cyrilzakka/clinical-trials huggingface dataset:
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)

Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic. These retrospective studies have limitations because self-reported race is likely not an accurate metric for level of skin pigmentation and the retrospective nature of these studies may impact the accuracy of simultaneous measures of arterial oxygen saturation and pulse oximeter values. The few prospective studies that have evaluated this issue have utilized color-matching techniques to quantify skin pigmentation, and fewer studies have directly measured skin pigmentation in relation it to pulse oximeter accuracy. The aim of this study is to prospectively measure pulse oximeter accuracy in relation to measured levels of skin pigmentation in the congenital heart disease population.

This is a prospective observational study aiming to evaluate the relationship between pulse oximeter accuracy to the measured level of skin pigmentation in pediatric patients with congenital heart disease (CHD). These patients live with varying levels of hypoxemia, making them an ideal study population to investigate this critical patient safety issue. The study population will be pediatric patients (age \<18 years old) with a diagnosis of congenital heart disease presenting for cardiac surgery at the Mount Sinai Hospital. These patient's will undergo surgery as per protocol, as if they were not in a research study, but will have their skin pigment measured using a non-invasive device (color spectrophotometer) prior to surgery. As part of the normal surgery protocols, arterial blood gas samples will be completed. The measured oxygen levels (SaO2) on arterial blood gas will be compared to the pulse oximeter value using simultaneous measurements to ensure the measures are concurrent. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (age less than 18 years old) with a diagnosis of CHD (cyanotic or acyanotic) who are presenting for cardiac surgery under general anesthesia with planned arterial access.

Exclusion Criteria:

* Age greater than 18 years old
* Emergency surgery
* Significant preoperative anemia (hemoglobin \<8.0 g/dL)
* Preoperative hemodynamic instability (i.e., \>1 vasoactive infusions or mechanical circulatory support)
* The presence of any colored nail polish on the planned site of pulse oximeter placement, planned use of any intravenous dyes intraoperatively, and patient, parent, or guardian refusal.
Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children

Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.


Eligibility Criteria:
Inclusion Criteria:

* Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB

Exclusion Criteria:

* Patients with preoperative coagulation abnormalities
* Parental refusal
* Emergency surgery
* Patients with preoperative renal or hepatic dysfunction
Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome

The purpose of this study is to determine whether children and adolescents 8-18 years of age with HLHS and related lesions who have undergone stage I palliation during infancy using an allograft patch demonstrate continued evidence of HLA antibody formation.

This study will be of a prospective cross-sectional design, consisting of three groups. The first two groups (study groups) will consist of (1) subjects with HLHS and other related lesions who have undergone stage I palliation using an allograft patch during infancy and (2) subjects with "single ventricle" lesions who have undergone stage II palliation using allograft without antecedent stage I palliation. The third group (control group) will consist of subjects who have undergone corrective or palliative surgery for CHD during infancy in which an allograft patch was not used, and in which there have been no further exposures to allograft. We have chosen to study both (1) subjects who have undergone stage I and II palliation and (2)subjects who have undergone stage II palliation only in an attempt to distinguish between sensitization that may occur from allograft exposure during stage I palliation and that which may occur during stage II palliation.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between 8 and 18 years of age.
* Parents/guardian permission (informed consent)
* Assent of the study subject
* Subjects followed within the CHOP Cardiology Division
* Operative note(s) available for review in medical record
* Have undergone stage I, stage II palliation, or corrective surgery for congenital heart disease during infancy (\<1 year of age) not requiring allograft material.

