cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People

The trial medicine (LEO 152020) is being developed to treat people with eczema.

The aims of this trial are to find out about:

* How the trial medicine affects participant's heart rhythm.
* How much of the trial medicine is absorbed into the bloodstream, and how quickly the body gets rid of it.
* The safety of the trial medicine and any side effects that might be related to it.

The trial will last up to 45 days, and there will be up to 6 visits.

Four treatment periods are planned for this trial. In each treatment period, participant will receive a single dose of the trial medicine at dose A, trial medicine at dose B, dummy tablet, or an approved medication named moxifloxacin (used for the treatment of bacterial infections). The order of these 4 treatment periods is chosen at random. Participant will receive all 4 treatments; it is only the order of the treatments that is random.

There will be 6 trial visits and they will include 1 screening visit, 4 treatment period visits and 1 final, follow-up visit at the clinic. The 4 treatment period visits will last for 3 days, from Day -1 (check-in to the clinic) to Day 2 (check-out of the clinic). There will be a period of at least 3 days between the 4 dosing occasions.


Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 55 years of age, inclusive, at screening.
* Body mass index between 18.0 and 30.0 kg/m2, inclusive.
* In good health at screening and check-in (as applicable) for Treatment Period 1, as assessed by the investigator (or designee) based on medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable).
* Female subjects of childbearing potential must be willing to comply with the contraception requirements.

Exclusion Criteria:

* ECG with any clinically relevant abnormality, such as QTcF \>450 ms (males) or \>460 ms (females), QRS duration \>110 ms, or PR interval \>220 ms.
* Subjects at risk for Torsades de pointes based on any of the following:

  1. Uncorrected hypokalaemia or hypomagnesaemia at screening or check-in for Treatment Period 1, history of cardiac failure, history of clinically significant/symptomatic bradycardia.
  2. (Congenital) long QT syndrome or family history of idiopathic sudden death.
* Known history of ventricular arrhythmias.
* Second- or third-degree atrioventricular block.
* Use or intend to use any medications or products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in for Treatment Period 1, considered to potentially impact subject safety or the objectives of the trial, as determined by the investigator (or designee).
* Use of tobacco- or nicotine-containing products within 3 months prior to check-in for Treatment Period 1, or positive cotinine at screening or check-in for Treatment Period 1.

Other protocol defined criteria may apply.
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies

To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Primary Objective:

* Determine response rate (RR; complete and partial response \[CR, PR\]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.

Secondary Objective:

* Determine the safety and tolerability of Aroplatin

Eligibility Criteria:
Inclusion Criteria:

* Advanced solid malignancies;
* Amenable to therapy with DACH platinum agents;
* Measurable disease (RECIST criteria);
* ECOG performance score of 0-2;
* Adequate hematopoietic, liver and renal function;
* Adequate cardiac function (maximum of class II, NYHA);
* Women of childbearing potential must have a negative urine or serum pregnancy test;
* Signed written informed consent;
* Subjects must be willing to be followed during the course of treatment/observation and follow-up.

Exclusion Criteria:

* No other active malignancies;
* No prior therapy with oxaliplatin;
* No known brain metastases;
* Active, uncontrolled infection or other serious medical illnesses;
* Not using or have used any investigational therapy during four weeks before start of protocol treatment.
Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage

The purpose of this study is to determine the safety and efficacy of a drug minocycline in improving outcomes at 3 months after rupture of an aneurysm in the head.

Prior to the drug:

If you decide to take part in this study, you will have a brief interview about your medical history and any medications you are taking. You will have a medical and neurological examination, CT scan and/or an angiogram to look at the blood vessel and blood supply going to the brain, and blood samples drawn for a complete blood count, chemistry analysis and cardiac enzymes (to assess any recent damage to your heart). You will have a surgery or an image guided procedure to close your aneurysm.

Additionally, during the course of the study you may be asked to have a computerized tomography (CT scan) or magnetic resonance imaging (MRI) if there is a necessity. These tests will reveal areas that might have been damaged in your brain.

Drug:

If the tests show that you qualify as a candidate for this study, you will be randomly assigned (like a flip of a coin) to have either the minocycline drug or a dummy drug that looks the same but does not have the drug in it. For the first 7 days, the drug will be given as an injection two times a day and after that for 14 days once a day by mouth. Rest of the care will be standard like in any aneurysm patient. We study the status of your blood vessel surrounding the brain with ultrasound daily to see if they have any narrowing. If the doctors find any narrowing, you will be treated to relive the narrowing. If you are discharged home at any point in the 21 days, you will be switch the oral drug and given the required drugs with instructions.

Follow up:

Before you are discharged from the hospital and at 7, 21, 30 and 90 days after the start of the drug, the following evaluations will be performed: a complete physical and neurological examinations.

