cyrilzakka/clinical-trials huggingface dataset:
The Effect of Morphine on Prasugrel Absorption in STEMI Patients

Heart Attacks are a major cause of death in this country. When patients have a heart attack, they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is important that Prasugrel starts to work as quickly as possible following a heart attack. As many patients who have a heart attack experience excruciating pain, they are often given morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend to study the effect of morphine on the absorption of Prasugrel.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age and willing and able to provide informed consent
* Admission to hospital with a STEMI \>12 months prior to recruitment
* Previous prasugrel and morphine use with no adverse effect

Exclusion Criteria:

* Active respiratory disorder, resting oxygen saturation \< 95% or decompensated congestive cardiac failure
* Current use of anti-platelet or anti-coagulant drugs apart from aspirin 75 mg daily, or receipt of any dose of clopidogrel, prasugrel or ticagrelor in the last 2 weeks
* Current use of opiate analgesia
15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease

The investigators examine the 15-year mortality after an admission for an exacerbation of Chronic Obstructive Pulmonary disease (COPD).

Several prognostic factors will be examined. Cause of death will be examined. Data will be recruited from medical records and calling general practitioners to find out if a patient is still alive. Statistical analysis will be done with Kaplan Meier, Cox proportional hazards and Chi square

Eligibility Criteria:
Inclusion Criteria:

* admission with exacerbation of COPD

Exclusion Criteria:

* none
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.

Eligibility Criteria:
Inclusion Criteria:

* must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion Criteria:

* none
A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The Body

To investigate the pharmacokinetics of PF-04776548 following administration of a micro-dose of PF-04776548 via both intravenous and oral routes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Study objective is to determine whether Pioglitazone (PGZ) can improve clinical outcomes in hyperglycemic acute ischemic stroke (IS). The rationale for the proposed research is to develop an acute intervention that can improve neurological recovery and decrease mortality and morbidity in high-risk diabetic stroke patients.

This is a prospective, randomized, double blinded stroke intervention study. Patients presenting with hyperglycemia (blood glucose level = or \> than 150mg/dl) and acute stroke symptoms within 12h of onset will be randomized to either treatment with PGZ or placebo. Patients will receive oral drug vs placebo once daily for three consecutive days. Blood samples will be obtained at baseline and during the subsequent three days to collect various biomarkers of the stress-immune response following ischemic stroke. Clinical outcomes (NIH-SS and mRS) will be determined at 3 months. Secondary outcome measures are changes in the various blood biomarkers comparing both study groups.

Eligibility Criteria:
Inclusion Criteria:

1. Stroke Patients ages 21 and over
2. Blood sugar ≥ 150 mg/dl
3. Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown)
4. MRI or CT proven ischemic stroke
5. Initial NIH SS of ≥ 2
6. Willing and able to provide consent

Exclusion Criteria:

1. Known hypersensitivity to PGZ.
2. Infection at the time of presentation as defined by body temperature \> 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment.
3. Active malignancy and / or autoimmune disease requiring treatment.
4. Use of immunomodulatory drugs or chemotherapy.
5. History of stroke or brain injury within the last 90 days prior to presentation.
6. Acute illness within the last 30 days which could have affected the white blood cell count.
7. Known history of clinically significant hypoglycemia.
8. Patients already taking PGZ.
9. Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin \> 1.2 mg/dl).
10. Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure.
11. History of bladder cancer
12. Pregnant and nursing women.
13. Currently incarcerated patients.
Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial

Schizophrenia is a chronic mental disorder characterized by the occurrence of both positive symptoms, such as hallucinations and delusions, and negative symptoms, such as apathy and withdrawal, repetition of cognitive skills and disorganization. There are approximately 20 million people with schizophrenia worldwide and this number will continue to increase every year.

The aim of this study was to compare the effects of computer-based cognitive stimulation and aerobic/strengthening exercises on cognition, physical capacity, depression, quality of life, quality of life, and activities of daily living in schizophrenia patients receiving community mental health center services.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria Patients treated at TRSM Individuals diagnosed with schizophrenia between the ages of 20-60

Exclusion Criteria:

* Those who did not give consent to participate in the study Patients with a diagnosis other than schizophrenia Pregnancy Patients with chronic metabolic diseases such as diabetes, heart problems and cancer
Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

The purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.

