quantifying cocaine and its metabolites.

Official Title
-----------------
Cocaine in Parotid Saliva, Blood and Urine

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

Intervention / Treatment
-----------------
* Procedure: Parotid Gland


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Parotid Gland|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine & benzoylecgonine content in saliva, plasma, & urine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Detection, Parotid Saliva