Kornimate/medical-research-clean huggingface dataset:
mealtime interactions and risk of toddler obesity

Conditions: Obesity

Summary: the purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. the overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zbmi and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zbmi change from birth to 36 months.


Eligibility criteria:
inclusion criteria: * mother participated in clinical trial #nct01545934 * child 18-36 months old exclusion criteria: * child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).

Keywords: toddler obesity responsive feeding behavioral weight control pregnancy weight gain early life risk factors
randomized study on endometrioma treatment

Conditions: Ovarian Endometrioma

Summary: this is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres * no counter-indication for the use of gnrh analogues exclusion criteria: * previous pelvic surgeries * history of cancer * suspected malignancy * presurgical suspicion or evidence of deep endometriosis * presurgical suspicion or evidence of premature ovarian failure * use of oestrogen suppressive drugs in the preceding 6 months
benzbromarone-controlled, double-blind, comparative study of fyu-981 in hyperuricemia with or without gout

Conditions: Hyperuricemia With or Without Gout

Summary: fyu-981 or benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.


Eligibility criteria:
inclusion criteria: * hyperuricemic or gout patients * serum urate level: \>= 7.0mg/dl in patients with history of gout, or \>= 8.0mg/dl in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dl exclusion criteria: * gouty arthritis within two weeks before start of study treatment * secondary hyperuricemia * hba1c: \>= 8.4% * uric acid-overproduction type in the classification of hyperuricemia * history of, clinically significant cardiac, hematologic and hepatic disease * kidney calculi or clinically significant urinary calculi * hepatic dysfuction, or ast: \>=100 iu/l or alt: \>=100 iu/l at the pre-examination * egfr: \< 30ml/min/1.73m\^2 * systolic blood pressure: \>= 180 mmhg * diastolic blood pressure: \>= 110 mmhg
the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis

Conditions: Hemodialysis

Summary: the aim of this study is to examine the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis

the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis

Eligibility criteria:
inclusion criteria: * be over 18 * ability to communicate adequately * absence of psychiatric problems * volunteering to participate in the research * receiving hemodialysis treatment for at least 6 months exclusion criteria: * none

Keywords: fatigue psychological well-being stress
imaging intravenous iron

Conditions: Iron-deficiency

Summary: the aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. we will track iron in tissues using mri relaxometry parameters r1/r2/r2\* which are well established as accurate indicators of tissue iron content.

this is a prospective, observational, study exploring the kinetics of tissue iron uptake following intravenous iron infusion (ferinject), received as part of standard clinical care in a group of iron-deficient patients. participants will be recruited through the iron deficiency management service, part of the oxford university hospitals nhs foundation trust (ouhft) . participants will receive their intravenous iron infusion (ferinject) as part of their standard clinical care by an nhs clinician. they will undergo all the study mri scans and additional study procedures at the oxford centre for clinical magnetic resonance research (ocmr), which is based at the john radcliffe hospital and is part of the division of cardiovascular medicine within the radcliffe department of medicine at the university of oxford. each participant will undergo 4 mri scans; baseline, 3hours, 14 days and 42 days post intravenous iron infusion. blood samples will also be collected at those timepoints for assessment of relevant heamatological and iron parameters.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * aged 18 years or above. * anaemia (haemoglobin less than 120g/l for women and less than 130g/l for men) and/or confirmed iron deficiency (ferritin less than 100mcg/l and/or transferrin saturation less than 20%). * scheduled to receive intravenous iron for correction of iron deficiency. exclusion criteria: * any mri incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel/bullets) * pregnant or lactating participant * acute decompensated heart failure * unstable clinical status * any other medical conditions which would influence the reliability of the study results determined by the investigators. * any other contraindication to mri to be confirmed by the qualified mri operator, e.g. tattoos containing traces of metal.
comparative tolerability of protease inhibitors

Conditions: HIV

Summary: this study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among human immunodeficiency virus (hiv) patients treated with cart regimens including one of four different protease inhibitors \[atazanavir sulfate (atv), darunavir (drv), fosamprenavir (fpv), or lopinavir (lpv)\] and the impact of these identifiable tolerability problems on pi persistence, healthcare utilization, and healthcare costs.


