linjc16/ctgov huggingface dataset:
Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Official Title
-----------------
Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: adalimumab
* Drug: placebo for adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject participated and relapsed in prior PS study Exclusion Criteria: Subject has other active skin diseases Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) Poorly controlled medical conditions History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease. History of cancer or lymphoproliferative disease History of active TB or listeriosis, or persistent chronic or active infections Known to have immune deficiency or is immunocompromised Clinically significant abnormal laboratory test results Erythrodermic psoriasis or generalized pustular psoriasis

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: adalimumab<br>* OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24<br>* Other names: Humira;|
| Placebo Comparator: B<br> | Drug: placebo for adalimumab<br>* OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 12 | 
| Adverse Events |  | Throughout Study Participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 12, Week 24 | 
| Physician's Global Assessment |  | Week 12, Week 24 |
Tryptophan Requirement of Healthy School Age Children

Study Overview
=================
Brief Summary
-----------------
Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.

Detailed Description
-----------------
Seven healthy children will participate in the study. The children will participate as an outpatient basis with study days carried out in the Physiological Research Unit at the Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not taking any medications, no recent weight changes, no history of significant illness, willing to participate in the study. Exclusion criteria were the presence of illness, significant weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill 3 days food record form to ensure his or her normal dietary behavior. The study will be explained to subjects and their parents/guardians, benefits and potential risks will be explained as well and written assent, from the children, and consent from parents will be obtained. Subjects will receive financial compensations. Each subject will receive compensation for participation. Each parent/guardian will be reimbursed for the transpiration/parking expenses and a meal each study day.

Official Title
-----------------
Tryptophan Requirement of Healthy School Age Children Determined by the Indicator Amino Acid Oxidation Method

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children age 6-10 inclusive Exclusion Criteria: significant recent illness

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tryptophan intake<br>Graded levels of tryptophan will be given to each subject on different study days around the anticipated breakpoint. | Dietary Supplement: tryptophan<br>* graded levels of tryptophan will be given to each subject<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of tryptophan in school age children | By collection of stable isotope labeled CO2 from the indicator amino acid phenylalanine in response to different intake levels of tryptophan we will be able to determine tryptophan requirements. | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
requirements, amino acid, tryptophan
Study of ONO-8539 in Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Official Title
-----------------
A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Tolterodine
* Drug: ONO-8539
* Drug: ONO-8539
* Drug: ONO-8539


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with medical history of Overactive Bladder symptoms for > 6 months Exclusion Criteria: Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: Placebo<br>* Placebo / 12 weeks<br>|
| Active Comparator: A<br> | Drug: Tolterodine<br>* 4mg / 12 weeks<br>|
| Experimental: E1<br> | Drug: ONO-8539<br>* low dose / 12 weeks<br>|
| Experimental: E2<br> | Drug: ONO-8539<br>* medium dose / 12 weeks<br>|
| Experimental: E3<br> | Drug: ONO-8539<br>* higher dose / 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptoms |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptoms (QOL) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-8539, Overactive bladder, OAB
Contribution LUS in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to the ED

Study Overview
=================
Brief Summary
-----------------
This study assesses the potential of lung ultrasonography to diagnose heart failure.

Detailed Description
-----------------
Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management. Lung ultrasonography is becoming a standard tool in critical cases in the ED. the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team. Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles. This study assesses the potential of lung ultrasonography to diagnose heart failure.

Official Title
-----------------
Contribution of Pulmonary Ultrasonography in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department (ED) for Dyspnea

Conditions
-----------------
Dyspnea; Cardiac

Intervention / Treatment
-----------------
* Diagnostic Test: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non traumatic dyspnea with the final diagnosis of heart failure Exclusion Criteria: coma, shock,Mechanical Ventilation, vasopressor drugs arrhythmia serious and sustained, non consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HF/HFpEF<br>patients with heart failure with a preserved ejection fraction(HFpEF) perform LUS | Diagnostic Test: lung ultrasound<br>* we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis<br>|
| HF/HFrEF<br>patients with heart failure with a reduced ejection fraction(HFrEF) perform LUS | Diagnostic Test: lung ultrasound<br>* we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the accuracy of LUS in the diagnosis of heart failure | the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve | 0 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung ultrasound,, heart failure, diagnosis, accuracy
Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.

