cyrilzakka/clinical-trials huggingface dataset:
University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project

The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS).

The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS). The first intervention consists of the use of a home monitoring tool utilizing a tablet interface. The device facilitates collection of heart failure patient self-care information, including weight, blood pressure, heart rate and heart failure symptoms. This information is collected and stored on a secured server provided by the vendor, and can be viewed by the physician and nursing team. The second intervention is a flexible diuretic regimen strategy. This intervention will be applied in an independent randomized fashion. The flexible regimen will be prescribed by the patient's physician. The two interventions will be applied to heart failure patients treated at the University of Michigan. A total of 400 patients will be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

1. University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days.
2. Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment.
3. Patients must have an assessment of left ventricular function within the previous 2 years.
4. Patients must have LVEF ≤ 40%, or LVEF \>40 with evidence of left atrial enlargement (LA dimension \> 40 mm), BNP \> 200 ng/ml or PCW \> 18 mmHg.

Exclusion Criteria:

* Prisoners
* Residents of long term nursing facilities
* Enrollment into a hospice program
* Receiving dialysis
* Patients with dementia
* Patients with dGFR less than 20ml/min.
* Patients being worked up for heart surgery.
* Patients being worked up for heart transplant.
* Patients being evaluated for revascularization.
* Patients being evaluated for heart valve intervention.
* Patients with primary pulmonary hypertension.
Hyponatraemia and Mortality in Schizophrenic and Bipolar Patients: Protocol for a Bayesian Causal Inference Study

This study seeks to investigate if hyponatraemia be a direct contributor to death in schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.


Eligibility Criteria:
Source population:

* Danish residents
* At least one International Classification of Diseases version 10 (ICD-10) F2 or F31 diagnosis from a hospital in Region Zealand and the Capital Region (Denmark)

No exclusion criteria.
Evaluation of Drug Display in Critical Care Setting

To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display.

This study has two objectives: First, before the medication monitor is shown to anesthesiologists in a clinical setting, the PKPD models must be validated to assess the clinical reliability of the model-based predictions for patients undergoing general anesthesia. Second, once the PKPD models have been successfully validated, presenting it to anesthesiologists during administration of anesthesia will assess the impact of the graphical medication monitor. Differences in performance and patient care will be determined by comparing anesthesiologists who are presented with the monitor to those who care for patients without the monitor.

Eligibility Criteria:
Inclusion Criteria:

* Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents and have been trained on the graphic display

Exclusion Criteria:

* Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents that have not been trained on the graphic display
Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?

Conventionally, physical therapy (PT) clearance is sought before total joint arthroplasty (TJA) discharge. However, PT staffing limitations may preclude same-day discharge in patients having surgery late in the day. Failed same-day discharge in eligible TJA patients results in unnecessary hospital bed occupancy, which increases costs, limits operating room throughput for patients requiring inpatient admission, and introduces risks associated with longer length-of-stay.

In collaboration with an institutional PT department, the investigators developed a protocol for discharging same-day TJA patients without postoperative PT clearance. Immediately preoperatively, PT administers gait training. Patients are then discharged home after ambulating with post-anesthesia care unit (PACU) nurses trained by PT on postoperative mobilization. This allows for the maximum number of patients discharged home, including the last patient of the day, PT staffing limitations notwithstanding. Single-institution pilot data demonstrates no increased risk of falls, emergency room (ER) visits, or readmissions with this process.

The investigators propose a prospective, controlled, multicenter study to expand on pilot data. The study aim is to assess safety of day-of-surgery preoperative PT and postoperative ambulation with PACU nursing before TJA discharge. The primary endpoint is postoperative falls, while secondary endpoints include 90-day ER visits, 90-day hospital readmissions, patient-reported outcome measures, and patient satisfaction scores.


Eligibility Criteria:
Inclusion Criteria:

* are 18 years of age or older
* undergo primary THA or TKA
* are eligible for same-day home discharge (friends or family available to stay at home with the patient for one week postoperatively and medically stable for discharge from PACU per anesthesia).

Exclusion Criteria:

* 90 years of age or older
* have sleep apnea (not eligible for same-day discharge)
* require overnight stay for any reason
* undergo revision THA or TKA.
Autologous Umbilical Cord Blood Treatment of Neonate With CHD

The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA).

Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process.

Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems

The aim of this pilot study is to evaluate the safety and feasibility of infusion of autologous umbilical cord blood (UCB) in neonates with with hypoplastic left heart syndrome (HLHS) or transposition of great arteries (TGA).

This is a prospective, matched control study, Phase I-II trial to evaluate the safety and efficacy of autologous UCB infusion in neonates with HLHS or TGA. The study group will consist of neonate that were diagnosed by prenatal fetal ultrasound with HLHS or TGA and their UCB was collected at the time of delivery.

The study group will include the patients with UCB and the control group will be patients without UCB.

All patients will have their surgery within 2 weeks from birth. The UCB will be infused to the patients in study group as soon as the patient has stabilized after the surgery and not more than 7 days after surgery.

Both groups will be followed similarity:

During hospitalization:

Neurological and cardiac evaluation a day before surgery, 7 days after surgery and at discharge.

