Kornimate/medical-research-clean huggingface dataset:
atomoxetine treatment of adults with adhd and comorbid alcohol abuse

Conditions: ADHD; Comorbid Alcohol Abuse

Summary: atomoxetine treatment of adults with adhd and comorbid alcohol abuse


Eligibility criteria:
inclusion criteria: you must be at least 18 years old. you must have a diagnosis of adhd and a diagnosis of alcohol abuse or dependence. you must have acceptable results on blood and urine tests and an electrocardiogram (ecg). your recent drinking history must meet specific requirements. exclusion criteria: you have taken atomoxetine in the past. you have a psychiatric disorder, other than adhd and alcohol abuse or dependence, for which you will need psychiatric medication. you have cognitive impairment (such as memory loss), a brain injury, or a seizure disorder. you have a history of severe allergies to more than 1 class of medication or multiple bad reaction to drugs.
sorafenib in relapsed high grade osteosarcoma

Conditions: Osteosarcoma

Summary: aim of this exploratory phase ii study is to assess the clinical activity of sorafenib as single agent, in terms of percentage of patients with high grade advanced osteosarcoma free from progression following 4 months of therapy


Eligibility criteria:
inclusion criteria: * histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease. * measurable disease as defined by having at least one lesion that can be accurately measured by means of ct or mri. * ecog ps of 0, 1 and an estimated life expectancy of at least 3 months. ecog p.s. 2 is acceptable provided that it depends solely on orthopedic problems * age ≥15 years. * adequate bone marrow, liver and renal function * written informed consent exclusion criteria: * dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. * coexisting malignancies, except for basal or epithelial cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥3 years. * history of cardiac disease: congestive heart failure \>nyha class 2; active cad (mi more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. * history of hiv infection or chronic hepatitis b or c. * active clinically serious infections (\> grade 2 nci-ctc version 3.0) * symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) * patients with seizure disorders requiring medication (such as steroids or anti-epileptics) * pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial. * patients with evidence or history of bleeding diathesis * patients undergoing renal dialysis * patients unable to swallow oral medications

Keywords: osteosarcoma sorafenib target therapy
efficacy of angiolite stent vs a second-generation drug-eluting stent xience for percutaneous coronary intervention

Conditions: Coronary Artery Disease; Drug-eluting Stent

Summary: clinical trial with an "european community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent. clinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an angiography follow up + oct (optical coherence tomography) a randomized clinical trial to compare the efficacy of angiolite stent versus a second-generation drug-eluting stent such as xience stent.(non-inferiority design)


Eligibility criteria:
inclusion criteria: * patients with clinical or subclinical ischemic heart disease with indication of percutaneous revascularization. * "de novo" lesions ≥ 70% * reference diameters ≥ 2 mm and ≤ 4 mm accepted participation in the registration with the signing of informed consent exclusion criteria: * cardiogenic shock * pregnancy * intolerance or allergy to anti platelet or anticoagulant therapy * elective surgical procedure scheduled within 6 months after inclusion in the study * expectancy of life of less than 1 year. * impossibility of doing 1 year clinical follow-up. * primary angioplasty in patients with killip class iii-iv or mechanical complications. * patient with pre-procedure restenosis. * patients who will not be treated all lesions with the angiolite stent. * total occlusions * truncus disease
feasibility of mindfulness meditation training and home practice in persons with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to evaluate the feasibility and acceptability of a 6-week app-guided mindfulness meditation training (mm) intervention and health education (active control) condition in people with spinal cord injury (sci) who have chronic pain and to examine the feasibility of data collection procedures

our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 sci patients experiencing chronic pain to practice audio-guided mm for ≥ 10 minutes daily for 6 weeks using the free app "mindfulness coach" developed by the department of veteran affairs, or to listen or view health education presentations (active control) ≥ 10 minutes daily for 6 weeks on the free ted app (active control). primary outcomes are the feasibility and acceptability of proposed interventions in people with sci and chronic pain. secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, quality of life, stress, fatigue and sleep disturbance.

