linjc16/ctgov huggingface dataset:
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.

Official Title
-----------------
Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age. The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics. It is allowable for the patients to be treated with IV inotropes and vasodilators. Exclusion Criteria: The following criteria would exclude the patient from study: invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization), rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate), severe ventricular outflow obstruction, angina, hypotension, uncorrected hypokalemia, CNS (e.g. stroke, TIA), respiratory (e.g. COPD, intubated patients, oral, intravenous or intramuscular steroids), renal insufficiency (e.g. increased serum creatinine, dialysis), hepatic impairment (e.g. significant increase in liver enzymes), decompensation from active infection and acute bleeding (e.g. severe anemia). Female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions. Also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.

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: Levosimendan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decompensated chronic heart failure
Studies of Pancreatic Islet Mass by Positron Emission Tomography (PET)

Study Overview
=================
Brief Summary
-----------------
This study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (PET) tracer [11C]5-hydroxytryptophane.

Official Title
-----------------
Open Study to Investigate Pancreatic Islet Mass by Positron Emission Tomography Using the Tracer [11C]5-hydroxytryptophane

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with type 1 diabetes Adult, healthy controls Exclusion Criteria: Pregnancy Impaired renal function

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetes<br> | |
| healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pancreatic uptake of % injected dose (ID) [11]5-hydroxy tryptophan between healthy volunteers and patients with long-standing type 1 diabetes |  | To be measured at Positron emission tomography investigation for all study persons. |
The SBAR Effect on Safety Attitudes in the Perinatal Department

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the impact of SBAR by the SAQ questionnaire in the perinatal department.

Conditions
-----------------
Fetal Distress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Physicians and Nurses in the Perinatal Department Exclusion Criteria: nil

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of patient safety attitude after introducing SBAR | Changes of patient safety attitude after introducing SBAR in the perinatal ward | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SBAR,, SAQ,, Team Resource Management
Airway IgA: Respiratory Tract IgA Levels in Anesthetized Patients Undergoing Elective Surgical Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the variability of airway IgA levels in anesthetized, well-nourished and malnourished patients undergoing elective general surgical procedures and the effect of gender and race on this baseline variable. The hypothesis is that airway IgA levels are lower in malnourished than in well-nourished patients.

Official Title
-----------------
Respiratory Tract IgA Levels in Anesthetized Patients Undergoing Elective Surgical Procedures

Conditions
-----------------
Healthy, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing surgery via general anesthesia Exclusion Criteria: Patients with a history of asthma or documented airway irritability Patients who have undergone previous pulmonary resection Patients receiving cardiac medications for arrhythmias.

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 |
| --- | --- |
| 1<br>well-nourished | |
| 2<br>malnourished | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Detailed Description
-----------------
Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR Exclusion Criteria: One eye patient Best corrected visual acuity better than 20/50 Pregnancy Use of internal tamponade such as silicone oil during surgery Concurrent ophthalmic surgery such as cataract extraction
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intravitreal bevacizumab injection 1-2 weeks before surgery | Drug: Bevacizumab<br>* One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy<br>|
| Sham Comparator: 2<br>Sham injection (needleless syringe pressed against conjunctiva) | Drug: Bevacizumab<br>* One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early post-vitrectomy vitreous hemorrhage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proliferative diabetic retinopathy, Bevacizumab, Early post-vitrectomy vitreous hemorrhage
The Application Of Lung Ultrasound In Postoperative Hypoxemia Patients

Study Overview
=================
Brief Summary
-----------------
Postoperative hypoxemia was persistent and common after surgery.Rapid diagnosis and subsequent therapeutic measures must be adopted by anesthesiologists.Lung ultrasound has been confirmed to be more sensitive and accurate for diagnosis of pulmonary ailment than chest radiography.The primary objective of the present study was to evaluate lung complications by bedside lung ultrasonography on patients suffered from hypoxemia after general anesthesia in the postoperative period.

Official Title
-----------------
The Application Of Lung Ultrasound About Pulmonary Complications In Postoperative Hypoxemia Patients After General Anesthesia：A Prospective Observational Study

Conditions
-----------------
Hypoxemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - at least 18 years of age, hypoxemia after general anesthesia ( definded as a SPO2 <92%,greater than 30s) Exclusion Criteria: Covered with surgical dressings from opening thoracic and breast surgery, noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, unstable hemodynamics, dyspnea from residual opioids or muscle relaxants, hemoglobin of 8g/L or less, risk of bleeding, body temperature was more than 38℃ or less than 36℃

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Pulmonary Complications of Lung Ultrasound | Pulmonary disease including atelectasis, pneumonia, pneumothorax and pleural effusion would be discovered by lung ultrasound | 20 minutes after tracheal extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Lung Ultrasound and Computed Tomography(CT) | Lung ultrasound offers high sensitivity and specificity when compared with CT | Within 1 hour after examnation of Lung Ultrasound |
Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes is a risk factor of heart failure and cognitive decline. Heart failure at its early stage is often silent. At present, primary prevention for heart failure is not available. Our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies. Type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. Our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies

Official Title
-----------------
Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes : Longitudinal Cohort Study of Immuno-inflammation, Cardiac Energetics and Cognition.PreciDIAB-HEART&BRAIN