Dialysis patient inevitably suffered from uremic bleeding although improvement of dialysis care in the past decades. Physicians used to check bleeding time as a surrogate marker for uremic bleeding. However, bleeding time isn't accurate and as well known, is poorly correlated with clinical bleeding such as surgical bleeding. Platelet function assay (PFA) is a newly developed method to measure platelet aggregation in vitro and is validated in many sorts of platelet disorders. Recently, PFA was also used to evaluate aspirin responsiveness in patients who had taken aspirin. Our study is aim to investigate uremic thrombocytopathy via PFA of dialysis patient in Taiwan. Furthermore, we will study aspirin resistance in dialysis patient.

Eligibility Criteria:
Inclusion Criteria:

* dialysis \>3 months
* Hb\>10 g/dl \& Plt \> 10000

Exclusion Criteria:

* using medication which interfere PFA except aspirin
* terminal disease such as malignancy
* active vasculitis
Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer

Clinical decision support has been shown to improve the performance of screening tests; however, few studies have documented direct clinical benefit resulting from the increased screening promoted by clinical decision support systems.

The purpose of this study was to determine if a standards-based, sophisticated decision support system could not only promote additional breast cancer screening, but also detect significantly more breast cancer

Breast cancer is the most common female cancer. In the United States, the second most common cause of cancer death in women, and the main cause of death in women ages 45 to 55 years old. The U.S. Preventive Services Task Force recommends screening mammography, with or without clinical breast examination, every one to two years among women aged 50 to 69 years old.

Recent research has shown that health care delivered in industrialized nations often falls short of optimal, evidence based care. US adults receive only about half of recommended care. To address these deficiencies in care, health-care organizations are increasingly turning to clinical decision support systems. A clinical decision-support system is any computer program designed to help health-care professionals to make clinical decisions. In a sense, any computer system that deals with clinical data or knowledge is intended to provide decision support.

Examples include manual or computer based systems that attach care reminders to the charts of patients needing specific preventive care services and computerized physician order entry systems that provide patient-specific recommendations as part of the order entry process. Such systems have been shown to improve prescribing practices, reduce serious medication errors, enhance the delivery of preventive care services, and improve adherence to recommended care standards.

The aim of this study is to show the efficacy of a decision-support system as a strategy for improving the performance of the mammography care process and the detection of significantly more breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women between 50 and 69 years old

Exclusion Criteria:

* Breast Neoplasms
* Bilateral mastectomy
* Disabled Persons
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis

The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.


Eligibility Criteria:
Inclusion Criteria:

* Clinically or genetically proven familial adenomatous polyposis
* Restorative proctocolectomy with ileal pouch anal anastomosis

Exclusion Criteria:

* Chronic or acute renal or hepatic disease
* History of oesophageal, gastric or duodenal ulcers
* Known hypersensitivity to sulindac
* Daily use during the last three months of:
* Aspirin
* Non-Steroidal Anti-Inflammatory Agents
* Probiotics
Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and sign a statement of informed consent;
* Willing and able to complete all required postoperative visits;
* Cataracts in both eyes with planned cataract removal by phacoemulsification;
* Calculated lens power within the available range;
* Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
* Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion Criteria:

* Significant irregular corneal aberration as demonstrated by corneal topography;
* Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
* Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
* Previous refractive surgery;
* Diabetic retinopathy
* Other eye conditions as specified in the protocol
* Pregnant.
Comparison to Early Detect of the Sepsis

The aim of the study was to identify co-variates associated with 30-day mortality in septic patients admitted to the emergency department in order to improve morbidity \& mortality as a sequence of sepsis in Assiut \& Suez Canal Universities by comparing both scores by utilizing parameters that are readily available .

There are a relatively large number of conditions where urgent intervention is required in order to secure the best outcome for the patient. Examples include sepsis, myocardial infarction (MI). Clinical diagnosis of some of these conditions is not always straightforward, but a common theme is that many present with deranged physiology and vital signs. Implementation of an early warning score on arrival at hospital has helped to identify seriously ill patients .

There is a high mortality rate associated with severe infection at all ages Sepsis occurs when life-threatening organ dysfunction is associated with infection.