Eligibility criteria:
inclusion criteria: * traumatic sci of at least 6 months duration * chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\] * understand spoken and written english sufficiently to provide informed consent * participate in the intervention and complete study surveys exclusion criteria: * lack of daily access to the internet using a smart phone or smart tablet * cognitive impairment (determined by their inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions pertaining to the study) * significant visual/hearing impairment that does not allow use of the mm app's audiovisual presentations or health education presentations on ted-talk * use of any kind of meditation more than once a week in the last 3 months * inability to provide or obtain an email address for communication with study staff * inability to operate the app download or study related survey using a smartphone.
body composition in children with inflammatory bowel disease

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: background: growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (ibd), mainly those with crohn's disease (cd). there is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with ibd compared with controls. evidence regarding the effect of different therapeutic approaches on body composition in children with ibd is scarce and inconsistent. furthermore, most studies used anthropometric measures and dual energy x-ray absorptiometry (dexa) for body composition assessment, while information on the usefulness of air displacement plethysmography (adp) for this assessment is lacking. objectives: to assess body composition in children with ibd by adp and dexa at diagnosis and at various intervals during follow up. design: a prospective cohort study. setting: pediatric gastroenterology institute, schneider children's hospital. participants: children 6 year to 17 years who are diagnosed with either cd or ulcerative colitis (uc). main outcome measures: accuracy of adp in comparison to dexa and percentage of fat mass and lean mass at diagnosis and during treatment. secondary outcome measures: correlation of body composition to skin fold, mid arm circumference measurements, bmi, inflammatory markers, gender, disease activity and physical activity.

children diagnosed with either crohn's disease (cd) or ulcerative colitis (uc) under follow-up at the pediatric gastroenterology institute, schneider children's hospital, will be enrolled. patients can be enrolled at diagnosis or at any time point during follow-up. patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. at enrollment all patients will perform body composition assessment by air displacement plethysmography (adp) and dexa (no greater than 7 days between the 2 methods of measurement). at one and two years following initial assessment adp measurement will be repeated, mid arm circumference and skin fold measurements will be taken and the patient will fill a physical activity questionnaire. disease activity score (either pediatric crohn's disease activity index for cd or pediatric ulcerative colitis activity index for uc) will be calculated. similar evaluation will be performed prior and immediately following exclusive enteral nutrition or corticosteroid courses and prior to any biologic therapy initiation.

Eligibility criteria:
inclusion criteria: * diagnosis of ibd * age: 6 - 17 years ( inclusive) * informed consent exclusion criteria: * pregnancy * non ibd associated chronic diseases * morbid obesity
validation of sensitivity and specificity of a multi-omic precision diagnostic for acute stroke evaluation

Conditions: Stroke

Summary: valtari bio has early proof of concept clinical data of a multi-omic peripheral blood biomarker profile that can be used to determine stroke from no stroke in the emergency setting. the objective of this observational cohort clinical study is to determine the clinical utility of this multi-omic biomarker profile. primary study aims: 1. the diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke (ischemic stroke, transient ischemic attack (tia) and hemorrhagic stroke) versus no stroke (stroke mimic). 2. the ability of a multi-omic biomarker profile to differentiate ischemic stroke from hemorrhagic stroke and tia.

