linjc16/ctgov huggingface dataset:
Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)

Official Title
-----------------
A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: SKI-606
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential; 18-50 years old; healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SKI-606 alone | Drug: SKI-606<br> <br> * Other names: Bosutinib;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: 3<br>Moxifloxacin | Drug: Moxifloxacin<br> <br> |
| Experimental: 4<br>SKI-606 plus ketoconazole | Drug: SKI-606<br> <br> * Other names: Bosutinib;|
| Placebo Comparator: 5<br>Placebo plus ketoconazole | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected QT interval, including QTcN, QTcB, and QTcF |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory evaluations, Vital Sign measurements, Adverse Event reports |  | 6 weeks |
Measurement of Perioperative Glomerular Filtration Rate

Study Overview
=================
Brief Summary
-----------------
Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

Detailed Description
-----------------
The considerable morbidity and mortality associated with perioperative acute kidney injury (AKI) is well documented and known to complicate recovery from surgery. Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to monitor perioperative onset of rapidly changing renal function. This may subsequently lead to design of randomized controlled trials examining the effects of earlier intervention with the aim to reduce the incidence of perioperative AKI. Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data also showed that the continuous infusion protocol of low-dose iohexol is an accurate and precise method when measuring changing GFR even in critical ill patients with variable AKI risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research questions related to perioperative change in renal function.

Official Title
-----------------
Clinical Observational Study Using Iohexol to Measure Perioperative Glomerular Filtration Rate in Patients Undergoing Robotic Surgery for Rectum or Large Bowel Cancers

Conditions
-----------------
Rectal Cancer, Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectum or colon cancer Exclusion Criteria: Acute kidney injury grade 3 or higher

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate | Measured glomerular filtration rate | 72 hours |
Treatment of Hyperuricemia in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.

Detailed Description
-----------------
Hyperuricemia is often observed in patients with congestive heart failure (CHF). It has been reported that hyperuricemia is related to exercise capacity, inflammation markers and diastolic dysfunction in such patients. In addition, hyperuricemia in CHF relates to both symptomatic status (i.e. morbidity) as well as impaired prognosis (i.e. mortality). Hyperuricemia is likely to play an important role in the pathophysiology of CHF. Up-regulation of xanthine oxidase (XO) activity in CHF has been shown to contribute to higher uric acid (UA) in CHF and the therapeutic concept of XO inhibition has shown beneficial effects in a number of surrogate markers in these patients. The XO inhibition accounts for substantial decrease in oxygen radical load, the latter is discussed as the main benefit of XO inhibition treatment in hyperuricemic patients. However, whether high uric acid itself is important or merely a marker of XO activity (and hence of increased radical accumulation) is currently under discussion. Therefore, this study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.

Official Title
-----------------
Hyperuricemia and the Effects of the Uricosuric Agents Benzbromarone in Patients With Chronic Heart Failure

Conditions
-----------------
Heart Failure, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Benzbromarone (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic heart failure hyperuricemia Exclusion Criteria: renal dysfunction (Cr > 2.0 mg/dl) under treatment with anti-diabetic agents
Sexes Eligible for Study
-----------------
All

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: Benzbromarone (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parameters of echocardiography at 16 weeks |  |  | 
| BNP levels at 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parameters of glucose metabolism at 16 weeks |  |  | 
| Parameters of lipid metabolism at 16 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Insulin, Metabolism, Pharmacology, Uric Acid
Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

Study Overview
=================
Brief Summary
-----------------
Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these high-risk patients.

Official Title
-----------------
Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.

Conditions
-----------------
Hypertension, Dialysis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysed patients predialytic blood pressure greater or equal to 140/90 mmHg Exclusion Criteria: history of heart failure history of ischemic heart disease severe aortic stenosis known allergy to aliskiren or amlodipine severe disorders of liver function

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren<br> | Drug: Aliskiren<br>* Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg<br>* Other names: Rasilez, Norvasc;|
| Active Comparator: Amlodipine<br> | Drug: Aliskiren<br>* Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg<br>* Other names: Rasilez, Norvasc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke |  | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation |  | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, dialysis, aliskiren, amlodipine, outcome
Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Official Title
-----------------
Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 1 or Type 2 diabetes, including newly diagnosed Age: Levemir® above 6 years Age: Novomix® above 18 years Exclusion Criteria: Current treatment with NovoMix® 30 or Levemir®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: NovoMix® 30;|
| B<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control as measured by HbA1c |  | After 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects to reach HbA1c below 7.0% and =6.5% |  | After 24 weeks | 
| Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30 |  | After 24 weeks | 
| The effect on glycamic control as measured by FPG |  | After 24 weeks | 
| The effect on glycamic control as measured by PG profile |  | After 24 weeks | 
| Change in body weight |  | After 24 weeks |
Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.

