cyrilzakka/clinical-trials huggingface dataset:
PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery

A triple-arm, randomized, simple-blinded clinical trial will be conducted. A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair (AAOR), Group 2: vascular anastomosis (VA) and AAOR, and Group 3: specific micro-surgical skills, VA and AAOR. Surgical residents of general, vascular, or cardiovascular surgery programs will be included. Sample size calculation resulted in 45 participants, 15 in each group. Simple blinding will involve external evaluators. Randomization will occur as a simple randomization.


Eligibility Criteria:
Inclusion Criteria:

* Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.
* Over 18 years old.

Exclusion Criteria:

* Serious illnesses, such as advanced cancer, decompensated cardiovascular diseases, or severe neurological disorders, could be exclusion criteria due to concerns about the participant's safety and ability to complete the study.
* Participants who have known allergies to components of the interventions or have experienced severe adverse reactions in the past will be excluded from the study.
* Any medical condition that could interfere with the participant's ability to complete assessments or follow study guidelines could be a reason for exclusion. This could include, for example, severe physical disabilities or illnesses requiring continuous hospitalization.
* Individuals who cannot provide valid informed consent due to cognitive issues, mental impairment, or legal incapacity will be excluded from the study.
* Individuals who have had prior exposure to structured simulation programs in vascular surgery will be excluded. Previous familiarity with simulation could influence study outcomes, introducing a prior learning bias that could distort the assessment of the intervention's effectiveness.
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method

This study evaluates the incidence of cardiac arrhythmias during the perioperative period in patients undergoing open kidney cancer surgery in the lateral position. All the participants will be randomly allocated to receive general (Group G) or combined epidural/general anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM)

Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They are also a major source of morbidity and mortality. After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete. There is no literature data about their incidence during kidney surgery in the lateral position when the bed is scissored so the legs and head are low. The aim of this study was to define what types of arrhythmias are the most common during kidney cancer surgery, their incidence and whether combining general with epidural anesthesia prevents them.

An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study.

It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral position, under general or combined anesthesia will be enrolled.

A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM).

Patients will be randomly allocated (random permuted blocks within strata) to receive general or combined epidural/general anesthesia. The anesthetic technique is standardized. All the data registered by the Holter ECG monitor will be analyzed and compared with the nursery and anesthesia records.

Eligibility Criteria:
Inclusion Criteria:

* Open renal cell carcinoma surgery, lateral position
* American Society of Anesthesiologists (ASA) physical grade I-III
* No history of cardiac arrhythmias
* Informed consent

Exclusion Criteria:

* Pregnancy and breast feeding
* Contraindications for epidural anesthesia
* Laparoscopic or robotic surgery
* Suspected difficult intubation (ex. fibroscopic)
* Chest deformations
* Prior cardiac/thoracic surgery
* Cardiac insufficiency
* abnormal ECG before the surgery
Intra-Operative Adductor Canal Blocks

Adductor canal blocks (ACB) have been recommended in total knee arthroplasty (TKA) to provide better control of post-operative pain, facilitate early ambulation, and reduce length of stay in the hospital. ACB is typically done before surgery by an anesthesiologist, which may increase time per case, cost, and requires the specialized skills of an anesthesiologist trained in regional anesthesia. Recent studies have suggested that surgeons can safely and reliably administer the adductor canal blocks (sACB) during surgery. However, there is currently very limited data on the clinical efficacy of such sACBs, and no studies assessing this technique in the context TKA that are discharged the same day. As such, this randomized control trial (RCT) is being done to compare sACBs to conventional anesthesiologist-performed adductor canal blocks (aACB).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Primary TKA booked as SDD
3. Diagnosis of osteoarthritis

Exclusion Criteria:

1. Inability or refusal to sign informed consent form
2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
3. Non-osteoarthritis primary diagnosis
4. Allergy to analgesic medications
5. Contraindication to spinal and/or regional anaesthesia
6. Any use of opioid pain medication within four weeks of the index procedure(13)
7. Pain catastrophizing scale score ≥16 (8, 9, 14)
8. History of cirrhosis
9. History renal insufficiency
10. History or sensory and/or motor neuropathy to the ipsilateral limb
11. Simultaneous, bilateral TKA
12. Non-TKA prosthesis
13. Scheduled for non-SDD TKA.
14. Preoperative varus/valgus of \>10 degrees.
15. Planned General Anaesthetic
16. Use of Intrathecal Morphine
Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery

This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.

