cyrilzakka/clinical-trials huggingface dataset:
Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.

Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith\&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years, any sex;
* Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
* Normal water contrast enema prior to surgery;
* Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
* Both immunosuppressant and biological medications are allowed for IBD patients.

Exclusion Criteria:

* Patients age at screening \< 18 years;
* Pregnant or breastfeeding women;
* Neurodegenerative disorders or psychiatric diseases;
* Contraindications or hypersensitivity to the use of the investigational product or its components;
* Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
* Patients with post-operative bleeding (to be assessed 24 hours after surgery).
Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection

The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 patients.

The investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of COVID-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. This will be conducted as a Phase II open label study. After being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. The study will be conducted at a single site (Loma Linda University Medical Center).

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 18-85
* Diagnosed with q-PCR confirmed infection with SARS-Cov-2 virus and admitted to the hospital.
* Receiving non-invasive respiratory support through a nasal cannula or a face mask.
* Ability to take oral medication and be willing to adhere to the tazemetostat regimen.

Exclusion Criteria:

* Unable to take PO medication.
* Need for intubation or ECMO.
* Pregnancy or lactation
* Known allergic reactions to tazemetostat.
* Active malignancy (not in remission).
* Treatment with another investigational drug.
Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis

In progressive kidney diseases, fibrosis represents the common pathway to end-stage kidney failure. The potential for stem cells to treat kidney failure was recently confirmed. Particularly, mesenchymal stem cell (MSC) has been demonstrated to protect kidney function and alleviating renal injury in these patients. Therefore, the investigators propose a hypothesis that MSCs (MSC) can also improve the disease conditions of kidney fibrosis patients, particularly reducing the decompensated conditions in these patients.

Kidney fibrosis represents the common pathway to end-stage kidney failure.The potential for stem cells to treat kidney failure was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, kidyney injury and displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs (MSC) can improve the disease conditions in patients with kidney fibrosis. This study will also look at safety in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Glomerular sclerosis ratio ≤ 50%.
3. Renal tubulointerstitial fibrosis ratio ≤ 50%.
4. Negative pregnancy test.
5. Moderately active disease under standard treatment.

Exclusion Criteria:

1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"

The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) \& High Dose (HD) (Zacras Combination Tablets LD \& HD) in hypertensive patients in daily medical practice.

This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD \& HD (Zacras Combination Tablets LD \& HD) in hypertensive patients in daily medical practice.

For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg \[for LD tablets\] or 20 mg/5 mg \[for HD tablets\] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.

Eligibility Criteria:
Inclusion Criteria:

-Hypertensive patients

Exclusion Criteria:

-Hypertensive patients who meet any of the following conditions, \[1\] to \[3\], are excluded from the survey:

1. Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
2. Patients who are pregnant or having possibilities of being pregnant
3. Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
PAINED: Project Addressing INequities in the Emergency Department

Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.


Eligibility Criteria:
Inclusion Criteria:

* All Children's National Hospital Emergency Department clinicians

Exclusion Criteria:

* None
Parents as the Agent of Change for Childhood Obesity

The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.

This study is a randomized clinical trial in which 150 overweight 8-12 year old children and their parent will be randomly assigned by the gender of the child to one of two conditions; a parent-only intervention or a parent + child intervention. Both treatment arms will provide behavioral treatment for childhood obesity for 5 months, and participants will be followed for 18-months post-treatment. Assessments will occur at baseline, immediately post-treatment, 6-12- and 18-months post-treatment. The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity (parent-only), and to evaluate the cost effectiveness compared to the current gold standard treatment of parent + child. Results of these studies will be utilized as evidence to recommend changes in the standard treatment for childhood obesity. This program of research is critical for exploring and developing interventions that mobilize parents to intervene with their overweight and obese children. The timing of this research is optimal given the increase in childhood obesity in the United States, and the need for disseminative intervention and prevention programs.

Eligibility Criteria:
Inclusion Criteria:

* Overweight child 8-12 years of age and above the 95th% for age and gender
* An overweight (BMI \> 25) parent willing to participate and attend all treatment meetings
* Eligible parent who can read at a minimum of an 8th grade level
* Family willing to commit to 5 months of treatment attendance, and follow-up for 18 months post-treatment.

