linjc16/ctgov huggingface dataset:
Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

Conditions
-----------------
Hypertension and Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Telmisartan
* Drug: Amlodipine
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male who are ≥19, <50 years old Man who weights over 55kg and whose BMI is 18 30(kg/m2) Man who doesn't have any chronic disease or history of disease Exclusion Criteria: man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference1<br>single(Reference1) -> combination(Reference1+Reference2) | Drug: Telmisartan<br> <br> Drug: Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |
| Experimental: Reference2<br>single(Reference2) -> combination(Reference1+Reference2) | Drug: Telmisartan<br> <br> Drug: Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Reference 1 |  | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour | 
| Cmax of Reference 1 |  | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour | 
| AUC of Reference 2 |  | 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour | 
| Cmax of Reference 2 |  | 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour |
Registry of Patients That Have Undergone ICA or PCI

Study Overview
=================
Brief Summary
-----------------
In Invasive Coronary Angiography there are multiple invasively obtained measurements to determine the funcitonal significance of Cornary Artery Disease. In this Registry, patients who have undergone Invasive Coronary Angiography or Percutaneous Coronary Intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.

Official Title
-----------------
Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years Has undergone or will undergo a clinically indicated invasive coronary angiography. Has undergone or will undergo a clinically indicated percutaneous coronary intervention. Exclusion Criteria: Not willing / unable to provide informed consent.

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 |
| --- | --- | --- |
| Fractional Flow Reserve (FFR) | Invasively obtained FFR | Upon inclusion at index procedure | 
| Instantaneous wave-free ratio (iFR) | Invasively obtained iFR | Upon inclusion at index procedure | 
| Quantitative Flow Ratio (QFR) | Invasively obtained QFR | Upon inclusion at index procedure | 
| Stenosis percentage | Invasively obtained stenosis percentage | Upon inclusion at index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events, cardiac death or repeat revascularization | The secondary endpoint is to assess the prognostic value of the obtained parameters. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quantiative Flow Ratio, QFR, Fractional Flow Reserve, FFR, Instantaneous wave-free ratio, iFR, Invasive Coronary Angiography, Percutaneous Coronary Intervention
A Quality Rating Scale for Patients in Complex Situations and Their Caregivers

Study Overview
=================
Brief Summary
-----------------
Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination arrangements between professionals on the transformation of modes of exercise of professional care, and on the experience of patients / users and that of caregivers, particularly on dimensions constituted that the quality of care in order to build a coordinated exercise structures rating scale primary care on the basis of criteria suggested by patients

Official Title
-----------------
Establish a Quality Rating Scale for Primary Care Centers and Nursing Homes Pluri Professionals Integrating the Perspective of Patients in Complex Situations and Their Caregivers

Conditions
-----------------
Patients in Complex Situations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Professionals: Medical or paramedical professionals working in the exercise coordinated groups (GECO) initially defined Professionals who made his non_opposition For patients and family caregivers: Binomials patients / caregivers over the age of 18. Binomials patients / caregivers who formulated his non_opposition Patients experiencing complex care (multi-morbid and chronic) Exclusion Criteria: Refusal of a participant (Professionals / Patients / caregivers) to respond to inquiries

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 |
| --- | --- | --- |
| A quality assessment scale | Perform a quality assessment scale for primary care in the exercise coordinated groups (GECO) of perspective in complex situations patients, their caregivers and healthcare professionals | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multimorbidity, Exercise coordinated groups (GECO), Caregivers
Presbyopic Phakic Intraocular Lens for Myopia Correction

Study Overview
=================
Brief Summary
-----------------
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).

Detailed Description
-----------------
Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and monitored during 2 years period. Visual acuity for near and distance is evaluated, along with refraction and endothelium cell density.

Official Title
-----------------
Presbyopic Phakic Intraocular Lens for Myopia Correction

Conditions
-----------------
Presbyopia, Myopia

Intervention / Treatment
-----------------
* Device: Presbyopic posterior chamber phakic intraocular lens IPCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CDVA < 0.3 LogMAR Presbyopia with moderate to high myopia Phakic Exclusion Criteria: Corneal endotehleial cell density below 2000 cells/mm2 Corneal dystrophies ACD less than 2.8 mm history or current uveitis acute ocular inflammation glaucoma chronic uveitis previous intraocular or refractive surgery preexisting ocular pathologic which may affect postoperative results

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 50 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: Implantation phakic intraocular lens<br>Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye | Device: Presbyopic posterior chamber phakic intraocular lens IPCL<br>* Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Uncorrected Distance Visual Acuity (UDVA) | Distance visual acuity tested without any correction | 2 years | 
| Change in Uncorrected Near Visual Acuity (UNVA) | Near visual acuity tested without any correction | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corrected Distance Visual Acuity (CDVA) | Distance visual acuity tested with correction | 2 years | 
| Change in Corrected Near Visual Acuity (CNVA) | Near visual acuity tested with correction | 2 years | 
| Change in distance refraction | Expressed as spherical equivalent sp.Eq (D) | 2 years | 
| Change in near refraction | Expressed as spherical equivalent sp.Eq (D) | 2 years |
Study Of Perennial Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.