PRIMARY OBJECTIVE:

I. To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures.

SECONDARY OBJECTIVE:

I. To determine the accuracy of the MRI-based image guidance.

OUTLINE:

Patients undergo standard of care spine surgery with MRI-based image guidance.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson
* Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
* All diagnoses are eligible
* Vertebral body site to be treated located from T2 to T12
* Signed informed consent

Exclusion Criteria:

* Requires open spinal procedure or a percutaneous procedure without the use of image guidance
* Unable to tolerate general anesthesia and prone position
* Unable to undergo MRI scan of the spine
NAC Supplementation and Skeletal Muscle Performance

In this investigation the investigators utilized NAC administration to foster GSH availability during an 8-day period following eccentric exercise-induced muscle damage in order to test our hypotheses: i) antioxidant supplementation does not disturb performance and adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.

The major thiol-disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a key-regulator of major transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced cellular adaptations.

Our objective was to examine how thiol-based antioxidant supplementation affects skeletal muscle's performance and redox-sensitive signalling during the inflammatory and repair phases associated with exercise-induced micro-trauma.In a double-blind, counterbalanced design, 12 men received placebo (PLA) or N-acetylcysteine (NAC, 20 mg/kg/day) following muscle-damaging exercise (300 eccentric contractions). In each trial, muscle performance was measured at baseline, post-exercise, 2h post-exercise and daily for 8 consecutive days. Muscle biopsies from vastus lateralis and blood samples were collected pre-exercise and 2h, 2d, and 8d post-exercise.

Eligibility Criteria:
Inclusion Criteria:

a) recreationally trained as evidenced by their maximal oxygen consumption levels (VO2max \>45 ml/kg/min), b) were engaged in systematic exercise at least three times/week for ≥12 months), c) non-smokers, d) abstained from any vigorous physical activity during the study, e)abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study.

Exclusion Criteria:

a) a known NAC intolerance or allergy, b) a recent febrile illness, c) history of muscle lesion, d) lower limb trauma
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention

The purpose of this study is to investigate the effect of two types of education on HbA1c level and future amputations in inpatient diabetics after initial minor foot amputation

This is a single center prospective randomized study evaluating inpatient diabetics after initial minor foot amputations.

b) When a potential enrollee has been identified, while still inpatient, one research associate from a group of trained residents and medical students will spend 15-30 minutes with the patient to enroll and give one of the two education video presentations. The video presentations are the narrated versions of the slides attached to the IRB application. We will have both English and Spanish videos available. Because we are using video education, the education provided will be standardized across all patients, and there will be minimal variation in education provided despite using different research associates. The patients will be randomized to one of the two presentations. Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes. Each enrollee will also be asked if they are receiving structured diabetes education at the Montefiore Diabetic Center and will be encouraged to follow up to receive structured education there.

The education presentation will occur after post-operative day 1 after minor foot amputations.

Primary Outcome: HbA1c level Secondary Outcomes: LDL level, Mortality, Re-amputation (higher level or contralateral leg)

Eligibility Criteria:
Inclusion Criteria:

* HbA1c 6.5 and above
* had minor foot amputation this hospitalization
* Age 18 years old and older
* All ethnicities
* Both genders

Exclusion Criteria:

None
Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee

OA knee is a common degenerative diseases of the joint.

* There are many methods to treat this condition.
* Hyaluronic acid is one of the recomended treatment of OA knee.
* There is no any study on MRI change after injection hyaluronic acid.
* The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .

This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with OA of the knee joints. Randomization will be stratified by Kellgren-Lawrence(KL) grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in this study. The study will be conducted over approximately 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Ambulatory non pregnant females and males 40-\<80 years of age.
* Subjects who withdraw pain medication or nutritional supplements for symptom relief for OA hand for a total of at least 30 days before screening visit 0.
* Pain at or below 40 mm on a 100 mm VAS in the index knee joints.
* A documented diagnosis of OA of the knee joint, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening.
* Subject has been documented radiographic evidence of OA of the knees from the screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading.
* Subject has no any contraindication for MRI
* Subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.