Exclusion Criteria:

* Major child psychiatric disorder diagnoses
* Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed (self-report)
* Family with restrictions on types of food, such as food allergies, religious, or ethnic practices that limit the foods available in the home
* Child with physical difficulties that limit the ability to exercise
* Child with an active eating disorder (based on EDE interview)
* Families where children or parents are involved in swimming or weight training more than 5 hours per week
* Major parent psychiatric disorder
Abbott Vascular Medical Device Registry

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
3. Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
4. Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent.

Exclusion Criteria:

1. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.
Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

The ultimate goal is to improve our understanding of the pathophysiology and resistance to effective treatment of sleep disordered breathing in patients with heart failure, with a focus on selecting patients that will benefit specifically from acetazolamide treatment.

The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the most severe ventilatory control instability (strongest chemoreflex response to carbon dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary congestion, and cardiac function.


Eligibility Criteria:
Inclusion Criteria (Heart failure patients)

* Left ventricular ejection fraction (EF) \<50%, or heart failure with preserved EF
* Age 18-89

Exclusion Criteria:

* severe obstructive respiratory disease
* unstable heart failure status
* recent use of positive airway pressure therapy
* current use of opioids, benzodiazepines
* severe kidney disease
* severe anemia
Tight Closed-loop Systolic Arterial Pressure Control

The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA).

In this case series, the investigators will report the percentage of case time in hypotension (defined as systolic arterial pressure (SAP) \< 117mmHg). The target mean arterial pressure (MAP) will be set at a SAP of 130mmHg in all patients. Definition of Hypotension is target SAP - 10% (130mmHg - 13 mmHg = 117 mmHg). We will use the same SAP target in all patients even if we used a modified definition of hypotension from the study of Futier and colleagues ( JAMA 2017). We won't use a individualized SAP for each patient but the same SAP target in all patients.

The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.

The Investigators have shown the system works well based on a target MAP but not yet using a target of SAP.

The investigators will test the system in a pilot study of 13 patients undergoing High-risk abdominal surgery which require the placement of a arterial catheter, the optimization of fluid therapy and a tight SAP control.

Participants will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of vasopressor administration ( automatically delivery instead of manually adjustments)

Fluids will be given as goal directed fluid therapy in order to maintain stroke volume variation below 13% (hospital guidelines).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age of \>17)
* Elective high-risk abdominal surgery
* Patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation \< 13%)

Exclusion Criteria:

* Atrial Fibrillation
* Pregnancy
* Subjects without the capacity to give informed consent
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)

With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate. Purpose of this study is: 1) to assess the feasibility to re-engage coronary ostia after TAVR; 2) to discover potential native anatomical or prosthesis-related features that may preclude proper coronary cannulation after TAVR.

Single-center, prospective, pilot study. Aim of this study is to assess the feasibility of coronary ostia re-engagement beyond transcatheter aortic valve (TAV) stent through a transfemoral access in 300 consecutive patients undergoing transfemoral TAVR with pre-procedural computed tomography assessment available.

The possibility to selectively cannulate each coronary, the amount of time and contrast will be evaluated in each patient before and after implantation of either balloon-(SAPIEN 3) or self-expanding (Evolut R/PRO, Acurate Neo or Portico) TAVs, thus generating an internal comparator.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices
* Availability of preprocedural aortic root evaluation by computed tomography angiography scans

Exclusion Criteria:

* TAVR in degenerated bioprostheses
* Known ostial chronic total occlusion
* Transcatheter valve not deployed in its anatomical position
* Patients with hemodynamic instability during the procedure
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients

In view of the known link between pre-eclampsia, overweight/obesity and chronic kidney disease, the aim is to offer for obese and overweight patients to reduce their BMI without reducing lean body mass.

