linjc16/ctgov huggingface dataset:
MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial Allergic rhinitis.

Official Title
-----------------
MK0476 Phase III Long-term Study -Perennial Allergic Rhinitis-

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patients With Perennial Allergic Rhinitis Exclusion Criteria: Patients Who Have Nasal Diseases (E.G., Nasal Polyp, Septonasal Arcuation, Hypertrophic Rhinitis), Upper Respiratory Infection, Sinusitis, Infectious Rhinitis And Those Disease Severe Enough To Interfere With Assessment Of Effectiveness Patients Who Have Rhinitis Medicamentosa, Or Nonallergic Rhinitis (E.G., Vasomotor Rhinitis, Eosinophilia Rhinitis) Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Ages Eligible for Study
-----------------
Minimum Age: 15 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: 1<br>MK0476 5mg | Drug: montelukast sodium<br>* Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.<br>* Other names: Singulair;|
| Experimental: 2<br>MK0476 10mg | Drug: montelukast sodium<br>* Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.<br>* Other names: Singulair;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any clinical or laboratory adverse experience |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The daily mean of the composite nasal symptoms score at each of biweekly visits during the treatment period (average over the previous 2 weeks) or at time of termination |  | 12 weeks |
A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.

Official Title
-----------------
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects

Conditions
-----------------
Diabetes Mellitis Type 2

Intervention / Treatment
-----------------
* Drug: DA-1229
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-45 years healthy male subjects Body weight :50-90kg, BMI between 18.5-25 Blood glucose level of 70-110mg/dL on the FPG test Exclusion Criteria: have a family history of diabetes Serum AST(SGOT), ALT(SGPT)>1.25 times upper limit of normal Creatinine clearance rate<80mL/min show SBP =<100mmHg or >=150mmHg, or DBP=<65mmHg or >=95mmHg, or tachycardia (PR>=100times/min) have a history of drug abuse or show positive for drug abuse or cotinine at urine screening smokers can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo<br>|
| Experimental: DA-1229<br>DA-1229 | Drug: DA-1229<br>* single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg multiple dose study : DA-1229 5,10,20,40mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects |  | Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerance of DA-1229 |  | up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study) |
Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)

Official Title
-----------------
An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension

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

Intervention / Treatment
-----------------
* Drug: Terbogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19) provide informed consent to participate in this trial are in a stable or improving medical condition, in the opinion of the investigator enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim Exclusion Criteria: Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
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: Terbogrel<br> | Drug: Terbogrel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 18 months | 
| Number of patients with clinically significant findings in laboratory tests |  | up to 18 months | 
| Number of patients with clinically significant changes in ECG |  | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient status | change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death | baseline, up to 18 months |
Diet and Activity in Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
This study aims to fill a gap in the literature, identify relevant clinical measures, and provide insight into the independent modifiable risk factors of obesity in the CP population with the long-term goal of improving screening, management and prevention of obesity in this at-risk and underserved population.

Official Title
-----------------
DIET, ACTIVITY AND MEDICAL CO-MORBIDITIES IN ADOLESCENTS and ADULTS WITH CEREBRAL PALSY: WHAT ARE THE EFFECTS ON THE METABOLIC PROFILE?

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent and adult subjects 16-89 years with a diagnosis of Cerebral Palsy Exclusion Criteria: Concurrent severe neurologic or other medical diagnosis that is likely to be contributing to the subject's functional impairment, as determined by the study investigators. For example, associated spinal cord injury. Subjects with major limb amputations Pregnant or lactating females

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Calories per day | Subjects will complete dietary recall and total calories per day will be calculated | 24 hour dietary recall | 
| Total saturated fats per day | 24 hour dietary recall will be performed, and total saturated fats ingested over 24 hours will be calculated. | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, Adolescents, Adults, Diet, Activity, Metabolic Syndrome
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury

Study Overview
=================
Brief Summary
-----------------
Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.

