linjc16/ctgov huggingface dataset:
Platelet Modulation: A Study of Angiogenic and Coagulation Proteins in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
Blood samples on persons with cancer will be sampled for angiogenic, metastatic and coagulation proteins.

Official Title
-----------------
Platelet Modulation in the Control of Angiogenesis: A Study of Angiogenic and Coagulation Proteins in Patients With Cancer

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of malignancy Exclusion Criteria: Patients taking aspirin, NSAIDs, warfarin or platelet inhibitor 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?
-----------------
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
-----------------
breast cancer, platelets, metastatic cancer, malignancy
Fibrin Sealant in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Background: Post-operative wound complications arise in as many as 50% of kidney transplant recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the accumulation of post-operative fluid collections with varying success. The use of fibrin products has been proposed as a means of reducing local wound complications in the immunocompromised renal transplant recipient but as yet has not been studied. Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or not at the time of their renal transplant. Patients were analyzed per the randomization assignment. The operating team was blinded to the decision until after the iliac fossa dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound. Patients in whom the peritoneum was entered were excluded from data analysis. The incidence of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by necessitating incision and drainage, and urine leak was recorded.

Official Title
-----------------
Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Device: Tisseelä fibrin sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All renal transplant recipients Exclusion Criteria: Patients declining study
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: Fibrin sealant<br>received intraoperative fibrin sealant | Device: Tisseelä fibrin sealant<br>* Fibrin sealant applied intraoperatively<br>|
| No Intervention: Control<br>No fibrin sealant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of postoperative fluid collection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection |  |  | 
| wound dehiscence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomised, controlled, double blinded
Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.

Official Title
-----------------
The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.

Conditions
-----------------
Nephrectomy, Laparoscopic Donor Nephrectomy

Intervention / Treatment
-----------------
* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients donating a kidney via laparoscopic donor nephrectomy Exclusion Criteria: History of NSAID allergy Asthma History of long term opioid use Intraoperative blood loss greater than 300 mL Postoperative hemodynamic instability Active peptic ulcer disease Advanced renal impairment (Cr > 2.0 mg/dL) Bleeding diathesis Current use of probenecid Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. | Drug: Ketorolac<br>* 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.<br>* Other names: Acular;|
| Placebo Comparator: Placebo<br>1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. | Drug: Placebo<br>* 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 'Right Now' | Visual analog scale score for pain on a scale from 0 = None to 10 = Worst. | 24 hours after the end of surgery | 
| Morphine Equivalents of Concomitant Pain Medication | The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient. | 24 hours after the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic, donor, nephrectomy
Rheos System for the Treatment of HFpEF Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.

Detailed Description
-----------------
The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure. The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.

Official Title
-----------------
Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Rheos® system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently implanted with the Rheos device and actively participating in the HOPE4HF Trial (G090001). Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study. Exclusion Criteria: 1. Treating physician decision that the subject should not continue with therapy.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Rheos® system | Device: Rheos® system<br>* Implant procedure<br>* Other names: BAROSTIM NEO® LEGACY System;|
| No Intervention: Medical Management<br>Medical Management Therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To ascertain long-term adverse events for subjects implanted with the device. | To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device. | Trial duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Diastolic dysfunction
The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to assess the effect of intralipid as regard efficiency in decreasing myocardial ischemia , given during preconditioning in off pump coronary artery revascularization

Official Title
-----------------
The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Intralipid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between 40 to 75 undergoing off bump CABG surgery Exclusion Criteria: emergency surgery Ejection fraction less than 50% redo procedures history of allergy to peanuts

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IL group<br>receive 1.5 ml /kg intralipid 20% through Central venous line after sternotomy over 1 hour | Drug: Intralipid<br>* intralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia<br>|
| Placebo Comparator: NS group<br>recieve 1.5 ml /kg normal saline 0.9% through central venous line after sternotomy over 1 hour | Drug: Placebo<br>* normal saline is given in same volume to normal saline group over the same duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | measuring the duration of stay in the ICU | long icu stay is considered if more than 7 days |
Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

Study Overview
=================
Brief Summary
-----------------
The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.

Official Title
-----------------
Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: Tiotropium
* Drug: Tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent (IC) obtained. Healthy males and females, aged 18-60 Normal weight at least 50 kg. Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug. Pregnant or lactating females. Females of childbearing potential not using proper contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Tiotropium with concomitant charcoal | Drug: Tiotropium<br>* Oral capsule 20 μg<br>|
| Experimental: Treatment B<br>Tiotropium without concomitant charcoal. | Drug: Tiotropium<br>* Oral capsule 20 μg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameter Area Under Curve (AUC) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax) |  | (0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration |
Is Orthostatic Hypotension Associated With Nondipping Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether orthostatic hypotension is associated with nondipping hypertension. Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner regarding their medical background and medications. All patients will be subjected to orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure and heart rate will be correlated to the changes in blood pressure and heart rate from day to night as recorded by the 24H ABPM.

Conditions
-----------------
Orthostatic Hypotension, Nondipping Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are referred for ABPM Exclusion Criteria: Known secondary hypertension
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthostatic hypotension, ambulatory blood pressure monitoring
Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate postoperative pain control for pediatric patients.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients scheduled for elective day-case orchiopexy. Exclusion Criteria: Infants or children with history of steroid allergy, renal, hepatic disease, or contraindication for caudal analgesia.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|Intravenous dexamethasone (0.5mg/kg) before incision|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC |  | postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric patients (6 months-5 years) scheduled elective day-case orchiopexy
Body Composition Analysis in Patients Undergoing Chemoembolization

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of patients with hepatocellular carcinoma are associated with cirrhosis. Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into the hepatic tumor where the principal artery is embolized. Bioelectrical impedance bases its evaluation in a model where the body is conformed by two different compartments: fat mass and fat free mass. Bioelectrical impedance is complemented by vectorial analysis, which is independent to the state of hydration and is helpful to monitor any changes in corporal composition. It can be used as a control for the interpretation of the bioelectrical impedance.

Official Title
-----------------
Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization.

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hepato-renal disease Patients with hepatocellular carcinoma that are put down to radiofrequency ablation Patients with depression or any psiquiatric disease. Patients that don't agree to participate in the project. Exclusion Criteria: Patients with hepatocellular carcinoma that are put down to radiofrequency ablation Patients with depression or any psiquiatric disease. Patients that don't agree to participate in the project.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Changes in body composition | To evaluate any changes in corporal composition in patients undergoing chemoembolization. | 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body composition, hepatocellular carcinoma, chemoembolization
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.

Detailed Description
-----------------
Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant. The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.

Official Title
-----------------
Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa

Conditions
-----------------
HIV Infections, HIV Positive, Pregnant Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive pregnant woman on antiretroviral treatment Able and willing to participate and provide informed consent Be at least 18 years of age or older than legal age to provide consent If under legal age, must have legal guardian who is able to give consent Be an emancipated minor Exclusion Criteria: History of mental illness History of condition that would preclude provision of consent Inability to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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 Congenital birth defects | Number of congenital birth defects among infants born in the study | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Pregnancy outcomes | Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight | At outcome of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Pregnancy, Antiretrovirals, HIV Seronegativity, Treatment Experienced