As part of this study, you are required to return to the hospital or to your physician at one (1), seven (7), twenty-one (21), thirty (30), ninety (90) days after stroke onset. You will have a physical exam, a complete neurological exam. Additionally, you will be asked questions about any health problems or hospitalizations you have had since you were discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 yrs of age
* Ruptured aneurysm
* Initiate treatment within 72 hours of SAH
* Pre Rankin ≤ 1

Exclusion Criteria:

* Hunt \& Hess 5 with no improvement
* ICP \> 30
* No plans to treat aneurysm
* Allergy to Tetracycline / Antibiotics
* Creatinine \>2
* Platelets \< 75,000
* Other brain diseases
* Previous infection requiring Tetracycline
Mentoring Program for Nursing Students

University life is a challenging period for many students. University students mostly leave their families and live in crowded environments such as home and home. Research shows that students have difficulty in adapting to university life and often experience emotional, academic, professional and economic problems. Peer mentoring is one of the methods of learning and developing life skills in meeting the needs of university students.The peer mentoring intervention, which is used effectively in nursing education, provides benefits to both mentor and menene; It provides the opportunity to grow and improve by improving positive interaction between peers.It can be said that peer mentoring has a significant effect on students in line with the literature information. In this study, it was planned to examine the impact of the peer mentoring program applied on the perceived stress and self -confidence in order to ensure that the first year students of the nursing students adapt to the university life and the profession and to gain the necessary skills to survive in this process.

In this study, it was planned to examine the impact of the peer mentoring program applied on the perceived stress and self -confidence in order to ensure that the first year students of the nursing students adapt to the university life and the profession and to gain the necessary skills to survive in this process. Study has been planned as a type of randomized controlled intervention type with pre -test and monitoring patterns, one of the quantitative research methods. 40 mentees (experiment = 20; control = 20) and 20 mentors were included in the study.12 -week mentoring program was applied to the mentees by the mentors. In the collection of research data, "Personal Information Form", "General Self -Qualification Scale", "Self -Confidence Scale" and "Perceived Stress Scale" were used. The measurements were taken 3 times:pre test, post-test and 3-months post-test.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the study

Exclusion Criteria:

* being a foreign national
* taking first-year courses repeatedly
* be in another ongoing mentoring or psychosocial support/counselling program
A Study of Galcanezumab in Healthy Participants.

The main purpose of this study is to evaluate how much galcanezumab gets into the body after it is given as an injection just under the skin by two different devices. This study will measure how much galcanezumab reaches the blood stream and will test how it affects calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may occur will be collected. The study will last about 20 weeks for each participant. Screening is required within 45 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy as determined by medical history and physical examination
* Have a body mass index (BMI) between 19.0 and 35.0 kilogram per meter square (kg/m²)
* Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

* Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab
* Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Intend to use over-the-counter or prescription medication within 7 days prior to dosing and during the study (especially systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, drugs with known hepatic toxicity, etc). Stable doses of hormone replacement therapy (HRT) are allowed for inclusion at the discretion of the investigator
* Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
A Tissue Sparing, Laser Assisted Penile Prosthesis Implantation Technique

A surgical technique using laser assisted penile prosthesis implantation

A surgical technique using deep-red laser diode for visualization of the implantation track of the penile implant or Holium Laser for clearing the track whenever it is obstructed by fibrotic tissue.

Eligibility Criteria:
Inclusion Criteria:

* Men with ED not responding to medical treatment

Exclusion Criteria:

* Men with HBA1c more than 10
Effect of Beta-blocker Therapy on QTc Response in Exercise and Recovery in Normal Subjects

Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by the abnormal QT response to exercise testing (failure of the QT interval to shorten normally). Preliminary data from our laboratory show that the exercise QT intervals of patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently not known if beta-blockers modify the QT/heart rate relationship (a primary effect on repolarization) or if the "normalizing" effect is due to the inability of subjects on beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for prolongation to occur. Moreover, the physiologic response of the exercise QT interval to beta-blockers in healthy control subjects is not known.

Objective. The objective of this study is to define the impact of beta-blocker therapy on the QT response to exercise and recovery in normal subjects.

Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1 subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker and placebo will be given in random order in a double-blind fashion. The QT response to exercise and recovery will be compared between drug-free and beta-blocker-treated states. These data will be compared to those previously collected for LQT1 subjects.

Implications. These results will provide new information about the effect of beta-blocker therapy on repolarization parameters in normal subjects, and will provide a context in which to interpret the previous findings that beta-blocker administration modifies the QT response to exercise in LQT1 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy normal adults, age- and gender-matched to previously studied LQT1 subjects

Exclusion Criteria:

* Cardiac disease
* Diabetes
* Hypertension
* Severe allergic reaction
* Asthma requiring treatment
* Use of medications other than oral contraceptives, acetaminophen, nonsteroidal anti-inflammatory drugs, or synthroid or other thyroid medications
* Pregnancy (subjects will be asked if they are pregnant)
* Inability to sign informed consent
Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea

This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.

