cyrilzakka/clinical-trials huggingface dataset:
Selection of Allogeneic Hematopoietic Cell Donors Based on KIR and HLA Genotypes

This study tests whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA).

Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will be tested for the KIR genes. If there is more than 1 donor available, a recommendation will be provided to study doctors as to which donors have potentially favorable KIR genes. The study doctors may or may not choose to use this donor for transplant or not based on his/her own judgment. Transplant care will not change otherwise as a result of this study.

This study is being done to demonstrate that AML patients who have donors with specific KIR and HLA genes will have a better outcome following transplant.


Eligibility Criteria:
Inclusion Criteria:

RECIPIENT

* Persons of all ages are eligible for this study.
* Patient must have diagnosis of acute myelogenous leukemia (AML) at MSK or a collaborating treating institution. Patients with de novo AML or AML with preceding myelodysplastic syndrome (MDS) are eligible.
* Patient must be a potential candidate for an unrelated transplantation procedure at the time of enrollment even though patient may not be eligible for transplantation in the future due to relapse or presence of co-morbidity(ies).
* An unrelated donor does not need to be identified at the time of enrollment. If an HLA-compatible unrelated donor is not identified for the patient, the patient will be removed from the study.

Exclusion Criteria:

* Recipients with an available sibling donor matched at HLA-A, HLA-C, and HLA-DRB1 (excluding identical twin siblings).
* Patients for whom post-transplant treatment is planned are not excluded from enrollment.
* Patients with prior allogeneic hematopoietic cell transplantation for AML. Note: Patients who have undergone prior hematopoietic cell transplantation for a diagnosis other than AML are still eligible for this study.
Dispatcher-Assisted Resuscitation Trial (DART)

The purpose of this study is to determine whether dispatcher-assisted CPR instructions with compressions and ventilations versus dispatcher-assisted CPR instructions with compressions only improves survival from out-of-hospital cardiac arrests.

Out-of-hospital cardiac arrest, a condition characterized by a person suddenly collapsing due to heart stoppage, is a leading cause of death in the United States. In out-of-hospital cardiac arrest, survival is dependent upon what the American Heart Association has termed the chain of survival which includes quick activation of the 9-1-1 system, prompt cardiopulmonary resuscitation (CPR), early defibrillation, and qualified advanced life support care (paramedic care). CPR allows for some circulation and delivery of oxygen to vital organs when the heart is no longer beating on its own. However, in some instances, the citizen bystander has not been trained in CPR, presenting a circumstance where the cardiac arrest victim may not receive CPR until the arrival of emergency medical services (EMS) personnel (i.e., paramedics). The delay in CPR adversely affects outcome and dcreases the chance of survival. In response to this need, the EMS Division of Public Health - Seattle and King County developed and instituted telephone CPR instructions that could be provided "on-the-spot" during a cardiac arrest by the emergency medical (9-1-1) dispatcher. The instructions are designed to be given over the phone to persons who have not had previous CPR training so that they can initiate CPR prior to the arrival of EMS personnel and have been termed "dispatcher-assisted" CPR. The dispatcher instructions provided by the dispatch agencies of King County include the standard "full" CPR protocol of ventilations (breathing into the victim's mouth to inflate the lungs) and chest compressions(pumping on the patients chest to help circulate the blood). The ventilations oxygenate the blood while the chest compressions pump the oxygenated blood forward. This EMS program has led to a considerable increase in the proportion of cardiac arrest victims in King County that receive citizen bystander CPR prior to EMS arrival and has been associated with improved survival (appendix 1).

Comparison: Dispatcher-assisted CPR instructions with compressions and ventillations compared to dispatcher-assisted CPR instructions with compressions only.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest events where CPR is not ongoing but a bystander is willing to attempt with assistance

Exclusion Criteria:

* Pregnancy
* Prisoners
* Cardiac arrest due to asphyxia, drowning, hanging, or electrocution
Assessment of Trunk Aesthetics: Development of a New Tool

Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale.

This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of scoliosis
* age between 10 and 17 years old
* scoliosis \>10° Cobb
* humps \> 5° ATR

Exclusion Criteria:

* History of spinal surgery
* positive neurological assessment
Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects

The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 18-65 years of age at the time of signing informed consent;
2. Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
3. Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.

Exclusion Criteria:

1. Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
2. Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
3. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy

The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.

This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)

Exclusion Criteria:

1. History of Human Immunodeficiency Virus (HIV)
2. History of Hepatitis C
3. History of diabetes that, in the opinion of the investigator, may delay healing
4. Current use of systemic corticosteroids
5. Active infection of genitals, vagina, cervix, uterus or urinary tract
6. Active bacteremia, sepsis or other active systemic infection
7. Presence of Sexually Transmitted Infection (STI)
8. Evidence of pelvic inflammatory disease (PID)
9. Known clotting defects or bleeding disorders
10. Hemoglobin \< 8 g/dL
11. Metastatic disease
12. On anticoagulant therapy
13. Participation in another interventional trial
14. Pregnancy
15. Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
17. Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
20. Intra-operative: Cases requiring conversion to laparotomy prior to study intervention
Shear Wave Elastography Registry Study

This study shall be a prospective, multicenter, single arm, consecutive, blinded, study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS ShearWave Elastography technology will be compared to FibroScan. The data collected during this study will be evaluated in accordance with the procedures set forth in this protocol.

