Kornimate/medical-research-clean huggingface dataset:
prevention of hip displacement in children with cerebral palsy in denmark

Conditions: Child; Cerebral Palsy; Radiography; Hip Dislocation; Hip Displacement; Prospective Studies

Summary: children with cerebral palsy have an increased risk of hip dislocation, which is a painful and severe complication of cerebral palsy. the 20-years evaluation of the swedish surveillance programme shows that hip dislocation in children with cerebral palsy can be prevented with regular clinical and radiographic examination and early intervention. we would like to determine the individual risk for hip displacement for danish children with cp in the danish cerebral palsy follow-up program. this could be a valuable clinical tool in deciding on further follow-up and treatment.

migration percentage (mp) which is measured from the pelvis radiograph is commonly used to assess lateral displacement of the femoral head and is being used in the swedish and in the danish surveillance programme. most children with an mp \> 40 % need surgery to prevent further displacement and prevent dislocation of the hip. in the swedish surveillance programme they have developed the cerebral palsy follow-up programme (cpup) hip score as a risk score to determine which children are at high or low risk for hip displacement (mp \> 40 %) within five years after first radiographic examination. the aim of this study is to predict the likelihood that a child with cerebral palsy will develop hip displacement (mi\> 40) within three years. the design is a prediction study. data will be obtained from the national clinical quality database the danish cerebral palsy follow-up program and the danish national patient register.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy * gross motor function classification system iii to v * migration percentage \< 40 % for both hips at the first pelvic radiographic examination exclusion criteria: * previous femoral osteotomy * previous pelvic osteotomy * previous selective dorsal rhizotomy * intrathecal baclofen pump treatment * children whose diagnosis was not confirmed * children who were no longer followed in the children's ward at the hospital * children who moved out of the area * children who died during the study period
first study in humans with gsk206136

Conditions: Depressive Disorder and Anxiety Disorders

Summary: this is the first study in humans with gsk206136 to evaluate what effects: good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). also the study aims to investigate the penetration of the drug in the human brain by using pet (positron emission tomography) imaging technology


Eligibility criteria:
inclusion criteria: * healthy males aged 18-45 years, limited to 25-40 years of age for pet section exclusion criteria: * the subject has a positive: drug/alcohol, hepatitis, hiv screen.. * the subject has a history of psychiatric illness suicidal attempts or behaviour. * abuse of alcohol. * clinically significant laboratory, ecg abnormality; * the subject has recently received an investigational. * use of prescription or non-prescription drugs, * history or presence of allergy to the study drug or drugs of this class, * donation of more than 500 ml blood within the 90 days before dosing. * an unwillingness of male subjects to comply with contraceptive requirements * average daily caffeine intake exceeding protocol requirements.

Keywords: nk1 antagonist and ssri safety first time in humans healthy subjects
study of bms-833923 in two specific patients with basal cell nevus syndrome

Conditions: Basal Cell Nevus Syndrome

Summary: this is an extension study of protocol ca194002 to allow 2 specific participants with basal cell nevus syndrome in the ca194002 study at princess margaret cancer centre who are still benefitting from the study drug bms-833923 to continue receiving the study drug. this study will continue to evaluate the safety and tolerability of bms-833923 in these participants.

the purpose of this study is to evaluate the safety and tolerability of bms-833923 administered on an extension protocol in subjects with basal cell nevus syndrome (bcns). this is an extension study of protocol ca194002 to allow 2 specific participants with bcns in the ca194002 study at princess margaret cancer centre who are still benefitting from the study drug bms-833923, to continue receiving the study drug. in this open-label extension protocol, no new subjects will be recruited. the two bcns subjects from protocol ca194002 (subjects ca194002-1-14 and ca194002-1-25) will continue to receive bms-833923 at the dose and schedule administered on ca194002 until fulfilling protocol criteria for discontinuation. these patients are receiving different doses: one being 60mg once every 2 weeks, and the other is receiving 300mg once daily. this study will continue to evaluate the safety and tolerability of bms-833923 in these participants.