at the completion of this project the investigators will have evaluated a peripheral blood test that determines the expression of a multi-omic biomarker profile to differentiate stroke from no-stroke in the emergency setting. five hundred patients aged 18 years or older who present to the hospital with stroke-like symptoms will be recruited within 24 hours of symptom onset at participating clinical sites. data will be obtained from the medical records. blood for research purposes will be obtained. research evaluations for stroke severity, symptoms and outcome will be performed by trained personnel. all clinical evaluation and management will be per standard of care. the primary outcome of this study is the criterion standard stroke diagnosis. this will be used to estimate the diagnostic test characteristics of a multi-omic biomarker profile in the peripheral whole blood for distinguishing stroke (is, tia, sah, ich) versus non-stroke in ed patients with acute neurologic symptoms. secondly, the investigators will estimate the ability of the multi-omic biomarker profile to differentiate between stroke subtypes. a diagnosis of stroke will be defined as clinical syndromes consistent with stroke (i.e., sudden onset neurological deficit) plus imaging confirmation (or symptom resolution and lack of imaging findings in tia). finally, the investigators will explore the relationship between the multi-omic profile and time from symptom onset in ischemic stroke patients. descriptive and inferential statistics will be used to address the aims of the study. pattern recognition analysis and machine learning will be employed as a systems level approach to determine relevant pathophysiologic pathways associated with diagnosis and symptom onset time.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older who present with symptoms of a possible stroke in whom blood can be collected for this study within 12 hours of symptom onset will be eligible. exclusion criteria: * age less than 18 years

Keywords: stroke stroke mimic
a clinical study to assess the effect of vildagliptin on postprandial lipid parameters in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study was not conducted in the united states. many people with type 2 diabetes also have high cholesterol levels. the purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * blood glucose criteria must be met * genetic markers associated with increased risk of cardiovascular disease * not currently on drug therapy for type 2 diabetes * body mass index (bmi) in the range 25-40 exclusion criteria: * pregnancy or lactation * type 1 diabetes * high cholesterol as defined by the protocol * evidence of serious diabetic complications * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
piloting pathways with lung cancer patients

Conditions: Metastatic Lung Cancer

Summary: the purpose of this research is to determine the feasibility of a new supportive intervention, called pathways, for patients with advanced stage and metastatic lung cancer.

in this study, investigators will first test the pathways procedures with 6 patients to identify any improvements that need to be made. then, investigators will test the feasibility of the pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. pathways is designed to help patients set and pursue personal goals during lung cancer treatment. in this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the university of kentucky markey cancer center to participate in the pathways intervention.

Eligibility criteria:
inclusion criteria: * new or recurrent stage iiib, stage iiic or stage iv non-small cell lung cancer (nsclc) or extensive stage sclc * 18 years of age or older * ecog ps 0-2/karnofsky 60-100 * 3 to 12 weeks into active cancer treatment exclusion criteria: * unstable brain metastases * cognitive or psychiatric condition for which participating would be inappropriate * unable to speak and read english
cytokine response in septic shock

Conditions: Septic Shock

Summary: this study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease. the specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (tnf, il-1, il-6, mif, lif, hmgb1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, hr, blood pressure, wbc, etc).

patients must be on vasopressors patients cannot be on pressors for \> 24 hrs prior to consent

Eligibility criteria:
inclusion criteria: * adult icu patients: . 18 years admitted with septic shock * receiving vasopressors \< 24 hrs exclusion criteria: * consent refused by patient or sdm * received vasopressors \> 24hrs

Keywords: icu population
the effects of pre-operative magic tricks performance on pre-operative anxiety in children

Conditions: Anxiety

Summary: it is not uncommon for children to undergo surgery. surgery is a threatening event that is composed of various stress-provoking stimuli. pre-operative anxiety is a common emotional response among operated children and their parents. in the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. a successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate. study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks. 2. similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.


Eligibility criteria:
inclusion criteria: * age 3-12 years * minor surgeries / diagnostic procedures such as endoscopy, biopsy exclusion criteria: * children that do not speak hebrew * american society of anesthesiologists (asa) status above ii * a need for regional anesthesia only * a need for an intravenous (iv) cannulation at the induction room or operating room before the induction of anesthesia.

