linjc16/ctgov huggingface dataset:
Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Official Title
-----------------
A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20 - 75 years old Gender: Male or female Status: Outpatients Mild to moderate essential hypertension Exclusion Criteria: Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3 Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.) Patients suspected of having malignant hypertension Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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: Aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan |  |  | 
| Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg |  |  | 
| Control rate; msDBP <90mmHg and msSBP<140mmHg |  |  | 
| The pharmacokinetics / pharmacodynamics |  |  | 
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, renin
Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
This medication is used for procedural sedation and sedation for diagnostic imaging. The purpose of this study is to find out what happens to pentobarbital in the body after it is given to children who have had heart surgery.

Detailed Description
-----------------
This clinical trial of pentobarbital admistered as a bolus dose for procedural or imaging seddation will determine the PK of the drug in neonates, infants,, and children who are postoperative from cardiac surgery. Pediatric patients hsopitalized in the CICU who would receive IV bolus doses of pentobarbital as standard of care are eligible.

Official Title
-----------------
The Pharmacokinetics and Pharmacodynamics of a Single Dose of Pentobarbital for Clinically Indicated Sedation for Neonates, Infants, and Children Recovering From Open Heart Surgery

Conditions
-----------------
Cardiac Surgical Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Will receive intravenous pentobarbital for procedural/imaging sedation as standard of care Age(Neonates, Young Infants, Older Infants, and Children Up to 6 years old) Diagnosis either postop from cardiac surgery or requrie sedation with IV pentobarbital as standard of care Adequate liver function tests Informed consent Exclusion Criteria: Pregnant or lactating females Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Procedural sedation, Sedation for diagnostic imaging
Phase 4 Study Comparing IOP Lowering in OAG or OH in Caucasian or Japanese Subjects C-02-32

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after six weeks of treatment in Caucasian and Japanese subjects.

Official Title
-----------------
Phase 4 Study to Compare Two Different IOP Lowering Medications for the Treatment of Open Angle Glaucoma or Ocular Hypertension in Caucasian and Japanese Subjects C-02-32.

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: IOP Lowering Medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Adults of Caucasian and Japanese Ethnicity

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

| Intervention/Treatment |
| --- |
|Drug: IOP Lowering Medications|nan|

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
-----------------
open-angle, glaucoma, ocular, hypertension, POAG, Iris, Pigmentation, Japanese
Evaluation of Celsior® in Liver Transplant Preservation.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.

Detailed Description
-----------------
The quality of organ preservation is a major determinant of initial graft function and survival. Graft viability is based on hypothermia, the organ being stored in a cold preservation solution. Celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. The aim of the study is to evaluate the efficacy and safety of Celsior® in liver transplant preservation. Celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the European transplantation register between 1997 and 2001).

Official Title
-----------------
Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Other: Celsior®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Primary liver transplantation Whole organ transplantation Agreement for a 1 year follow-up Informed written consent Exclusion Criteria: Liver disease secondary to clotting abnormalities Uncontrolled bacterial or viral disease at the time of transplantation Combined transplantations

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Celsior preservation solution | Other: Celsior®<br>* Graft preservation solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft failure leading to patient death or retransplantation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset and severity of hemodynamic troubles at reperfusion |  | Reperfusion after transplantation | 
| Onset of surgical complications |  | 1 year | 
| Liver graft function during the fourteen first days |  | 14 days | 
| Incidence, treatment and evolution of acute and chronic rejections histologically proven |  | 1 year | 
| Onset of infections |  | 1 year | 
| Onset, treatment and evolution of serious adverse events |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cold storage, Liver transplantation, Preservation solution
Endothelin-1 and Methabolites Concentrations in Mycrodialysis and Cerebrospinal Fluid in Subarachnoid Hemorrhage Patients

Study Overview
=================
Brief Summary
-----------------
Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of ET-1 are not sensitive enough to predict the development of vasospasm representing the average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a technique able to detect molecule concentrations in a small perivascular area. The investigators performed a prospective observational clinical study to test the hypothesis that MD ET-1 concentrations should be a sensitive predictor for vasospasm. Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale admitted to the ICU were consecutively studied. All patients received surgery within 48 hours from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels; ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and after 7 days two angiographies were performed to detect the degree and extent of vasospasm, Transcranial Doppler and neurological evaluation were daily performed. Patients were then classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV), presence of vasospasm (CV), acute neurological deterioration (AND).

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosys of subarachnoid hemorrhage angiographic proof of aneurysm admission within 24 hours from the subarachnoid hemorrhage presence of an intraventricular catheter and a microdialysis catheter placed either after admission or at the time of the surgery Exclusion Criteria: moribund GCS=3 denied 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subarachnoid hemorrhage disease<br>subarachnoid hemorrhage patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral vasospasm incidence |  | 14 days |
Confirm Rx Insertable Cardiac Monitor SMART Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.

