cyrilzakka/clinical-trials huggingface dataset:
Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

The PROTEUS study is a randomized, cross-over, open-label, pharmacodynamic trial designed to compare the antiplatelet effect of reduced maintenance doses of prasugrel and ticagrelor in stable patients who recently had non-ST-elevation acute coronary syndrome (non-ST-elevation myocardial infarction or unstable angina).


Eligibility Criteria:
Inclusion Criteria:

* provision of informed consent prior to any study specific procedures
* diagnosis of non-ST-segment elevation acute coronary syndrome (non-ST-segment elevation myocardial treatment or unstable angina)
* male or non-pregnant female, aged 18-75 years old

Exclusion Criteria:

* known hypersensitivity to ticagrelor or prasugrel
* presence of contraindications for ticagrelor or prasugrel
* current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
* history of ischemic stroke or transient ischemic attack
* history of intracranial hemorrhage
* recent gastrointestinal bleeding (within 30 days)
* history of moderate or severe hepatic impairment
* history of major surgery or severe trauma (within 3 months)
* patient required dialysis
* concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
* body weight below 60 kg
Reliabılıty,Validity Of The Turkish Version Of The NIH-Minimal Dataset

This study, we performed the Turkish version validity and reliability of the NIH Task Force's Recommended Multidimensional Minimal Dataset

Low back pain is defined as the pain that can occur in the region between the lower border of the scapula and the hip, sometimes spreading to the lower extremities, which causes activity limitation and is one of the most common health problems in the society. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of our study is to determine the Turkish version, validity and reliability of NIH Task Force's Recommended Multidimensional Minimal Dataset. 200 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Having a low back pain Literate

Exclusion Criteria:

* pregnant,
* canser
* trauma
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers.

EktoTherix™ is a medical device developed by Neotherix Limited, manufactured by the polymer processing technique of electrospinning. Described as a "tissue scaffold", EktoTherix is placed into the surgical wound to help the patients' own cells repair the wound, enhancing healing and improving quality (including cosmetic outcome). The tissue scaffold is completely absorbed by the body during the healing process, which means that there is no need to remove it when the wound is healed.

All patients recruited into this study are treated with EktoTherix, are seen weekly until they heal and seen again at the final follow-up visit three months post-surgery.

The investigators hypothesise that the use of EktoTherix will increase incidence of complete healing and result in an overall better cosmetic result of the healed wound.


Eligibility Criteria:
Inclusion Criteria:

* Is the patient at least 18 years of age
* Is the patient male, or is not pregnant or lactating and is using contraception
* Has the patient been diagnosed with a non-melanoma skin cancer (basal cell carcinoma BCC or squamous cell carcinoma SCC) for which the chosen therapeutic option is surgical excision followed by secondary intention healing
* Is the excisional wound greater than 10mm x 10mm in size and less than or equal to 35mm x 35mm after any attempt at primary closure
* Does the patient have limited skin laxity which would make primary closure of the surgical excision difficult
* Is the patient able to understand the aims and objectives of the trial and are they willing to consent

Exclusion Criteria:

* Has the patient been diagnosed with any transmittable viral diseases (HIV, Hepatitis B or C)
* Has the patient been diagnosed with, or is it suspected that they have metastatic disease
* Does the patient have a history of malignant melanoma or any concomitant disease likely to impede wound healing
* Has the patient been diagnosed with pre-existing wound infection
* Is the patient taking any medication known to interfere with skin grafts (i.e. warfarin and other anticoagulants, steroids, NSAIDs and immunosuppressants)
* Has the excised wound been entirely treated by primary closure
* Does the patient have a history of any significant cardiac, pulmonary, renal, hepatic, neurological and/ or immune dysfunction that may affect wound healing
* Does the patient know of any allergy to any of the device materials to be used in the trial
* Does the patient have a known history of poor compliance with medical treatment
* Has the patient participated in this trial previously and healed or been withdrawn
* Is the patient currently participating in any other clinical trial
Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS

This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq. Using prospectively collected patient data, coupled with physician surveys, the investigators seek to determine the feasibility of implementing ChromoSeq in addition to standard genomic testing, for patients with the diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).


Eligibility Criteria:
Inclusion Criteria Patient

* Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested.
* Adult patients 18 years or older.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Inclusion Criteria Physician

* Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies.
* Able and willing to complete standardized questionnaires about usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process.

Exclusion Criteria Patient

* Younger than 18 years of age

Exclusion Criteria Physician

* Does not treat patients at Washington University School of Medicine
The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease

The purpose of this study is to investigate whether there is a difference in endothelial function, heart rate variability and carotid intimal media thickness in patients with coronary artery disease who are receiving fish oil therapy.