What is a national early warning score (NEWS)? The following six simple physiological parameters are included in the scoring system: respiratory rate, oxygen saturation, temperature; the normal human body temperature range is typically stated as 36.5-37 °C( ), systolic blood pressure, pulse rate \& level of consciousness.

What is a sepsis patient evaluation in the emergency department (SPEED)? The following simple clinical, physiological and laboratory parameters are included in the scoring system : hypotension (systolic pressure \<90 mmHg) hypothermia (body temperature \<36.0°C) , hypoxemia (pulse oximetry \<90%), low hematocrit (hematocrit \<0.38), Acidosis (blood PH \< 7.35), elevated blood lactate \>2.4 mmol/L \& source of infection as pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 80 years.
* Patients of both genders.

Exclusion Criteria:

* Patient refusal .
* Accepts Healthy Volunteers .
* Aged below 18 years
Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed.

Left Ventricular Capture Management (LVCM) refers to the overall method for determining left ventricular thresholds (level of energy needed to effectively pace the tissue in the lower left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the CRT device to the pacing lead.

The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D) devices


Eligibility Criteria:
Inclusion Criteria:

* Subjects who successfully underwent implantation of an InSync II Marquis system

Exclusion Criteria:

* Subjects who are post-heart transplant
* Subjects enrolled in a concurrent study that may confound the results of this study
Pilot Study of Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy

Patients with breast cancer receive low doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy. Indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold. The investigators wish to develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects. These patients can then be targeted for close monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to radiotherapy (RT) field design for patients sensitive to RT effects. Finally, this information can be incorporated into better designs of treatment plans for future patients.

Radiotherapy plays an integral role in breast cancer therapy. Multiple randomized studies have demonstrated decreased local-regional recurrence rates and decreased breast-cancer mortality. However, balanced with this survival benefit is the potential toxicity of the treatment itself. In particular, cardiac effects of radiotherapy have been a concern and an area of research for the past 20 years. From long-term follow up of patients with lymphoma, it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular dysfunction, systolic and diastolic function abnormalities, and heart failure among cancer-survivors. Patients with breast cancer receive lower doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy. Indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold. The investigators hypothesize that they can develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects. These patients can then be targeted for close monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to RT field design for patients sensitive to RT effects. Finally, this information can be incorporated into better designs of treatment plans for future patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will receive radiotherapy as treatment for left-sided breast cancer
* Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion Criteria:

* Patients with a contraindication to contrast-enhanced MRI
Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.

The study's primary objective is to determine whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hollenhorst or other plaques, and/or areas of ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 80 years of age.
* No known prior history of retinal disease.
* Able to participate in a clinical eye examination setting.
* Able to consent.
* Subjects receiving standard of care carotid duplex ultrasounds.

Exclusion Criteria:

* Known ophthalmologic disease (e.g. glaucoma, macular degeneration, ocular injury) other than corrected refractive error.
* Lack of capacity to provide informed consent.
* Subjects younger than 18 years of age or older than 80 years of age.
* History of stroke or acute loss of vision.
* Unable to participate in a clinical eye examination setting.
Enable® Aortic Sutureless Bioprosthesis Evaluation

The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.

The EASE Enable study is intended to characterize the clinical performance of the Medtronic Enable® aortic bioprosthesis in a post-market real-world setting.

This is a Non-randomized, prospective, non-interventional multi-center post-market release (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic valve replacement with the Enable® aortic bioprosthesis, each patient will have routine follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant or prior to hospital discharge, whatever comes first), within 6 months following implantation, 1 year and annually thereafter up to 5 years post-implant.

Eligibility Criteria:
Inclusion Criteria:

* Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the two.
* Patient requires replacement of his/her native aortic valve with a bioprosthesis with or without concomitant procedures.
* Patient is above the minimum age as required by local regulations to be participating in a clinical study.
* Patient is willing to return to the implant site for follow-up visits.
* Patient has been adequately informed of this clinical study and is willing to sign the patient Data Release Form.

Exclusion Criteria:

* Patient requires replacement of two or more valves.
* Patient who underwent previous aortic valve replacement (AVR).
* Patient with native bicuspid aortic valve.
* Patient with active endocarditis or other systemic infection.
* Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or ascending aorta geometry as seen via preoperative imaging.