linjc16/ctgov huggingface dataset:
Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The primary focus of this proposal is to address growing concern of overweight/ obese adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical trial to compare the effectiveness of Motivational interviewing (MI) interventions with the parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have more success due to the possible synergetic effect compared to adolescents alone. The study's primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes include overall improvement in their lifestyle and their responses to the MI intervention.

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Other: Motivational Interviewing/Counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at randomization: 10-17 years old 12 hour fasting lipid profile with triglycerides ≥39 mg/dL (1.0 mmol/L) or HDL-C ≤46 mg/dL (1.2 mmol/L), and with non-HDL-C ≥123 mg/dL (3.2 mmol/L) Waist to height ratio ≥0.5. Exclusion Criteria: On lipid lowering medication non-English speaking Developmentally delayed

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Group A (Parent-adolescent dyads) | Other: Motivational Interviewing/Counselling<br>* Motivational Interviewing/Counselling<br>|
| Active Comparator: Control Group - Active Comparator<br>Group B (Adolescents only) | Other: Motivational Interviewing/Counselling<br>* Motivational Interviewing/Counselling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total cholesterol to HDL-C ratio |  | Initial clinic visit (baseline); Repeated 6 months after baseline; | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motivational Interviewing
Endoscopic Submucosal Dissection Using a Thulium Laser

Study Overview
=================
Brief Summary
-----------------
We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia.

Detailed Description
-----------------
Instead of endoscopic knives, a thin, flexible fiber is inserted through the working channel of the endoscope. Acetic acid (1.5%) and indigo carmine dye are sprayed onto the lesion to clarify the margin. Markings are made 10 mm outside the tumor margin using a laser fiber with a power setting at 30 W. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine (1:25000) is injected into the submucosa outside the marking dots. A circumferential mucosal incision and submucosal dissection are performed by a thulium laser fiber with a power setting at 30 to 40 W. Activation of the laser beam is controlled by stepping on a foot pedal. Hemostasis during procedure is also attempted using the thulium laser. When hemostasis is not achieved properly, additional use of hemostatic forceps or a hemoclip will be considered.

Official Title
-----------------
Endoscopic Submucosal Dissection Using a Thulium Laser: Preliminary Results of a New Method for Treatment of Gastric Epithelial Neoplasia

Conditions
-----------------
Gastric Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-proven gastric epithelial neoplasia Exclusion Criteria: a.differentiated adenocarcinoma, ulcer(+), more than 3cm b.differentiated adenocarcinoma, submucosal invasion(+), more than 3cm c.undifferentiated adenocarcinoma, more than 2cm

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Technical success | Curative resection rate | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Procedure-related bleeding, perforation | 7 days |
Autonomic Regulation Trial (ART)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to develope and evaluate a new method for risk stratification which predicts high mortality risk in patients with cardiac disease based on simultateous examination of high resolution ECG, continuous arterial pressure and a breathing signal.

Official Title
-----------------
Autonomic Regulation Trial (ART)

Conditions
-----------------
Infarction, Myocardial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute myocardial infarction, presence of sinus rhythm Exclusion Criteria: diseases (other than acute myocardial infarction) with impact on prognosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
-----------------
AUTONOMIC NERVOUS SYSTEM, Assessment, Risk
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

Detailed Description
-----------------
This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).

Official Title
-----------------
Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life

Conditions
-----------------
Measles, Rubella, Mumps, Varicella

Intervention / Treatment
-----------------
* Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination. Exclusion Criteria: History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Ages Eligible for Study
-----------------
Minimum Age: 11 Months
Maximum Age: 13 Months

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody levels after vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the study vaccines |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis measles, mumps, rubella and chickenpox
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.

Official Title
-----------------
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine

Conditions
-----------------
Other Abortion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having an ongoing pregnancy of 13-22 weeks gestation Be willing to undergo surgical completion if necessary Have no contraindications to study procedures, according to provider Be willing and able to consent to participate in the study Be willing to follow study procedures Exclusion Criteria: Known allergy to mifepristone or misoprostol/prostaglandin Any contraindications to vaginal delivery, including placenta previa Unable to provide consent
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Rate of successful abortion |  | 15 hours after start of misoprostol induction |
Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Detailed Description
-----------------
The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Official Title
-----------------
Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort

Conditions
-----------------
Primary Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study Exclusion Criteria: Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study Patients not previously enrolled in Glaukos Study GC-003
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Randomized iStent<br>Implantation of one iStent in conjunction with cataract surgery, patients randomized to group | |
| Randomized cataract surgery<br>Cataract surgery alone, patients randomized to group | |
| Non-randomized iStent<br>Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Sight-threatening Adverse Events | The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group. | 80 Month average | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to assess patient satisfaction after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as treatment for diabetes mellitus under normal clinical practice setting.

