linjc16/ctgov huggingface dataset:
Effects of ONO-2506PO in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the presence of an effect of treatment with ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.

Official Title
-----------------
Effects of ONO-2506PO in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: ONO-2506PO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable Alzheimer's Disease using NINCDS/ADRDA criteria Standardized MMSE Score of 13 to 24 points (inclusive) Modified Hachinski score equal or less than 4 Exclusion Criteria: Serious systemic disease that may preclude survival to study completion Other illnesses that may include dementive features

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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

| Intervention/Treatment |
| --- |
|Drug: ONO-2506PO|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function Scale |  |  | 
| Global Function Scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADL Scale |  |  | 
| Psychiatric Symptom Scale |  |  |
Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Study Overview
=================
Brief Summary
-----------------
As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: sustained-release recombinant human GH (SR-rhGH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: sustained-release recombinant human GH (SR-rhGH)<br>12-week subcutaneous administration, 2mg/week | Drug: sustained-release recombinant human GH (SR-rhGH)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse event | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | QoL-AGHDA | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults, GH deficiency
Liver Injury After COVID-19 Vaccination

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is still raging across the world and vaccination is expected to lead us out of this pandemic. Although the efficacy of these vaccines is beyond doubt, safety still remains a concern. Liver injury, such as autoimmune hepatitis (AIH), has been reported after COVID-19 vaccination. The aim of this prospective study is to investigate the spectrum and profile of liver injury after COVID-19 vaccination in Asia-Pacific region and to explore the potential risk factors for the development of liver injury.

Official Title
-----------------
APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)

Conditions
-----------------
Subjects After COVID-19 Vaccination

Intervention / Treatment
-----------------
* Biological: Approved COVID-19 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received at least one dose of approved COVID-19 vaccine; Volunteer to participate in this study. Exclusion Criteria: No valid consent.

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| COVID-19 Vaccination Group<br>Subjects who have received at lease one dose of approved COVID-19 vaccine | Biological: Approved COVID-19 vaccine<br>* Vaccination for COVI9-19<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with liver injury after COVID-19 vaccination | The COVID-19 vaccine-related liver injury (such as elevated liver enzymes, total bilirubin, etc.) was recorded and its spectrum and profile were evaluated. | Within 24 weeks after COVID-19 vaccination |
LEft Atrial Pacing in Diastolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.

Official Title
-----------------
LEft Atrial Pacing in Diastolic Heart Failure

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony

Intervention / Treatment
-----------------
* Procedure: pace make active/inactive cross over


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 65 Sinus rhythm, PR < 220ms, QRS < 110ms Heart failure (NYHA class III-IV or II with hospitalization for heart failure) Ejection Fraction > 50%, restrictive mitral inflow, Lateral E/e' > 12 or septal E/e' > 15, Left atrial index volume > 34 ml/m² Atrial dyssynchrony syndrome: (TTE) inter-atrial time delay ≥ 70ms (difference between tricuspid and mitral P-A intervals or between mitral and tricupsid P-A' intervals with DTI) Left atrio-ventricular asynchrony: Time Difference between tricupsid and mitral A wave duration ≥ 35ms.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Experimental: first active<br> | Procedure: pace make active/inactive cross over<br> <br> |
| Experimental: first inactive<br> | Procedure: pace make active/inactive cross over<br> <br> |

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
-----------------
Heart failure with preserved ejection fraction, atrial dyssynchrony syndrome, left atrio-ventricular asynchrony, pacemaker, left atrial pacing therapy
Effects of Cocoa Flavanols on Human Cognitive Function

Study Overview
=================
Brief Summary
-----------------
To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

Detailed Description
-----------------
This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.

Conditions
-----------------
Neural Degeneration

Intervention / Treatment
-----------------
* Dietary Supplement: Cocoa Drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 62 - 75 years A signed consent form Exclusion Criteria: Blood pressure > 160/90 mmHg Haemoglobin (anaemia marker) < 125 g/l Gamma GT (liver enzymes) > 80 IU/l Had suffered a myocardial infarction or stroke in the previous 12 months Suffers from any gastrointestinal/stomach disorder Suffers from any blood-clotting disorder On medication for hypertension Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases) Depression or major mental illness Any dietary restrictions or on a weight reducing diet Drinking more than 21 units per week On any medication affecting blood clotting Smoking Vegans

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Flavanol<br>High Flavanol cocoa drink containing 495mg cocoa | Dietary Supplement: Cocoa Drink<br>* High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients<br>|
| Placebo Comparator: Low Flavanol<br>Low Flavanol cocoa drink (23mg) | Dietary Supplement: Cocoa Drink<br>* High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive function - attention |  | change from baseline to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | change from baseline to 2 hours | 
| Plasma flavanols |  | change from baseline to 2 hours |
Effect of Bosentan on Exercise Capacity at High Altitude

Study Overview
=================
Brief Summary
-----------------
This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude. We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.

