cyrilzakka/clinical-trials huggingface dataset:
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children

The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.

The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.

COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.

Eligibility Criteria:
Inclusion Criteria:

* Children \<15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.

Exclusion Criteria:

* Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
* Children with persistent severe arrhythmias.
* Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.
GSK1120212 Rollover Study

This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.


Eligibility Criteria:
Inclusion Criteria:

1. Has provided signed informed consent for this study.
2. Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
3. Is currently participating in GSK1120212 study and is receiving treatment with GSK1120212.
4. Is currently receiving clinical benefit as determined by the investigator from previous treatment with GSK1120212 either as monotherapy or as part of a combination treatment regimen.
5. Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
6. Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 months after the last dose of GSK1120212.
7. Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
8. Subjects enrolled in France: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression.
2. Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
3. Any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study.
4. Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study
5. Left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN) by ECHO (preferred) or MUGA scan at the time of transition to this study.
6. Nursing female.
7. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.

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The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis

This is a retrospective study of End-Stage Kidney Disease (ESKD) patients on dialysis receiving apixaban or warfarin at Tawam Hospital \[a tertiary care hospital in Al Ain, UAE\]. The study aims to assess the appropriateness of prescribing apixaban and warfarin in this population and evaluate their safety and effectiveness.

Direct oral anticoagulants (DOACs), including apixaban, are used for stroke prevention in non-valvular atrial fibrillation (NVAF) and for venous thromboembolism (VTE) management. Patients with end-stage kidney disease (ESKD) on dialysis face elevated risks of thromboembolic events and bleeding. While apixaban is FDA-approved for use in this population, its safety and efficacy compared to warfarin are not well established in this vulnerable population.

This retrospective observational study aims to assess the prescribing appropriateness of apixaban compared to warfarin and evaluate their safety and effectiveness in a cohort of ESKD patients undergoing dialysis. This study will include ESKD patients on dialysis receiving apixaban or warfarin at Tawam Hospital from May 1, 2018, to January 31, 2024. Data on demographics, anticoagulant dosing, therapy duration, bleeding events, CHA2DS2-VASc score, HAS-BLED score, and thromboembolic events will be collected. Safety will be assessed by bleeding incidents, and effectiveness will be measured by VTE and stroke events. Dose appropriateness was evaluated according to FDA guidelines for apixaban and INR targets for warfarin. Data will be collected for eligible patients through electronic medical records (EMR).

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18
* CKD on dialysis for at least 1 month
* NVAF or VTE
* On Apixaban or Warfarin for at least 1 month

Exclusion Criteria:

* Age less than 18
* Received dialysis for less than 1 month (i.e., were treated with dialysis for acute kidney injury).
* On Apixaban or Warfarin for less than 1 month
* Pregnancy
WallFlex Biliary Post Liver Transplant IDE Pilot

The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:

   * Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis
   * Abnormal liver function tests (serum bilirubin \> 1.5 and/or elevated alkaline phosphatase levels)
   * Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary stricture
3. Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Roux-en-Y choledochojejunostomy
2. Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis)
3. Living donor transplants
4. Transplants performed within 30 days (fresh transplants)
5. Perforation of any duct within the biliary tree
6. Patients with known sensitivity to any components of the stent or delivery system
7. Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
8. Patients with poor Karnofsky score
9. Life expectancy of less than one year
10. Inability to pass a guidewire through the strictured area
11. Previous biliary metal or multiple plastic stent placement
12. Drug-induced or cholestatic hepatitis from an infective cause
13. Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy
14. Choledocholithiasis/biliary "cast" syndrome
RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL

The purpose of this study is to determine the efficacy and safety of the new treatment proposed in this study. Conducting a prospective study "CNS-2015" in patients with PDLBCL CNS made it possible to achieve 2-year EFS, DFS and OS of 83%, 83% and 88%, respectively. The presence of early relapses of the disease has now led to the need to find an alternative program for patients with PDLBCL CNS. In the new "CNS-2021" protocol, lenalidomide was included in the R-MPV program in order to intensify the induction stage. In the conditioning regimen, thiotepa was replaced by carmustine, due to its significant CNS bioavailability. In order to possibly prevent early relapses, an anti-PD-1 inhibitor (nivolumab) was used as maintenance therapy.

