linjc16/ctgov huggingface dataset:
Effect of Plant Stanols on Cholesterol Absorption

Study Overview
=================
Brief Summary
-----------------
This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations

Detailed Description
-----------------
Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method. Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period. Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.

Official Title
-----------------
The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Behavioral: plant stanol consumption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults with mild to moderate hypercholesterolemia Exclusion Criteria: lipid lowering medication pregnancy or lactation severe diseases (inc. diabetes, unstable CVD, malignant diseases) severe obesity regular plant sterol consumption

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 68 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: plant stanol consumption|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholesterol absorption efficiency |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in blood lipids |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plant sterols, plant stanols, cholesterol absorption
An East Asian Study of LDE225

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.

Official Title
-----------------
An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: LDE225


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of advanced solid tumor (including medulloblastoma and basal cell carcinoma) blood work criteria Exclusion Criteria: patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases positive HIV, hepatitis B or C impaired intestinal function impaired heart function pregnant or breast-feeding women Other protocol-defined inclusion/exclusion criteria may apply

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: LDE225<br> | Drug: LDE225<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine maximum tolerated dose of single agent LDE225 |  | 28 day cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterize safety and tolerability |  | 28 day cycles | 
| characterize pharmacokinetics (PK) of single and repeated doses of LDE225 |  | 28 day cycles | 
| assess preliminary anti-tumor activity |  | 28 day cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced tumors, hedgehog, smoothened inhibitor
Internet Cognitive Behavior Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Study Overview
=================
Brief Summary
-----------------
The primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered via the Internet.

Official Title
-----------------
Internet-based Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Pilot Study

Conditions
-----------------
Body Dysmorhpic Disorder

Intervention / Treatment
-----------------
* Behavioral: Internet based CBT for body dysmorphic disorder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients male or female -≥ 18 years currently living in Stockholm county primary diagnosis of BDD according to the DSM-IV-TR signed informed consent regular access to a computer with Internet access and skills to use the web. Exclusion Criteria: psychotropic medication changes within two months prior to the treatment completed CBT for BDD within the last 12 months BDD-YBOCS < 12 at psychiatrist visit other primary axis I diagnosis current substance dependence lifetime bipolar disorder or psychosis suicidal ideation Axis II diagnosis that could jeopardize treatment participation other current psychological treatment that could affect BDD symptoms

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: Internet CBT<br> | Behavioral: Internet based CBT for body dysmorphic disorder<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body dysmorphic disorder symptoms |  | Measured after 12 weeks of treatment, and after 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning and life satisfaction |  | After 12 weeks of treatment, and 3 months after treatment | 
| Depressive symptoms |  | After 12 weeks of treatment, and 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BDD, CBT
Qidong Hepatitis B Intervention Study

Study Overview
=================
Brief Summary
-----------------
During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.

Conditions
-----------------
Hepatitis B, Liver Neoplasms, Liver Diseases

Intervention / Treatment
-----------------
* Biological: Hep-V Vax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all infants born in Qidong between September 1983 and November 1990 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hep-V Vax|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
-----------------
hepatitis B, hepatocellular carcinoma, prevention, vaccination
Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

Study Overview
=================
Brief Summary
-----------------
The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.

Official Title
-----------------
Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female patients aged 12 and older Evaluation in at least one of the following settings: Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring Exclusion Criteria: Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Individuals with suspected epilepsy<br>The study will enroll individuals who are attending their first visit at the University of Pennsylvania for suspected epilepsy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis | Epilepsy diagnosis determined by three epileptologist's review of subject's medical records | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Seizures, Diagnosis, Diagnostic, Inflammation
Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the role of endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values in predicting the tumor regression after concurrent chemoradiotherapy for rectal cancer.

Detailed Description
-----------------
We use endoscopic ultrasound to measure the primary tumor maximum diameter changes to predict the tumor regression after concurrent chemoradiotherapy for rectal cancer

Official Title
-----------------
Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0). tumor distance from anus less than 12 cm. KPS score not less than 70 can be tolerated chemotherapy and radiotherapy. pelvic who had no history of radiation therapy. Non-allergic history of fluorouracil or platinum-based chemotherapy drugs. a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. Exclusion Criteria: other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). pregnant or lactating patients. fertility but did not use contraceptive measures. existing active infection. merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. concurrent treatment with other anticancer drugs. can not complete treatment or follow-up.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Local advanced rectal cancer EUS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic ultrasound, pre-operative concurrent chemoradiotherapy
Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines

Study Overview
=================
Brief Summary
-----------------
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.

