cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)

This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).


Eligibility Criteria:
Inclusion criteria

* Participant has a history of primary hypercholesterolemia or mixed dyslipidemia and meets LDL-C and triglyceride criteria.
* Visit 2:
* Participant is high risk coronary heart disease (CHD) or CHD risk-equivalent.

Exclusion Criteria

* Participant is pregnant or breast-feeding, or expecting to conceive during the study.
* Participant has a history of malignancy.
* Participant consumes more than 3 alcoholic drinks per day (14 per week).
* Participant is high risk CHD patient on statin therapy or any patient on statin therapy equivalent to 80 mg simvastatin.
* Participant with Type 1 or Type 2 diabetes mellitus that is poorly controlled, or on statin therapy.
* Participant currently engages in vigorous exercise or is on an aggressive diet regimen.
* Participant uncontrolled endocrine or metabolic disease, uncontrolled gout, kidney or hepatic disease, heart failure, recent peptic ulcer disease, hypersensitivity or allergic reaction to niacin or simvastatin, recent heart attack, stroke or heart surgery.
* Participant is human immunodeficiency virus (HIV) positive.
* Participant has taken niacin \>50 mg/day, bile-acid sequestrants, hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase inhibitors, ezetimibe, Cholestin™ \[red yeast rice\] and other red yeast products within 6 weeks, or fibrates within 8 weeks of randomization visit (Visit 3).

  * Note: Fish oils, phytosterol margarines and other non-prescribed therapies are allowed provided participant has been on a stable dose for 6 weeks prior to Visit 2 and agrees to remain on this dose for the duration of the study.
* Participant is currently receiving cyclical hormonal contraceptives or intermittent use of hormone replacement therapies (HRTs) (e.g., estradiol, medroxyprogesterone, progesterone).

  * Note: Participants who have been on a stable dose of non-cyclical HRT or hormonal contraceptive for greater than 6 weeks prior to Visit 1 are eligible if they agree to remain on the same regimen for the duration of the study.
* Participant is taking prohibited medications such as systemic corticosteroids, itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, HIV protease inhibitors, verapamil, amiodarone, cyclosporine, danazol, diltiazem or fusidic acid.
* Participant consumes \>1 quart of grapefruit juice/day.
Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients

The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+ years
* Scheduled elective knee- or hip surgery
* Must be able to understand and speak danish
* Must be able to chew and swallow food with a regular consistency
* Must be able to consume the assigned protein supplementation
* Must be able to consent participation

Exclusion Criteria:

* Vegan
* Demensia
* Critical complications to the surgery which prevents the patient from participating in the rehabilitation program
* Plasma-creatinin above 250 micromol/L
* Palliative patients
* Known intolerance of whey protein and/or collagen
* Patients with a pacemaker
Post Marketing Study on Pluvicto in Korea

Post marketing study on Pluvicto in Korea

This is open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Pluvicto in patients with mCRPC in the real-world setting in South Korea.

Eligibility Criteria:
Inclusion criteria

Study participants eligible for inclusion in this study must meet all of the following criteria:

1. Male adult patient age ≥ 18
2. Subject who are being treated with Pluvicto or whose treatment plan is finalized and scheduled to be administered at the time of consent by physician in accordance with the approved indication in South Korea
3. Subject who provided the written informed consent prior to the study enrollment

Exclusion criteria

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

1. Subject whose medical record is not accessible
2. Subject who is not willing to provide the informed consent
Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.

This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.

A total of 30 subjects will take part in the study; 10 per study part.

The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* BMI 18 - 30 kg/m2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
* Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
* Allergy or sensitivity to NSAIDs
The Impact of CRT on Renal Function

The study is observational, prospective, including patients undergoing CRT-D / CRT-P implantation in the department of cardiology. In the current project, the researchers assumed that the improvement in cardiac function obtained in patients qualified according to the ESC / PTK guidelines for resynchronization therapy may improve renal function in a prospective 12-month follow-up. In addition, it is planned to take into account the possibility of temporary deterioration of kidney function, which may occur immediately after implantation of the resynchronization device due to the nephrotoxic effect of the contrast agent.


Eligibility Criteria:
Inclusion Criteria:

Adult patients with heart failure who had met the criteria for CRT implantation according to European Society of Cardiology guidelines for the treatment of heart failure

Exclusion Criteria:

* no written consent to participate in the study
* no indications for CR implantation
* current infection
* children
* pregnant women
Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy

This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. pPCA uses magnetic resonance imaging (MRI) to create images of blood vessels inside the body. Using pPCA may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods.