Eligibility criteria:
inclusion criteria: * initiated treatment with a protease inhibitor (pi)-based combination antiretroviral therapy (cart) regimen * between 18-64 years of age on the index date * at least 6 months of continuous enrollment and pharmacy benefits prior to the index date * at least 6 months of continuous enrollment and pharmacy benefits following the index date * at least 1 medical claim during the 6-month follow-up period
beneficial effect of hypothermia plus hemicraniectomy compared with hemicraniectomy

Conditions: Hypothermia

Summary: to study safety and feasibility of mild therapeutic hypothermia after decompressive hemicraniectomy compared with hemicraniectomy alone in patients with malignant cerebral infarction

the current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, single arm, open-label, prospective design. the subject meeting inclusion/exclusion criteria will be assigned to treatment group. the subjects of treatment group should be initiated hypothermia therapy as soon as possible after surgery (less than 6 hours). it can be duration at least 72 hours according to subject status. also process of recovery temperature period will be allowed within 20-40 hours. after 6 month, 12 month of the onset of symptom, mrs score are measured. this is followed by closure of clinical trial.

Eligibility criteria:
inclusion criteria: a. written informed consent obtained from the patient or his/her legally acceptable representative b. acute ischemic stroke within middle cerebral artery or internal carotid artery occlusion * regardless of anterior cerebral artery (aca) or posterior cerebral artery (pca) involvement c. patients of both sexes aged ≥ 19 years and ≤ 82 years d. nihss score ≥ 15 points, nihss loss of consciousness 1a score ≥ 1 point e. patients with proximal cerebral arterial occlusion (such as middle cerebral or internal carotid artery) f. unilateral ischemic lesion of at least 2/3 of the middle cerebral artery (mca) territory involving basal ganglia confirmed by computed tomography (ct) or magnetic resonance imaging (mri) * decided to perform decompressive hemicraniectomy within 48 hours after symptom onset - onset time was defined as the time when patients were lastly seen normal exclusion criteria: a. premorbid modified rankin scale (mrs) score ≥ 2 b. presence of other type of brain lesions including traumatic brain injury, contralateral or infratentorial infarct. c. absence of bilateral pupillary reflex d. known bleeding disorder or coagulopathy e. sepsis f. end stage malignant disease g. pregnancy or during breast feeding h. life expectancy less than 3 year

Keywords: therapeutic hypothermia
clinical and diagnostic value of ribosomal p2 autoantibodies in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a chronic autoimmune disorder characterized by production of autoantibodies directed against nuclear and cytoplasmic antigens. clinically, this disorder is characterized by periods of remission and relapse (1). the early and accurate diagnosis of sle is challenging (2). the sle pathogenesis involves multiple cellular components of the innate and immune systems, presence of autoantibodies and immune complexes, engagement of the complement system and cytokine dysregulation (3). about 180 autoantibodies have been identified in sle patients, 102 of which are reported to have an organ-specific correlation with sle disease identified in sle patients, with sle disease activity (4). however, with the exception of autoantibodies such as antinuclear antibody (ana), anti double stranded dna (dsdna), anti-smith and antiphospholipid antibodies, currently proposed by the american college of rheumatology (acr) (5)

systemic lupus international collaborating clinics (slicc) (6) for the diagnosis of sle, most of these autoantibodies lack sufficient sensitivity and/or specificity for use in clinical diagnosis. discovery of additional autoantibodies with high sensitivity and specificity is important for early diagnosis and assessment of the prognosis of sle (7). anti-ribosomal p(anti-rib-p) antibody, routinely tested in sle, targets a homologous 22-amino acid c-terminal (c-22) sequence shared by three ribosomal phosphoproteins known as p0, p1, and p2 (8). the prevalence of anti-rib-p antibody is about 15-40% in sle patients and varies with the ethnicity, disease activity and detection method (9). studies have disclosed that anti-p antibodies react with activated t cells but not with b cells, suggesting possible direct effects of anti-p antibodies on immune regulation (10).