Patients will receive 4 cycles of RL-MPV (rituximab, methotrexate (MTX), procarbazine, vincristine, and lenalidomide (RL-MPV) as induction. The conditioning regimen prior to autologous blood stem cell transplantation includes high doses busulfan, thiotepa, and cyclophosphamide. After 3 months after autologous blood stem cell transplantation, maintenance therapy with nivolumab 3 mg/kg every 2 weeks for 6 months will be started.Patients will be out of the study at the time of death. All patients believe in the possibility of survival within 3 months throughout their lives. Survival status can be obtained by phone call, storage visit, or medical records (eg doctor's note/lab results from a clinic or storage visit).

Eligibility Criteria:
Inclusion Criteria:

All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.

A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.

Patients must be HIV-1 negative. Patient must have left ventricular ejection fraction ≥ 50%. Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration.

Patients must have adequate bone marrow function (defined as peripheral leucocyte count \>3000 cells/mm3 and platelet count \> 100,000 cells/mm3), liver function (bilirubin \< 2.0 mg/%), and adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance \> 50cc/min/1.73M2).

Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.

Patients must be between 18 and 70years-old. Patients must sign an informed consent.

Exclusion Criteria:

Prior cranial irradiation Other active primary malignancy. Pre-existing immunodeficiency such as renal transplant recipient. Prior treatment with chemotherapy for CNS lymphoma.
Narcotic Use After Minor Hand Surgery

This study evaluates the effect of larger or smaller opioid prescriptions following minor surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and leftover narcotic.

Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to request additional medication as needed. Patients are contacted by phone 10-14 days after their surgery to answer a questionnaire regarding number of pills taken, number of refills requested, number of remaining pills, their satisfaction with their pain control and their surgery, and their opinion regarding the appropriateness of the prescription size.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing minor hand surgery by a participating surgeon within the study period

Exclusion Criteria:

* narcotic use within previous 3 months
* concurrent procedure
* acute trauma
* pregnancy
* allergy or other contraindication or intolerance to hydrocodone or acetaminophen
* post-operative complications
* inability to provide personal consent to the procedure or the research
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy

This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Adult cerebral palsy patients over 20 years old
* Clinically diagnosed for cervical dystonia more than a year ago
* No improvement with antispasmodics for the last month
* Actively participated and gave informed consent

Exclusion Criteria:

* Allergic to the botulinum toxin
* Limited range of motion in cervical spine
* Patients with fever, infection, cancer, uncontrollable seizure
* Generalized neuromuscular junction disease patients
* Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
* Patients enrolled in other studies
* History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
* Botulinum toxin injection history in 6 months
* Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
* Otherwise clinically non-eligible patients
Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258

This study will evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy. This study will also evaluate the effect of age, race, native language, education level, type of cancer and chemotherapy regimen on the oncology teaching session.

Chemotherapy teaching sessions, often coordinated in the outpatient setting by nursing personnel, are meant to educate patients about the chemotherapy they will be receiving. Education topics include an understanding of side effects, treatment schedule, medications to treat side effects and how to contact the oncology team if adverse events develop. Some of these issues are addressed in the American Society of Clinical Oncology's Quality Oncology Practice Initiative (QOPI). This study will perform an analysis of the teaching process that is provided prior to chemotherapy administration.

This study will provide data for each participating hospital to individually assess their teaching process. Multivariate analysis can be performed to evaluate whether age, sex, native, language, race highest level of education, cancer type, chemotherapy regimen, institution where chemotherapy will be administered, and type of personnel performing the teaching visit, influences the effectiveness of the teaching visit. In addition, results can be compared across different hospitals.This analysis may lead to improvements in each hospital's chemotherapy teaching practices and lead to advances in patient's cognitive and emotional preparedness.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age who will be receiving chemotherapy (including targeted anticancer therapy) at a Brown University Oncology Research Group Affiliated Hospital for a period of 1-year after study activation.
* Patients who will be undergoing a chemotherapy teaching session at an institution affiliated with the Brown University Oncology Research Group.
* No prior chemotherapy or targeted anticancer treatment.
* Signed informed consent

Exclusion Criteria:

Patients must meet eligibility criteria
Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ages 18-65 years old.
* DSM-IV diagnosis of schizophrenia.
* PANSS≥70.
* Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
* Written informed consent.

Exclusion Criteria:

* Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
* Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.
The Cxbladder Monitoring Study

The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy.

