cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with an LDL-cholesterol greater than 100 mg/dL
* Patients willing and able to provide signed informed consent

Exclusion Criteria:

* Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
* Patients intolerant of statins
* Patients receiving ezetimibe
* Patients intolerant of ezetimibe
* Patients receiving a niacin preparation
* Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
* Cancer undergoing active treatment
* Creatinine clearance \< 50 ml/minute
* Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level
* Participation in any clinical study within the last 30 days
* Drug addition or alcohol abuse within the past 6 months
* Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
* Active use of macrolide antibiotics or verapamil
* Consumption of grapefruit juice on a daily basis
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential
Loop Isolation-based Uploading Pre-conditioning

Myocardial protection is of crucial importance for surgical coronary revascularization in patients with ischaemic heart diseases. The investigators proposed loop isolation-based uploading preconditioning to protect heart from ischemic-reperfusion damage (LiuPhD) as a novel cardioprotective strategy, and applied to patients who underwent on-pump coronary artery bypass grafting (CABG).

Myocardial protection is of crucial importance for surgical coronary revascularization in patients with ischaemic heart diseases. Considerable effort has been made to optimize cardioprotective strategy for improving cardiac performances after global myocardial ischemia. Of various strategies, terminal warm blood cardioplegia (TWBC) delivery has been proven to be effective in reducing risk of ischemic attack at the time of myocardial reperfusion. Based on TWBC strategy and Frank-Starling law of heart, the investigators proposed loop isolation-based uploading preconditioning to protect heart from ischemic-reperfusion damage (LiuPhD) as a novel myocardial protective strategy, which procedurally renders coronary loop via brief warm blood delivery independent of extracorporeal loop following TWBC delivery just before declamping. The investigators hypothesize that LiuPhD strategy allows myocardial cells complete depolarization and drives heart into zero-loading heat cycles, contributing to enhancing myocardial physiologic reserve and improving cardiac initiative capacity responding to upcoming loading increases after onset of clamp release. The aim of the present study was to determine whether LiuPhD strategy during on-pump coronary artery bypass grafting (CABG) can attenuate reperfusion injury after global myocardial ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a first, elective, isolated, open thoracotomy, on-pump CABG were eligible for enrollment if they if they had coronary angiography-confirmed unprotected left main disease, 3-vessel disease with or without proximal LAD artery disease, or 2-vessel disease with proximal LAD artery disease.
* Inclusion criteria were evidence of preserved left ventricular function (LVEF≥35%) and normal or mild pulmonary hypertension (sPAP\<50mmHg).

Exclusion Criteria:

* Exclusion criteria were secondary CABG, emergency CABG, conversion operations form off-pump CABG or minimally invasive CABG surgery, or any additional cardiac lesions necessitating concomitant surgery, as well as being considered too high risk for surgical revascularization.
OCTA in Epivascular Glia After Dex Implant

The aim of this prospective study was for the first time, to analyze specific morphologic features in diabetic eyes with macular oedema, such as changes of the foveal avascular zone and the presence of epivascular glia, and see how they would change after dexamethasone intravitreal implant


Eligibility Criteria:
Inclusion Criteria:

* diabetic retinopathy complicated by macular edema

Exclusion Criteria:

* congenital eye disorders,
* previous diagnosis of other ocular diseases
* history of vitreous hemorrhage
MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients

The purpose of the study is to determine the usefulness of Microvolt T Wave Alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. MTWA testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The objective of the study is to prove that if a patient has a positive MTWA test, they will be more likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. The results of the study will help doctors to determine which patients would benefit the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of heart attacks
* LVEF \>0.30 and \<= 0.40 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment.

Exclusion Criteria:

* Patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (Class I indications)
* Patients who have undergone an electrophysiologic study with ventricular stimulation or a MTWA test within 1 year prior to enrollment
* Patients with medical conditions that preclude the testing required by the Investigational Plan or limit study participation
* Patients unable to complete MTWA testing requirements due to current atrial fibrillation or flutter
* Patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for MTWA testing are not available
* Patients who have experienced an MI within 1 month prior to enrollment
* Patients with advanced cerebrovascular disease per physician's assessment
* Patients classified as NYHA Class IV at time of enrollment
* Patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment
* Patients with a life expectancy of less than 1 year
Effects of Telehealth Initiative on Lupus Patients

SLE is mostly seen in young women and causes significant deformity in patients. In SLE, disease activity, body damage due to disease or treatment, comorbidities, and drugs affect body image negatively. SLE causes changes in the body such as skin rashes, uneven pigmentation, vitiligo, scars, tooth loss, alopecia, increased facial hair, stretch marks, weight gain, fatigue, pain, depression, the unpredictability of exacerbations or lack of independence, which worsens the subjective well-being of patients. can affect in that direction. Subjective well-being (SBL) is the scientific term for happiness, and SLE is thought to have a significant negative impact on SWB.