Eligibility criteria:
inclusion criteria: * signed consent * two specific study participants enrolled on protocol ca194002 at princess margaret cancer centre and remain on bms-833923 at the time of study entry * women, age 18 years and above * agree to use methods to prevent pregnancy, not pregnant or breastfeeding exclusion criteria: * known symptomatic brain metastasis * a serious uncontrolled medical disorder or active infection, which would impair the ability of the patient to receive protocol therapy * gastrointestinal disease or surgery that could impact the absorption of study drug * inability to swallow oral medication * inability to be venipunctured and/or tolerate venous access * uncontrolled or significant cardiovascular * any other medical, psychiatric and/or social reason * have hiv, hepb, or hepc * exposure to immunosuppressants and immunotherapy concurrently with study treatment and up to 3 months * acceptable physical and laboratory test findings * history of allergy to compounds chemically-related

Keywords: bms-833923 ca194002
formation of health professionals through in situ simulation to improve performances during the initial step of thrombectomy for ischemic strokes

Conditions: Time; Benefit of in Situ Simulation for This Kind of Training; Installation of the Patient Until the Percutaneous

Summary: the thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. this first and essential time required the intervention of many health professionals. the approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).


Eligibility criteria:
inclusion criteria: * voluntary professionals
effects of hyperthermic baths on motor symptoms of parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this study is to further evaluate the effects of seasonal variation and the aquatic thermal environment of hyperthermic baths (htb) on the motor symptoms (ms) of parkinson's disease (pd), and whether the environmental temperature is associated with these effects.

after being informed about the study and potential risks, all participants will give written informed consent. all participants who meet the inclusion criteria will undergo a complete history and physical examination, including an assessment using the movement disorder society-united parkinson's disease rating scale (mds-updrs), h\&y stage, mmse and moca. each participant will receive two subjective measures (the movement disorder society-united parkinson's disease rating scale part iii motor examination total scores and the modified webster symptoms score) nine times in an open medication state (open state). each participant will take hyperthermic baths (htb) at the same time on the first, third and fifth days. the participants will receive subjective measures before and after the htb. the time at which the subjective measures begin after the htb will be recorded. in the second week, no participants accept any intervention. to avoid the effects of fluctuations in dopaminergic drugs concentrations, subjective measures will be given without htb at the recorded times on the fifteenth, seventeenth and nineteenth days.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosis of idiopathic parkinson's disease（ipd）based on the movement disorder society clinical diagnostic criteria for parkinson's disease * subjective feeling that motor symptoms（ms）of parkinson's disease （pd） were affected by seasonal variation (i.e., ms were more severe in winter than in summer) and improved after htb * no change in the patient's pd medication regimen during the study exclusion criteria: * symptomatic bradycardia, severe postural hypotension, symptomatic coronary insufficiency, severe organic heart damage, severe cerebrovascular disease, and active psychosis * dementia (mini-mental state examination (mmse) \< 24 and montreal cognitive assessment (moca) \< 26) * failure to cooperate with the study requirements and poor compliance

Keywords: parkinson's disease temperature hyperthermic baths physiotherapy
hyper-arousal in chronic primary insomnia

Conditions: Chronic Insomnia

Summary: the purpose of this study is to determine whether individuals with chronic insomnia disorder have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good sleepers. the primary goal is to perform a rigorous quantitative assessment of physiologic hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass index (bmi) and race/ethnicity.


Eligibility criteria:
inclusion criteria for insomniacs: * men and women with primary insomnia of at least 3 months in duration * ages 21-65 years old * bmi \<35 kg/m2 to enable microneurography * moderate to severe insomnia based on the insomnia severity index (isi) questionnaire * pittsburgh sleep quality index (psqi) \> 5 * self-reported habitual sleep duration \< 6.5 hours inclusion criteria for good sleepers: * 21-65 years old men and women with bmi \<35 kg/m2 * no insomnia based on isi questionnaire * self-reported habitual sleep duration ≥ 6.5 hours but \< 9 hours * psqi\<5 * sleep efficiency on psg with trt of 8 hours \> 85% * no history of mental illness, shift work, circadian rhythm disorders exclusion criteria for both insomniacs and good sleepers: * sleep disorders other than insomnia as assessed by screening psg (apnea-hypopnea index or ahi ≥ 10, plm arousal index ≥ 5) * circadian rhythm sleep disorders * diabetic based on hba1c ≥ 6.5 %. for those with hba1c ≥ 6.0 but \<6.5%, the non-diabetic condition will be confirmed by 2-h oral glucose tolerance test * history of meeting dsm-ivr criteria based on the mini international neuropsychiatric interview version 6.0 for any major psychiatric disorder * unstable or serious medical conditions * current, or use within the past month, of psychoactive (other than stable treatment with antidepressants), hypnotic, stimulant or analgesic medications (except occasional non-narcotic analgesics), beta blockers or alpha blockers * shift work or other types of self imposed irregular sleep schedules * habitual smoking * habitual alcohol consumption * pregnancy

