cyrilzakka/clinical-trials huggingface dataset:
Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant

The purpose of this pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed hyper-responsive to donor) or have not experienced rejection (unknown responsive state).


Eligibility Criteria:
Inclusion Criteria:

* Kidney or liver transplant recipients for whom donor cells are available

Exclusion Criteria:

* HcT \<32%
Bispectral Index: A Comparison of Bifrontal Montage Agreement

The researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead.

Bispectral Index (BIS) monitors are FDA approved to gauge depth of sedation by analyzing segments of electroencephalogram (EEG) waves. The BIS monitor utilizes a proprietary algorithm to process the EEG information second by second, and outputs a number (0-100) that corresponds with a patient's level of consciousness. A level of 0 indicates no EEG activity; a level of 100 indicates awake EEG activity. Several studies demonstrated that BIS monitors may not be useful in paralyzed patients, as patients who were paralyzed and not sedated unexpectedly showed a large decrease in their BIS values following administration paralytic medications. Vivien et al found BIS values dropped an average of 24 points in already sedated patients when the patients were given paralytics. In the same year, Messner and colleagues paralyzed non-sedated volunteers and found a dramatic drop in BIS values until paralysis wore off or was reversed. Schuller et al repeated the Messner experiment and found similar results with 18 of 20 non-sedated volunteer's BIS values dropping to levels expected of patients who were sedated. These results suggest that BIS monitors are integrating electromyography (EMG) data into its algorithm to derive a BIS value. Our hypothesis is that a BIS monitor commenced after paralysis, thereby lacking exposure to any "awake" EMG activity, will result in a cleaner data set and more accurate representation of a patient's level of sedation. Studying in this manner will require the subject to wear two BIS sensors in a frontal montage. The manufacturer of the sensors gives no guidance as to which side of the forehead an individual sensor is placed, and no studies demonstrate BIS validity with the use of concurrent sensors. The purpose of the present investigation is to assess the measurement difference and variability associated with use of concurrent bifrontal BIS sensors. The data obtained will be used as a framework for a future study related to the use of paralytics and BIS monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient having elective cardiac surgery

Exclusion Criteria:

1. Patient refusal.
2. Pediatric patients.
3. Emergency procedure.
4. Patients with known or suspected carotid or cerebrovascular disease.
5. Patients with prior stroke.
6. Skin condition or anatomy preventing proper sensor placement.
Electronic Notification of Teratogenic Risks

This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).

Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 seen at a participating primary care clinic

Exclusion Criteria:

* Non-English speakers
Health-Related Quality of Life (QOL), Physical and Respiratory Function in Patients With Myeloma Affecting the Spine

The purpose of this study is to create a prospective database of patients with myeloma affecting the spine. This database will define changes in health-related quality of life over time, and the effect of incident fractures and their treatment on specific measures of pain, physical function, pulmonary function, and future fractures. In 2008, the UCSF Myeloma Service was actively caring for 347 patients with myeloma, of which 150 patients had lytic lesions on radiographs, and 100 had a known vertebral fracture. This population, as well as any new myeloma patients, will serve as the source of the study population.

The UCSF Adult Hematology Program maintains a data base of all patients with a diagnosis of multiple myeloma seen in the Clinic. As patients are treated, relapse, receive new treatment, are transplanted, or pass away, these data are entered into this Multiple Myeloma Data Base (MMDB).

The MMDB will be expanded to include parameters to identify those patients with myeloma affecting the spine. A recruitment letter will be sent to all patients in the MMDB identified as having myeloma affecting the spine asking if they would be interested in participating in this study.

Patients who agree to participate in the study will be given an appointment to meet with Dr. Wolf or Dr. Martin to discuss the study and if willing, to sign the informed consent document. They will have an exam and history taken that includes fracture history.