Official Title
-----------------
A Prospective, Open-labelled, Non-controlled Observational Study to Assess Patient Satisfaction, Physician Acceptability and Safety of Mixtard® 30 NovoLet® for the Treatment of Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic human insulin 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus (type 1 or type 2) Patient not presently using Mixtard® 30 NovoLet®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovoLet®<br> | Drug: biphasic human insulin 30<br>* Administered via the NovoLet® device and according to the instructions in the product insert or as instructed by the physician. Individually adjusted dosage as instructed by the physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Technical complaints of NovoLet® device |  |  |
Quality of Life and Surgical Late Effects of Melanoma Treatment

Study Overview
=================
Brief Summary
-----------------
Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.

Detailed Description
-----------------
The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients: Health-related quality of life assessing psychological, physical and social well-being Physical long term side effects (lymphoedema, scarring and neuropathic pain) Lymphoedema assessed by clinical examination and DXA scans

Official Title
-----------------
Quality of Life and Surgical Late Effects of Melanoma Treatment

Conditions
-----------------
Melanoma, Quality of Life, Lymphedema, Depression, Anxiety, Pain, Cicatrix

Intervention / Treatment
-----------------
* Radiation: DXA scan
* Procedure: Clinical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AJCC stage IB-III cutaneous melanoma patients At least one year follow-up after melanoma surgery Exclusion Criteria: Pregnancy Bilateral axilla or groin melanoma surgery

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 |
| --- | --- |
| Cutaneous melanoma AJCC stage IB-III<br>Patients treated for cutaneous melanoma (AJCC stage IB-III) will fill out a questionnaire, undergo clinical examination and DXA scan | Radiation: DXA scan<br>* DXA scan<br>Procedure: Clinical examination<br>* Clinical examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Health Score | Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS) | 12 months | 
| Depression | Depression will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS) | 12 months | 
| Lymphoedema | Lymphoedema will be assessed with a questionnaire including the LYMQOL questionnaire, clinical examination and DXA scan | 12 months | 
| Neuropathic pain | Neuropathic pain will be assessed with a questionnaire including painDetect | 12 months | 
| Volume and tissue composition assessed with DXA scan | DXA scan | 12 months |
Association Analysis for Chronic Diseases Based on Resident Health Records by Using Big Data Methods

Study Overview
=================
Brief Summary
-----------------
This is an observational study to analysis the association factors for common diseases, including chronic obstructive pulmonary disease, coronary artery disease, hypertension, diabetes etc, based on resident healthcare records. More than 10 million resident healthcare records should be collected for the associations study by using big data methods.

Official Title
-----------------
Association Analysis for Chronic Diseases Based on Resident Health Records in China by Using Big Data Methods

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Other: not any intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Survey Chinese residents aged 20 - 100 years, were included in this study. Exclusion Criteria: Serious hepatic or renal dysfunctions.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| Group<br> | Other: not any intervention<br>* not any intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regular diagnosis and medical history of common diseases | resident health records for medical history of common diseases, questionnaire | an average of 1 year |
Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

Study Overview
=================
Brief Summary
-----------------
A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers

Official Title
-----------------
A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy Volunteers

Conditions
-----------------
Capsaicin Evoked Pain, Heat Sensitivity

Intervention / Treatment
-----------------
* Drug: AZD1386
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg. Non-fertile females Exclusion Criteria: History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator. History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>36 subjects receiving a specified volume of the active component AZD1386 in a single dose. | Drug: AZD1386<br>* Oral solution fixed dose (95 mg given orally on two occasions)<br>|
| Placebo Comparator: 2<br>36 subjects receiving a specified volume of placebo in a single dose. | Drug: Placebo<br>* Oral solution fixed dose (95 mg given orally on two occasions)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS, HPT |  | Visit 2-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia |  | Visit 2-4 | 
| Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3 |  | Visit 1-5 | 
| Pharmacokinetics/Pharmacodynamics |  | Visit 2-4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proof of Mechanism, Capsaicin evoked pain