linjc16/ctgov huggingface dataset:
Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Study Overview
=================
Brief Summary
-----------------
Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Detailed Description
-----------------
Preoperative risk assessment is important, but inexact, in older patients because physiologic reserves are difficult to measure. This also makes an important difference related to brain tumor patients, who may be burdened with systemic disease, alterations in cognition, or affected by other comorbidities. When assessing quality of life for brain tumor patients, having a better predictor of postsurgical outcome would be beneficial in appropriately counseling these patients. Frailty is thought to estimate physiologic reserves, and its use has been found to predict postoperative complications, length of stay, and discharge to a skilled or assisted-living facility in neurosurgical patients. Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Official Title
-----------------
Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Conditions
-----------------
Brain Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Ambulatory (able to walk) Scheduled for neurosurgical resection of brain tumor Exclusion Criteria: Parkinson disease Previous stroke Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants

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 |
| --- | --- | --- |
| Number of patients with a Complication risk | Number of patients with a complication risk based on a Hopkins Frailty Score (HFS). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay based on a Hopkins Frailty Score (HFS). | Number of patients with a prolonged length of stay based on a Hopkins Frailty Score (HFS). | 30 days | 
| Number of patients Discharge to a skilled or assisted-living facility | Number of patients discharged to a skilled or assisted-living facility based on a Hopkins Frailty Score (HFS). | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Frailty
Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.

Detailed Description
-----------------
Study Design: Prospective observational study with blinded assessment of study endpoint variables. Collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. The information will be collected from 60 patients undergoing cardiac surgery in the Department of Cardiac Surgery of Sheba Medical Center. Study endpoints Primary endpoint- resternotomy for bleeding after the surgery. Secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.

Official Title
-----------------
Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Conditions
-----------------
Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery with the history of aspirin and/or ADP receptor antagonist for at least 7 days prior the surgery Exclusion Criteria: Emergent surgery Heart transplant surgery Implantation of ventricular assist devices Enrollment into conflicting study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| No Treatment<br>Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-sternotomy d/t Bleeding |  | Hospitalization Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube output during first 24 hours after the surgery |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombelastogram, Microvascular bleeding, antiplatelet medication, cardiac surgery, consumption of blood products, preoperative platelet mapping derived from modified TEG, postoperative bleeding
Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

Study Overview
=================
Brief Summary
-----------------
Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Detailed Description
-----------------
Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR). This causes pressure overload in the right heart, and thereby right ventricular (RV) and right atrial (RA) dysfunction, which may implicate considerable morbidity and even mortality. Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced (partially irreversible) stage and treatment is often initiated too late. Dismissal from follow-up after a surgical correction of simple CHD was customized in the seventies and eighties. There is no literature available that learns us whether these patients really need follow-up or not. A substantial number must have insidiously developed PAH or mild pulmonary vascular disease (PVD) and still are prone to develop PAH later in life. It is relevant to recall these patients dismissed from follow-up in the past, because they might carry a lot of useful information on the natural history of PAH development. Focus will lie mainly on patients with simple shunt lesions, as atrial septal defect (ASD) and ventricular septal defect (VSD).

Official Title
-----------------
Prospective, Monocentric Study for the Evaluation of Latent Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions Lost to Follow-up.

Conditions
-----------------
Atrial Septal Defects, Ventricular Septal Defects

Intervention / Treatment
-----------------
* Other: No intervention was applied, because it is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous repair for secundum ASD, VSD Exclusion Criteria: Other congenital heart disease Chronic lung disease or total lung capacity < 80% of predicted value History of pulmonary embolism

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 |
| --- |
|Other: No intervention was applied, because it is an observational study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | From date of birth until date of study inclusion (up to 100 months) |
Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.