Official Title
-----------------
Study of Perennial Allergic Rhinitis -Long Term Treatment Study-

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: GW685698


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed consent. Outpatient. Diagnosis of perennial allergic rhinitis with symptoms. Able to comply with study procedures. Exclusion criteria: Significant concomitant medical condition. Use of corticosteroids/allergy medications. Laboratory abnormality. Positive pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: GW685698|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and laboratory blood test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of nasal symptom score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perennial allergic rhinitis
A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.

Official Title
-----------------
An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Behavioral: integrative rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who meet the diagnostic criteria of chronic fatigue syndrome Clinically evaluated, exclude any disease that can explain the chronic fatigue; Diagnosed and evaluated within the health region, Central Norway With written consent form signed by themselves and their parents. Exclusion Criteria: serious comorbidity such as anorexia, psychosis serious depression

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum 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: integrative rehabilitation program<br>28 sessions during 12 months with focus on psychoeducation, activity planning, and thoughts and feelings connected to having a serious chronic disease. From week 13 to week 32 a training programme aiming at balancing heart rate variability. | Behavioral: integrative rehabilitation program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue change | assessed by Fatigue Severity Scale | baseline and 52 weeks | 
| quality of life change | assessed by Inventory of Life Quality for Children and Adolescents | baseline and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mood change | assessed by Mood and Feelings Questionnaire | baseline and 52 weeks | 
| change in heart rate variability |  | baseline and 52 weeks | 
| school attendance change |  | baseline and 52 weeks | 
| general health change | General Health Questionnaire (GHQ-12) | baseline and 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, adolescent, heart rate variability biofeedback, psychoeducation
Mood Effects of Serotonin Agonists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.

Official Title
-----------------
Mood Effects of Serotonin Agonists

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lysergic Acid Diethylamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English fluency High school level education BMI between 19 and 30 Exclusion Criteria: Diagnosed medical condition women who are nursing, pregnant, or plan to become pregnant within 3 months History of psychotic disorder or family history of psychotic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Lysergic Acid Diethylamide<br>* Drug will be administered in solution form.<br>|
| Experimental: low dose MDMA<br>6.5ug dose of serotonin agonist | Drug: Lysergic Acid Diethylamide<br>* Drug will be administered in solution form.<br>|
| Experimental: medium dose<br>13ug dose of serotonin agonist | Drug: Lysergic Acid Diethylamide<br>* Drug will be administered in solution form.<br>|
| Experimental: high dose<br>26ug dose of serotonin agonist | Drug: Lysergic Acid Diethylamide<br>* Drug will be administered in solution form.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Profile of Mood States (POMS) | The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument. | End of study (Baseline - time 0 and approximately 8 weeks later) |
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.

Official Title
-----------------
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 3 to 6 Months

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: MK-0476, montelukast sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms Exclusion Criteria : A history of any significant illness that will pose additional risk to the patient

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 Months

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: Montelukast sodium<br>Participants receive montelukast sodium for 14 days. | Drug: MK-0476, montelukast sodium<br>* Duration of Treatment: 14 Days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the single-dose population pharmacokinetics, maximum plasma concentration, time to maximum plasma concentration, and apparent half-life of montelukast 4-mg oral granules in children aged 3 to 6 months. |  | 24 hours |
Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.

Detailed Description
-----------------
Correct device design depends on getting good information about the shape and size of the different parts of the heart. Measurements from computed tomography images of hearts will be studied. By looking at measurements from a wide range of patients, an understanding of the differences in the size and shape of the heart chambers will be gained.

Official Title
-----------------
Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: There is no intervention that is a part of this study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care. Exclusion Criteria: Patients who have not received cardiac CT imaging as part or normal care.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with atrial fibrillation<br>Patients with atrial fibrillation who have received a cardiac CT scan as part of normal care prior to catheter-based treatment of atrial fibrillation. | Other: There is no intervention that is a part of this study.<br>* There is no intervention that is a part of this study. Imaging data is gathered as part of normal care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LA size measurements |  | 3 months |
Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with chronic stroke.

Official Title
-----------------
A Clinical Study of Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Chronic Stroke

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Biological: Autologous bone marrow mononuclear cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females above 18 years of age diagnosed as stroke by clinical and MRI findings Exclusion Criteria: presence of respiratory distress presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus malignancies acute medical conditions such as respiratory infection, fever hemoglobin less than 8 bleeding tendency bone marrow disorder left ventricular ejection fraction < 30% pregnancy or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells<br>autologous bone marrow mononuclear cell transplantation | Biological: Autologous bone marrow mononuclear cell transplantation<br>* bone marrow derived mononuclear cells are administered intrathecally in chronic stroke patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure |  | 6 months |