Patients who have signed consent will be sent for thoracic-lumbar spine films (unless they had prior spine films taken within the last 3 months). Those with normal films will not be eligible to be enrolled to the study. Those with abnormal spinal films will then be sent for MRI of the spine, pulmonary function testing, and meeting with Dr. R. Yonge who will administer the various QOL tests described below.

All eligible established and new patients will be invited to participate in the prospective study. Patients who sign the informed consent will be included in the prospective study. A minimum of 25 patients with vertebral fractures and 25 patients without fractures, will be observed to measure the impact of fractures on health-related quality of life. Study enrollment will be complete when 25 patients without a new fracture and 25 patients with a new fracture treated by balloon kyphoplasty have been enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Adults with a diagnosis of Multiple Myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures.

Exclusion Criteria:

* Myeloma patients without evidence of bony lesions in the spine.
Same-Day Antiretroviral Therapy Initiation

Data from a total of 2,500 walk-in or referred individuals who have been confirmed (diagnosed) HIV positive and accessing care and treatment services at the hospitals targeted by this study will be examined. The starting period for this project is estimated to be the last quarter (Q4) of fiscal year 2018.

This 24-month observation study will be conducted in 13 hospitals of 5 provinces in Thailand: Chiang Rai, Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. The research team of TRCARC will collect and analyze secondary and de-identified data from the hospitals' databases. In each site, clients who agree to receive Same-Day ART service will go through standard of care procedures at each hospital, which include: post-test counseling and psychosocial support, baseline lab test, clinical screening, and physical examination. The drug regimen prescribed for clients will mirror the first line ART regimen in Thailand's national guideline, which is tenofovir (TDF), emtricitabine (FTC), and efavirenz (EFV). Retention of the clients will reflect that of the hospital's protocol, and CD4 and viral load will be tested according to the national guideline.

Eligibility Criteria:
Inclusion Criteria:

1. Thai nationals
2. HIV-positive status
3. Acceptance of Same-Day ART

Exclusion Criteria:

1. not Acceptance of Same-Day ART
Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With CVD

Implement an intensive cardiac rehabilitation program at Arkansas Heart Hospital (AHH) to find out if the AHH-ICR is equivalent to the CMS approved programs when it comes to results.

Implement the ICR Program to determine if

1. AHH-ICR will increase patients physical and psychological well-being and is non-superior/comparable to current ICR programs.
2. To determine the most appropriate ICR program protocols to improve fitness and decrease cardiovascular risk factors.
3. To determine if the ICR program has a direct relationship to improvements in the health of cardiovascular patients.
4. To determine non-inferiority to already established ICR programs in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for cardiac rehab per CMS requirements.
2. Males and Females Age ≥ 65≤ 85 years
3. Acute myocardial infarction within the preceding 6 months
4. Coronary artery bypass surgery
5. Current stable angina pectoris (chest pain)
6. Heart valve repair or replacement
7. Percutaneous transluminal coronary angioplasty or coronary stenting
8. BMI ≥ 18 ≤35
9. HgA1C ≤10

Exclusion Criteria:

- 1. Renal or hepatic dysfunction 2. Amputees (unless both groups have similar patients) 3. Current chemo/radiation treatment (unless both groups have similar patients) 4. Malnutrition 5. HIV/AIDS 6. Post-Bariatric surgery patients 7. History of substance abuse 8. Gastroparesis 9. Patients taking Warfarin/Coumadin 10. CHF patients on fluid restrictions requiring monitoring of water intake from food and liquids.

11. Cognitive deficits that would preclude cardiac rehabilitation 12. Patients with physical limitations that would prevent cardiac rehabilitation 13. Patients who are unable to attend the program 14. Patient who live \>45... miles from cardiac rehab center
Shared Decision-making on Medical Tests and Care Cascades

The purpose of this randomized controlled trial is to evaluate the impact of patient and provider facing educational materials and peer comparison on medical testing conversations during annual physicals. The investigators hypothesize that education materials and peer comparison will improve conversation quality about medical testing decisions.

