Kornimate/medical-research-clean huggingface dataset:
brief behavioral sleep intervention for obesity prevention in primary care

Conditions: Obesity, Childhood; Short Sleep; Obesity Prevention

Summary: the goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. participating families will meet with a nurse 6 times or receive 6 educational handouts. participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.

the present study is assessing the feasibility and preliminary effectiveness of a brief behavioral intervention to enhance children's sleep and prevent development of obesity. fifty short sleeping (\< 9 hours/night) children 6-11 years old who are primarily aa/black and from lower socioeconomic backgrounds will be enrolled into a 6-month study. children will be randomly assigned to 1 of 2 conditions: 1) optimize sleep primary care (ospc; behavioral intervention to enhance sleep duration delivered by a nurse in primary care) or 2) enhanced usual care (euc; usual care plus sleep education). all children will receive standard pediatric care. families randomized to ospc will receive a four-session intervention (two zoom-delivered sessions and two brief phone follow-ups) over the first two months with two additional phone follow-ups during maintenance (months 2-6). families randomized to euc will receive sleep education that is delivered at the same points of contact as ospc sessions. at baseline, end of treatment (2 months), and 6 months, the following will be measured from a reach, effectiveness, adoption, implementation, maintenance (re-aim) perspective: reach (e.g., enrollment), adoption (e.g., pediatric provider engagement), implementation (e.g., session attendance, treatment fidelity), maintenance (e.g., retention), and preliminary effectiveness (e.g., changes in sleep duration (actigraphy), eating behaviors (24-hour dietary recalls), physical activity (accelerometry), and anthropometrics (measured height and weight).

Eligibility criteria:
inclusion criteria: * patient at temple pediatrics * child age 6-11 years * child time in bed of less than 9 hours per night on most days per week * body mass index (bmi) for age and biological sex great than the 10th percentile but less than the 95th percentile * understanding of and ability to complete the protocol * parent age at least 18 years and primary caregiver * willingness to be randomized to either condition exclusion criteria: * diagnosed sleep disorder * medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status * current or planned treatment for weight control

Keywords: sleep behavioral intervention primary care obesity prevention child pediatric
couples coping with multiple chronic medical conditions

Conditions: Chronic Disease; Illness Behavior

Summary: handling of complex health situations (as defined by multimorbidity) in partnership: communication between romantic partners; subjective illness perception; coping with stressful experiences due to multimorbidity. intervention : expressive writing about subjective illness perception vs. writing about individual time-management primary endpoint: subjective health (e.g. sf 12 questionnaire) secondary endpoints: psychosocial adjustments (depression, somatic symptoms, quality of partnership and others)

coping in complex health situations (as defined by multimorbidity) and the role of relationship processes for psycho-social adaption: the study investigates interpersonal emotion regulation, disclosure, and illness perceptions in couples with a multimorbid patient. the intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing), the control condition are 3 sessions writing about individual time-management (placebo). primary endpoint: subjective health (sf 12 questionnaire) secondary endpoint: psychosocial adjustments (depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality)

Eligibility criteria:
inclusion criteria: * age 18 or older * multimorbid condition (two or more chronic medical conditions) * patients living with romantic partner * very good oral and written command in german * written consent for participation by patient and partner exclusion criteria: * pregnancy * mini mental state less than 26 * substance abuse * patients in palliative situation * patients isolated due to infectious diseases * patients participating in other clinical trials within the last 4 weeks before inclusion
24-month ticagrelor-based dual-antiplatelet therapy versus clopidogrel-based dual-antiplatelet therapy after 12 months of drug-eluting stent implantation in high ischemic risk patients: p-reduce trial

Conditions: High Ischemic Risk

Summary: the purpose of this prospective randomized clinical trial is to compare the clinical outcomes between aspirin with ticagrelor versus aspirin with clopidogrel in high ischemic risk patients beyond 12 months after percutaneous coronary intervention with drug-eluting stent implantation


