cyrilzakka/clinical-trials huggingface dataset:
LUNA-EMG to Enhance Motor Functions in Multiple Sclerosis

The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the lower limb in multiple sclerosis. This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG, 30-45 minutes once a week for 12 weeks) or in the control group (standard care).

The effect of the training will be measured based on the muscular strength, walking tests, proprioception and a quality of life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* EDSS less or equal to 6.5
* Between 18 and 70 years old
* Having signed the informed consent

Exclusion Criteria:

* Acute pain syndrome
* Severe cognitive deficits
* Risk of fracture or unconsolidated fracture
* Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints
* Severe ataxia and apraxia
* Epilepsy
* Pacemakers and similar implants
* Insufficient skin conditions
Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia

This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.

1. Disease control group: patients proceeded to allogeneic HSCT as soon as possible. Patients were allowed to receive low-dose chemotherapy that is not intended for the purpose of achieving a second remission.
2. Retreatment group: Receive a second course of anti-leukemic treatment prior to allogeneic HSCT. The anti-leukemic treatment regimen will be determined based on the genetic mutation status. Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy. Patients with targetable mutations will receive appropriate targeted therapy (e.g., FLT3 inhibitors, IDH inhibitors).

For patients who have already received targeted therapy during induction treatment, the researchers may choose the treatment regimen based on the individual patient's condition.

Eligibility Criteria:
Inclusion Criteria:

1. AML patients aged ≥ 18 years.
2. High-risk AML patients according to the 2022 ELN standards who received one cycle of induction therapy.
3. Requires allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic HSCT and unrelated donor transplant).
4. KPS score greater than 60.
5. Informed consent must be signed before the start of the study procedures; if it is detrimental to the patient's condition for them to sign, the consent may be signed by a legal guardian or immediate family member.

Exclusion Criteria:

1. Acute promyelocytic leukemia.
2. Patient has received more than 440 mg/m2 daunorubicin equivalents. The cumulative dose is calculated by summing up isotoxic daunorubicin-equivalents for daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone. The conversion factors are derived from the comparison of the respective maximum doses. The conversion factor is 1 for daunorubicin, 1 for doxorubicin, 0.6 for epirubicin, 4.6 for idarubicin, and 2.7 for mitoxantrone (see worksheet for calculation).
3. Severe organ dysfunction, defined as:

1) Left ventricular ejection fraction \<50%. 2) Patients who receive supplementary continuous oxygen. 3) Serum bilirubin \>1.5 x ULN (if not considered Gilbert-Syndrome) or ASAT/ALAT \>5 x ULN.

4) Estimated Glomerular Filtration Rate (GFR) \< 50 ml/min, where: Estimated GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) 4. History of allogeneic transplantation. 5. Manifestation of AML in the Central Nervous System. 6. Pregnant or breastfeeding women.
Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction

The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in routine clinical practice. The study has a retrospective design, and will be conducted in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases


Eligibility Criteria:
Inclusion Criteria:

* have to be adults (≥18 years of age)
* newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug)
* have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period)
* have at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and
* have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period

Exclusion Criteria:

* valvular AF (at least one inpatient diagnosis in the baseline period)
* pregnancy (inpatient or outpatient diagnosis in the baseline period)
* transient cause of AF (inpatient or outpatient diagnosis in the baseline period)
* venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or
* overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date)
* have a pharmacy claim for an oral anticoagulation (OAC) dispensation (warfarin, apixaban, dabigatran, edoxaban or rivaroxaban) in the baseline period
* receive both warfarin and rivaroxaban 15 mg on the index date
* have an end-stage kidney disease or be on dialysis (one inpatient or outpatient diagnosis or procedure code in the baseline period).

For the main analysis, patients having malignant cancers (inpatient or outpatient diagnosis in the baseline period) will be excluded. A sensitivity analysis, omitting this exclusion criterion, will be performed.
Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.

Preterm neonates who start receiving enteral feeding will receive the intervention with docosahexaenoic acid (DHA) since the first day and throughout 14 days, one dose per day.

The opthalmic evaluation will be done after 4-5 weeks after birth and followed until 42-45 corrected gestational age.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1500 g
* Plan to feed by enteral way at a short term
* Written informed consent, signed by both parents.

