cyrilzakka/clinical-trials huggingface dataset:
Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney

The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.


Eligibility Criteria:
Inclusion Criteria:

1. All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
2. Males and females ≥ 18 years of age.
3. Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
4. Patient is to be the recipient of a first kidney transplant from a deceased donor.
5. Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
6. Body mass index \< 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used..
7. Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).

Exclusion Criteria

1. Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
2. Recipient of an ABO-incompatible kidney.
3. Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
4. Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
5. Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
6. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation.
7. Concurrent sepsis or active bacterial infection.
8. Has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients

A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.


Eligibility Criteria:
Inclusion Criteria:

1. The American Society of Anesthesiologists' (ASA) class 1 to 3
2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
3. Nutrition status: 18.5 \< body mass index \< 30 kg/m2, stable weight over the preceding three months (\< 10% body weight loss), serum albumin \> 35g/l

Exclusion Criteria:

1. History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
2. Renal impairment (Serum Creatinine outside normal range)
3. Cardiac failure (New York Heart Association (NYHA) classes I-IV)
4. Hepatic, Renal, Cardiac transplant
5. Endocrine disorders: diabetes type I \& II, hyper and hypothyroidism
6. Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
7. Musculoskeletal or neuromuscular disease
8. Anemia defined as hematocrit \< 30, hemoglobin \< 10 g/dl, albumin \< 25 mg/dl
9. Previous spine surgery or scoliosis limiting use of epidural
10. Pregnancy
11. Use of Steroids
12. Milk protein allergy or intolerance
Dose-Response Effect Exercise and Depression

The present study aims to address gaps in the literature by evaluating the objectively measured dose-response relationship between exercise and depression symptoms; examining changes in resting (Brain-derived Neurotrophic Factor) BDNF from baseline to week 10 of an exercise intervention; and assessing varying exercise intensities on enjoyment, affect, and health-related quality of life in sedentary young adult college students.

This 10-week randomized single-blind controlled trial will consist of an exercise intervention and attention control condition. A two-week familiarity trial period will be followed by 8 weeks of structured exercise. Objectively measured physical activity will be remotely monitored via Fitbit to examine its effect on depressive symptoms in sedentary young adult college students.

Approximately 48 enrolled college students ages 18 - 25 will be recruited for the proposed study and randomized with a 1:1:1 allocation to one of the following conditions:

1. high-dose (HD) moderate to vigorous physical activity (MVPA) (n=16)
2. moderate-dose (MD moderate to vigorous physical activity (MVPA) (n=16)
3. a walking (W) attention control (n=16)

Eligibility Criteria:
Inclusion Criteria:

* enrolled UCF college students aged 18 to 25
* mild to moderate depressive symptoms
* willing to wear a Fitbit for extended periods of time during the study
* willing to participate in moderate-to-vigorous PA
* physically able to participate in exercise safely

Exclusion Criteria:

* under 110 lbs
* history of bad reaction to a past blood draw
* have been advised by a medical provider to not give/donate blood
* presence of anemia
* current cognitive therapy or antidepressant medication
* diagnosis of a co-occurring condition such as attention deficit hyperactivity disorder (ADHD)
* diagnosis of a serious mental illness (SMI) such as schizophrenia or bipolar disorder
* pregnant or nursing
* current smoker
* beta-blocker medications
MARCH Vascular Endothelium Substudy

This is a substudy of MARCH, in which we are exploring the changes in the vascular endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure the changes in small and large arterial elasticity in participants of the MARCH study who switch to maraviroc-based regimens over 96 weeks of follow-up.

Cardiovascular disease is increasingly recognised as a complication of HIV +/- therapies to treat it. Blood vessel elasticity, or compliance, can be depicted as the ability of the vessels to convert intermittent blood flow (cardiac ejection during systole) to continuous blood flow throughout the cardiac cycle. The compliance, or ability of vessels to accept energy, can be subdivided into elasticity of large and small vessels. Pulse wave tonometry is a non-invasive technique performed using a hand-held tonometer that generates two indices which correspond to large artery elasticity (LAE) and small artery elasticity (SAE). LAE and SAE estimates by pulse waveform analysis have previously shown greater correlation to Framingham risk when directly compared with other techniques such as flow-mediated diltation, and both LAE and SAE are associated with traditional cardiovascular risk factors (smoking, insulin resistance, hypertension).

