cyrilzakka/clinical-trials huggingface dataset:
Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring

200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week.


Eligibility Criteria:
Inclusion Criteria:

* patient with acute ischemic stroke or TIAs (within one week of onset)

Exclusion Criteria:

* history of persistent AF
* initial ECG is AF
* primary hemorrhagic stroke
* acute large vessel dissection
* inability or refusal of consent
Kidney Coordinated Health Management Partnership

As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention that targets improvements in the delivery of evidence-based CKD care.

To test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention to improve the delivery of evidence-based Chronic Kidney Disease (CKD) care in patients with high-risk CKD. Investigators will perform a 42-month pragmatic, cluster randomized (at the practice level) controlled trial in 1,650 patients with high-risk CKD (as defined by validated risk prediction models or by current estimated Glomerular Filtration Rate (eGFR) value or recent decline in eGFR values) managed by their Primary Care Physicians (PCPs) to determine whether EHR-based PHM improves key processes of care and clinical outcomes.

The investigators hypothesize that EHR-based PHM will improve hypertension control, use of renin angiotensin aldosterone system inhibitors (RAASi), and avoidance of renally contraindicated medications (Aim 1a-1c) and delay CKD progression (Aim 2).

Investigators will also characterize the acceptability and experience of Primary Care Physicians (PCPs) in the intervention arm of the CKD PHM study (Aim 3).

Eligibility Criteria:
Inclusion criteria for PCPs: presence of an ambulatory continuity clinic in the University of Pittsburgh Medical Center (UPMC) community medicine practice.

Inclusion criteria for patients:

1. age greater than or equal to 18, and less than or equal to 85
2. most recent eGFR less than 60 ml/min/yr
3. established care with UPMC PCP
4. high risk CKD based on validated external and internal risk prediction models or severe reduction in eGFR, or substantial loss in eGFR in prior 18 months.

Exclusion Criteria for PCPs: none

Exclusion Criteria for patients:

1. history of kidney transplant
2. receiving maintenance dialysis
3. recent (within 12 months) outpatient nephrology visit
4. baseline eGFR less than 15ml/min
5. expected survival less than 6 months or hospice enrollee (e.g., stage IV heart failure, metastatic cancer, oxygen dependent Chronic Obstructive Pulmonary Disease)
Effectiveness of HIV Risk Reduction Program Among African American Men

This study will test the effectiveness of a brief clinic-based program designed to promote the correct use of condoms among young African-American men newly diagnosed with a sexually transmitted disease.

Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a major health concern, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this knowledge, safe sexual practices, including correct condom use, are not the norm among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. This study will test the effectiveness of a brief clinic-based program designed to promote the correct use of condoms among young African-American men newly diagnosed with an STD.

Participants in this single blind study will be randomly assigned to an experimental or control group. Upon being diagnosed with an STD, men in both groups will receive standard of care follow-up treatment. Men in the experimental group will also receive a one-on-one educational session on condom use. The educational session will be led by a health educator and will last about 30 minutes, depending on the existing skills and learning abilities of the participants. Using information provided by the participants on past experience with condoms, the health educator will attempt to correct misunderstandings about and problems with condom use. Upon enrollment, all men will respond to a series of pre-recorded questions and will be required to demonstrate their ability to apply condoms to a penile model. The same questions and procedure will be repeated 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* Identifies as African American
* Clinically diagnosed with an STD
* Reports at least one episode of condom use with a female within 3 months of study entry (this requirement does not restrict men who also have sex with men from study participation)
* Fluent in English

Exclusion Criteria:

* Known HIV infection
Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.

The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* any parturient 18 years of age or older
* undergoing elective cesarean delivery under spinal anesthesia
* able to consent to the study and participate in the follow-up.

Exclusion Criteria:

* any known allergy to morphine
* general anesthesia
* urgent or emergent cases
* any bleeding diathesis or other coagulopathy
* known G6PD deficiency
* any known liver disease
* known alcohol abuse or dependence
* HELLP syndrome
* thrombocytopenia or known platelet dysfunction
* history or active gastrointestinal bleeding
* acute kidney injury or chronic renal insufficiency
* contraindication/refusal to spinal anesthestic
* chronic pain
* chronic narcotic use
* illicit drug use
* allergy to any study related medications
Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC)

The purpose of this study is to assess the treatment patterns in participants with metastatic castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate specific antigen (PSA) levels and pain related to disease and overall survival will be observed.