Exclusion Criteria:

* Congenital malformations that avoid enteral feeding
* immunosuppressor diseases
* Need for major surgery
* Persistent bleeding at any level
* Mother taking n-3 supplements and planning to breastfed
* Parents who decline the authorization for participating in the study
* Early discharge to other hospital outside the metropolitan area
Mindfulness in the OR

The purpose of this research study is to understand the effect of a short mindfulness video on self perceived performance in the OR. Specifically, assessing the effectiveness of brief mindfulness intervention on physician focus, anxiety and perceived performance at the time of a procedure through a survey containing a modified flow state scale and modified applied mindfulness process scale


Eligibility Criteria:
Inclusion Criteria:

* practicing physicians or medical trainees
* employed in a hospital setting
* providing surgeries in an operating room setting.

Exclusion Criteria:

• practitioners involved in counseling roles
Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

The purpose of this study is to compare reflexology to meditative practices to reduce symptoms in cancer patients.

First, dyads were randomized to receive caregiver-delivered reflexology or meditative practice. Fatigue severity was assesses weekly via phone calls to the cancer patients during weeks 1-4 of the intervention. For patients who did not respond to the intervention during the first 4 weeks, those dyads were referred to as non-responder and re-randomized. A non-responder was determined if the level of reported fatigue remained the same or increased from the first week of the intervention.

The re-randomization placed the non-responders in either a group that received a higher dose (more time) with the first intervention or to the alternate practice (meditative practice to those randomized to reflexology and vice versa) for weeks 5-8. Those who did respond during weeks 1-4 continued the same therapy they began with.

Eligibility Criteria:
Inclusion Criteria:

* 21 year of age or older
* Solid tumor cancer diagnosis
* Able to perform basic activities of daily living (ADLs)
* Undergoing chemotherapy, hormonal therapy, or targeted therapy
* Able to speak and understand English
* Have access to a telephone
* Able to hear normal conversation
* Reporting a severity of 3 or higher on fatigue using a 0-10 standardized scale at intake.

Exclusion Criteria:

* Diagnosis of major mental illness on the medical record (verified by the recruiter)
* Residing in a nursing home
* Bedridden
* Currently receiving reflexology or meditative practices
* Suspected or diagnosed deep vein thrombosis or painful foot neuropathy.
Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients

Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* patients on hemodialysis for more than 3 months;
* patients without cardiological or infectious event for at least 3 months;
* patients having at least 2 dialysis session per week;
* patients affiliated with a health insurance plan;
* patients having signed an informed consent.

Exclusion Criteria:

* Pulmonary fibrosis or active lung disease;
* residual diuresis over 500 mL per day;
* body mass index (BMI) \< 21 and \> 28 Kg/m²;
* medical history of major amputation (subgonal or transfemoral);
* pacemaker carrier;
* patients with orthopedic prosthesis.
Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection

Liver resection have been a primary treatment option for lesions found in the liver. With improvements in surgical technique and perioperative patient management, morbidity and mortality related to liver resection have been greatly reduced. However, many patients with hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease plays an important role in decision making of resection extent. Therefore, liver failure and decreased liver function following liver resection still remains to be an critical issue.

Postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dL and prothrombin time of less than 50% of normal (INR \>1.7). Pathophysiology of postresection liver failure is not yet well known. However, sepsis after liver resection, small-for-size syndrome (SFSS), and ischemia/reperfusion injury are known to have important roles in persistant liver injury after resection.

After a liver resection, kupffer cells are drastically decreased and innate immunity of the patient is also damaged. This process causes the patient to be vulnerable to infection. In addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and liver regeneration is affected.

Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute inflammatory cytokines.

Recent studies have reported on many promising effects of the synthetic protease inhibitor, such as Gabexate mesilate. These include antioxidant effect, inhibition of acute inflammatory cytokine reaction, and anticoagulatory property. Based on these effects, synthetic protease inhibitor have gained attention in the role of hepatocyte protection after liver resection.

Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in surgical technique and equipment, many surgeons now perform liver resection without Pringle maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in the liver resection performed without Pringle maneuver.


Eligibility Criteria:
Inclusion Criteria:

* All liver tumors that require resection of more than two segments of the liver.
* Age ≥20 and ≤80
* General performance status: the Karnofsky score\> 70% or ECOG 0-1

Exclusion Criteria:

* Hepatic duct reconstruction was performed
* ASA (American society of anesthesiologists' physical status classification) score: ≥3
* Patients with drug or alcohol addiction
* Patients showing low compliance
* Patients who not want to involve the clinical trial
* Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?

The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty.

The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty. Therefore, factors such as patient characteristics, indication for procedure, pre-operative shoulder pain, pre-operative shoulder function, patient expectations, psychosocial factors, lifestyle factors, length of immobilization and soft tissue integrity, are subject to study.