Conditions
-----------------
Diabetes Mellitus, Type 2, Heart Failure, Cognitive Decline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Persons able to understand and object to the information provided. Type 2 diabetic patient free of heart failure ≥stade B Patient affiliated with a social security scheme. Patient agreeing to sign the informed consent form Exclusion Criteria: Patient with dementia Patient with at least one of the criteria for heart failure ≥stade B

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Heart failure (≥ stade B). |  | at 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive decline (composite endpoint) | a decrease in cognitive performance quantified at 1.5 standard deviation on at least 1 neuropsychological test within a cognitive domain (attention and speed of information processing, memory, executive functions) compared to the neuropsychological assessment performed at inclusion. Appearance of dementia defined as a cognitive disorder highlighted in the neuropsychological evaluation carried out at the end of the study leading to a loss of functional autonomy in activities of daily living defined by the loss of at least 1 point on the activities of daily living ADL scale (DSM V). | at 48 months | 
| Major cardio-neuro-vascular events | cardioneurovascular event (composite endpoint) defined by the occurrence of death from any cause, myocardial infarction, stroke (ischemic or hemorrhagic), acute limb ischemia or a doubling of creatinine. | at 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Stroke Prevention
Head and Neck Cancer Registry (LORHAN)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient

Official Title
-----------------
Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: Therapy for head and neck cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically (histologically or cytologically) confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy Written informed consent Exclusion Criteria: Registry participation does not exclude participation in clinical trials. Patients scheduled to receive or who have received surgery are eligible for Registry participation as long as they are also scheduled to receive medical therapy.

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 |
| --- | --- |
| Patients with head and neck cancer<br> | Other: Therapy for head and neck cancer<br>* radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of care for head and neck cancer |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival by treatment regimen |  | study entry to death from any cause or to end of study | 
| Determine the incidence and severity of major dose-limiting and other important treatment toxicities |  | up to 10 years | 
| Identify supportive care received for managing nutrition, pain, nausea and other complications |  | up to 10 years | 
| tumor control by treatment regimen |  | study entry to progressive disease |
Assessment of Wrist Joint and Knee Joint Inflammation in Patients With Rheumatoid Arthritis by Quantitative Three Dimensional Power Doppler Ultrasonography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: To investigate the wrist joint synovial blood flow intensity and model by quantitative three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid arthritis before and after initiation of a new medicine and compare these data with routinely used clinical data and laboratory findings, such as pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS assessment of the vascularity in wrist joints and knee joints using automatic volume scan.

Official Title
-----------------
Taichung Veterans General Hospital

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who fulfill the 1987 ARA criteria for RA Patients with at least one painful swollen wrist or knee joint observed by a rheumatologist Patients who will receive a new medicine, including oral corticosteroid, intravenous methylprednisolone pulse therapy, intraarticular injection with steroid or methotrexate, DMARDs, or biologic agent Exclusion Criteria: Patients with active infection Patients with concurrent malignant disease Patients with a history of traumatic, septic, or cystal arthritis, previous joint surgery, or arthroscopic synovectomy of any wrist or kneejoint within the past 12 months before the study Patients who have severe wrist or knee joint deformity that makes the US assessment protocol unable to complete
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 |
| --- | --- | --- |
| Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) |  | cross-sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
three-dimensional power Doppler ultrasonography, wrist, knee, rheumatoid arthritis
A Comparison of Recombinant Human Brain Natriuretic Peptide and Dobutamine

Study Overview
=================
Brief Summary
-----------------
To compare the therapeutic efficacy of recombinant human brain natriuretic peptide (rhBNP) with dobutamine on acute decompensated heart failure patients with different blood BNP levels

Detailed Description
-----------------
Patients with acute decompensated heart failure (ADHF) whose left ventricular ejection fraction(LVEF) was <40%, were assigned to a high BNP group (BNP ≤ 3000 pg/mL) or an extra-high BNP group (BNP > 3000 pg/mL) , depending on their admission plasma BNP levels. Each group was then subdivided into rhBNP or dobutamine subgroups according to intravenous administration with either rhBNP or dobutamine for 24-72h. The effects of rhBNP and dobutamine on patients in the high and extra-high BNP groups were compared.

Official Title
-----------------
Comparative Effects of Recombinant Human Brain Natriuretic Peptide and Dobutamine on Acute Decompensated Heart Failure Patients With Different Blood BNP Levels

Conditions
-----------------
Acute Decompensated Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients were classified as NYHA class III-IV ejection fraction <40% Exclusion Criteria: intravenous administration with rhBNP or dobutamine in the 2 weeks before study entry acute myocardial infarction significant valvular stenosis serious ventricular arrhythmia (frequent ventricular premature beat of >5 bpm, nonsustained and sustained ventricular tachycardia) blood pressure <95/60 mmHg or >140/90 mmHg shock hypovolemia hepatic or renal impairment pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| left ventricular ejection fraction (LVEF) in the High and Extra-high BNP Groups |  | baseline and 5 days | 
| Left ventricle end diastolic dimension (LVEDD)in the High and Extra-high BNP Groups |  | baseline and 5 days | 
| Blood BNP in the High and Extra-high BNP Groups |  | baseline and 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in New York Heart Association (NYHA) Class from Baseline to Day 5 after Treatment |  | baseline and 5 days | 
| Blood Pressure (mmHg) |  | baseline and 5 days | 
| Heart Rate |  | baseline and 5 days | 
| Plasma Creatinine |  | baseline and 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, rhBNP, Dobutamine