It is unclear what the net effect of maraviroc, a chemokine-receptor blocker is on cardiovascular function.

The aims of this substudy are:

* To compare changes in the vascular endothelium between the control arm ((N(t)RTI) plus PI/r) and each of the maraviroc switch arms over 48 weeks of follow-up.
* To compare the changes in biomarkers and selected immunological markers between the control arm ((N(t)RTI) plus PI/r) and each of the maraviroc switch arms over 48 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled prior to treatment in the parent study;
* Provision of written, informed consent for participation in the substudy

Exclusion Criteria:

* Known supraventricular tachycardia such as atrial flutter and/or fibrillation that precludes the measurement of pulse wave using tonometry.
Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Excision of Primary Liver Tumors

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1\~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Twenty to eighty-year-old.
2. ASA class I-III.
3. Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.

Exclusion Criteria:

1. Severe mental disorder
2. Pregnant or lactating women
3. Morbidly obese
4. Allergy to any of the drugs used in this study
5. Recurrent tumor or repeat surgery
6. Biopsy cases
7. Incomplete data collection before the surgery
8. Palliative treatment after surgery
9. simultaneous treatment of other malignancies
10. Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
11. Diagnosed as benign liver tumor
12. Emergency surgery
Register for Longitudinal Recording of Brain Function

The aim of this observational register study is to establish a registry that completely records and compiles the data from routinely performed technical examinations (navigated transcranial magnetic stimulation, intraoperative neuromonitoring and stimulation, MRI imaging including tractography and connectome) and clinical tests over time (pre-, intra- and postoperative, under adjuvant therapy, as part of follow-up care) of patients with intracranial masses and lesions.


Eligibility Criteria:
Inclusion Criteria:

* Intracranial lesion
* Age ≥ 18 years
* Written consent to participate in the study

Exclusion Criteria:

* Age \< 18 years
* Patients not able to give consent
* Patients with intracranial ferromagnetic metal implants
* Patients with implanted electronic devices
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery

Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).

Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)

Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)

Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury

Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality

Aim of the work:

Is to validate the impact of Sevoflurane versus ischemic \& Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* American Society of Anesthesiologists physical status II and III
* Patients scheduled for open heart surgery

Exclusion Criteria:

* Emergency surgery
* Clinically significant kidney or liver disease
* Patients allergic to local anesthetic
* Patients with prolonged cardiopulmonary bypass time (\>120 min)
* Patients required intra-aortic balloon pump
* Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy

Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.

However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.

The gold standard technique for thymectomy used to be transsternal approach. Advancements in modern technology bring many evolutions in minimally invasive surgery such as Video-assisted thoracic surgery (VATS) thymectomy gained popularity after 2000s. Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.

However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
2. Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.

Exclusion Criteria:

1. Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
2. Thymic carcinoma.
3. Thoracic deformity.
Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in Treating Allergic Rhinitis Patients

Budesonide is a medication of the corticosteroid type. Available as an inhaler, nebulization solution, The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate

The current study aims to compare between results of budesonid nasal irrigation and fluticasone nasal spray in the treatment of adult patients with Allergic Rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* Adult age between 18 and 60 years old.
* Patients with allergic rhinitis evidence by past skin prick testing. Patients were given a skin prick test with a panel of dog, cat, Dermatophagoides farinae, D pteronyssinus, Alternaria, Penicillium, Hormodendron, Aspergillus, grass pollen mix, tree pollen mix, and ragweed allergen extracts (100,000 Allergen Unit/mL). Histamine, 10 mg/mL, was used as a positive control, and the diluent was used as the negative control. A positive reaction was defined as a wheal diameter at least 3 mm greater than the diluent control and/or at least a 50-mm flare (ie, erythema measured as the sum of the greatest diameter and the perpendicular diameter through the midpoint of the greatest diameter)

Exclusion Criteria:

* Patients who had autoimmune diseases or any immune compromised diseases including diabetes, chemotherapy.
* Patients with a history of nasal surgery.
* Patients who received systemic or topical corticosteroids, herbal drugs, beta blocking agent within the previous month of enrolment.
* Patients with asthma and COPD, nasal bleeding, obstructing nasal polyps, paranasal sinus.
Prevention of Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry

Computerized physician order entry with clinical decision support system CPOE+CDSS)completely eliminated errors in filling in the resuscitation medications order forms and significantly reduced time to completing the forms in a pediatric critical care department (PCCD).