Keywords: anxiety maladaptive behavior anesthesia anxiety before anesthesia and maladaptive behavior after anesthesia.
continuation of protease-inhibitor based second-line therapy vs. switch to b/f/taf in virologically suppressed adults

Conditions: HIV-1-infection; Antiretroviral Therapy

Summary: this randomized trial compares the efficacy of switching to a fixed-dose combination of b/f/taf versus continuing a boosted protease inhibitor (bpi) regimen in hiv-1 infected participants who are virologically suppressed (hiv-1 rna \<200 copies) on a second-line bpi regimen. half of participants will receive b/f/taf and half will continue a bpi regimen. the hypothesize is that b/f/taf will have efficacy that is non-inferior to the boosted pi regimen.

the second generation integrase strand transfer inhibitors (instis) dolutegravir (dtg) and bictegravir (bic) are widely prescribed for the treatment of hiv, due to their favorable tolerability and toxicity profile, durable efficacy, and high barrier to resistance. however, there are limited data to guide the management of patients who are already virally suppressed on a second-line bpi regimen. though bpis have a high barrier to resistance and durable virologic efficacy, they have several important drug-drug interactions, are associated with unfavorable long-term metabolic effects, and may be poorly tolerated. for these reasons, a second-generation insti would be preferable to a boosted pi regimen, as long instis are demonstrated to have non-inferior efficacy for patients who are already suppressed on a second-line bpi regimen. in the proposed study, the efficacy of continuing the bpi regimen will be compared to switching to b/f/taf.

Eligibility criteria:
inclusion criteria: * the ability and willingness to give informed consent. * age ≥18 years * history of meeting who criteria for immunologic or virologic failure after receipt of a first-line treatment regimen for ≥6 months * currently receiving a second-line art regimen including either atvr or lpvr + 2 nrtis for ≥6 months * at least one hiv-1 rna \<200 copies/ml within 12 months prior to enrollment, and no hiv-1 rna of at least 200 copies/ml during this period. * plasma hiv-1 rna \<200 copies/ml at screening visit. * egfr ≥ 50 ml/min according to the mdrd study equation for creatinine clearance * hepatic transaminases (ast and alt) \</=5x upper limit of normal (uln) * no active tb * women of childbearing age must agree to take reliable contraception exclusion criteria: * active world health organization stage 3 or 4 condition * treatment with an insti in the past * gap in care of at least one month in the prior six months * current alcohol or substance use judged by investigator to potentially interfere with participant study compliance * history of poor adherence, that in the opinion of the investigator, would potentially interfere with study compliance * pregnant or breastfeeding at screening visit * planning to transfer care

Keywords: hiv second-line therapy integrase strand transfer inhibitor protease inhibitor
eagle european post market study

Conditions: Acute Knee Cartilage Injury; Tear of Articular Cartilage of Knee, Current

Summary: prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.

biomatrix crd is a ce marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. biomatrix crd™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. the device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone. the purpose of this post-market study is to confirm the safety and performance of the biomatrix crd for its intended use. fifty (50) patients will be enrolled at up to 10 hospitals in europe. patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.

Eligibility criteria:
inclusion criteria: * pre-procedure koos pain subscale score less than or equal to 70. * icrs grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures less than or equal to15mm in diameter. * cartilage lesion is amenable to treatment with a single biomatrix crd or an osteochondral autograft. exclusion criteria: * previous cartilage repair procedure (i.e., microfracture, oats, aci) at the intended implantation site. * clinically significant (\> 5 degrees) varus or valgus malalignment in either knee. * osteoarthritis in the injured knee. * inflammatory arthropathy * osteomyelitis or other active infection in either lower limb. * cortisone or hyaluronic acid knee injections in the past 3 months * body mass index greater than 35.

Keywords: knee cartilage repair, osteochondral defects, biomatrix crd
biomechanical effects of digitally constructed subperiosteal implants

Conditions: Bone Loss

Summary: subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.

with the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.

Eligibility criteria:
inclusion criteria: * a 3d image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient. * maxilla with cawood and howell class 4 or 5 classification exclusion criteria: * a 2d image of an edentulous maxilla bone * a non atrophied maxilla

Keywords: polyetherketoneketone titanium polyethereetherketone