Medical tests may show unexpected findings leading to additional tests, treatments, and visits that cost money and take time but may not have benefits. This is a prevalent issue with major consequences for patients and clinicians. Making informed decisions about when to order medical tests may help avoid unnecessary costs and worry. However, doctors don't always have detailed conversations about medical testing and there are patient gaps in knowledge. The investigators hypothesize that education materials and peer comparison to promote conversations about medical tests will improve conversation quality about medical testing decisions. The investigators have developed patient and provider-facing interventions to educate on and promote conversations about the uses and consequences of medical tests, and the investigators will test the impact of this just-in-time educational and peer comparison intervention on the likelihood of patients having productive conversations about medical tests. The effects of the intervention will be assessed using surveys before and after the study. This work has the potential to help patients feel more supported by their healthcare system, empower patients to participate in shared decision-making, and build trust between patients and clinicians.

Eligibility Criteria:
Inclusion criteria (Physicians):

* Primary care physicians at Brigham and Women's Hospital
* In active practice

Inclusion criteria (Patients):

* Adults age 18 years old or older
* English-speaking
* Access to email
* Did not opt out of receiving research invitations from health system
* Patients of participating physicians
* Scheduled annual physical during the study period
Sleep Quality Underwent Heart Transplant, an Observational Study

The SQ_Heart has been designed as an observational study that evaluates the difference in sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98 Cardiotransplant patients.

The Primary objective of the SQ_Heart study is to evaluate the significant difference in sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of \> 5 for poor sleepers.

Patients, to be enrolled, must provide:

* Age ≥ 18 and \< 90;
* Cardiotransplant patients, with VAD or non;
* patients with VAD.
* subjects able to sign informed consent.

All the patients will have to complete some questionnaires:

* questionnaire about the diagnosis of pathology and lifestyle;
* questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep Quality (PSQI);
* questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L).

Questionnaires are necessary for the data collection for the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \< 90;
* Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;
* patients with VAD ;
* subjects able to sign informed consent.

Exclusion Criteria:

* Age \< 18;
* subjects don't sign informed consent;
* hospitalization for more than 30 days before compilation in intensive care unit.
Risks of COVID19 in the Pregnant Population

It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to collect maternal and neonatal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive or COVID19 negative with respiratory symptoms will be enrolled and followed during this study.

The objectives are to understand the prevalence of maternal fetal transmission, risk factors and outcomes of a COVID19 positive pregnancy, and how the virus can be passed from mother to infant in the pregnant population at Mayo Clinic Rochester MN. Assessments will include the viral detection and viral load in maternal and fetal specimens collected from COVID19 positive mother-baby dyads, presence of maternal and fetal inflammatory markers in blood and tissues, anti-COVID IgG and IgM in maternal and neonatal blood, viral load and viral antigens in maternal and fetal specimens. placental gross and histopathologic changes in COVID19 infected mothers, stratified by gestational age and disease severity, compared to control samples.

.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages 18 - 45 years of age and their newborn infants
* Willing and able to provide written informed consent
* Planning to deliver at Mayo Clinic in Rochester, MN

Exclusion Criteria:

* Positive for HIV, HBV, or TB
* Delivery does not occur at Mayo Clinic
Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI

ACS are a potent risk factor for AF, with new onset AF occurring in up to 1 in every 5 patients hospitalized with an ACS.

Despite its relatively frequent occurrence and the many etiologic factors involved in its pathogenetic condition, the frequency and prognostic significance of AF complicating ACS remain unclear

There are limited data available, particularly from a representative population-based perspective describing recent pharmacological and non-pharmacological management and clinical event rates associated with AF complicating ACS in the era of novel treatment strategies (in both AF and ACS) and high coronary reperfusion rates.

This registry will assess the current in-hospital management and clinical events at 6 months of consecutive patients admitted in Italian cardiology intensive care units (CCUs) for an ACS treated invasively with PCI and stent implantation who present AF at admission or during hospital stay, before or after stent implantation .