Introduction: Computerized physician order entry with clinical decision support system (CPOE+CDSS) is an important tool in attempting to reduce medication errors. The objective of this study was to evaluate the impact of a CPOE+CDSS on (1) the frequency of errors in ordering resuscitation (CPR) medications and (2) the time for printing out the order form, in a pediatric critical care department (PCCD).

Methods: Setting: An 18-bed PCCD in a tertiary-care children's hospital. Design: Prospective cohort study. Measures: Compilation and comparison of number of errors and time to fill in forms before and after implementation of CPOE+CDSS. Errors were identified by reviewing orders and classified as potential adverse drug events (ADEs), medication prescribing errors (MPEs), and rule violations (RVs). They were compared during the year preceding and following implementation of CPOE CDSS. Simulated forms were also used to further test error occurrence. Time to fill in conventional, simulated and CPOE forms was measured and compared.

Results: There were 3 reported incidents of errors among 13,124 CPR medications orders during the year preceding implementation of CPOE+CDSS. These represent errors that escaped the triple check by three independent staff members (two nurses and one physician). There was an average of 11.6 errors/100 orders in the simulated CPR form and potential ADEs occurred at a rate of 11.3/100 orders and MPEs at a rate of 0.3/100 orders. There were no errors after CPOE+CDSS was implemented (100% error reduction). Time to completion of drug forms dropped from 14 min 42 sec to 2 min 14 sec (p\<0.001).

Conclusions: CPOE+CDSS completely eliminated errors in filling in the forms and significantly reduced time to completing the form.

Eligibility Criteria:
Inclusion Criteria:

* all admissions to PICU January 2002 - August 2006

Exclusion Criteria:

-
Ilaris NIS in Korea

This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes, Cryopyrin-associated periodic syndromes (CAPS), colchicine resistance familial Mediterranean fever (crFMF), TNF receptor associated periodic syndrome (TRAPS), Hyper-IgD syndrome / Mevalonate kinase deficiency (HIDS/MKD) or Systemic juvenile idiopathic arthritis (sJIA).

This is a prospective observational, multicenter, uncontrolled, open-label non-interventional study in ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome patients and ≥2 year and \<19 year-old sJIA patients receiving Ilaris for the treatment of CAPS, crFMF, TRAPS, HIDS/MKD and sJIA, respectively, partially using retrospective observation to collect and evaluate data on the safety and effectiveness of Ilaris in patients receiving this drug in a clinical setting for any of these indications. The whole study period is up to 4 years, consisting of a 2-year enrollment period and 2-year observation period.

As all pediatric and adult hereditary periodic fever syndrome patients and all sJIA patients receiving Ilaris for approved indications will be enrolled, this study has no fixed sample size.

For subjects who started Ilaris before enrolling in this study, the safety and effectiveness baseline and early period data will be retrospectively collected.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent/assent of the patient or their legal representative/parent (≥2 year and \<19 year-old pediatric patient) for voluntarily participating in this study
2. Age: ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) patients and ≥2 year and \<19 year-old sJIA patients
3. Patient who have an agreement to be treated or who have already started treatment with Ilaris in accordance with the approved label information

Exclusion Criteria:

1. Patients receiving Ilaris treatment for autoimmune disease other than CAPS, crFMF, TRAPS, HIDS/MKD or sJIA
2. Patients participating in an interventional clinical trial which would have an impact on routine clinical treatment
Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation

Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.

Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. a glenoid defect ≥10%
2. contact sport athletes with a glenoid defect \< 10%
3. failure after Bankart repair.

Exclusion Criteria:

1. epilepsy
2. multidirectional shoulder instability
3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
4. Follow-up was less than 2 years or incomplete follow-up data.