Exclusion Criteria:

* Refusal or withdrawal of informed consent and/or assent.
* unavailability of medical records to confirm operative details.
* Additional surgeries (e.g., other than stage I or II palliation) utilizing allograft
* Exposure to allograft at any point in control group AGE \<8 or \>18 years
* Presence of genetic syndrome known to affect immunologic function (e.g., DiGeorge syndrome)
Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures

The purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the abdomen improves surgical outcomes. The investigators hope to determine how a multimodal peri-operative prehabilitation program can be most effective in engaging and motivating patients to physically and mentally get ready for an abdominally-based plastic surgery operation. The overall goal is to determine if this program will improve post-operative recovery after abdominally-based plastic surgery. The importance of this new knowledge is better understanding of ways that plastic surgeons can improve outcomes, engagement, and experience of patients undergoing abdominally-based plastic surgery operations. This would translate to increased healthcare value and better long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients (\>18 years) who are undergoing elective abdominally-based plastic surgery operations in 3+ weeks by one of the following plastic surgeons: Nazerali, Lee, Murphy, Nguyen, Lorenz.

Exclusion Criteria:

* Patients who do not speak English
* Patients who do not have access to a smartphone or internet/cell service.
* Patients who are undergoing another intervention study that consists of a nutrition and/or exercise behavior change.
Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections

Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the most common pathogens associated with multidrug resistance and HAIs. These bacteria are of special concern because few therapeutic options are available.

Traditionally, the duration of treatment for severe multidrug-resistant (MDR)-GNB infections is 14 days. Studies of severe infections by GNB, regardless of susceptibility profile, have shown that shorter antimicrobial treatments are not inferior to traditional durations of therapy and are associated with a lower incidence of adverse effects. However, there are currently no studies assessing whether shorter duration of antimicrobial treatment is effective for MDR-GNB.

This open-label, randomized clinical trial aims to assess the non-inferiority of 7-day antibiotic therapy compared to conventional 14-day treatment in severe infections by MDR-GNB.


Eligibility Criteria:
Inclusion criteria

* Infection's diagnosis while in the ICU
* Severe infection in any site (defined as the presence of sepsis/septic shock or bloodstream infection or pneumonia) associated with a positive culture by MRD-GNB (Acinetobacter baumannii complex, Pseudomonas aeruginosa, and Enterobacterales bacteria, only susceptible to carbapenems and/or polymyxins)
* Hemodynamically stable and afebrile (axillary temperature less than 37.8ºC) for at least 48 hours on day 7 of adequate antibiotic therapy
* Consent of the team providing care to the patient regarding their inclusion in the research

Exclusion criteria

* Inclusion in other experimental studies involving antimicrobial therapy
* Infections that have as the primary site: endocarditis/endovascular infection, necrotizing fasciitis, osteomyelitis, abdominal abscess or other abdominal infections requiring surgical intervention (except infections that have been treated surgically, with curative character within the first 3 days of appropriate antimicrobial therapy), central nervous system Infections, empyema, prosthetic infection;
* Immunosuppression defined as: neutrophil cells \<1000/mm³ in the current hospitalization, HIV/AIDS diagnosis with last CD4 count \<200/mm³, solid organ transplantation in the last year and/or need for increased immunosuppression due to acute rejection in the last year, hematopoietic stem cell transplantation in the last year, and/or current therapy for chronic graft-versus-host disease
* Positive blood cultures for the same pathogen within 48 hours prior to randomization, when collected
* Uncontrolled concomitant infection with another GNB (regardless of susceptibility profile)
* Previous inclusion in this study
* Known pregnancy
* Patient in palliative care who has already decided not to restart antimicrobials, if necessary, or hemodynamic support measures.
Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients

This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.


Eligibility Criteria:
Inclusion Criteria

* Completion of core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)

Eligibility Criteria:
Inclusion criteria:

* Subjects with HIV-1 infection.
* Are willing and able to understand and provide written consent prior to participation in this study.

Exclusion criteria:

* Are pregnant or breastfeeding.
* Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
* Have certain medical conditions that may make participation unsafe.
* Take medication that may interact with the study medication.
* Have a history of allergy to any of the study drugs or any excipients therein.
* Other inclusion/exclusion criteria to be evaluated by the physician.
Vitamin D Improves Depression in Liver Patients

This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with normal vitamin D levels will be monitored as controls, and they will not receive any intervention.