Telehealth has been proposed as a component of patient education for disease management. Telehealth, which is defined as the remote delivery of health services via telecommunication tools including telephone and internet, enables accessible and appropriate health care service and provides communication, support, and monitoring opportunities with patients. Researchers think that a telehealth education initiative can be effective on the pain and life activities of SLE patients and this effect will improve their happiness in a good way. Based on these findings, this study aimed to examine the effects of a specific telephone educational intervention on pain, happiness, and activities of living in patients with SLE. The hypothesis of this study is; is that adapted telehealth education intervention can increase the happiness and life activities of patients with SLE and reduce pain.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-45,
* Diagnosed with SLE disease
* Those who are in remission of the disease
* Those who do not use biological DMARDs
* Non-smokers
* Those who do not drink alcohol
* Those with low disease activity score,
* Neurological, psychiatric disease and non-malignant,
* Individuals who are literate, able to communicate verbally and agree to participate in the study, among those evaluated and approved by their physicians.

Exclusion Criteria:

* Having a chronic disease other than SLE
* Having a rheumatological disease other than SLE
* Having a disability to use the phone
* Those with hearing loss or visual impairment,
* Those who have undergone changes in the treatment process and those who practice non-drug therapy during the study will not be included in the study.

In determining the inclusion, exclusion and termination criteria, both the literature and the consultation of a specialist in the field were taken.
Respiration After Robot Assisted Laparoscopic Hysterectomy

The study will investigate how respiratory function is affected by robot-assisted surgery. Previous studies have investigated the impact after open and laparoscopic surgery, but there are no studies yet after robot-assisted surgery.

80 women undergoing robot-assisted hysterectomy will undergo measurements of lung function and oxygen saturation before and after the operation.

It is well known that respiration is affected during surgery under general anesthesia. Despite optimal ventilation in a respirator during the procedure, lung volume decreases, leading to atelectasis. Other effects include increased secretions in the airways, while ciliary function deteriorates. After surgery performed under general anesthesia, the patient therefore often develops hypoventilation. This can largely be explained by lingering effects of anesthetics, reduced lung volumes, atelectasis, pain and immobilization.

In a previous study, lung effects have been studied in open and laparoscopic surgery, including after hysterectomy. With the development of robotic surgery and operations on patients with an increasing number of risk factors, complementary studies are needed.

The aim of the study is to investigate changes in lung function during robot-assisted laparoscopic surgery due to uterine cancer or endometrial intraepithelial neoplasia in the uterus, and to search for predictors of low lung volume, hypoxia and pneumonia.

A consecutive series of 80 patients undergoing robot-assisted hysterectomy will be included in the study.

At the preoperative visit, a dynamic spirometry (Easyone, ndd, Medical Technologies, Switzerland) is performed in a sitting position according to international guidelines. Before the test, oxygen saturation will be measured with a finger probe. In addition, patients will assess their lung function on a visual analogue scale

Postoperatively, patients will undergo the same spirometry 2-3 hours after arrival at the postoperative ward, before the first mobilization. The test will be performed while sitting in bed with the head of the bed elevated at 60˚ and with optimal pain relief (VAS\<4). Pre-test pain assessment will be recorded as well as the patient's assessment of their lung function. The day after surgery, the same test will be performed again (including assessment of pain and lung function) in the morning before and after mobilization to walk in the room. During the hospitalization, mobilization and any breathing exercises are recorded on a special protocol.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age undergoing robotic-assisted laparoscopic hysterectomy for endometrial cancer or endometrial intraepitelial neoplasty..

Exclusion Criteria:

* cognitive impairment and difficulty understanding Swedish or English instructions.
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor

This proposal is a pilot study to describe the variations of blood sugar in pregnant women with various degrees of glucose intolerance, and how they relate to standardized meals. Blood sugar control during pregnancy is important to prevent complications for the newborn. The variation and timing of the blood sugar measurements in gestational diabetics and how this relates to the baby's outcome is controversial. We will use an FDA approved device called Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics. It is very small, similar to a beeper, and is connected to the patient through a small plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of 288 readings a day with minimum discomfort. The hypothesis of this study is that use of the Minimed glucose monitor will provide information about variations of blood sugar in gestational diabetics that is missed by capillary glucose monitors.

Our conclusions will allow us to compare blood glucose trends among the groups. After the data is analyzed in this pilot study, we plan to design a bigger study involving more subjects to study the impact of the blood sugar variations in the outcome of the newborn, and to obtain generalizable results for the population in general.

