linjc16/ctgov huggingface dataset:
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.

Detailed Description
-----------------
This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes. In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks. In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks. In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.

Official Title
-----------------
Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

Conditions
-----------------
Dyslipidemia, Type II Diabetes

Intervention / Treatment
-----------------
* Drug: YH14755
* Drug: Metformin
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Subjects with Dyslipidemia and Type II Diabetes 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening BMI ≤ 45kg/m2 Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit. 19 years later, men and women under the age of 75 Exclusion Criteria: Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study Subject with type I Diabetes Subject with hypertension which does not controlled by treatment(have blood pressure > 160/110mmHg) Have a known allergy to drugs Have administered Cyclosporine Have administered Obesity treatment within 12 weeks prior to screening visit Participated in any other clinical trials within 30 days prior to the first administration Subject who is judged to be ineligible by investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH14755<br>PO, Once Daily, 16 weeks | Drug: YH14755<br>* 20/1500mg, QD<br>|
| Active Comparator: Metformin<br>PO, Once Daily, 16 weeks | Drug: Metformin<br>* 1500mg, QD<br>|
| Active Comparator: Rosuvastatin<br>PO, Once Daily, 16 weeks | Drug: Rosuvastatin<br>* 20mg, QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL Cholesterol |  | Change from baseline at 16 weeks | 
| Change in HbA1c |  | Change from baseline at 16 weeks |
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre

Study Overview
=================
Brief Summary
-----------------
The main hypothesis: The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The groups waiting for rehabilitation is compared with the group receiving rehabilitation

Detailed Description
-----------------
nn

Official Title
-----------------
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre. A Randomized Study.

Conditions
-----------------
Physically Disabled

Intervention / Treatment
-----------------
* Behavioral: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with physical disabilities admitted to treatment at BHC Exclusion Criteria: Patients with severe cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>Physical activity 2-4 times pr. day | Behavioral: Physical activity<br>* Swimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing<br>* Other names: Exercise;|
| No Intervention: Control group<br>No intervention in the control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Short Form 12 v2 | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | VAS Pain | 8 weeks | 
| Behavioural Regulation in Exercise Questionnaire (BREQ 2) | Measures motivational regulation | 8 weeks | 
| Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) | Measures Physical Activity level | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical disabilities, rehabilitation
Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan

Study Overview
=================
Brief Summary
-----------------
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Dihydroartemisinin- piperaquine
* Drug: artemether- lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncomplicated malaria Exclusion Criteria: Severe cases Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 95 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: Dihydroartemisinin- piperaquine<br>orally tablets | Drug: Dihydroartemisinin- piperaquine<br>* three tablets per day<br>* Other names: Hoy-Cotec;Drug: artemether- lumefantrine<br>* twenty tablet in eight doses<br>* Other names: Coartem;|
| Active Comparator: artemether- lumefantrine<br>oral tablets | Drug: artemether- lumefantrine<br>* twenty tablet in eight doses<br>* Other names: Coartem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing the cure rate between the two drugs | PCR cure rate Parasite clearance time Fever clearance time | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimalarials, ACTs, Piperaquine, uncomplicated
CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

Detailed Description
-----------------
To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.

Official Title
-----------------
A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: CD5789 (trifarotene)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits. The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face. Exclusion Criteria: The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.). The Subject has more than 1 nodule on the face at Screening and at Baseline visits. The Subject has any acne cyst on the face at Screening and at Baseline visits.

Ages Eligible for Study
-----------------
Minimum Age: 9 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: CD5789 (trifarotene) cream<br> | Drug: CD5789 (trifarotene)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) Success Rate up to Week 52 | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear). | From Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment (PGA) Success Rate up to Week 52 | Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear). | From Baseline to Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trunk, Acne vulgaris, Safety, Face
Role of the Immune Environment in Response to Therapy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.

Official Title
-----------------
Role of the Immune Environment in Response to Therapy in Breast Cancer

Conditions
-----------------
Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer

Intervention / Treatment
-----------------
* Other: Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System. Exclusion criteria: Males Children Pregnant individuals

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.|Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collecting, processing and archiving breast cancer tumor tissues | This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers. | Through study completion, average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associating breast cancer dendritic cell infiltrate with outcome | We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune microenvironment
Rapid Detection of COVID-19 by Portable and Connected Biosensor

Study Overview
=================
Brief Summary
-----------------
The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.

Official Title
-----------------
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

Conditions
-----------------
Sars-CoV2

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 RT-PCR
* Diagnostic Test: Biosensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female or child without age limit Admitted to a Reference Health Establishment in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity. Patient to be diagnosed using a PCR test on nasopharyngeal swab. Social insured Exclusion Criteria: Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative Patient refusal to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| positive SARS-Cov2<br>100 patients with a positive diagnosis of SARS-CoV-2 | Diagnostic Test: COVID-19 RT-PCR<br>* Nasopharyngeal swabs for COVID-19 RT-PCR<br>Diagnostic Test: Biosensor<br>* Portable and Connected Biosensor viral<br>|
| negative SARS-Cov2<br>100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team | Diagnostic Test: COVID-19 RT-PCR<br>* Nasopharyngeal swabs for COVID-19 RT-PCR<br>Diagnostic Test: Biosensor<br>* Portable and Connected Biosensor viral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical team |  | Baseline (at admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and COR-DIAL based on nasopharyngeal swabs taken on patient admission |  | Baseline (at admission) |
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

Official Title
-----------------
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 diabetes for at least 3 months Stabilised on current treatment with premixed human insulin for at least 4 weeks Body mass index (BMI) between 18-40 kg/m2 HbA1c below 13.0% Able and willing to perform self-blood glucose monitoring Exclusion Criteria: The receipt of any investigational drug within the last three months prior to this trial Has a history of drug abuse or alcohol dependence within the last 5 years Active proliferative retinopathy requiring laser or surgical intervention within the last year Recurrent major hypoglycaemia as judged by the Investigator Known or suspected allergy to trial product or related product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: biphasic human insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hr postprandial plasma glucose (PPPG) excursion |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 
| Fasting plasma glucose |  |  |
Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.

Conditions
-----------------
Helicobacter Infected Patients

Intervention / Treatment
-----------------
* Drug: sequential versus triple


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peptic ulcer diseae two test positive rapid urease test, culture, histology Exclusion Criteria: lactating or pregnant previous stomach surgery severe underlying disease

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

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: sequential therapy<br>first five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole | Drug: sequential versus triple<br>* sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid<br>|
| Active Comparator: conventional triple thearpy<br>PPI+amoxicillin+clarithromycin | Drug: sequential versus triple<br>* sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the eradication rate by urea breath test | to compare the eradication rate (intention-to-treat and per protocol) by urea breath test at least four weeks after treatment | 4-6 week later after completion of therapy |
Safety Study in Outpatient Japanese Children With ADHD

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.

Official Title
-----------------
An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 6 - 18 years of age Patients must meet DSM-IV diagnostic criteria for ADHD Patient must be able to swallow capsules Patients must be of normal intelligence Laboratory results must show no significant abnormalities Exclusion Criteria: Patients who weigh less than 15 kg or more than 75 kg at study entry Patients who have a documented history of bipolar disorder or any history of psychosis Patients taking any antipsychotic medication within 26 weeks of visit 1 Patients with a severe history of allergies Patients taking methylphenidate

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy. |  |  | 
| To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine |  |  |