Official Title
-----------------
Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Biological: AIN457
* Other: Placebo
* Drug: prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy subjects Normal sputum neutrophil levels at screening Ozone responsive Exclusion criteria: Smokers Prior treatment with antibody treatment or immunosuppressive agent Presence or history of a major chronic inflammatory autoimmune disease History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease). Other protocol-defined inclusion/exclusion criteria may apply

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457<br> | Biological: AIN457<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |
| Active Comparator: oral corticosteroid<br> | Drug: prednisolone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total neutrophil cell count in 106/mL in induced sputum |  | Day 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total IL-17A |  | Day 1- Day 120 | 
| Percentage neutrophil cell count in induced sputum |  | Day 16 | 
| Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs) |  | Day 1-Day 120 | 
| Airway function (FEV1, FVC, and FEF25-75) |  | 4h, 24h, and 48h after the start of the ozone exposure | 
| Serum AIN457 pharmacokinetics (PK) |  | Day1-Day 120 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ozone challenge, airway neutrophilia, induced sputum, Healthy volunteers
Inflammatory Response After One-lung Ventilation According to Ventilation Methods

Study Overview
=================
Brief Summary
-----------------
Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated thoracic surgery.

Official Title
-----------------
Comparison of the Inflammatory Response After One-lung Ventilation With Positive Ventilation and Self-respiration

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Ventilation method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective video-assisted thoracoscopic surgery (VATS) lobectomy 20 < age < 75 American Society of Anesthesiologists (ASA) classification I II Exclusion Criteria: preoperative inflammation (CRP>10ng/㎖, WBC>10,000/mm3, body temperature >38℃) steroid administration within 1 month hematologic / autoimmune disease congestive heart failure (NYHA class III IV) or significant arrhythmia severe obstructive / restrictive pulmonary disease previous history of thoracic surgery BMI >28kg/m2 expected difficult airway

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Intubated<br>The patient was intubated with a left-sided double-lumen endobronchial tube. The protective ventilation was performed as follows: a tidal volume of 6 mL/kg predicted body weight, I:E ratio of 1:2, a respiratory rate to maintain PaCO2 within 35 to 45 mmHg, and positive end-expiratory pressure at 5 cmH2O. If the airway pressure exceeded 25 cmH2O, tidal volume was adjusted. | |
| Experimental: Non-intubated<br>The patients were oxygenated via facial mask with O2 5 10 L/min during the whole procedure. The end-tidal carbon dioxide (EtCO2) was measured by insertion of a detector inside one of the nostrils. Respiration rate was maintained between 12 and 20 breaths/min with adjustment of anesthetics. | Other: Ventilation method<br>* Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin (IL)-6 | Blood samples collected from the antecubital vein | 24 hours after surgery |
Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery. The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.

Official Title
-----------------
Prospective Pilot Study of Partial Chest Wall Radiation Therapy (PCWRT) for Positive or Close Margins After Modified Radical Mastectomy for Lymph Node-Negative Breast Cancer

Conditions
-----------------
Breast Cancer, Breast Cancer Female, DCIS, Stage II Breast Cancer, Stage I Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Partial Chest Wall Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DCIS or stage T1 or T2 invasive breast cancer, lymph node negative Must have undergone mastectomy Presence of cancer cells on or close to surgical margins Negative pregnancy test for women Must receive radiation at Stony Brook University Hospital Exclusion Criteria - Received prior radiation to are to be irradiated

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

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

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: Radiation Treatment<br> | Radiation: Partial Chest Wall Radiation Therapy<br>* Patients will receive radiation therapy (30 Gray in 5 fractions) to the affected chest wall, delivered on consecutive days or every other day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer recurrence | Number of patients with recurrent breast cancer | 5 years | 
| Acute toxicity | Frequency of radiation-related adverse events | 3 months | 
| Delayed toxicity | Frequency of radiation-related adverse events | 5 years | 
| Surgical complications | Number of patients with surgical complications | 5 years |