One hundred patients with established coronary artery disease by coronary angiography will undergo randomization for enrollment in the study. Baseline evaluation will include assessment of brachial artery endothelial function, heart rate variability and carotid intimal media thickness. Evaluation of the endothelial function of the brachial artery will be elucidated by inflation of a blood pressure cuff around the arm for five minutes and measuring blood vessel dynamics after release of the cuff. Heart rate variability will be evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal media thickness will be evaluated by ultrasound measurements guided by predetermined protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at 2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Established coronary artery disease as determined by coronary angiography within the last 5 years demonstrating at least 50% stenosis in one of the major coronary vessels
2. Age \>18 and \<75.

Exclusion Criteria:

1. Baseline fish oil intake ≥1g/day or fish intake \>100g/day
2. Need for urgent or emergent CABG
3. Contraindication for plavix, aspirin or statin
4. Gastrointestinal malabsorption syndrome
5. Pregnancy
6. Oral contraceptive use
7. Ejection fraction \<40%
8. Underlying atrial or ventricular arrhythmia
9. History of rheumatoid arthritis
Thoughts and Health - Preventing Depression in Adolescents

This study aims to test the feasibility of implementing an Icelandic cognitive-behavioral program designed to prevent depression, called "Thoughts and Health" in a Swedish school setting. The investigators will also evaluate whether implementation of the program has an impact on the participating students, regarding both their mental health and their success in finishing junior high school with passing grades.

Clinical depression is a crucial problem among adolescents. In eighth grade more than half of all students experience headaches, stomach pain, stress, feeling down, and difficulties sleeping. Adolescents affected by depression at a young age are at greater risk of experiencing depressive symptoms as adults, with serious impacts on their quality of life and ability to work. Recent reports from the National Board of Health and Welfare have shown that depression is increasing among adolescents and there is now focus on implementing practice-oriented preventative programs for youth.

Studies by members of our research team have shown that a cognitive-behavioral, developmentally-based intervention program, called "Thoughts and Health", prevented initial episodes of depression and/or dysthymia in adolescents for up to 12 months after program completion.

This study aims to test the feasibility of implementing that program in a Swedish school setting, while also collecting and analyzing preliminary results regarding the potential impact of the program on number of students developing depressive symptoms and the number passing junior high school with full grades.

This is an intervention study with a control group. Students from two Swedish junior high schools will be identified as "at-risk" and invited to participate in the program (n=40), while students from two other schools will act as controls (n=40). All participating students will be followed from study start (baseline) and 1, 6, 12, and 18 months after program completion. Results will include quantitative clinical measures, qualitative focus group discussions, and students' final grades. Two courses of the program will be run over two school years. This study involves close collaboration between academia, primary care, and the community.

This is to our knowledge the first study in Sweden that employs a longitudinal design to evaluate the effects of a school program aimed at preventing depression in adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Eight grader (school)
* Completed Childrens Depression Inventory (CDI) screening
* Able to understand Swedish both orally and written to a level that he/she can complete forms and questionnaires by themselves

Exclusion Criteria:

* Current or past depression
* Unable to function in a group session
* Current psychotherapeutic treatment
* Past or current suicidal thoughts or attempts
vDOT for Newly Diagnosed Pediatric Asthma

The goal of this research study is to compare the impact of video directly observed therapy on inhaler technique accuracy with participants receiving video directly observed therapy vs. participants receiving standard asthma care. Participants will be randomized between the two groups. We will follow up and compare the two groups to see if they have improved asthma control as measured by symptom-free days (SFD), higher inhaler technique at 3-month follow up, higher checklist scores on a standardized inhaler technique checklist, higher proportion of days covered (PDC) of their inhaled asthma controller medication, and have fewer acute care visits for asthma.

Emocha® was originally developed by researchers at the Johns Hopkins University School of Medicine, the HIPAA-compliant platform was commercialized in 2014. Emocha® platform uses virtual communication tools (e.g. asynchronous video technology and secure 2-way messaging) to support and encourage adherence through timely feedback and positive reinforcement: helping users develop healthy behaviors and maintain high levels of medication adherence. The company leverages a public health practice called Directly Observed Therapy (DOT). DOT is a Center for Disease Control (CDC)-endorsed model of care that has been used by public health departments for decades to contain deadly infectious diseases.

Our overarching hypothesis is that compared to standard asthma medication education, vDOT will improve accuracy of inhaler technique (primary aim) and improve clinical outcomes such as medication adherence and asthma symptoms among children newly referred to asthma specialty clinic or those with a new inhaled asthma medication inhaler type.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 6 and ≤ 11 years old
2. Physician diagnosed persistent asthma (any severity) and verified by review of electronic medical record
3. New patient with a new prescription for inhaled preventive asthma medication referred to an asthma subspecialty clinic at Arkansas Children's OR established patient in the asthma, allergy or pulmonary subspecialty clinic with a new prescription for inhaled preventive asthma medication.
4. Regular access to Wi-Fi

Exclusion Criteria:

1. Significant underlying respiratory disease other than asthma such as cystic fibrosis
2. Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the ability to communicate via interactive video
3. Current smoker
4. Caregiver/patient does not have access to a smartphone compatible with the Emocha® smartphone application
5. Caregiver and patient speaks and understands English as their primary language.
Antenatal Corticosteroid in Elective Cesarean Section

Caesarean section is a risk factor for the development of neonatal respiratory complications, mostly respiratory distress syndrome (RDS) and transient tachypnoea of the new-born, both in term and preterm infants.