Blood tests for immune and growth factors a day before surgery, at the time of infusion (or intended infusion for the control group) ,1 and 7 days after infusion.

have a cardiac and brain MRI before the surgery and within 14 days after surgery.

Brain and cardiac MRI before surgery, 7-14 days after surgery.

Ambulatory follow up (similar to routine follow up):

Cardiac and neuro-developmental evaluation at 1,6,12 month Blood tests for immune and growth factors at 1 month

Eligibility Criteria:
Inclusion Criteria:

1. At least 35 weeks of gestation
2. Prenatal diagnosis of HLHS including mitral stenosis/atresia, aortic stenosis/atresia, arch hypoplasia and the presence of hypoplastic left ventricle with or without VSD.
3. Norwood procedure will take place within 14 days from birth.
4. Treatment with cord blood should be given within 7 days after surgery.
5. Parental informed consent for collection of umbilical cord blood.

Exclusion Criteria:

1. Total nucleated cells (TNC) lower than 1X107 in the collected umbilical cord blood unit.
2. Infected umbilical cord blood unit.
3. Parents refusal to continue in the study at any stage.
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management

The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in patients with pleural infection.

The regimen 10 mg alteplase and 5 mg DNase twice daily that was used in MIST-2 trial is still an empiric choice. The rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg DNase) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.

Eligibility Criteria:
Inclusion Criteria:

* adult patient with age more than 17 year old
* evidence of complex parapneumonic effusion or empyema; with poor pleural fluid drainage of ≤150 mL after 24 hours of insertion of chest drain
* clinical evidence of infection such as fever and or elevated C-reactive protein (CRP) or white-cell count
* complex pleural effusion proven by ultrasound
* pleural fluid analysis that fulfilled at least one of the characteristics: frank pus, exudative nature (according to light's criteria), gram stain or culture positive, lactate dehydrogenase (LDH) \> 1000 U/L, pH \< 7.2 and/or glucose level \< 3.3mmol/L

Exclusion Criteria:

* known allergy to pulmozyme or alteplase
* acute stroke, active bleeding diathesis
* major surgery in past 5 days
* previous pneumonectomy on the infected side
* bronchopleural fistula
* pregnancy
* coagulopathy (INR \> 2, APTT \>100, platelet count \< 50,000 cells)
Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery

Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. It is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability.

Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. It has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. However, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects.

The aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.

Exclusion Criteria:

* Patients younger than 70 years of age
* Pathological fractures or multiple trauma
* Contraindications to spinal anesthesia:
* allergy to the local anesthetic
* patients treated by clopidogrel (Plavix®)
* patients treated by oral anticoagulants: dabigatran (Pradaxa®), rivaroxaban (Xarelto®), or apixaban (Eliquis®).
* Coagulation disorders: (Prothrombin Time \< 50 %, or Partial Thromboplastin Time ratio \> 1.5, or platelets \< 80 G/L),
* Local infection of the puncture site
* hyperthermia (\> 38.5°C)
* agitated patients
* patients included in another study
* patients under judicial protection
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.

Eligibility Criteria:
Inclusion Criteria:

1- Patients diagnosed as EB wounds must be chronic

Exclusion Criteria:

1. Patients Must stop other line of treatment
2. Exclude patients have:

   1. Autoimmune diseases
   2. Diabetes
"Generation Fit and Exerlearning With In the Groove"

In middle schools participating in a statewide program called "Take Time", we are randomizing youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance Dance Revolution). This program is testing feasibility of using the dance mats as a way to increase activity during the school day. We are using "Groove Masters" as a peer-mentored mechanism to keep track of the activity of youth in the intervention compared to the control group. Our main objective is increase in activity time.

We met with administrators and teachers and obtained consent and assent for this study. After assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of Life, physical fitness, GEMS Activity Rating Scale, Dennison's measure of sedentary screen time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of activity) we randomized to the intervention or control group.

In our intervention, youth play a dance game at school called "In the Groove", with the goal of 40 additional minutes each week of physical activity during the school hours.

We will obtain change scores and compare the groups to find an effect size for future studies, this this proves acceptable and feasible in Maine schools.

Eligibility Criteria:
Inclusion Criteria:

* Take Time middle school in Maine with consent/assent

Exclusion Criteria:

* Any condition that prevents a child from doing physical activity on the dance mat like photic seizures, broken leg, blindness.
Pcrit and TPP for Risk Stratification in Patients with Sepsis

The goal of this observational study is to learn about the roles of critical closing pressure and tissue perfusion pressure in monitoring hemodynamic status, evaluating organ damage, and predicting mortality risk in patients with sepsis. The main question it aims to answer is:

• Whether increases in critical closing pressure or tissue perfusion pressure are associated with a reduced risk of poor prognosis?

Within the 24 hours following the diagnosis of sepsis, patients will be categorized into four groups based on their 24-hour mean critical closing pressure (Pcc) and tissue perfusion pressure (TPP) estimated from the hourly hemodynamic data within 24 hours. Outcomes will then be compared across these different groups.

The study has been approved by the Medical Ethics Committee of Peking Union Medical College Hospital (K24C1937 and K25C0792).