A total of up to 300 subjects will be enrolled and treated at four US sites. Enrollment is expected to be completed within 18 months. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography), End of study will be reached after pathology results have been obtained (within a week of the initial procedure).

This study has been designed as a post-market clinical registry to evaluate the effectiveness of Endoscopic Ultrasound with Shear Wave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. All consenting, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Willing and able to provide informed consent
3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
4. Patient scheduled to undergo or have undergone Fibroscan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
5. BMI \>/=28
6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, Fibroscan)

Exclusion Criteria:

1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
2. Prior history of Hepatitis B or C infection
3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
4. Histological evidence of other concomitant chronic liver disease on biopsy
5. Inadequate liver biopsy
Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices

This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.

Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).

Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution.

Introduction: Stress related disorders may result in absenteeism and less productivity in companies. This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. In the modern world not all people are willing to attend classroom training for several reasons. In this sense, the investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.

Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).

Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution. The GI will participate in the Flourishing App Program, for eight weeks, while the GC will have access to a Control App. Then, after the evaluations, the GC will receive the intervention (Flourishing App Program), while the first group will not receive any intervention. Questions will be applied to evaluate the levels of stress and well-being of participants before and after the program and before and after each training period.

Eligibility Criteria:
Inclusion Criteria:

* Female aging from 18 to 60
* Complete higher education
* Employees from Natura Inovação/Cosméticos and from Hospital Israelita Albert Einstein

Exclusion Criteria:

* none
Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short \[HI-SHORT\] and low-long \[LO-LONG\]. Both groups (n=10 per group) will exercise on the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). \[HI-SHORT\] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. \[LO-LONG\] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for \[HI-SHORT\] and \[LO-LONG\] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 6-weeks post-trauma after SCI.
* Traumatic and atraumatic spinal cord injuries between C7 and T10
* Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B.
* Age between 18-75 years old.
* Both male and female.
* Have at least 90º bilateral knee flexion.
* Able to perform FES muscle contractions (not FES intolerant).
* Able to follow verbal instructions.

Exclusion Criteria:

* A recent history of trauma to the lower limb.
* Severe or infected pressure sore on weight-bearing skin areas.
* Illness caused by acute urinary tract infection.
* Uncontrolled spasticity or pain.
* History of cardiovascular / cardiorespiratory disease contraindicating exercise.
* Uncontrolled orthostatic hypotension.
* Unhealed decubiti at electrode placement area.
* Recurrent and uncontrolled autonomic dysreflexia.
* Active heterotopic ossification.
* Other peripheral or central neurologic injury.
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Eligibility Criteria:
Inclusion Criteria:

* Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
* Study procedure completed after 31 December 2016

Exclusion Criteria:

* Heavily calcified valves
* Valvular retraction with severely reduced mobility
* Active bacterial endocarditis
* Complex mechanism of MR (leaflet perforation, etc.)
* Significant tethering of leaflets
* Inflammatory valve disease
Cost-Effectiveness in Bladder Cancer

This randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite analysis on voided urine to detect tumour recurrences in the follow-up of patients with superficial urothelialcell carcinoma (UCC). Further, this study aims to identify subgroups of patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics in combination with a genetic marker (FGFR3 gene), such that the frequency of follow-up contact can be reduced. The overall objective is to reduce the frequency of cystoscopy during follow-up in patients with superficial UCC, leading to an improvement in quality of life at equal or lower costs. This study evaluates the cost-effectiveness of follow-up in bladder cancer.

The randomized clinical study consists of two intervention arms. The control arm consists of a conventional follow-up based on regular monitoring for urinary bladder UCC recurrences by cystoscopy. In the test arm a proportion of the cystoscopies is replaced by microsatellite analysis on voided urine. Both arms will be stratified for clinical and pathological tumour parameters as well as for the mutation status of the prognostic FGFR3 gene mutation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with resectable pT1 or pTa, grade G1-G2 transitional cell carcinoma of the bladder which is biopsy proven

Exclusion Criteria:

* Patients who present or presented with a transitional cell carcinoma of the bladder, stage pT2 or more invasive, or carcinoma in situ (CIS) and/or G3 diagnosed in history
SURgical Registry of ENDocarditis EuRope

This is a prospective, multicentric, european registry of patients with infective endocarditis undergoing cardiac surgery. Patient demographics, clinical data and laboratory values will be collected, as well as treatment outcomes at day 30, day 90 and 1-5 years after the intervention.

Infective endocarditis (IE) is now a relatively rare but worldwide disease (3-10 IE/100000 population/year) with increasing incidence especially in the Western world. IE is still associated with high morbidity and mortality, prolonged hospital stay, high risk of reinfection, significantly worsened prognosis for patients, substantially reduced quality of life, and in any case represents a major financial burden for the respective healthcare systems \[1-11\].

Patients who need to undergo cardiac surgery due to infective endocarditis (IE) are heterogeneous and present with a persistently high perioperative morbidity and mortality rate. Despite optimal and individualized perioperative management strategies, perioperative complications such as heart failure, systemic inflammatory response, vasoplegia, and sepsis is still the main reason for adverse outcomes following cardiac surgery.

The present European, multicenter IE registry (Surgical RegistRy of infective ENDocarditis in EuRope - SURRENDER) was initiated and established to record and appropriately analyze current surgical treatment options and perioperative adjunctive treatment strategies, as well as short- and long-term patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
* Missing declaration of consent
* Current participation in another interventional trial