Morphea, also known as localized scleroderma, is a rare autoimmune fibrosing disorder that affects children and adults. Morphea causes significant morbidity through atrophy and fibrosis of the skin and underlying structures. Treatment can halt the progression of disease but cannot reverse disease damage, leaving children with disfiguring scars and sometimes functional impairment. Consequently, it is of extreme importance to intervene early in the disease course with effective therapies to limit morbidity.

Circumscribed morphea is the second most common subtype in children, comprising approximately 1/3 of pediatric morphea cases. It is a disfiguring disease that can cause pain and pruritus. There are no FDA-approved treatments and no consensus exists on the ideal therapy for circumscribed morphea, either in adults or children. Most physicians use topical medications for circumscribed morphea yet there is little evidence to support these therapies. Topical immune modulators such as tacrolimus, imiquimod, and calcipotriene have been investigated in small studies, though these trials were limited by very small sample sizes of 9-19 patients and lack of a control in most. Surveys have demonstrated that topical steroids are the most commonly prescribed medication, even though the only evidence to support their use comes from case reports. With insufficient evidence regarding topical therapies, providers have no guidance when making treatment decisions, practice patterns vary widely even amongst pediatric dermatologists, and children continue with preventable scars.

The investigators specific aim is to identify effective topical therapy for circumscribed morphea. The investigators will utilize a comparative cohort study design to evaluate the comparative effectiveness of three topical medications: clobetasol ointment, calcipotriene ointment, and tacrolimus 0.1% ointment. The investigators will enroll subjects at CHW and other institutions to achieve the study enrollment necessary to power this study.

Eligibility Criteria:
Inclusion Criteria:

* presence of at least 1 active lesion of morphea on the neck, trunk, or extremities with no prior treatment to that lesion for at least 4 weeks

Exclusion Criteria:

* children receiving phototherapy or systemic therapy for their morphea
* children with linear or generalized morphea
* lesions on the face
* greater than 3% body surface area involvement
* open or ulcerated skin within morphea lesions
How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?

A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.

A single-center cohort study performed in the department of Anesthesia and Intensive Care in our Hospital. All endotracheal isolates realised in the period of study are collected from the Department of Microbiology of our Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring mechanical ventilation for more than 24 hours

Exclusion Criteria:

-
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient has evidence of myocardial ischemia or a positive functional study
* Target lesion has a visually estimated stenosis of ≥50% and \<100%
* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm
* Lesion length ≤ 20 mm by visual estimate (N/A for Cohort C)
* Baseline TIMI flow ≥ 2

Exclusion Criteria:

* The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
* Patient has a left ventricular ejection fraction \< 40%
* Patient has unprotected left main coronary disease with ≥50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
* Is receiving opioids on a regular schedule, not just as needed to control pain.
* Likely to continue to need treatment of OIC for the duration of participation in the study.

Exclusion Criteria:

* Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
* Currently using an opioid antagonist or partial antagonist.
* Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
Characteristics and Outcomes of Hospitalized Patients With COVID-19 in Spain

COVID-19@Spain is a retrospective cohort study that aims to determine the clinical characteristics of hospitalized patients with COVID-19 in Spain and to identify prognostic factors of mortality and the need for mechanical ventilation

COVID-19@Spain is a retrospective cohort study of patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The Ethics Committee for Research with Medicines of Hospital General Universitario Gregorio Marañón approved the study and waived informed consent for the collection of clinical data.

Investigators from participating centers were asked to include the first consecutive hospitalized patients (up to 100) meeting the study criteria from the start of the epidemic until March 17, 2020.

The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.

The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, and the RT-PCR cycle threshold (Ct) of the confirmatory gene. We also registered demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results, chest X-ray findings at baseline and during follow-up, complications during hospitalization, medications with potential activity against COVID-19, and supportive treatments including oxygen therapy, admission to intensive care unit (ICU), mechanical ventilation (intubation), and use of adjuvant anti-inflammatory medications such as tocilizumab and systemic corticosteroids. Drug-related adverse events of medications for COVID-19 needing discontinuation were also recorded. The clinical status of the patients as of April 17, 2020, was categorized as discharged alive (with the date of discharge), alive and currently hospitalized, and death (with the date of death).

The primary endpoint is all-cause mortality at day 28, and the secondary endpoint is the need for mechanical ventilation. Baseline was the date of hospital admission. The follow-up censoring date is April 17, 2020.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay
* Hospital admission

Exclusion Criteria:

* None