To validate the reliability of mean Pcc estimated in the primary analysis, we prospectively collected hemodynamic data over a 24-h period from adult ICU patients with invasive arterial monitoring. Two methods were employed to estimate the mean Pcc for reliability validation. Based on the results of preliminary experiment, the sample size calculation showed that at least 12 individuals were needed for reliability validation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Sepsis was diagnosed according to Sepsis 3.0 criteria;
* ICU stay exceeding 24 hours after enrollment;
* Undergoing continuous monitoring of vital signs.

Exclusion Criteria:

* Significant absence of blood pressure and heart rate data within 24 hours of enrollment;
* Pregnancy or breastfeeding;
* brain death.
Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide

SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants \< 29 weeks and / or with birth weight \< 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates with gestational age \< 29 weeks and / or birth weight \< 1000 g
* Admission in the Intensive Care Unit within 6 h after birth
* IV Lipid Emulsion (LE) started latest at first day of life
* Anticipated duration of Parenteral Nutrition \>10 days
* Informed consent from legal representative

Exclusion Criteria:

* Inherited metabolic diseases
* Major congenital malformations
* Participation to another study evaluating any kind of medications
Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease

To explore the efficacy and safety of near infrared light therapy for Alzheimer's disease. Each subject will be numbered and their medical records will be established. The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.Follow-up visits will be conducted at 2 months, 4 months and 2 months after treatment. At each follow-up, scale assessment, blood, MRI, and EEG were observed


Eligibility Criteria:
Inclusion Criteria:

* The age of registration is 50-85 years old, male or female.
* The MMSE score \< 26 points can be used to complete the scale assessment.
* Patients who are not on medication and who are taking psychotropic or cognitive-improving drugs must have a stable dose for at least 12 weeks before the trial and remain the same for the duration of treatment.
* Agree to participate in the clinical trial, willing to maintain the original treatment plan during the trial, and have signed the informed consent

Exclusion Criteria:

* MRI showed evidence of abnormalities other than Alzheimer's disease, such as cerebral infarction at key sites and severe leukodystrophy (Fezakas\>Level 3).
* There are contraindications to MRI scanning, such as metal implants, claustrophobia, etc.
* A history of stroke or seizures.
* Photosensitive to sunlight or visible light, eczema or increased sensitivity of the skin at the treatment site.
* Severe vision or hearing impairment.
* Alcohol dependence, drug or other drug addiction or addiction tendency.
* During the study , subjects were pregnant, breastfeeding, or planning to pregnancy.
* He/She is currently participating in another study related to the treatment of AD.
* Researchers think that participants could not be included.
Kidney Function and Cardiovascular Events: Cohort Study in General Population

Prospective multicenter follow-up study of 10 years. Cohort established between 2005-2007 with stratified random sample of general population older than 20 years (Census 2001), N= 2746 subjects.

The aim of this study is to analyse the evolution of kidney function (KF) in the general Spanish population and its impact in terms of quality of life, survival and prognosis for relevant clinical events: mortality, major vascular events and end stage renal disease (ESRD), over a period of 10 years. This is in line with the research priorities highlighted by Kidney Disease: Improving Global Outcomes (KDIGO) 2012.

The study is a prospective multi-centre 10 year follow-up study. Cohort established in Phase I of the EPIRCE study conducted in 2005-2007; stratified random sample of the general population over age 20 (2001 Census), with 2746 subjects studied with complete baseline characterization: socio-demographic variables, lifestyle factors, vascular risk, morbidity, and RF. Cox proportional hazard additive predictors will be used to study the predictive value of renal function models. All models will be adjusted for socio-demographic factors and lifestyle. IDI and NRI will be used to determine whether the addition of KF improves the predictive ability of the existing scores. Decision curve analysis will be used to indicate different KF cut-off points take cost and benefit into account in the decision to treat or not treat.

This project addresses the predictive capacity of glomerular filtration and albuminuria on mortality and vascular events after a 10-year follow-up in the general population, with an analysis of potential improvement in predicting vascular mortality and/or major vascular events by incorporating renal function into existing scales. It also establishes associated serum DNA samples to a well phenotyped cohort for subsequent studies of gene expression and inflammatory markers on CKD. These results will therefore provide insight into the natural evolution of CKD and associated vascular risk.

Eligibility Criteria:
Inclusion Criteria:

* Subjects studied in Phase I of the EPIRCE study. Give their informed consent to participate in this phase of EPIRCE 2 study.

Exclusion Criteria:

* Exclusion criteria: subjects that cannot be located or who refuse to give their consent to participate in this monitoring phase will be excluded.
Study of Hemospray for Lower Gastrointestinal Hemorrhage

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis

Exclusion Criteria:

* Less than 19 years old
* Unwilling or unable to sign and date the informed consent
* Pregnant, lactating or planning to become pregnant within 30 days of the procedure
* Contraindicated to undergo colonoscopy

Medical/Endoscopic Exclusion Criteria

* Actual or suspected lower GI perforation or fistula
* Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* Actual or suspected ischemic colitis or infectious colitis
* Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)
* Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)