Official Title
-----------------
A Phase I, Randomized, Open Label, 2-Way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of AZD2624 (Tablet Versus Liquid Suspension) Followed by an Additional Period to Assess the Food Effect on the Tablet

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

Intervention / Treatment
-----------------
* Drug: AZD2624
* Drug: AZD2624


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female volunteers Exclusion Criteria: Donation of plasma or blood products within one month of of screening Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis. Previous participation in an AD2624 study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state. | Drug: AZD2624<br>* Single dose of 40 mg AZD2624 liquid suspension, PO<br>|
| Experimental: Treatment B<br>Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state. | Drug: AZD2624<br>* Single dose of 40 mg AZD 2624 (2x20mg tablets), PO<br>|
| Experimental: Treatment C<br>Single oral dose of 40 mg (2x20mg tablets) in a fed state. | Drug: AZD2624<br>* Single dose of 40 mg AZD 2624 (2x20mg tablets), PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state. |  | Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs. |  | Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Official Title
-----------------
MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

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

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: Comparator: pranlukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress) Exclusion Criteria: Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 64 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: 1<br>montelukast sodium 5 mg, QD 2-weeks | Drug: montelukast sodium<br>* montelukast sodium; 5 mg, 10 mg QD 2-weeks.<br>* Other names: Singulair;|
| Experimental: 2<br>montelukast sodium 10 mg QD 2-weeks | Drug: montelukast sodium<br>* montelukast sodium; 5 mg, 10 mg QD 2-weeks.<br>* Other names: Singulair;|
| Active Comparator: 3<br>Pranlukast 225 mg BID 2-weeks | Drug: Comparator: pranlukast<br>* Pranlukast 225 mg BID 2-weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Nasal Symptom Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime nasal symptom score, Nighttime nasal symptom score |  |  |
Blood Pressure Tracking--Childhood to Young Adulthood

Study Overview
=================
Brief Summary
-----------------
To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and young adulthood. Data were used from the same cohort of 339 children who had been followed for nine to twelve years in a previous study.

Detailed Description
-----------------
BACKGROUND: Blood pressure measurements in childhood and young adulthood are less predictive of future levels than those taken in middle age. In part, this may be due to the fact that within-person variability appears to make up a larger proportion of total variability in childhood than adulthood. Previous work on an NHLBI supported grant indicated that repeated blood pressure measurements and visits led to higher childhood tracking correlations over a period of three years. DESIGN NARRATIVE: Follow-up data were used as well as multiple visits which reduced the large within-person variability of blood pressure measurements and improved the tracking correlations. In addition, 'true' or 'corrected' tracking correlations were provided by eliminating the effects of random measurement error. The effects were examined of time-varying covariates on both the observed and true tracking correlations. Besides computing tracking correlations, predictive values were computed for young adult blood pressure given childhood levels. This was the probability that a young adult's true blood pressure was above a specific cutpoint conditional on childhood blood pressure. These values were validated using data from the Fels Longitudinal Study, which included serial blood pressure measurements over the age range in the study. The prediction models were also derived including terms for covariates such as age, sex, height and weight. From these models nomograms were constructed which were useful to physicians for prognostic purposes. Thus, because of the unique multiple-visit approach used in these data, the effect of random measurement error was eliminated. These methodologic improvements strengthened the usefulness of blood pressure screening in childhood to detect those at high risk of developing hypertension. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).

Official Title
-----------------
Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MS as defined by McDonald et al., criteria # 1-4 Between the ages of 18 and 55, inclusive Baseline EDSS score between 0.0 and 5.0, inclusive Have been treated with GA for at least the 12 months prior to randomization Exclusion Criteria: Primary progressive, secondary progressive or progressive relapsing MS MS relapse has occurred within the 50 days prior to randomization A clinically significant infectious illness History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: Group 1<br>Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks. | Drug: Natalizumab<br>* Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.<br>* Other names: Tysabri;Drug: Natalizumab<br>* Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.<br>* Other names: Tysabri;|
| Placebo Comparator: Group 2<br>Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks. | Drug: Placebo<br>* Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of development of new active lesions on MRI scans. |  | Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events. |  | Week 20 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS, Multiple Sclerosis