Eligibility Criteria:
Inclusion Criteria:

* All consecutive ACS patients treated with PCI with stent implantation who present AF at admission or during hospital stay, before or after stent implantation.

Exclusion Criteria:

* Patients admitted with a diagnosis of ACS at the time of enrolment but not confirmed during hospitalization
* ACS treated medically or with PCI but without stent implantation
* Patients not giving informed consent
The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp

The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp

Abdominal aortic temporary cross clamping procedures in patients with placenta accreta undergoing hysterectomy have been performed at Dr. Soetomo Hospital Surabaya for a period of 4 years. In the aortic cross-clamping procedure, an ischemic condition occurs, after the cross-clamp is released the distal tissue from the occlusion which was initially in an ischemic state gets blood flow suddenly (reperfusion) causing Ischemia Reperfusion Injury. This study aims to determine the effect of transdermal administration of carbon dioxide (CO2) as a protective factor for ischemia reperfusion injury in patients undergoing Abdominal Aorta Temporary Cross Clamp. The design of this study is experimental in patients who underwent Abdominal Aorta Temporary Cross Clamp. Subjects were divided into two groups. The first group was treated with CO2 transdermal administration and the second group was the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Placenta Accreta diagnosed with placental accreta index (PAI) based on the results of ultrasound and underwent Abdominal Aorta Clamping Surgery (Control of Bleeding in Accreta)

Exclusion Criteria:

* Patients with severe comorbid disorders based on previous clinical examination: chronic kidney disease, heart disease
* Patients with septic shock and sepsis
* Patients with peripheral artery disease
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma

This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from multiple real-world sources, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older at index date
* Diagnosis of MM
* Measurable disease according to IMWG criteria
* ECOG performance status ≤2
* Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory \[TCR\])
* At least 1 treatment following their TCR eligibility

Exclusion Criteria:

* Acute plasma cell leukemia
* Amyloidosis
* Smoldering MM
* Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
* Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
* Administration with an investigational drug within 30 days prior to index
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth).
* Between ages of 18 - 70 inclusive.
* Develop GERD symptoms following ingestion of a refluxogenic meal.
* Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study.
* Understand and sign the informed consent form.

Exclusion Criteria:

* Pregnant or lactating women.
* Allergic to pumosetrag or formulation excipients.
Brief Binge Eating and Drinking Online Intervention

This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling.

Despite the prevalence of binge drinking and binge eating behaviors among college students, few students seek care for either. Intervening with college students early is essential as untreated symptoms of binge drinking and binge eating behaviors can become more severe and persistent over time, often leading to diagnosed disorders and lasting consequences on students' social functioning, physical health, and educational attainment. Thus, the major goal of this research study is to target both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors, as well as encourage students to seek more formal in-person counseling. The intervention combines two innovations to facilitate behavior change: (1) personalized drinking and binge eating intervention content with harm reduction and cognitive behavioral skills proven to be efficacious in reducing these problematic behaviors among college students delivered via (2) a mobile-based program that increases accessibility, is easy and engaging to use, and broadens the accessibility of the intervention content to an often non-treatment seeking group. The intervention is informed by evidence-based practices, with student and expert feedback, to help limit alcohol consumption, engage in healthier eating behaviors, and practice alternate strategies to manage negative affect.

Eligibility Criteria:
Inclusion Criteria:

* full time undergraduate student at the study site
* between the ages of 18 and 24
* ability to speak and read English
* at least two occasions of binge drinking (5 or more drinks in a row for males, 4 (i.e., an objectively large amount of food with a self-reported loss of control) in the past 28 days
* at least two occasions of binge eating (i.e., an objectively large amount of food with a self-reported loss of control)151 in the past 28 days
* no receipt of mental health or substance use care in the past month.

Exclusion Criteria:

* not meeting eligibility criteria