Eligibility criteria:
inclusion criteria: 1. patients who fulfilled the 2012 slicc criteria (6). 2. sle patients \>= 18 years old. exclusion criteria: * 1-sle patients \< 18 years old. 2- patients with other autoimmune diseases or malignancy.
total versus robotic assisted unicompartmental knee replacement

Conditions: Osteo Arthritis Knee; Arthritis Knee; Arthropathy of Knee

Summary: the purpose of this research is to compare the functional outcomes of patients with end stage medial compartment oa of the knee undergoing a conventional mtka to those undergoing ruka and to assess the associated cost economics of such technology.

unicompartmental knee arthroplasty (uka) is an accepted surgical alternative to total knee arthroplasty (tka) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. however, some surgeons continue to favour tka over uka due to a lower revision rate. the higher revision rates associated with uka are thought to be primarily due to component malpositioning and postoperative limb malalignment. robotic-arm assisted (r)uka offers a greater level of precision of component positioning compared to manual uka and more recently the survivorship of ruka has been shown to be greater than manual uka. early functional outcomes following robotic uka appear to be better than those observed after manual tka. therefore, the benefits of uka could potentially be enjoyed by the patient without the increased risk of revision when compared to tka for those with medical compartment disease. the primary aim of this study is to compare the early knee specific functional outcome of ruka with manually performed (m)tka when performed for patients with medial compartment osteoarthritis of the knee. a single centre randomised control trial will be carried out powered to the oxford knee score.

Eligibility criteria:
inclusion criteria: * listed for elective primary tka for end stage medial compartment osteoarthritis * intact anterior cruciate ligament * full thickness and good quality lateral cartilage * correctable intra-articular varus deformity and intact medial collateral ligament * american society of anesthesiologists (asa) grades 1 and 2 * male or female, age 50 - 75 at the time of listing for surgery * suitable candidate for a cruciate retaining tka (triathlon prosthesis) and a uka exclusion criteria: * varus deformity of \> 20 degrees * fixed flexion of \>10 degrees * patient is unable to comply with the study protocol (incl. refusal for ct scan) or functional assessments * female participants who are pregnant, lactating or planning pregnancy during the course of the study * requires patella resurfacing or lateral compartment has significant oa * inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons * inflammatory disorder e.g. rheumatoid arthritis * symptomatic foot, hip or spine pathology * prior surgery (other than arthroscopy) or septic arthritis of the knee * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study,

Keywords: arthroplasty robotic knee total partial outcome mako
safety and tolerability of escalating intravenous doses of pf-05231023 in adult subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a trial in subjects with type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of pf-05231023.


Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the american diabetes association guidelines. * body mass index (bmi) of 25 to 35.5 kg/m2, and a total body weight \>50 kg (110 lbs). * hba1c \>7% and not to exceed 10.5%. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * diagnosis of type 1 diabetes mellitus * evidence of diabetic complications with significant end organ damage.

Keywords: type 2 diabetes intravenous single dose
olanzapine for the treatment of refractory chronic nausea and vomiting

Conditions: Nausea; Vomiting

Summary: prospective, observational study evaluating the effect of olanzapine for the treatment of refractory chronic nausea and vomiting.

patients will be identified who are seen in the johns hopkins gastroenterology clinic, suffer from chronic nausea and vomiting that is refractory to both prokinetic and antiemetic medications, and are being prescribed olanzapine for treatment of nausea and vomiting. patients who meet criteria will be enrolled and their gastrointestinal symptoms, quality of life, and psychological symptoms will be assessed by various questionnaires and followed over the course of 3 months.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * able to communicate in english without aid of interpreter * have chronic refractory nausea, meeting each of the following criteria: 1. baseline nausea and vomiting score on vas of 25mm or greater 2. duration symptoms of at least 6 months (does not have to be contiguous) 3. intolerance to or inadequate response to prior treatment with both 1) ondansetron or another serotonin (5ht3) antagonist and 2) metoclopramide or domperidone exclusion criteria: * history of chemotherapy within the last year * current diagnosis of cancer * pregnant or breastfeeding * for females, active efforts to conceive/become pregnant during the time of the study * chronic opioid use (3 times a week or greater use) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) elevation of greater than 2x upper limit of normal (within 3 months of enrollment) * cirrhosis * unable or unwilling to stop using metoclopramide while using olanzapine * concomitant use of other antipsychotics (e.g., haloperidol) * prolonged corrected qt interval (qtc) (\>470ms for men and \>480ms for women) * history of life-threatening arrhythmia * hypokalemia (potassium \<3.1) or hypomagnesemia (magnesium \<1.2) * metabolic syndrome, defined as per adult treatment panel iii criteria * granulocytopenia (absolute neutrophil count \<1500) * history of tardive dyskinesia * history of acute dystonic reaction to medications * history of neuroleptic malignant syndrome
left ventricular multispot pacing for crt (ispot)