Exclusion Criteria:

* Subjects with history of hypersensitivity to hyaluronate.
* Subjects with skin lesion at the knee joint.
* A history of knee surgery within 6 months prior to screening V0.
* Significant prior injury to the knee joint within 12 months prior to screening V0.
* Disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint.
* Treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
* chronic systematic corticosteroids
* Diacerin or glucosamine treatment within the last 12 months.
China ADVATE PTP Study

The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the treatment and prevention of bleeding episodes (BEs)


Eligibility Criteria:
Main Inclusion Criteria:

* Ethnic Chinese
* is of any age
* has a documented diagnosis of severe or moderately severe hemophilia A (congenital FVIII deficiency: baseline Factor VIII (FVIII) ≤ 2%)
* has documented and verified \>50 exposure days (EDs) to FVIII (recombinant or plasma derived)
* is receiving on-demand treatment with FVIII at the time of enrolment in this study
* has negative history of inhibitor development
* is HIV negative or HIV positive with stable disease and CD4+ count ≥ 200 cells per mm\^3
* is negative for Hepatitis C virus (HCV); Or participant is HCV positive with chronic stable hepatitis as assessed by investigator

Main Exclusion Criteria:

* has prior history of hypersensitivity or anaphylaxis associated with receipt of FVIII
* is diagnosed with other bleeding disorder(s) other than hemophilia A, including but not limited to thrombocytopenia (platelet count \< 100000 /mL)
* has been exposed to an investigational product (IP) within 30 days prior to the screening visit or is scheduled to participate in another clinical study involving an IP or investigational device during participation in the study
* is planned, or likely to have surgery during the study period
* has end-stage renal failure or evidence of a severe or uncontrolled systemic disease as judged by the investigator
* has active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 5 times the upper limit of normal)
* has clinical or laboratory evidence of severe liver impairment including (but not limited to) a recent \& persistent international normalized ratio (INR) \>1.4, and/or the presence of splenomegaly and/or significant spider angioma on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices
* is a family member of the investigator or site staff
Predictive Platform for PEople aGed and Requiring ASsistancE

The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.

The object of the present project is to evaluate an instrument for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss. The device consists of a set of sensors embedded in the house with minimal invasiveness. The solution transmits the collected data to a remote storage server. Data will then be available for distance consultations by users (i.e., patients, careers or physicians). The study will conduct a wide range of evaluations of the device (technical, clinical, and economic), which will allow the optimization of the prototype. The evaluation of the solution will involve 25 frail or disable community-dwelling subjects living alone for 6 months. Comprehensive assessments will be conducted to highlight the feasibility, integration in healthcare network, and clinical relevance of the technological device.

Eligibility Criteria:
Inclusion Criteria:

* patient aged 75 or more, living alone at home
* frail of disable (ADL superior or equal at 3)
* able to walk by themselves

Exclusion Criteria:

* patient presenting a Mini Mental State lower at 16/30 and without a daily intervention from a caregiver
* non agreement of study participation of patients or the reliable person when appropriate.
Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.


Eligibility Criteria:
Inclusion Criteria:

-Corrosive substance ingested children with grade IIb esophageal burn

Exclusion Criteria:

* Caustic substance ingested chldren grade I, IIa and grade III esophageal burns
* Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis
* Caustic substance ingested children with any chronic disease
Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors

This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a histologically or cytologically confirmed advanced solid tumor at screening.
* Male or female equal or greater than 18 years of age.
* All female subjects of childbearing potential must each have a negative serum pregnancy test result before initiating study treatment.
* An Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
* Adequate bone marrow, liver, and renal function, defined as:

  * Platelet count equal or greater than 75 x 10(9)/L
  * Hemoglobin (Hb) equal or greater than 9.0 g/dL
  * Absolute neutrophil count (ANC) equal or greater than 1.5 x 10(9)/L
  * Total bilirubin equal or less than 1.5 x upper limit of normal (ULN)
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal or less than 3 x ULN (equal or less than 5 x ULN for subjects with liver metastases)
  * Serum creatinine equal or less than 1.5 x ULN

Exclusion Criteria:

* History of cardiac disease: Active coronary artery disease (CAD), defined as myocardial infarction (MI), unstable angina, coronary bypass graft (CABG), or stenting within 6 months prior to study entry (an MI that occurred \> 6 months prior to study entry is permitted)
* Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as equal or greater than Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension
* Active, clinically serious infection(s) defined as equal or greater than Grade 2 according to NCI CTCAE, version 4.0.
* Known metastatic brain or meningeal tumors, unless the subject is \> 3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of first dose of study drug.
* Prior therapy with mesenchymal-epithelial transition factor (c-MET) inhibitors, including ARQ 197.
Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.

Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .

Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1D recorded by a pediatric endocrinologist
* Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.

Exclusion Criteria:

• No restrictions on HbA1c value at study recruitment or on use of CGMS -