This is an observational (study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes), longitudinal (correlational research study that involves repeated observations of the same variables over long periods of time) and retrospective (study looking back over past experience) study to describe the treatment patterns in mCRPC. Treatment patterns will be assessed by collecting medical charts from participants diagnosed with mCRPC in or prior 2009. Primarily, percentage of participants who received therapy as first line treatment will be assessed. All adverse events associated with the use of Sponsor drugs will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Report of previous surgical or medical castration
* Castration-resistant prostate cancer (CRPC) diagnosis in or before 2009
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging in or before 2009. If lymph node metastasis is the only evidence of metastasis, it must be 2 centimeters (cm) in diameter

Exclusion Criteria:

* Participation in any investigational drug or device study or early access programme
Cold Saline Irrigation Before Endobronchial Biopsy

Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital

Exclusion Criteria:

* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Is pregnant
* Has a bleeding disorder/diagnosis
* Currently taking anticoagulant medications and not stopped for procedure
* Documented low platelets (\<100,000)
* Had a biopsy taken immediately prior to the endobronchial ultrasound
Effects of Pulmonary Vasodilation Upon VA Coupling in Fontan Patients

The study involves documenting the effects of inhaled nitric oxide upon ventricular-arterial coupling in patients with congenital heart disease and passive pulmonary blood flow. Consenting patients undergoing a clinically-indicated cardiac catheterization will be given inhaled nitric oxide for 10 minutes while intraventricular pressure-volume analysis will be make via conduction catheters.

Patients with complex congenital heart disease and single ventricle physiology typically undergo a staged surgical palliation to a situation where the single ventricle is recruited as the systemic pumping chamber and some (following a Glenn surgery) or all (following a Fontan surgery) systemic venous return flows passively to the lungs. While this physiology eliminates ventricular volume loading and normalizes systemic arterial oxygen saturations, there remain a number of physiologic burdens that limit functional capacity and life expectancy. Evidence suggests that this surgical imposition of the systemic and pulmonary vascular beds in series results in ventricular loading conditions that adversely affect ventricular function. At present, there exist limited means by which to mitigate these burdens, however, new therapies directed at reducing total pulmonary resistance may favorably affect patients with this physiology by reducing systemic venous pressures and improving both ventricular preload and afterload. One such therapy is inhaled nitric oxide (iNO), which is a selective pulmonary vasodilator that has been shown to reduce total pulmonary resistance and improve systemic venous pressures in this patient population. However limited data exist regarding the affects of pulmonary vasodilators like iNO on ventricular loading and ventricular-arterial coupling. This study proposes to assess the effects of pulmonary vasodilator therapy upon ventricular loading and ventricular-arterial coupling in single ventricle patients with passive pulmonary blood flow presenting for elective cardiac catheterization. The study components include obtaining routine (they would be obtained as a part of the clinically-indicated catheterization) hemodynamic measurements with hi-fidelity catheters rather than standard fluid-filled catheters, as well as simultaneous additional measurements with the same catheters at rest and during administration of iNO.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with single ventricle hearts having passive pulmonary blood flow presenting to the cardiac catheterization laboratory for clinically indicated cardiac catheterization.

Exclusion Criteria:

* Patients with coarctation of the aorta or known bilateral femoral arterial obstruction
* Patients with known severe systemic venous/Fontan obstruction
* Patients already receiving sildenafil or other vasodilator therapy
Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA

This study will explore the preliminary efficacy of multiple intra-articular injections of LRX712 by evaluating the ability of the drug to restore structural integrity of articular cartilage. Efficacy will be evaluated in the context of the systemic safety and local tolerability of the investigational drug.

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of multiple intra-articular injections of LRX712 in the knee when treating patients with knee osteoarthritis of mild/moderate severity, in order to support the further clinical development. This study will also allow refinement of the systemic and local pharmacokinetics of LRX712 and the exploration of drug effects on biomarkers of cartilage breakdown and regeneration in OA patients.

Eligibility Criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.