Official Title
-----------------
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)

Conditions
-----------------
Acute Lung Injury

Intervention / Treatment
-----------------
* Other: Assisted mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 75 yrs 150 mmHg < PaO2/FIO2 < 300 mmHg mechanical ventilation with PSV or BIPAP less than 15 days of mechanical ventilation at least 20% of minute ventilation originated from spontaneous breathing Exclusion Criteria: BMI > 35 esophageal disease neuromuscular disease instable thorax pneumothorax head trauma brain injury increased intracranial pressure agitation increased need for vasoactive drugs chronic lung disease acute coronary disease participation in another clinical trial within the last 4 weeks at enrollment Interruption criteria: acute change of mental status SaO2 < 92% pHa < 7.30 respiratory rate > 30 or < 6 /min dyspnea diaphragm/thorax antagonism diaphoresis abnormal use of respiratory muscles increase of the heart rate above 120% of baseline or absolute value < 60 or > 130 /min mean arterial pressure above 120% of baseline or absolute value < 70 or > 110 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Noisy PSV<br>Assisted mechanical ventilation with noisy PSV | Other: Assisted mechanical ventilation<br>* Patients will be mechanically ventilated with noisy PSV and PSV in random sequence<br>|
| Other: PSV<br>Assisted mechanical ventilation with PSV | Other: Assisted mechanical ventilation<br>* Patients will be mechanically ventilated with noisy PSV and PSV in random sequence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the arterial oxygenation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the work of breathing |  |  | 
| Effect on PaCO2 |  |  |
Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term. The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life. The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques. These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen. The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin. A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin. Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin. Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney. More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times. Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.

Conditions
-----------------
Congenital Heart Defect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Children under 5 years Allowed in pediatric intensive care unit Having received heart surgery for management of congenital heart disease Exclusion criteria Patients aged over 5 years Violations preexisting brain to the intervention (brain malformation) Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- | --- |
| oxygen saturation in brain and kidney tissue |  | 1 hour after cardiac surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congenital heart, NIRS
A Study of SYNT001 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001.

Official Title
-----------------
A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: SYNT001
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
IInclusion Criteria: Subjects must meet the following criteria to be included: Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations Body mass index 18.5 to 30.0 kg/m2 Must use medically acceptable contraception Willingness to complete all study measurements and assessments in compliance with the protocol Exclusion Criteria: Subjects meeting any of the following criteria are to be excluded: Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations Subject unable or unwilling to comply with the protocol Any exposure to an investigational drug within the 30 days prior to screening Use of any tobacco or nicotine-containing products Abuse of alcohol Positive drug test or history of drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single IV infusion<br>|
| Experimental: 1 mg/kg<br> | Drug: SYNT001<br>* single IV infusion<br>|
| Experimental: 3 mg/kg<br> | Drug: SYNT001<br>* single IV infusion<br>|
| Experimental: 10 mg/kg<br> | Drug: SYNT001<br>* single IV infusion<br>|
| Experimental: 30 mg/kg<br> | Drug: SYNT001<br>* single IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of safety data (counts and percentages of adverse events) | counts and percentages of adverse events | Day 0 - Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (serum concentration of SYNT001) | serum concentration of SYNT001 | Pre-dose and 0.08, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72, and 120 hours post dose | 
| Pharmacodynamics | total serum IgG levels | Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28 |
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the safety and performance of the Twelve TMVR System

Detailed Description
-----------------
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.

Official Title
-----------------
Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

Conditions
-----------------
Mitral Valve Insufficiency

Intervention / Treatment
-----------------
* Device: TMVR Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Severe mitral regurgitation (MR Grade 3-4+) Symptomatic mitral regurgitation (NYHA Class II-IV) Trans-apical access deemed feasible by the treating physician Native mitral valve geometry and size compatible with the Twelve TMVR Key Exclusion Criteria: Left ventricular ejection fraction (LVEF) < 20 Evidence of intracardiac mass, thrombus, or vegetation Prior valve surgery or need for other valve surgery Prior stroke within 4 weeks Need for coronary revascularization History of, or active, endocarditis Renal insufficiency (Creatinine > 2.5 mg/dL)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>TMVR Implant | Device: TMVR Implant<br>* Implantation of the Twelve TMVR System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of patients with adverse events associated with the delivery and/or implantation of the device | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Number of patients with successful TMVR implant | Through 5 years | 
| Reduction of MR | Number of patients with a reduction of MR Grade | Through 5 years |
Ambu AuraOnce Versus Ambu AuraGain LM in Children

Study Overview
=================
Brief Summary
-----------------
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.

Official Title
-----------------
Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position

Conditions
-----------------
Airway Management

Intervention / Treatment
-----------------
* Device: Ambu AuraOnce
* Device: Ambu AuraGain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II age 1 - 16 years minor surgery extraglottic airway device Exclusion Criteria: age (<12 months, >16 years) weight (<12 kg, >50 kg) a known difficult airway risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oropharyngeal leak pressure<br>Ambu AuraOnce | Device: Ambu AuraOnce<br>* Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).<br>|
| Experimental: Fiberoptic position<br>Ambu AuraGain | Device: Ambu AuraGain<br>* The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oropharyngeal leak pressure |  | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fiberoptic position |  | 5 min |