Secondary aims are to investigate:

1. the influences of early mobilization vs. delayed mobilization of the shoulder after shoulder arthroplasty on post-operative shoulder pain, shoulder function and quality of life.
2. the inter- and intrarater reliability of the test battery used in this project, in the shoulder arthroplasty population.
3. the inter- and intrarater reliability of the shoulder joint position sense (SJPS) test and the shoulder joint force sensation (SFS) test.
4. the routines of the orthopedic shoulder surgeons before, during and after performing a shoulder arthroplasty.
5. the routines of physiotherapists in the post-operative rehabilitation of patients with shoulder arthroplasty.
6. the associations between the Patient Reported Outcome Measures (PROMS) used in AZ Monica and the Constant Murley Score (CS), and the PROMS and the Visual Analogue Scale (VAS).

and to conduct a questionnaire - and assess its reliability - measuring the expectations of the shoulder arthroplasty patients.

In order to reach the aims of this project, a prospective longitudinal study with randomized group allocation will be carried out over 48 months with estimated starting point in January 2020 and finishing in January 2024.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women \>= 18 years of age
* Scheduled for primary shoulder arthroplasty

Exclusion Criteria:

* Revision surgery
Use of Breast MRI for Local Staging

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

The medical records of patients who received breast MRI for pre-treatment staging of breast cancer will be retrospectively reviewed to see if the MRI information affected management. UAMS surgeons will be asked if the breast MRI resulted in:

1. no change in management
2. Moderate change in management-what (modified lumpectomy-larger or smaller)
3. Significant change-what (contralateral breast, additional quadrants, lump to mast, neoadjuvant chemo)-note less dz than w/o MRI, more dz than w/o MRI. The medical record of patients who were imaged will be reviewed for presenting symptom, clinical exam, imaging studies (mammogram, breast ultrasound, breast MRi) and pathology results. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a breast MRI for staging

Exclusion Criteria:

* None
Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

A descriptive comparative project will be conducted to determine if there is a difference in outcomes for adult patients requiring pericardial reconstruction using CorMatrix compared to Gentrix

A descriptive, comparative project will be conducted utilizing a retrospective chart review on patients at Methodist Mansfield Medical Center(MMMC) undergoing cardiac surgery requiring pericardial repair between the dates of January 1, 2017 through December 31, 2022. The project will compare outcomes of a pre- and post-intervention following use of Gentrix ECM and the CorMatrix Extracellular Matrix(ECM) pericardial patch using information gathered from the patient's electronic health record (EHR). The main outcome measures of post-operative Length of Stay(LOS), all-cause unplanned readmission within 30 days, and significant pleural effusion requiring thoracentesis within 30-days and 60 days as well as long-term (12 months) patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Must have undergone a Coronary Artery Bypass Grafting(CABG) or valve repair/replacement surgery requiring pericardial reconstruction.

CABG or valve repair/replacement surgery must have been either elective or urgent status

Exclusion Criteria:

-CABG or valve repair/replacement surgery classified as emergent status Surgery classified as redo-sternotomy
Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. The intraoperative augmentation will also be enriched with the preoperative data (e.g., CT or MRI). This will simplify minimal invasive liver surgery, improve surgical safety and accuracy. It will also shorten hospital stays and contribute to an overall better quality of life for the patient, which in return will reduce the health-care costs.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hepatectomy;
* Patients for whom good-quality imaging is available (CT scan and/or MRI and/or ultrasound);
* Patients over 18 years of age;
* Minimally invasive surgery by conventional or robot-assisted laparoscopy.

Exclusion Criteria:

* Surgery by laparotomy
Prevalence of Delirium in Patients Undergoing Cardiac Surgery

The objective of this study is to determine prevalence of postoperative delirium and confusion in patients undergoing cardiac surgery. This proposal is a pilot study designed to evaluate effect of cardiac surgery on prevalence of delirium and confusion.

The primary aim is to evaluate prevalence of delirium and confusion in patients undergoing cardiac surgery and to determine risk factors for this condition.

A secondary aim is to evaluate organic brain injury by early postoperative diffusion weighted magnetic resonance imaging (DW-MRI) in patients who develop delirium and confusion.

The hypothesis to be tested is that patients with postoperative delirium and confusion have high incidence of organic brain injury as detected by DW-MRI.


Eligibility Criteria:
Inclusion criteria:

* All patients undergoing cardiac surgery in our institute in 2 year period
* Signed informed consent

Exclusion criteria:

* Past history of transient ischemic attacks, stroke, symptomatic carotid artery disease.
* Past history of psychiatric disorders
* History of alcohol and drug abuse
* History of severe kidney or liver disease (creatinine \>2.5mg/dL and bilirubin \> 2mg/dL)
* Known contraindications to MRI