Detailed Description
-----------------
Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice. Interventions: Infrared photoscreener / remote autorefractor 2 Winner (2WIN) (Adaptica - Padova, Italy) without and with infrared corneal reflex occluder. Child-friendly skiascopy before and after cycloplegic refraction. Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and strabismus. Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2003 and 2013 guidelines. **Please note that 2 Winner has nothing to do with actual device, but was required by the Clinical Trials Web entry.**

Official Title
-----------------
Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy

Conditions
-----------------
Refractive Errors, Development Delay, Amblyopia, Strabismus

Intervention / Treatment
-----------------
* Device: 2WIN photoscreener


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoing eye examination Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 90 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 |
| --- | --- |
| 2WIN<br>Accommodation, refraction and ocular alignment are estimated by infrared photoscreener using the 2WIN photoscreener device. Photoscreener screening makes use of light crescent quantification from off-axis flash-to-lens in a camera. | Device: 2WIN photoscreener<br>* conventional infrared off-axis photoscreener<br>|
| school bus skiascopy<br>Refractive error estimated by child-friendly skiascopy rack holding lenses from +1.00 D to +10.00 D and -5.00 D. Skiascopy is a common, old-fashioned form of retinoscopy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amblyopia Risk Factor (refractive error and/or strabismus) | Whether pre-defined, age-related risk factor is present. AAPOS has published standard levels of these refractive errors or binocular misalignment that render a child at risk of developing sight-threatening amblyopia. | 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour. |
The Living Experience of Hong Kong Chinese Adolescents With CHD.

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD. Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.

Detailed Description
-----------------
A qualitative study was adopted. Purposive sampling of 30 adolescents with CHD were done. Thematic analysis was used for data analysis. The participants unfold negative impacts of CHD and its treatments, and the challenges they were facing with their relationship with others.

Official Title
-----------------
The Living Experience of Hong Kong Chinese Adolescents With CHD.

Conditions
-----------------
Adolescent, Chinese, Congenital Heart Disease, Psychological Well-being, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hong Kong Chinese adolescents aged 12 to 18 able to read and write Chinese attending outpatient clinic of Department of Pediatric Cardiology Exclusion Criteria: adolescents with non-structural heart disease with developmental delay or comorbid medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- |
| Hong Kong Chinese adolescents with CHD<br>Hong Kong Chinese adolescents with CHD aged 12-18 who are able to read and write chinese | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| living experience of adolescents with CHD | Participants were asked to describe their living experiences with CHD and how has CHD affected their quality of life and psychological well-being during the semi-structure interview. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital Heart Disease, Hong Kong, Adolescent
Validation of Venogenic Hypothesis for Cough, Exertional and Sexual Headaches

Study Overview
=================
Brief Summary
-----------------
Clinical and neuroradiologic study concerning patients suffering of cough, exertional and sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication, redescribe clinical headaches specifications, confirmed if cough headaches is a clinical entity and if it has neuroradiologic differences with effort or sexual activity headaches.

Conditions
-----------------
Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering of headache disorders Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
headache
Ganaxolone Expanded Access Program Compassionate Use

Study Overview
=================
Brief Summary
-----------------
The primary objective is to provide GNX to patients ≥ 2 years with CDD-related seizures who are refractory to, or intolerant of, standard therapy.

Detailed Description
-----------------
This is a multi-center, long-term, open-label, expanded access protocol of adjunctive GNX treatment in children, adolescents, and adults with CDD. Patients with inadequate seizure control on their current anti seizure medications at therapeutic doses will be eligible for enrollment.

Official Title
-----------------
Expanded Access With Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin Dependent Kinase-like 5 Deficiency Disorder

Conditions
-----------------
CDKL5 Disorder

Intervention / Treatment
-----------------
* Drug: Ganaxolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molecular confirmation of a pathogenic CDKL5 variant, early onset, difficult to control seizures, and neurodevelopmental impairment are required. Male or female patients aged ≥ 2 years. In the opinion of the investigator, the patient has inadequate seizure control on current anti-seizure medications at therapeutic doses. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ganaxolone|ganaxolone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |