linjc16/ctgov huggingface dataset:
Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth

Study Overview
=================
Brief Summary
-----------------
Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.

Detailed Description
-----------------
Damage to the central nervous system as a result of oxygen deprivation at birth is a major cause of life-long mental and developmental handicaps. When there is not enough oxygen in the blood (hypoxemia) the brain is deprived of oxygen. Some brain cells respond by producing Epo. Epo then binds to oxygen-deprived brain cells. This binding triggers chemical reactions within the brain cell that prevent cell death. Epo also reduces inflammation around the brain cells and acts as an antioxidant. In animal studies, recombinant Epo (rEpo) administration, even up to six hours after oxygen deprivation, reduced subsequent brain injury by 50% to 70%. Epo has been used by neonatologists to stimulate erythropoiesis (red blood cell production) and reduce the incidence of blood transfusions. Doses of rEpo required for protection of brain cells are considerably higher than those traditionally used by neonatologists. This study will evaluate the pharmacokinetics, biologic effect, and safety of high dose Epo in neonates with brain injury due to hypoxemia. Within six hours of birth, each eligible infant will receive one dose of rEpo intravenously. Any infants who require a lumbar puncture during the first week of life will have levels of natural Epo and rEpo in their spinal fluid measured. Blood tests will be used to measure the antioxidant effect of Epo and the impact on red blood cell production. Neurodevelopmental outcome will be measured at 6 and 12 months of age.

Official Title
-----------------
High Dose Erythropoietin for Neonates With Asphyxia

Conditions
-----------------
Asphyxia

Intervention / Treatment
-----------------
* Drug: epoetin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Infant 6 hours of age or less Apgar scores less than or equal to 3 at 1 and 5 minutes Weight greater than 2500 grams (5.5 lbs) Central venous line in place Exclusion Criteria infants are ineligible if they do not meet the inclusion criteria above

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

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

| Intervention/Treatment |
| --- |
|Drug: epoetin|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
-----------------
neurodevelopmental outcomes
Predicting Physical Activity Change: an Epidemiologic Study

Study Overview
=================
Brief Summary
-----------------
To conduct a two-year follow up of participants in a cross-sectional study of physical activity determinants. Predictors of change in vigorous exercise habits and recreational walking habits were identified as were determinants of change in the proportion of the sample who initiated, maintained, or discontinued exercise.

Detailed Description
-----------------
BACKGROUND: In 1988 when the study began, epidemiological studies had shown the health benefits of physical activity and that prevalence of physical activity was well below recommended levels. Exercise-promotion interventions were typically ineffective, and lack of knowledge of exercise determinants inhibited the design of effective interventions. DESIGN NARRATIVE: Data from the San Diego Health and Exercise Baseline survey conducted in 1986 were used to contact participants for the follow-up. The difference in reported activity level from time 1 to time 2 served as an estimate of change in activity. The follow-up survey elicited a two-year history of vigorous exercise and moderate-intensity exercise, both of which have substantial health benefits, as well as different determinants. Potential predictors were assessed at baseline and included demographic variables and indices based on social learning theory. Multiple regression analyses determine the combined and independent relationships of such variables as self-efficacy, social support, perceived barriers and benefits and environmental factors on both types of physical activity change. A second analysis separated subjects into the baseline physical activity groups of low, intermediate, and high activity and examined prediction of change versus no-change in each category.

Official Title
-----------------
Predicting Physical Activity Change: an Epidemiologic Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Healthy Adults 18-60 Exclusion Cardiovascular Disease Heart Disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Exercise Study Participants<br>Data from the San Diego Health and Exercise Baseline survey conducted in 1986 were used to contact participants for the follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minutes of exercise | Change in minutes of exercise from pre to post | Over 2 years |
Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Study Overview
=================
Brief Summary
-----------------
Background: Trauma is the leading cause of death in young adults worldwide and the most common causes of mortality are haemorrhage and brain injury. About 40% of trauma related deaths are due to massive haemorrhage and approximately 30% of trauma patients have an associated trauma induced coagulopathy. In order to improve outcome, the optimal care for the bleeding patient need to be further understood. Aim: The overall aim of this project is to evaluate characteristics and outcomes in patients receiving blood transfusion in the early phase after major trauma at a Level 1 trauma center in Sweden. The specific aims are: i) To describe outcome, characteristics and effects on the coagulation system in patients receiving early blood transfusion compared to those not receiving transfusion in the early phase. ii) To describe outcome, characteristics and effects on the coagulation system in patients receiving prehospital blood transfusion compared to patients where transfusion is initiated in the trauma unit. iii) To describe the effect from concurrent treatment with procoagulant drugs and intravenous fluids on outcome, characteristics and effects on the coagulation system in patients receiving blood transfusion after major trauma. Method: This is an observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data from patients receiving blood transfusion (erythrocytes, plasma or whole blood) in the early phase of the resuscitation will be collected. All patients receiving transfusion within two hours from arrival will be included. Data on trauma details, injuries, physiological parameters, coagulations tests and treatment will be collected prospectively and from existing registries. The control group will consist of patients not receiving transfusion during the first two hours of care.

Official Title
-----------------
Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Conditions
-----------------
Trauma, Hemorrhage, Shock, Traumatic, Acute Coagulopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna. Exclusion Criteria: Patients with injuries från hanging, drowning, burns or smoke inhalation.
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 |
| --- | --- | --- |
| Survival |  | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma-induced coagulopathy defined as INR > 1.2 |  | Admission to 24 hours | 
| Survival |  | 24 hour | 
| Volume of transfusion |  | Admission to 24 hours |
Major Adverse Cardiac Events After Carotid Endarterectomy

Study Overview
=================
Brief Summary
-----------------
Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related.

Detailed Description
-----------------
The investigator plan to retrospectively investigate 175 carotid endarterectomy patients in Siriraj hospital to find the incidences of major adverse cardiac events, including Myocardial infarction is defined as rising of cardiac bio-markers in the setting of myocardial ischemia (Relevant anginal symptoms, ECG changes or Imaging e.g. Echocardiography)2,10 Significant arrhythmia is defined as symptomatic or causing hemodynamic changes without other explainable causes. Heart failure is defined according to Modified Framingham criteria3 Cardiac death is defined as mortality in association and as a direct result from myocardial infarction, arrhythmia or heart failure if possible, the investigators will try to find the associate or risk factors for those events.

Official Title
-----------------
Incidence of Postoperative Major Adverse Cardiac Events in the Patients Underwent Carotid Endarterectomy: A Single Center Retrospective Study

Conditions
-----------------
Carotid Stenosis, Carotid Endarterectomy, Adverse Cardiac Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patients undergoing carotid endarterectomy in Siriraj hospital Exclusion Criteria: Patients with other simultaneous surgery with carotid endarterectomy
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 |
| --- | --- | --- |
| Incidence of major adverse cardiac events after carotid endarterectomy | Major adverse cardiac event included myocardial infarction, significant arrhythmia, heart failure and cardiac arrest | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| associate factors with adverse cardiac event | Analysis of potential factors associated with major adverse cardiac event after carotid endarterectomy | 7 days | 
| other adverse events | respiratory complications, such as re-intubation, aspiration Neurologic complication, such as stroke length of hospital stay, ICU admission, length of ICU stay | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carotid endarterectomy, adverse cardiac events
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy

Detailed Description
-----------------
This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy

Official Title
-----------------
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial

Conditions
-----------------
Postoperative Delirium

Intervention / Treatment
-----------------
* Procedure: lobectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ Exclusion Criteria: Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: es-ketamine<br>es-ketamine 0.5mg/kg iv | Procedure: lobectomy<br>* Intravenous es-ketamine 0.5mg/kg or saline during lobectomy<br>|
| Placebo Comparator: saline<br>iv saline with the same volume of es-ketamine | Procedure: lobectomy<br>* Intravenous es-ketamine 0.5mg/kg or saline during lobectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Delirium | Confusion Assessment Method (CAM) or CAM-ICU for patients | 7 days after operation | 
| Postoperative Cognitive Assessment | Montreal Cognitive Assessment | 7 days after operation |
NIRS in Neonatal Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Due to the small size of infants and the use of bypass machines, physicians have difficulty assessing whether the infant's brain and body is getting enough oxygen during heart surgery. This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the traditional methods of determining oxygen saturation.

Detailed Description
-----------------
One of the limiting factors in treating infants undergoing cardiac surgery is the difficulty in assessing systemic perfusion with accuracy. At Children's Healthcare of Atlanta, Near-infrared Spectroscopy (NIRS) is available, but has never been studied. In patients undergoing first stage palliation (Norwood) for hypoplastic left heart, routine management will be utilized in addition to the NIRS monitor. The following will be documented pre- and post-bypass, then every 4 hours for 24 hours after admission to the Cardiac Intensive Care Unit:NIRS readings, Lactic acid levels,mixed venous saturations,hemoglobin, hematocrit, arterial blood gases, heart rate, blood pressure, central venous pressure, left atrium pressure,core temperature, toe temperature, pulse oximeter reading, urine output, ventilator settings, inotropic levels. All the data will be entered into a database and analyzed.

Official Title
-----------------
Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion

Conditions
-----------------
Hypoplastic Left Heart, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypoplastic left heart requiring stage 1 palliation informed consent obtained Exclusion Criteria: does not have hypoplastic left heart is not having stage 1 palliation no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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
-----------------
pediatric, cardiac surgery
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin AM
* Drug: vildagliptin pm
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 Body mass index in the range 22-40 Blood glucose criteria must be met Exclusion Criteria: Pregnancy or lactation History of type 1 diabetes Evidence of significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin am<br> | Drug: Vildagliptin AM<br> <br> |
| Experimental: vildagliptin pm<br> | Drug: vildagliptin pm<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 24 weeks |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vildagliptin in combination with metformin during 24 weeks of treatment |  | 24 weeks | 
| Change from baseline in fasting plasma glucose at 24 weeks |  | 24 weeks | 
| Patients with endpoint HbA1c < 7% after 24 weeks |  | 24 weeks | 
| Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks |  | 24 weeks | 
| Change from baseline in body weight at 24 weeks |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin, Hemoglobin A1c
Effect of Shock Waves on Tooth Movement and Miniscrew Stability

Study Overview
=================
Brief Summary
-----------------
The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew stability clinically. This randomized clinical study is carried out in orthodontic patients undergoing space closure therapy at the university clinic of dentistry. During this period the tooth movement rate as well as the miniscrew stability are evaluated consecutively chairside.

Official Title
-----------------
Effect of Low-energy Extracorporeal Shock Waves on Orthodontic Tooth Movement and Miniscrew Stability

Conditions
-----------------
Mesial Movement of Teeth, Miniscrew Stability

Intervention / Treatment
-----------------
* Device: Extracorporeal shockwave therapy
* Device: ESWT placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy patients which don´t fulfill the exclusion criteria Exclusion Criteria: disease (syndroms,infections,...) which influence the bone turnover and the oral health medication, which influences the bone turnover and the oral health pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal shockwave therapy (ESWT)<br>Active treatment | Device: Extracorporeal shockwave therapy<br>* 1000 impulses<br>* Other names: Orthogold 100 MTS;|
| Placebo Comparator: ESWT Placebo<br>No extracoporeal shockwave therapy | Device: ESWT placebo<br>* 0 impulses, acoustic effect<br>* Other names: Orthogold 100 MTS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthodontic tooth movement |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miniscrew stability |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Velocity, Location, Periodontal status