PRIMARY OBJECTIVES:

I. To assess the quality of surgical plans prepared under the guidance of the non-contrast, ionizing-radiation-free perforator phase contrast angiography (pPCA) against plans based upon the current gold standard, the X-ray-based, contrast-enhanced computed tomographic angiography (CTA).

SECONDARY OBJECTIVES:

I. To assess whether pPCA is more accurate than CTA for vessel size measurement.

II. To assess the impact of pPCA-based surgical planning on the clinical outcomes of abdominal-based free flap surgery.

III. To obtain and analyze cost/expenditure information for pPCA-guided abdominal-based free flap procedures.

OUTLINE:

Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.

After surgery, patients will be followed up at 24 hours, 1 week, 3 months, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Subject must weigh =\< 350 lbs.
* Subject must be scheduled to receive uni- or bilateral breast reconstruction using one of the abdominal-based free flap techniques (deep inferior epigastric perforator \[DIEP\] flap, superficial inferior epigastric artery \[SIEA\] flap, or free-transverse rectus abdominis musculocutaneous \[TRAM\] flap) within the next 12 months.
* Subject must have received, or be scheduled to receive at least one preoperative CTA prior to the surgery.
* Subject must be able to lie in both prone and supine positions for at least 30 minutes.

Exclusion Criteria:

* Subjects who are determined to be incompatible for MRI based on local policy.
* Subjects with previous history of abdominal-based free flap surgery.
* Severe anxiety or claustrophobia that would prohibit the required study procedures from being conducted.
* Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with the subject?s safety, the informed consent procedure, or compliance to the study protocol, in the opinion of the investigator.
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
* Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
* Sufficient tumor tissue for planned analysis
* ECOG performance status of 0 or 1
* Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent

Exclusion Criteria:

* Pure sarcomas or borderline tumors or mucinous tumors
* Active second malignancy
* Known central nervous system brain metastases
* Any prior treatment for ovarian cancer, other than the first-line platinum regimen
* Evidence of interstitial lung disease or active pneumonitis
* Active, known or suspected autoimmune disease
* Condition requiring active systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications
Effect of Vericiguat on Endpoint Events in Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%

Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection \<45% between participants who take vericiguat regularly and those who donot.

Vericiguat, a novel soluble guanylate cyclase stimulator, reduced the incidence of cardiovascular death or hospitalization for HF in a population of high-risk patients with heart failure with reduced ejection fraction （HFrEF ）who had recently been hospitalized or received intravenous diuretic therapy.Given the increasing incidence of patients with ACS and its challenges posing to life，investigators intend to conduct a prospective observational study. Investigators choose several meaningful endpoints including the time of cardiovascular death or heart failure（HF) hospitalization、inflammatory markers、the value of N-terminal pro-B-type natriuretic peptide(NT-proBNP)、results of echocardiogram and life quality score.By collecting these datas and work on a group of analysis ，investigators evaluate whether differences exsit in ACS patients with ejection \<45% between participants who take vericiguat regularly and those who donot.

Eligibility Criteria:
Inclusion Criteria:

* 1.Provide written informed consent for the trial.
* 2.Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction \[NSTEMI\], or ST elevation myocardial infarction \[STEMI\]) or coronary revascularization (coronary artery bypass grafting \[CABG\] or percutaneous coronary intervention \[PCI\]).
* 3.ejection fraction \<45%.
* 4.Be male or female, aged greater than18 and less than 90 on the day of signing informed consent.

Exclusion Criteria.

* 1.SBP\<100mmHg.
* 2.Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial.
* 3.Has severe hepatic insufficiency or renal insufficiency.
* 4.Has malignancy or other non-cardiac condition limiting life expectancy to \<1 years.
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine

To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

* None
Prospective Validation of a Points Score System Predicting 30-day Survival

This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, attendance to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment.

This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al (section 10.0) on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, visits to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment. The prediction tool assigns a score from 0-20, with 20 indicating the worst survival prognosis; the investigators have designated mortality risk groups as follows: low-risk (score 0-6), intermediate-risk (score 7-13), and high-risk (score 14-20). Patient survival and quality of life will then be monitored at 30-day, 90-day, and 365-day intervals. The study will test the hypothesis that patients with a score of \>14 have a less than 20% chance of survival at 30 days.