The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.
* Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner
* Patient is 18 years of age or older.

Exclusion Criteria:

* Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
* Patient has undergone total bladder cystectomy as treatment for bladder UC
The Application of Response Surface Model on Sedative Procedures

The purpose of this study is to find the application of Response Surface Model on Sedative Procedures.

It is very important to understand the influence of drug interactions of patients in clinical anesthesia. However, there were only a few quantitative studies on the pharmacodynamics of different drug combinations and patient responses. In recent years, the investigators have innovatively utilized the response surface models in patients receiving painless gastro-intestinal endoscopies. Appropriate pharmacodynamic models of clinical anesthesia for these procedures provide observation, evaluation, and prediction of the pharmacodynamic effects of a combination of clinical anesthetics to such patients. Patients with endoscopic retrograde cholangiopancreatography (ERCP) and bronchoscopy often have a need for painless service, but current clinical studies of using a pharmacodynamic model were lacking in these patients. The investigators therefore design a two-year prospective, observational project to investigate the optimal drug concentration combinations for the shortest wake-up time, adequate analgesia, and appropriate depth of anesthesia for sedative endoscopic ERCP and sedative bronchoscopy using pharmacodynamic models. Multidimensional surface charting will be performed by inputting diversified parameters to predict the drug interactions of the model groups. In this prospective, observational study, the investigators plan to enroll 40 ASA Class Forty ASA Class II-III, aged 20-80 adult patients who require sedative ERCP and bronchoscopy. Moderate to heavy sedation will be performed only after patients' inform consents and approval of the institutional ethics committee. The investigators plan to complete this series of studies within two years: The first year: ERCP(10 patients) and broncoscopy (10 patients). The second year: ERCP(10 patients) and broncoscopy (10 patients). Using response surface models, this study will offer us novel information about patients during procedures which may substantially increase the anesthesia quality and outcome of sedative ERCP and broncoscopy. Physiological signals such as anesthesia depth, drug concentrations and dosages, alertness/sedation score, heart rate, blood pressure, peripheral oxygen saturation, and physical activity responses during painless procedures will be collected and then the above data will be applied to the response surface models. Then the investigators will find the most appropriate anesthetic response surface which may delineate the effects of drug combinations, and will further improve the anesthesia safety and quality for painless ERCP and bronchoscopy patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA Class II-III,
* Aged 20-80 adult patients
* Undergoing moderate sedation during ERCP (endoscopic retrograde cholangiopancreatography) and brochoscopy

Exclusion Criteria:

* Neurological disorders
* Hearing impairment
* History of habitual sedative medication
* Alcoholism
PRP Use in Diabetic Patients Undergoing Cesarean Section

this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections

In this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to Minia University hospital. The patients will be randomly assigned into two groups. The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, two weeks, four weeks and eight week after the cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy

Exclusion Criteria:

* The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy
Postural Habits, Awareness and Spine

Alterations in posture are frequently seen as a risk factor for the development of spine pain. Postural awareness is essential for sustaining healthy postural habits in daily life. The first of the contribution to literature of our study is that the Postural Habits and Awareness Scale, which is a new questionnaire that provides easy inquiry about postural habits and awareness, is a low-cost method and has not been used in the literature before, was used to confirm the relationships between spine pain and functionality and scale parameters in accordance with the literature. Another contribution is that it is underlined that even among doctors, who are the direct managers of health, low postural awareness and bad postural habits that can lead to spinal problems are quite common.


Eligibility Criteria:
Inclusion Criteria:

* participants between the ages of 20-50
* who were working as research assistant physicians

Exclusion Criteria:

* with a history of previous trauma or surgery that could cause pain or postural disorders in the spine,
* known systemic, neurological, psychiatric, infectious, inflammatory, rheumatic, tumoral or degenerative diseases
The Evolving Use of Robotic Surgery

A retrospective, population-based analysis examining the rates of robotic surgery between the years of 2009 - 2018.

A retrospective, population-based analysis examining the rates of robotic surgery in Ontario between the years of 2009 - 2018. The purposes of the study were (i) to describe temporal trends and (ii) patient- and system-level determinants of receiving robotic compared to open or laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years old
* Received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018

Exclusion Criteria:

* Non-Ontario residents
* Non-elective procedure
* Patients without OHIP eligibility
* Patients who had an identical procedure in the previous two years