Patients with chronic liver diseases regularly suffer from vitamin D deficiency and depression. A recent meta-analysis reported an inverse correlation between depression and vitamin D levels. Indeed, vitamin D receptor is present and genomic and nongenomic vitamin D receptor-mediated signalling has been described in brain.

This intervention study investigates whether vitamin D therapy ameliorates depressive symptoms in chronic liver disease patients.

The investigators hypothesise that depressive symptoms will improve upon vitamin D replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* over 18 years of age
* chronic liver disease

Exclusion Criteria:

* severe hepatic encephalopathy (CFF \<35 Hz)
* Interferon treatment
* hypercalcaemia (\>2.7 mmol/l) or hypercalciuria (\>8.0 mmol/d) with or without hyperparathyroidism (\>65.0 pg/ml)
* history of calcium-containing kidney stones
* allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin
* sarcoidosis
* stage IV or V Chronic Kidney Disease
* Pregnancy
Opioid Dispenser for Microdiscectomy/Laminectomy

The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.

Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles.


Eligibility Criteria:
Inclusion Criteria:

* opioid-naive patients or intermittent opioid users within 3 months of scheduled surgery
* At least 18 years old
* presenting for primary elective one-level lumbar laminectomy and/or discectomy via posterior approach with participating surgeon
* planned discharge on day of surgery/23 hour admission
* planned discharge to home

Exclusion Criteria:

* patients with opioid-tolerance
* patients without a smart-phone or without the ability to perform Telehealth visits
* patients unable to utilize the medication dispensing device
* patients presenting for other surgeries/surgeries with combined anterior/lateral approaches
* patient refusal
* allergy or intolerance to opioids
* planned admission after surgery
* planned discharge disposition to nursing facility or skilled rehabilitation
* planned use of or preference for opioid other than oxycodone
* patients who are pregnant
Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors

This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.

Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.

Eligibility critera:

* age 18-60, females, as a marjority of lupus patients are female
* at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
* Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
* LDL cholesterol 100-190mg/dl

Exclusion criteria:

* Pregnancy, and or lactating or wants to get pregnant
* Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
* already on lipid lowering therapy
* already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
* has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of \<0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60, female
* have at least four ACR criteria for SLE
* SLEDAI score \> 4
* LDL cholesterol level from 100-190mg/dl

Exclusion Criteria:

* Pregnant, lactating, or wanting to become pregnant
* unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK
* already on lipid lowering therapy
* participating in another lupus study
* on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol
* has a diagnosis of myositis
Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death.

The main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

Fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (FETO group) or 2. Postnatal therapy only (Control)

Main outcome: Survival rate in both groups Second outcomes: Postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection).

Eligibility Criteria:
Inclusion Criteria:

* ultrasound diagnosis of congenital diaphragmatic hernia
* fetuses at gestational age between 24 and 28 weeks
* absence of chromosomal and/or other structural anomalies (isolated congenital diaphragmatic hernia)
* severe congenital diaphragmatic hernia defined by lung-head ratio \< 1.0 and more than 1/3 of liver herniated into fetal thorax and observed/expected fetal total lung volume \< 0.35
* patient's consent to participate in the present study

Exclusion Criteria:

* Patient's refusal to participate in the study after allocation
* Preterm labor diagnosed before the procedure
* Preterm rupture of membranes before fetal intervention
A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Age 18 to 55 years (inclusive).
3. Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
4. Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.

Exclusion Criteria:

1. Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
2. Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
3. Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
4. Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
5. Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
6. Subjects who had a history of smoking in the previous 3 months (average daily smoking \> 5 cigarettes), or who could not stop using any tobacco products during the test period.
7. Subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 mL beer, 150 mL wine or about 50mL low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period.
8. Subjects with a history of drug abuse, drug dependence or positive drug screening.
9. Determined by the investigator to be unfit to participate in this clinical trial.