Primary Objective:

1. To evaluate 30-day survival of patients with a score of \>14 (high-risk group)

Secondary Objectives:

1. To evaluate 30-day, 90-day, and 365-day survival of patients in low-risk (score 0-6), and intermediate-risk (score 7-13) groups, and to evaluate 90-day and 365-day survival of patients in high-risk group (score \>14)
2. To evaluate patient-reported quality of life at the above intervals using the validated FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 at time of consent
2. Ability to provide written informed consent
3. Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
4. Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
5. Those patients who undergo a course of palliative radiation therapy, it is not the requirement of this study to complete that course of treatment. Those who prematurely end their course of treatment will remain eligible Note: Patients who ultimately either choose to not receive radiation or not recommended to receive radiation will remain eligible

Note: Patients who ultimately do not complete prescribed radiation will remain eligible

Exclusion Criteria:

1. Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
2. Patients who are receiving definitive/curative course of radiation therapy
3. Patients who self-report as pregnant or nursing
Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis

This is a prospective cohort study of 30 patients who are 8-21 years of age with venous thromboembolism (VTE)- either lower extremity deep venous thrombosis (DVT) or pulmonary embolism (PE).

Participants will be in three groups- those with lower extremity DVT, those with PE, or those with both lower extremity DVT and PE. Patients will have blood drawn for thrombin generation assay, thromboelastography assay, and thromboinflammatory panel in addition to standard of care labs for diagnosis of VTE and management of anticoagulation. The patients will then fill out questionnaires on quality of life and level of exercise at their first outpatient visit 4 weeks after diagnosis. At approximately 3-6 months after diagnosis, patients will undergo two days of testing for the research study. All patients will have exercise testing using bicycle ergometry to measure global aerobic fitness. They will once again fill out questionnaires about their quality of life and level of physical activity. After a 24 hour rest period, DVT patients will undergo 31P-MR Spectroscopy and non-invasive spin labeling MRI to provide data on skeletal muscle bioenergetics (phosphocreatine metabolism), and lymphatic and venous flow respectively in the affected leg compared to the unaffected leg. This will allow each patient to be his or her own control. After these research procedures, patients will continue to receive standard of care treatment for their VTE in the Bleeding and Thrombosis clinic.

Eligibility Criteria:
Inclusion Criteria:

* Age 8- ≤ 21 years old AND
* Lower extremity deep venous thrombosis OR
* Lower extremity deep venous thrombosis AND pulmonary embolism OR
* Pulmonary Embolism

Exclusion Criteria:

* Contraindications to exercise, such as post-surgical patients with cast immobility or fractures
* Patients unable to follow instructions/commands at baseline due to developmental delay
* Patients with congenital heart disease and abnormal pulmonary circulation/perfusion
* Contraindications to undergoing magnetic resonance imaging
A Study of the Effects of Single Dose Corticosteroids on Response to Allergens

This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patient is allergic to Timothy grass pollen
* Female patients have a negative pregnancy test and agree to use birth control throughout the study
* Male patients agree to use birth control throughout the study
* Patient has been a nonsmoker for at least 6 months
* Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study

Exclusion Criteria:

* Patient is breastfeeding
* Patient has any respiratory disease other than mild stable asthma that does not require treatment
* Patient consumes more than 3 alcoholic beverages per day
* Patient consumes more than 6 caffeinated beverages per day
* Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening
* Patient has severe allergies
Natural Language Processing and Quality Assessment in Primary Care

The investigators propose to use a Natural Language Processing System (NLP) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a randomized trial, we plan to use a previously validated mailed survey (NCQA Provider Recognition Program) that requests information on the last foot exam, use of aspirin and tobacco. Patients who have been identified by NLP as not having had a foot exam will be randomized into treatment and control arms. Both arms will receive an informational letter; with a second mailing to nonresponders after one month, describing the key strategies for effective patient-physician communication during the clinical encounter. The treatment arm will also receive an informational letter and patient education brochure containing key messages about the importance of regular foot examinations. NLP will be repeated after 6 months to compare the impact of the patient education materials.


Eligibility Criteria:
Inclusion Criteria:

* primary care patients with diagnosis of diabetes

Exclusion Criteria:

* unwilling to give informed consent
Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery

Background:

The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients.

Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery.

Objectives:

Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.