Eligibility criteria:
inclusion criteria: 1. age ≥50 years old 2. history of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago 3. high-risk for ischemic events (at least one of the following) 1) age \>65 years old 2) medical treatments for diabetes mellitus 3) multi-vessel coronary artery disease 4) more than 2 episodes of myocardial infarction 5) chronic kidney disease (stage iii or iv) exclusion criteria: 1. age ≥85 years old 2. pregnant women or women with potential childbearing 3. life expectancy \< 1 year 4. inability to understand or read the informed consent 5. need for long-term anticoagulation therapy
natural history of isolated calf vein thrombosis - a prospective cohort under ultrasound surveillance

Conditions: Acute Embolism and Thrombosis of Calf Muscular Vein

Summary: the treatment of icvt is still controversial as conflicting international guideline strategies show. evidence suggests that propagation rates of icvt without risk factors are low. unless icvt propagates to proximal veins anticoagulation can safely been withheld, thereby avoiding a bleeding risk for the patient. however, the impact of different risk factors on propagation rates is not well understood. this gap in knowledge can only be filled by a natural history study of icvt without anticoagulation. since patients are safe as long as no propagation occurs close ultrasound surveillance is an adequate safety umbrella for the natural history study period. in addition, it provides an objective outcome measure to define the impact of risk factors.

for the purpose of this study, icvt is defined as any thrombus being present in the calf muscle veins and/or in the deep paired calf veins as long as they do not affect the confluence (trifurcation) area or the popliteal vein. patients presenting with symptomatic icvt will be examined by ccus for both legs (v1). inclusion/exclusion criteria will be checked, and patients will be informed about the nature of the study. in case patients provide informed consent, no anticoagulation therapy is given. compression stockings at the calf length will be prescribed for 30 days. ccus will be repeated on day 5±2 (v2), day 10±2 (v3), and day 30±4 (v4). if the icvt has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal dvt. if no propagation to proximal veins has occurred anticoagulation will be withheld further on

Eligibility criteria:
inclusion criteria: * presence of symptomatic icvt proven by ccus * absence of proximal dvt or pe * age of 18 or older * outpatient and inpatient status * written informed consent exclusion criteria: * bedridden patients * prior unprovoked vte * active malignancy (diagnosis within the last 6 months, and/or incomplete resection, and/or ongoing radiotherapy or chemotherapy, and/or metastatic disease). * pregnancy * therapeutic anticoagulation therapy for reasons other than vte

Keywords: isolated calf vein thrombosis ultrasound surveillance
fentanyl 12 mcg transdermal patch for postoperative pain

Conditions: Postoperative Pain

Summary: the investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.


Eligibility criteria:
inclusion criteria: * patients between the ages of 20-70 years * asa physical status 1-2 patients undergoing single-level laminectomy/discectomy exclusion criteria: * a history of allergy to any study drugs * history of opioid use, obstructive sleep apnea * any psychological disorders * hepatic or renal failure
effects of overload progressive in the treatment of shoulder

Conditions: Shoulder Impingement Syndrome

Summary: seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. the group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. the primary outcomes measures will be pain, function, quality of life, global impression of recovery. the change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). the secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. for these data, change will be measure from baseline at 10 weeks (after 20 sessions).


Eligibility criteria:
inclusion criteria: * people with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis * shoulder pain for more than 4 months, at least 4 points of pain in 0-10 nprs * at least 130° shoulder active elevation * 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, neer, empty can (jobe) and hawkins-kennedy * positive dynamic scapular dyskinesis in clinical observation exclusion criteria: * referred pain from vertebral spine * previous shoulder, elbow or neck surgery * complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness) * neoplastic or neurological disorders * previous fracture or dislocation injury (shoulder, humerus, clavicle) * adhesive capsulitis signs * inflammatory diseases * specific treatment for the shoulder in the previous four months (injection, physiotherapy) * using drugs in the previous week * inability to understand portuguese language
evaluation of the pharmacokinetics of tropifexor in subjects with mild, moderate, or severe hepatic impairment compared to healthy control subjects

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. the results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.