The POPADIPE project will make it possible to limit overweight or obesity by means of nutritional management chosen by the patient (hypocaloric or a dissociated diet). The latter has been the subject of little scientific investigation, particularly in relation to the management of post-pre-eclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Person affiliated to social security
* Free, informed and written consent signed by the participant and the investigator (no later than the day of day of inclusion and before any examination required by the research)
* Patient over 18 years of age at the time of inclusion and \< 45 years of age
* Having had an pre-eclampsia in the last 5 years according to the definitions of the ISSHP 2018
* Patient with a BMI between 25 kg/m² and 40 kg/m² who accepts dietetic follow up
* Patient with a medical prescription for dietetic follow-up aimed at losing weight loss
* Patient with a balanced diet

Exclusion Criteria:

* Patients with a mental disability or language barrier that prevents them from understanding or consenting to the study
* Patients deprived of their liberty by judicial or administrative decision
* Patients under psychiatric care
* Patients subject to a legal protection measure
* Patients with cognitive disorders or defined eating disorders
* Patients who are pregnant or breast-feeding
* Patients undergoing steroid treatment and/or immunosuppression
* Have been on a low-calorie or dissociated diet for at least 6 months
* Patients with CKD stage ≥ 3A
G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation

Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral cell harvest for poor graft function.

Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study.The peripheral cell harvest was aphaeresis on the fourth or fifth day after mobilization with recombinant human granulocyte colony stimulating factor. Hematogical response was assessed at 30 days after infusion. Good response was defined as neutrophil \> 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent platelet \>20×109/l without transfusion for at least 7 days. Otherwise, poor response was defined.

Eligibility Criteria:
Inclusion Criteria:

* patients received allogeneic stem cell transplantation;diagnosis of PGF after HSCT; without concurent GVHD,RELAPSE of underlying disease.

Exclusion Criteria:

* age\<14 years;active GVHD;relapse of underlying disease
A Clinical Trial Of Two Educational Strategies In Cardiovascular Health In Child Population

AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º grade in the community of Madrid.

DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an experimental group that the investigators organized a concert teaching focused on messages cardio, a second group or control group to which they will host a healthy breakfast as it has been offering the Community of Madrid .

MEASUREMENTS: The primary end result is the increase of correct answers on a standardized test to be administered before and after the activity.

Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall weight and center from before the intervention at 6 months of it.


Eligibility Criteria:
Inclusion Criteria:

* 2º grade of primary school students present the day of the activity, whose parents had signed the informed consent to participate in the study and with no exclusion criteria at the moment of the intervention

Exclusion Criteria:

* Students with food allergies or intolerances.
* Students with severe hearing impairment (not corrected).
* Students whose parents didn´t sign the informed consent to participate in the study.
* Students with a poor understanding of oral and written language.
* To have previously received healthy breakfasts interventions or educational concerts.
tDCS to Increase Aerobic Performance in Runners

Many different factors affect running performance, transcranial direct current stimulation (tDCS) is a widely used and available neuromodulation tool and could hypothetically facilitate the supraspinal drive and thereby act upstream of the motor cortex to prolong the muscles work in time to exhaustion trials. While it appears to decrease the rating of perceived exertion (RPE) during cycling, little is known about the effects of tDCS on physiological performance parameters such as maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and lactate thresholds in runners.

The aim of this prospective randomized sham-controlled clinical trial is to investigate the physiological effects of tDCS applied over the motor cortex on perceived exertion and performance-related parameters measured by an incremental treadmill test to exhaustion.

This research thus aims at answering the following questions:

1. Is active tDCS applied bilaterally over the motor cortex significantly more efficient than sham tDCS to improve the TTE?
2. Does active tDCS decreases the RPE, as compared to sham?
3. Is there any significant difference between active and sham tDCS on the physiological parameters measured during an incremental test to exhaustion, namely: VO2max, MAS, respiratory exchange ratio, blood lactate levels, maximal heart rate?
4. Does the baseline level of physical fitness influences response to tDCS?

The investigators hypothesize that 1) performance as measured by time to exertion will be increased following active and not sham tDCS due to a decreased perceived rate of exertion without significantly altering the other physiological parameters; and 2) performance as measured by incremental treadmill test to exhaustion will be more improved in recreational as compared to trained runners.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Regular running activity above 2 hours/week
* VO2max above 30 mL/min/kg

Exclusion Criteria:

* Pacemaker
* Intracerebral metallic implant
* Smoking
* Using dietary supplementation or medication potentially affecting the CNS
* Musculoskeletal injury within the past 6 weeks