To be eligible for inclusion in this study patients must meet all of the following criteria:

* Patient must have a BMI between 18 -35 kg/m2
* Patient must have symptomatic knee osteoarthritis predominantly in one knee (index knee)
* Patient must have knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) in the index knee, as confirmed by radiography
* Patient must have radiographic confirmation of a medial joint space width of 1.5 to 3.5 mm for females, or 2 to 4 mm for males within the medial tibio-femoral compartment of the index knee

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for inclusion in this study:

* Patient has a known autoimmune disease, inflammatory or chronic arthropathy
* Patient had partial or complete joint replacement in one or both knees
* Patient has symptomatic, isolated patello-femoral pain in the index knee as per the Investigator's examination
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Previous use of LRX712 or use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
* Patient has malalignment (valgus- or varus-deformity) ≥ 7.5° in the index knee as per anatomic PA axis measured by weight-bearing short knee radiography
* History of significant cardiac conduction/electrophysiological disorder, e.g. familial long QT syndrome or known family history of Torsades de Pointes or prolonged QT syndrome or QTcF ≥ 450 msec (Fridericia Correction) for males and ≥ 460 msec for females at screening or baseline (by local 12-lead digitized ECG reading)
* Signs or symptoms, in the judgment of the investigator, of a clinically significant systemic viral, bacterial or fungal infection within 30 days prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.
The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery

Patients aged 45 to 80 years with a clinical diagnosis of stage III and IV genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. These will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery


Eligibility Criteria:
Inclusion Criteria:

* Pelvic organ prolapse with POP-Q stage \>/= 3 in anterior and/or central compartments
* Women between 45 and 80 years old

Exclusion Criteria:

* Women who refuse to participate in the study
* Patients without baseline POPQ examination documented or with a pessary previously positioned
* Previous pelvic surgeries
* Women with any contraindication for surgery or preference for conservative treatment only (pelvic muscle exercise, vaginal pessary)
* Women who are not successfully fitted with pessaries
* Current genital ulcers/infections
* Active or chronic pelvic infection
* Women who are mentally incapable of completing the questionnaires.
Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves

The purpose of this study is to determine the optimal cooling strategies to alleviate cardiovascular strain of coronary artery disease individuals during a simulated North American and Australian heatwave.

Globally, heatwaves are occurring more frequently, are of greater intensity and longer in duration. The devastating health impacts of extreme heat are increasingly recognized, particularly in vulnerable populations, such as adults with coronary artery disease (CAD). While the most effective cooling strategy during a heatwave is the use of air conditioning (AC), economical concerns can limit AC use among vulnerable populations. In addition, widespread AC use places a significant burden on the electrical grid, causing brown-outs and black-outs during periods of extreme heat.

Electric fans offer a cooling strategy with a 50-fold lower power requirement and cost compared to AC. However, the efficacy of fan use during heat waves remains contentious. The primary objective of this study is to identify the optimal cooling strategy to alleviate cardiovascular strain of CAD patients exposed to typical North American heatwave conditions (38°C with 60% relative humidity). The secondary objective is to identify the optimal cooling strategy to alleviate cardiovascular strain of CAD patients exposed to typical Australian heatwave conditions (46°C with 10% relative humidity).

Eligibility Criteria:
Inclusion Criteria:

* History of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or stable angina and/or perfusion defect during exercise testing.
* No CAD-related hospitalisations or changes in cardiac medications or change in pattern of angina for at least 3 months prior to enrolment

Exclusion Criteria:

* Body mass index ≥35 kg/m2.
* Currently undertaking estrogen therapy.
* Evidence of current fluid and electrolyte disorders, anemia, abnormal thyroid function, arrhythmias, diabetes, renal disease, liver disease, cerebrovascular disease, significant pulmonary disease, endocrine abnormalities, significant cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition or any other medical condition deemed to pose risk during the proposed experiments.
* Uncontrolled hypertension (\>180/110 mmHg).
* Recent (\<3 months) coronary bypass surgery.
* Ejection fraction \<40% and/or clinical evidence/history of heart failure.
* Significant valvular heart disease
* Resting ECG abnormalities interfering with observation of ST segment changes during testing.
Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients

The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* ICU adult patients in the need of vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours
* Patients in which PiCCO monitoring is needed

Exclusion Criteria:

* Refusal of the subject
* Technical difficulties in insertion of the PiCCO catheters
* Significant cardiac arrhythmias
* Significant valvular disease
* Pregnancy
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.


Eligibility Criteria:
Inclusion Criteria:

* Must be 50 to 59 years of age
* No fever on vaccination days
* Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
* Females of child-bearing potential must use acceptable forms of birth control

Exclusion Criteria:

* Prior history of shingles
* Prior receipt of any chickenpox or shingles vaccine
* Pregnant or breastfeeding
* Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
* Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
* Received immunoglobulin or blood products
* Receiving treatment that may weaken the immune system
* Have an immune system disorder