Eligibility criteria:
all subjects: inclusions criteria: * subjects must weight at least 50 kg, with a bmi within the range of 18 to 38 kg/m2 * must be willing to remain in the clinical research unit as required by the protocol exclusion criteria: * use of other study drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations * history of hypersensitivity to the study treatment or to drugs of similar chemical classes * pregnant or nursing women * women of child-bearing potential healthy volunteers: inclusion criteria: - in good health as determined by past medical history, physical examination, ecg, laboratory tests, and urinalysis at screening. exclusion criteria: * liver disease or liver injury * chronic infection with hepatitis b or hepatitis c * history or presence of impaired renal function hepatically impaired subjects: inclusion criteria: - hepatic impairment as defined by the child-pugh classification for severity of liver disease exclusion criteria: * severe complications of liver disease within the preceding 3 months * emergency room visit or hospitalization due to liver disease within the preceding 3 months for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects * subject has received liver transplant at any time in the past and is on immunosuppressant therapy * acute hepatitis b or hepatitis c infection other protocol-defined inclusion/exclusion criteria may apply.

Keywords: ljn452 tropifexor pk safety healthy subjects hepatically impaired nonalcoholic steatohepatitis nonalcoholic fatty liver disease nafld
registry of patients with a diagnosis of spinal muscular atrophy (sma)

Conditions: Spinal Muscular Atrophy (SMA)

Summary: spinal muscular atrophy (sma) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (smn1) on chromosome 5q13, which leads to reduced smn protein levels and a selective dysfunction of motor neurons. sma is an autosomal recessive, early childhood disease with an incidence of 1:10,000 live births. sma is the leading cause of infant mortality due to genetic diseases. the purpose of this registry is to assess the long term outcomes of patients with sma in the context of advances in treatment options and also to characterize and assess long-term safety and effectiveness of oav-101.

this is a prospective, multi center, multinational, non-interventional observational study. all patients will be managed according to the clinical site's normal clinical practice, i.e., the diagnostic and clinical treatment/practice process that a clinician chooses according to their clinical judgement for an sma patient. clinical care will not be driven by the protocol. no additional visits or investigations will be performed beyond normal clinical practice. patients will be followed for 15 years from enrolment or until death, whichever is sooner.

Eligibility criteria:
inclusion criteria: * patients treated with oav-101 with a genetically confirmed diagnosis of sma regardless of the date of diagnosis. * appropriate consent/assent has been obtained for participation in the registry exclusion criteria: - currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat sma. note: patients who are participating in a compassionate use program (cup) for oav-101 (zolgensma) such as a managed access program (map), an expanded access program (eap), single patient investigational new drug (ind) (spi) or named patient program (npp) are eligible to enroll in the registry regardless of the date of a genetic or clinical diagnosis of sma.
a study of decolonization in patients with haematological malignancies (deham)

Conditions: Hematological Infection

Summary: mdr (multidrug resistant) gram-negative bacteria have emerged as an important cause of bloodstream infection in hospitalized patients, especially in immunocompromised hosts. it was previously shown, that intestinal colonization with extended-spectrum β-lactamases (esbl)-producing or carbapenem-resistant enterobacteriaceae, carbapenem-resistant a. baumannii and p. aeruginosa) is a clinical predictor of bloodstream infections in patients with haematological malignancies and/or haematopoietic stem cell transplantation \[stoma i. et al., 2016\]. to the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy and safety of selective intestinal decolonization strategies in high-risk patients with haematological malignancies. possible decolonization of mdr gram-negative bacteria in haematological patients could be important for the patient by reducing the risk of infection and for the community by reducing the risk of transmission. the purpose of the proposed study is to assess the efficacy and safety of selective intestinal decolonization of mdr gram-negative bacteria with oral administration of colistimethate sodium in high risk patients with haematological malignancies.