Conditions: Heart Failure

Summary: the purpose of the ispot study is to evaluate the contractility using positive left ventricular (lv) dp/dt max across lv pacing site(s) in patients indicated for cardiac resynchronization therapy (crt).


Eligibility criteria:
inclusion criteria: * subject is indicated for cardiac crt or crt-d device according to current applicable european society of cardiology (esc)/american heart association (aha) guidelines * subject has a left bundle branch block (lbbb) conduction pattern * subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (af) episodes allowed during the last 2 weeks prior to inclusion) * subject receives optimal heart failure oral medical therapy (ace inhibitor and/or angiotensin receptor blockers (arb) and beta blockers), and is on a stable medication scheme for at least 1 month prior to enrollment * subject (or the legal guardian) is willing to sign informed consent form * subject is 18 years or older or as specified minimal age per local law/regulation exclusion criteria: * subject has permanent atrial fibrillation/ flutter or tachycardia * subject experienced recent myocardial infarction (mi), within 40 days prior to enrollment * subject underwent coronary artery bypass graft (cabg) or valve surgery, within 90 days prior to enrollment * subject is post heart transplantation, or is actively listed on the transplantation list * subject is implanted with a left ventricular assist device (lvad) * subject is on chronic renal dialysis * subject has severe renal disease (defined as estimated glomerular filtration rate (equation provided by modification of diet in renal disease study): (egfr) \< 30 ml/min/1.73m2) * subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week) * subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period) * subject has complex and uncorrected congenital heart disease * subject has a mechanical heart valve * pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control * subject is enrolled in one or more concurrent studies that would confound the results of this study * subject is already implanted with a device
a prospective study comparing different clinical decision rules in adult and pediatric ankle trauma

Conditions: Ankle Injuries

Summary: comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.

patients with ankle trauma frequently present in the emergency department. in many institutions radiographies of the ankle and foot are obtained in most of these patients, although significant fractures occur only in 15%. therefore clinical decision rules were developed to clinically rule out significant ankle fractures, thereby reducing the number of radiographies resulting in significant time and cost savings. up until now the ottawa ankle and foot rules are the only clinical decision rules for ankle trauma that are widely accepted. they have a high sensitivity for the detection of fractures but a relatively low specificity. this led to the development of alternative clinical decision rules claiming equally high sensitivity but improved specificity. these alternatives have mostly not been replicated nor have they been directly compared. this is what the researchers want to do in this study: compare different clinical decision rules regarding sensitivity and specificity. radiographies of ankle and foot made for every patient are used as the gold standard for the detection of fractures. different clinical decision rules will be compared in a pediatric (5-15 years) and an adult population (from 16 years onwards). the researchers consider a clinical decision rule acceptable of it has a sensitivity of at least 95% and a specificity of at least 25%.

Eligibility criteria:
inclusion criteria: * pain due to blunt trauma to the ankle * must be at least 5 years old exclusion criteria: * skin defects in the injured area * time of trauma \> 72 hours before presentation * multiple significant injuries making clinical examination impossible * clinically obvious fracture * re-evaluation * referred with radiography * result of radiography already known to investigator * glasgow coma scale \< 15

Keywords: ottawa ankle and foot rules buffalo rule bernese ankle rules low risk exam malleolar zone algorithm clinical decision rule ankle injury ankle sprain inversion trauma