We will coordinate the study through the CRC. The women will have to come in only twice, to have the monitor placed and then taken off three days later. A blood sample will be collected at each visit. Meals and snacks will be provided for each day of the study, specially packaged, to supply an equivalent amount of calories for each subject. These will meet the nutritional requirements for both the mother and the fetus. Women will do separate fingerstick blood sugar measurements using a capillary glucometer four times a day, to ensure the accuracy of the sensor's readings.

Eligibility Criteria:
1. Inclusion Criteria

* Pregnant women, between 28 and 36 weeks of gestation. Gestational age will be determined by a combination of the date of the last menstrual period and ultrasound, done during the first or second trimester of pregnancy.
* Previous glucose challenge test and if abnormal, an oral glucose tolerance test.
* Body mass index (BMI) between 25 and 30 Kg/m2.
* Gestational diabetes in a previous pregnancy, if glucose between pregnancies was normal.
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD

Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).

Eligibility Criteria:
Inclusion Criteria:

* male or female aged 6-12 years
* females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
* a primary diagnosis of ADHD based on a detailed psychiatric evaluation
* a total score of =\>26 on the ADHD-RS-IV at the Baseline Visit
* a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
* no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.

EXCLUSION CRITERIA:

* a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
* a known non-responder to psychostimulant treatment
* overweight (Body Mass Index (BMI)-for-age \>90th percentile)
* a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
* Conduct Disorder.
* Subject has taken an investigational drug within 30 days prior to Screening.
Canine-assisted Psychotherapy Motivation Alliance

The aim of the study is to investigate the needed extent and the way a dog is integrated into psychotherapeutic interventions for them to be motivating and alliance building for children and adolescents with psychiatric disorders aged 9 to 17 years old. Specifically, we want to elaborate if the dog needs to be integrated into the therapy in a form that it is part of the therapeutic context or if the presence of the dog without being part of the therapeutic context per se is beneficial.


Eligibility Criteria:
Inclusion Criteria for children and adolescents: :

* Age between 9 and 17 years
* Children are seeing the therapist for the first time
* Basic knowledge of child and parents in either German or English to be able to fill in questionnaires
* Informed consent given by legal guardian
* Positive or neutral attitude towards dogs

Exclusion Criteria for children and adolescents: :

* acute psychosis; early childhood autism
* diagnosed developmental disorder or intellectual delay; if not diagnosed, exclusion when questionnaires cannot be completed due to development level
* fear of dogs
* allergic reactions to dogs
* reported aggressive behavior towards animals in the past

Inclusion criteria for therapists:

* working with an own therapy dog
* completed therapy training or if not completed far advanced therapy training under supervision
* working with children and adolescents aged 9 to 17 years

Exclusion criteria for therapists:

* not working with an own therapy dog
* no completed or far advanced therapy training
* not working with children and adolescents aged 9 to 17 years
Perioperative Exercise and Nutritional Optimisation Prehabilitation Before Surgery for Patients With Peritoneal Malignancy

People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known by doctors as surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Fitness for this surgery can improve if people undertake a prehabilitation programme at the time they get their diagnosis. To date, little research has focused on how exercise and nutrition support before surgery can help these patients during recovery. The aim of this study is to explore the use of exercise and nutritional support pre-treatment to enhance physical and psychological outcomes for patients.

The comparator in this study will be standard oncological care. Control patients will receive the same care as standard without the addition of a formal exercise and nutrition support programme. The pre-treatment (prehabilitation) programme will commence following diagnosis and continue up to the point of surgery and recommence for six weeks following surgery when deemed clinically fit to participate. Assessments will occur at baseline, pre-surgery, post-surgery, and 6 weeks later and a follow up... Mixed methods will be employed with patients taking part in self-report assessments, physical assessments, and qualitative interviews. The primary aim of the study is to assess the feasibility of the intervention and cardiorespiratory fitness pre-surgery. The secondary aims include assessing the effect of the intervention on physical health, psychological wellbeing, health-related quality of life, self-efficacy, nutrition, and serology markers. Exploratory aims also include post-operative morbidity, health economics analysis and qualitative interview of patient experience.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* multidisciplinary team referral for CRS-HIPEC for colorectal/appendix/ovarian peritoneal disease or pseudomyxoma peritonei (+/- completed neoadjuvant cancer treatment)
* WHO performance status ≤2.

Exclusion Criteria:

* inability to provide informed consent,
* impaired cognitive function with a reduced ability to either understand advice /instructions from or communicate with the research team,
* declined surgery,
* surgery in less than 2 weeks
* pregnancy or breastfeeding,
* inability to participate in the exercise training (unable to perform the 6 Minute Walk Test)
* absolute contraindications to exercise testing, veganism.
Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management.

Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort.

All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* able to provide informed consent

Exclusion Criteria:

* pregnancy
* prisoners
* psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up
* insulin dependent diabetics
* patients with prior musculoskeletal issues affecting the same extremity
* Patients cannot simultaneously be enrolled in any other studies.