Official Title
-----------------
Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Other: prophylactic anticoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip arthroplasty Exclusion Criteria: Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded. Coagulation related disease and cancer were excluded either.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 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 |
| --- | --- |
| No Intervention: non-prophylactic anticoagulation<br>without prophylactic anticoagulation | |
| Experimental: prophylactic anticoagulation<br>prophylactic anticoagulation by rivaroxaban | Other: prophylactic anticoagulation<br>* prophylactic anticoagulation by rivaroxaban<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause DVT | deep-vein thrombosis nonfatal pulmonary embolism, or death | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major DVT | major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism) | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Vein Thrombosis, total hip arthroplasty, prophylactic anticoagulation, randomized study
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the neuropsychological effects of transvascular aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive heart failure and low cardiac output which may limit their cognitive abilities. TAVI results in significant improvements in cardiac function and therefore may improve cognitive functions. However, TAVI may also be associated with stroke and may therefore have a negative impact on cognition. Therefore, in this study the investigators wish to perform a battery of standardized neuropsychological tests before and after TAVI to test the net effects of TAVI on cognitive performance over time. The investigators plan to include all patients planned to have TAVI in the study and to test them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.

Official Title
-----------------
Neuropsychological Testing in Patients Undergoing TAVI

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Other: Neuropsychological testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with severe aortic stenosis that are candidates for TAVI Able to perform the testing Able to sign informed consent Exclusion Criteria: Language barriers precluding the administration of the testing Existing dementia Existing disease limiting life expectancy to less than 180 days

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| TAVI<br>patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation | Other: Neuropsychological testing<br>* This is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| net change in neuropsychological tests between baseline and day 180 from TAVI | The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| net difference between cognitive measures before TAVI and at day 30 after TAVI | The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic stenosis, TAVI, neuropsychological, cognitive, candidates for TAVI
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

Study Overview
=================
Brief Summary
-----------------
the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure

Official Title
-----------------
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One previous failed attempt of IUD insertion. Exclusion Criteria: Uterine fibroid distorting the cavity. Anatomical uterine abnormality with distortion of the cavity Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months. Current purulent cervicitis (chlamydia or gonorrhea). Immediately after septic abortion. Uterus size less than 6 cm and more than 9 cm.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol group<br>misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion | Drug: Misoprostol<br>* vaginal misoprostol prior IUD insertion<br>|
| Placebo Comparator: placebo<br>while the control group received a placebo tablet in the same regimen as the study group. | Drug: Placebos<br>* vaginal placebo tablet prior IUD insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the success rate for IUD insertion. | the success of IUD insertion after previous attempt failure | four hours after misoprostol dose |
Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

Study Overview
=================
Brief Summary
-----------------
To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids

Official Title
-----------------
Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

Conditions
-----------------
Levels of Fatty Acids in the Blood Cells of Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton birth 12-25 days of age Gestational age of 37-42 weeks Solely formula fed for at least 24 hours prior to randomization Birth weight 2500 g - 4000 g Exclusion Criteria: Serious concurrent illness or congenital malformation Systemic or congenital infection Immunocompromised History of intolerance or allergy to cow milk Maternal autoimmune disorder Participation in another clinical study

Ages Eligible for Study
-----------------
Minimum Age: 12 Days
Maximum Age: 25 Days

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 |
| --- | --- |
| Control<br>Marketed cow milk-based infant formula containing DHA and ARA | |
| Investigational 1<br>Cow milk-based infant formula with differing level of ARA from Control formula | |
| Investigational 2<br>Cow milk-based infant formula with a differing level of ARA from Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.

Official Title
-----------------
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

Conditions
-----------------
Treatment of Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: Restasis, Refresh Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Using computers more than three hours per day Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder An abnormal confocal image of 5 or greater. Exclusion Criteria: All corneal disorders except for tear disorders.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: 1<br> | Drug: Restasis, Refresh Plus<br>* Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening<br>|
| Placebo Comparator: 2<br> | Drug: Restasis, Refresh Plus<br>* Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye disease |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | 6 months |
PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.

Official Title
-----------------
The Multi-center,Open-label,Single Arm Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age ≥ 18 years diagnosis of lymphoma(Hodgkin's lymphoma and non-Hodgkin's lymphoma) patients Karnofsky Performance Status Z70 life expectancy of at least 8 months normal white blood cell count and platelet count Written informed consent are acquired Exclusion Criteria: uncontrolled infection pregnancy Have accepted any other anti-tumor drug within 4 weeks before anticipated the study Other situations that investigators consider as contra-indication for this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy | Drug: PEG-rhG-CSF<br> <br> * Other names: pegfilgrastim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence rate of adverse event |  | up to 30 days after the patient study completion | 
| The severity of adverse event |  | up to 30 days after the patient study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles |  | through the study completion,an average of 5 months |