Official Title
-----------------
Confirm Rx Insertable Cardiac Monitor SMART Registry

Conditions
-----------------
Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Confirm Rx ICM insertion procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an approved indication for continuous arrhythmia monitoring with an ICM Have a cellular phone or the ability or willing to use a St. Jude Medical mobile transmitter that is compatible with the MyMerlin App and able to communicate with the Confirm Rx ICM device. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study. Have a life expectancy of less than 1 year due to any condition. Have a previous ICM placement.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Confirm Rx ICM insertion procedure|Insertion of Confirm Rx ICM device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device SADEs and serious procedure related SAEs |  | 1 month post insertion procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device SADEs and serious procedure related SAEs |  | 12 months post insertion procedure | 
| R wave amplitude |  | 12 months post insertion procedure |
BPF Genetics of ILD Study

Study Overview
=================
Brief Summary
-----------------
The investigators aim to examine the genetic determinants of interstitial lung disease in a cohort of subjects with regular exposure to pigeons, a known cause of one form of interstitial lung disease known as hypersensitivity pneumonitis. In addition we will examine immunological causes for hypersensitivity pneumonitis in this group. We anticipate our work will provide insights of use to clinicians and patients with hypersensitivity pneumonitis and other interstitial lung diseases.

Detailed Description
-----------------
The investigators aim to recruit participants with regular racing pigeon exposure at national (UK) and regional pigeon fancier meetings. Consenting subjects will complete questionnaires, provide blood samples for genetic analysis and immunological testing and undertake lung function measurements. Subjects will be observed, and encouraged to report referral to specialist respiratory services, and following this information will be sought on diagnosis (including supporting evidence). Where interstitial lung disease is detected this will be linked to subsequent unbiased analysis to detect potential predisposing genetic associations.

Official Title
-----------------
British Pigeon Fanciers Genetics of Interstitial Lung Disease Study

Conditions
-----------------
Lung; Disease, Interstitial, With Fibrosis, Alveolitis, Extrinsic Allergic, Bird Fancier's Lung, Idiopathic Interstitial Pneumonias, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Diagnostic Test: Genetic profiling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regular exposure to racing pigeons Exclusion Criteria: Unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Genetic profiling|All participating subjects will undergo detailed genetic analysis, with the aim of detecting novel genetic drivers for the development of interstitial lung disease in the context of known sensitising agent (pigeon antigen)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of specific genetic markers to development of interstitial lung disease | Participants will be screened for MUC5B genetic profile to allow examination of MUC5B genetic profile relationship with risk of developing interstitial lung disease in this group | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Lung Disease (ILD), Hypersensitivity Pneumonitis, Idiopathic Pulmonary Fibrosis (IPF), Extrinsic Allergic Alveolitis (EAA), Bird Fancier's Lung, Genetics
Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.

Detailed Description
-----------------
The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.

Official Title
-----------------
Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer

Conditions
-----------------
Metastases, Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: invasive lung cancer (small cell or non-small cell lung cancer) osteolytic bone metastasis determined by clinical exam, bone scan/XR age > 18 years Exclusion Criteria: concurrent malignancy with a second primary renal failure (serum creatinine > 3mg/dl) pregnancy active rheumatoid arthritis intolerance to zoledronic acid

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zoledronic acid<br>3.0-4.0 mg by IV (in the vein), once a month for 6 months | Drug: zoledronic acid<br>* 3.0-4.0 mg by IV (in the vein), once a month for 6 months<br>* Other names: Zometa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Percent Change From Baseline in TRAP Levels at 2 Weeks | Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline | TRAP levels at Baseline and 2 weeks after first Zometa infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zometa, bone metastasis, lung cancer, non-small cell lung cancer, small cell lung cancer, bone metabolic markers, tartrate resistant acid phosphatase
A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway

Study Overview
=================
Brief Summary
-----------------
The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Detailed Description
-----------------
The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Official Title
-----------------
A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway

Conditions
-----------------
Adverse Anesthesia Outcome

Intervention / Treatment
-----------------
* Device: Guardian Laryngeal Mask
* Device: Supreme Laryngeal Mask Airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 or 2 Age 18-75 yr Written informed consent Exclusion Criteria: Difficult airway Non fasted BMI > 35

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guardian<br>Guardian Laryngeal Mask | Device: Guardian Laryngeal Mask<br>* ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion<br>* Other names: Guardian Laryngeal Mask, Umedaes;|
| Experimental: Supreme<br>Supreme Laryngeal Mask Airway | Device: Supreme Laryngeal Mask Airway<br>* ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion<br>* Other names: Supreme Laryngeal Mask Airway, LMA Deutschland GmbH;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of oropharyngeal seal pressure | this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomic position | this will be determined fiberoptically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O | 5 min |