Infants born at term by caesarean delivery are more likely to develop respiratory morbidity than infants born vaginally, and this risk increases furthermore for the subgroup of children born by elective caesarean section, i.e. before onset of labour, with potentially severe implications. The risk is decreasing with advancing gestational age, and infants born between 37+0 and 37+6 weeks are at 1.7 times more risk for respiratory complications than those born between 38+0 and 38+6 weeks, which in turn are at 2.4 times more risk than the infants born between 39+0 and 39+6 weeks. If women were given two intramuscular injections of 12 mg of dexamethasone, two doses for 48 hrs,the rates of admissions were 5.2% at 37 weeks, 2.8% at 38 weeks, and 0.6% at 39 weeks. Although none of the babies in the control group died, admission will increase parental anxiety, the cost to nursery unit and invasive procedures including artificial ventilation giving mothers dexamethasone, two doses before elective section halved neonatal morbidity. Five studies lasting between three and 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid, neither through infection of the fetus or mother nor in long term neurological or cognitive effect In view of this evidence, it is currently recommended that elective caesarean section should be deferred to 39 weeks. However approximately 10%-15% of woman planed for c/s may deliver before 38 weeks, and there may be concern on waiting in the presence of speci c indications or previous history. Respiratory morbidity in cases of term elective caesarean birth appears to have a different pathophysiology than in preterm birth, and retention in the lungs being the most likely cause.

Interestingly, recent evidence indicates that apart from the traditional mechanical concept of vaginal squeeze, molecular mechanisms (predominantly lung epithelial sodium channels promote alveolar uid drainage, and these channels are under active in fetuses unexposed to the process of labor. Glucocorticoid appears to increase the number and the function of thyroid hormones, providing a rational for their exogenous administration in cases of elective caesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age (18-35 years)
* Singleton pregnancy
* Gestational age (38-40 years)

Exclusion Criteria:

* Major maternal morbidities as DM and pre-eclampsia
* Sever oligohydramnios
* Premature rupture of membranes
* Women who receive steroids during pregnancy
Monitoring Living Donor Liver Functions by Thromboelastometry

A prospective Observational study including 50 living donor liver transplant recipients to monitor the graft functions through thromboelastometry

This is a prospective observational study Includes 50 living donor liver transplant recipients performed in gastroenterology surgical center - Mansoura University liver transplantation program.

Study period: from June 2014 to May 2015 The early post-operative graft functions will be correlated with concomitant monitored thromboelastometric (TEM) parameters derived from a ROTEM Delt device

TEM Samples will be collected at the following times:

Pre-transplant 10 minutes post portal declamping at ICU admission Morning of Days from 1 to 7 Laboratory data relevant to graft functional status will be collected at the same times.

Eligibility Criteria:
Inclusion Criteria:

* Living donor liver transplant recipients successively performed in the liver transplantation program - Mansoura university

Exclusion Criteria:

* Non
Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation.

The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

The investigators will enroll 50 patients that will meet all the inclusion criteria and will agree to participate in the trial. In patients with preceding beta-blocker medication, it will be discontinued and a washout period of one month will be provided. The investigators will assess baseline characteristics and then divide patients randomly into two arms based on their date of birth (even/odd days of the month).

Arm A will be given metoprolol 50 mg daily for three months, after this period the effect will be evaluated and metoprolol discontinued. A month-long washout period will follow and after an additional three months without metoprolol medication, patients will be reevaluated.

Arm B will be without metoprolol for three months and will be evaluated thereafter. Then the patients will be given metoprolol 50 mg daily for three months followed by a reevaluation.

The investigators will evaluate the effect of metoprolol by multiple methods at the end of the 5th and 9th months of the trial. Quality of life will be assessed by a questionnaire (The Kansas City Cardiomyopathy Questionnaire), exercise tolerance by a spiroergometry (VO2 max). A conventional echocardiographic examination and an examination focused on exercise-induced left ventricular outflow tract obstruction will be performed. The investigators will also measure NTproBNP from a blood sample as a laboratory marker of heart failure and high sensitive troponin as a marker of myocardial injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients post alcohol septal ablation
* Pressure gradient in left ventricular outflow tract \<30 mmHg
* Written consent to participate

Exclusion Criteria:

* History of atrial fibrillation
* Symptoms of Class III or IV of New York Heart Association functional classification
* Permanent pacemaker implant
* Age above 75
A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
* Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
* Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

* Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
* Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
* Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)