Eligibility criteria:
inclusion criteria: 1. microbiologically proven rectal carriage of esbl-producing enterobacteriaceae or carbapenem-resistant enterobacteriaceae, a. baumannii, p. aeruginosa without signs and symptoms of active infection. 2. patient must give written informed consent to participate in the study. the informed consent can be given by the legal representative if necessary. exclusion criteria: 1. active bacterial, viral, fungal or protozoal infection 2. women who are pregnant or nursing 3. antibacterial therapy in previous 10 days 4. contraindication to the use of one of the study drugs (including known hypersensitivity) 5. patient already enrolled in another study, or in the present study for a previous episode 6. psychiatric disorder or unable to understand or to follow the protocol directions 7. resistance of the primarily isolated colonizing microorganism to polymyxin antibiotics proven by methods of polymerase chain reaction

Keywords: hematological infection, decolonization
to assess the level of adherence of subjects receiving saizen® via easypod™ in the uk

Conditions: Growth Disorders

Summary: this is a national, multicentre, observational registry to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment from hospital in the uk and to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational registry. parents/subjects will provide their informed consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: - to assess the level of adherence of subjects receiving saizen via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen via easypod™ * to identify adherence subject profiling * to assess the impact of adherence on insulin-like growth factor 1 (igf-1) (i.e. above, below or within normal ranges) * to assess the endocrinological profile including triiodothyronine (t3), thyroxine (t4), thyroid-stimulating hormone (tsh), insulin-like growth factor 1 (igf-1) and insulin-like growth factor-binding protein 3(igfbp-3) levels * temporal profile of igf-1 and igfbp-3 levels

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod electromechanical injection device according to summary of product characteristics (smpc) * over the age of 2 years * under 18 years of age, or over 18 without fusion of growth plates (to be confirmed by the investigator, where relevant) * appropriate informed consent/assent provided exclusion criteria: * patients taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen as defined in the smpc or any other condition which precludes the use of saizen in a given patient * use of an investigational drug or participation in an interventional clinical trial

Keywords: growth disorders saizen easypodtm growth hormone pediatric subject
a trial of cvx-060, an anti-angiogenic covx-body, in combination with sunitinib in patients with advanced renal cell carcinoma

Conditions: Solid Tumor

Summary: the safety and tolerability of cvx-060 have been established in the first-in-human clinical trial, cvx-060-101. thus, this phase ib/ii trial is to assess the safety and pharmacokinetics (pk) profiles of combining cvx-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mrcc).

on 23-nov-2010, b1131001 (cvx-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the pf-04856884 program. the study enrolled the phase 1b portion only. subsequently, on 25-oct-2012, due to data safety signals in a separate clinical trial with pf-04856884 (cvx-060), all pf-04856884 studies were discontinued and ongoing patients on b1131001 were permitted to remain on study at a reduced pf-04856884 dose if determined to have been deriving clinical benefit.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced/metastatic solid tumor * having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors * histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (no previous systemic therapy for the treatment of metastatic renal cell carcinoma) * adequate laboratory tests * eastern cooperative oncology group (ecog) 0-1, life expectancy \> or = 12 weeks and age \> or = 18 years exclusion criteria: * patients intolerant of prior anti-angiogenic agents * recent history of bleeding or bleeding disorders * history of tumors in the brain * history of heart problems * history of severe allergic reaction to antibody therapy

Keywords: phase ib phase ii advanced solid tumor clear cell renal cancer sunitinib plus / minus cvx-060
impact of pilates exercise in children with juvenile idiopathic arthritis

Conditions: Juvenile Arthritis; Cardiorespiratory Fitness; Quality of Life

Summary: juvenile idiopathic arthritis (jia) is one of the most common chronic childhood inflammatory diseases that is characterized by permanent joint inflammation attributable to immune system disturbance.

therapeutic exercises play an essential role as a non-pharmacologic treatment for children with jia. it has effectively been used to reduce pain, improve muscular function, increase physical activity and promote quality of life in children with chronic musculoskeletal disorders. clinical pilates exercise is usually perceived as enjoyable activity by children with jia, thereby, it can help them be more active for extended periods without causing discomfort while also allowing them to control their breathing and avoid becoming fatigued.

Eligibility criteria:
inclusion criteria: * polyarticular jia per the international league of associations for rheumatology classification. * age ranges from 10 to14 years. * stable medical treatment. exclusion criteria: * if they had contractures. * congenital anomalies. * history of surgery. * history of systemic disease * cardiorespiratory co-morbidity. * participation in regular exercises or sports activity.