Detailed Description
-----------------
Both the prostacyclin and the nitric oxide pathways are important in modulating hypoxic pulmonary vasoconstriction (HPV). There is little information about the role of the endothelin pathway at high altitude. The endothelin pathway involves the activation of two distinct receptors, A and B. Bosentan is a nonpeptide, specific, competitive, dual antagonist of both endothelin receptor subtypes. The primary objective of this study will be to determine the effect of endothelin receptor blockade with bosentan on exercise performance and HPV. This is a prospective, double blind, placebo-controlled, randomized cross-over study involving healthy subjects aged 25-55 years of age. Subjects will undergo echocardiography and exercise testing at low altitude (< 500m) and at 3800m. Subjects will receive either bosentan vs. placebo and will be studied at low and high altitude on two occasions in a crossover design. Primary outcome measures will be pulmonary artery systolic pressure measured by echo-Doppler and exercise capacity. A better understanding of the role of the endothelin pathway in HPV may lead to improved treatments for some patients.

Official Title
-----------------
Effect of Bosentan on Exercise Capacity at High Altitude

Conditions
-----------------
Altitude, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Bosentan administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy subjects aged 18 - 55 years Exclusion Criteria: Pregnancy Heart, lung or liver disease Use of glyburide, cyclosporin A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bosentan administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity |  |  | 
| Pulmonary artery systolic pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin oxygen saturation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoxia, endothelin, exercise
Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.

Detailed Description
-----------------
Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.

Official Title
-----------------
Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:

Conditions
-----------------
Epilepsy, Behavioral Disturbance

Intervention / Treatment
-----------------
* Procedure: Rapid versus slow conversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 yo and older on stable dose of valproate (Depakote DR) Exclusion Criteria: Unstable neurolgical, medical or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 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 |
| --- |
|Procedure: Rapid versus slow conversion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group comparisons of GI and CNS side effect burden |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group comparison of Quality of Life as measured bye the QOLIE-89 |  |  | 
| Between group comparison of trough Total and Free valproic acid serum levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tolerability, Depakote DR, Depakote ER, Elderly, Conversion
The Role of Endometrial Blood Flow in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The incidence of endometrial cancer is gradually increasing nowaday. Sonography can be used to evaluate the endometrial volume, the vascularity and the blood flow. This study will analyze the role of preoperative endometrial blood flow in the outcome of endometrial cancer patients.

Official Title
-----------------
The Role of Endometrial Blood Flow in Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - >20 years old female had Endometrial cancer Exclusion Criteria: - <20 years old female

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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 |
| --- | --- | --- |
| Correlation between the endometrial vascularity (VFI, FI, VI), endometrial volume, endometrial thickness and progression-free survival of endometrial cancer patients | Correlation between the endometrial vascularity (VFI, FI, VI), endometrial volume, endometrial thickness and progression-free survival of endometrial cancer patients | 12 months |
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Safety and bioequivalence of SPARC_147709

Official Title
-----------------
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: SPARC147709
* Drug: Reference147709


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Availability for the entire study period and willingness to adhere to protocol requirements. Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome 18 years of age or older No evidence of underlying disease (except multiple myeloma) Exclusion Criteria: History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease. History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day). Positive result to HIV, HCV, RPR and HBsAg.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SPARC147709 | Drug: SPARC147709<br>* SPARC147709 injection<br>|
| Active Comparator: 2<br>Reference147709 | Drug: Reference147709<br>* Reference147709 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference |  | 2 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events |  | 2 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple myeloma, Bio-equivalence
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Detailed Description
-----------------
Eligibility criteria: Age 6 - 16 yrs IgE-mediated milk allergy and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms Outcome measures: number of patients with successful desensitization (195 - 200 ml milk per day) number of patients with adverse events

Official Title
-----------------
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Conditions
-----------------
Milk Allergy, Anaphylaxis

Intervention / Treatment
-----------------
* Dietary Supplement: milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IgE-mediated milk allergy An immediately positive challenge test result to milk prior to inclusion Exclusion Criteria: Not willing to participate

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>rice/soy/oat milkdrink, masked | Dietary Supplement: milk<br>* milk for milk allergic children (1:25 dilution, whole milk)<br>* Other names: desensitization;|
| Experimental: milk<br>cow's milk | Dietary Supplement: milk<br>* milk for milk allergic children (1:25 dilution, whole milk)<br>* Other names: desensitization;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants drinking 2 dl/day of milk (success in desensitization) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
milk allergy, desensitization, anaphylaxis, school-age