Keywords: insomnia
effect of remimazolam versus dexmedetomidine on the incidence of delirium after elective cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled trial

Conditions: Delirium - Postoperative

Summary: the study aims to improve the post-open heart surgery lifestyle and overall experience, as well as assess the incidence of delirium using remimazolam and dexmedetomidine.

delirium is an acute brain dysfunction characterized by an acute onset and fluctuating course of disturbance in attention, awareness, and cognition, it is the most common neurocognitive complication following cardiac surgery, with an incidence rate between 11% and 52%. the occurrence of delirium correlates strongly with various short- and long-term poor outcomes following cardiac surgery, including prolonged icu stay and hospitalization and increased risk of hospital readmission. different risk factors contribute to delirium after cardiac surgery, including advanced age, pre-existing cognitive impairment, diabetes, history of stroke, type of surgery, extended cpb duration, and blood transfusion. dexmedetomidine is a highly and potently selective α2-adrenoceptor agonist with anxiolytic, sedative, and analgesic properties. it has neuroprotective effects by reducing neuroinflammation, apoptosis, and blood-brain barrier injury via central α2a adrenoceptors, but it can cause hypotension and bradycardia. remimazolam, a new ultra-short-acting benzodiazepine, also has a faster onset of action and a higher safety profile. it was recently approved for procedural sedation and general anesthesia. its metabolism is mainly induced by tissue esterase, independent of liver and kidney function, and its metabolites are inactive. in addition, flumazenil reverses the effects of remimazolam in the event of adverse events, an advantage not available in non-benzodiazepines. the objective of this clinical trial is to evaluate the efficacy of remimazolam compared with dexmedetomidine for preventing postoperative delirium after cardiac surgery.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * scheduled for cardiac surgery (cabg and/or valve replacement). * elective surgery exclusion criteria: * patients with known allergies to remimazolam or dexmedetomidine * refusal to participate. * history of psychiatric or neurological conditions (schizophrenia, epilepsy, severe dementia, etc.). * preoperative inability to communicate (severe visual/auditory dysfunction, language barriers). * severe hepatic or renal dysfunction * cardiopulmonary bypass time not ≥ 120 minutes * aortic clamping time not ≥ 90 minutes * emergency surgeries * on preoperative mechanical ventilation and long sedation time * reoperated patients

Keywords: cradiac surgery with cardiopulmonary bypass
investigation of psychophysiological correlation of aggression and response to aversive stimuli

Conditions: Conduct Disorder; ADHD; Oppositional Defiant Disorder

Summary: this study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (cd) and/or attention-deficit/hyperactivity disorder (adhd). data was gathered about participants' level of aggression through the reactive-proactive aggression questionnaire (rpq). the stimuli that were presented to the participants included 1) a loud sound, 2) threatening photographs from the international affective picture system (iaps), and 3) the trier social stress task (tsst). participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their rpq scores and clinical diagnosis.


Eligibility criteria:
inclusion criteria: 1. subjects between ages 7 and 16 years 2. subjects who fulfil all criteria for a dsm-iv diagnosis of adhd, conduct disorder, or oppositional defiant disorder 3. subjects with willingness to participate in a randomized, double-blind controlled trial 4. subjects with complete written, informed parental consent and child assent 5. subjects with iq of 70 or more exclusion criteria: 1. subjects who have iq in the below 70 2. subjects who are younger than 7 years old or older than 16 years old 3. those without written parental consent 4. those with brain pathology such as serious head injury, epilepsy, etc.
palliative lattice stereotactic body radiotherapy (sbrt) for patients with sarcoma, thoracic, abdominal, and pelvic cancers

Conditions: Sarcoma; Thoracic Cancer; Abdominal Cancer; Pelvic Cancer

Summary: this is a study evaluating the safety and efficacy of lattice sbrt for patients with large tumors (≥ 4.5 cm) planning to undergo palliative radiotherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed sarcoma (including extremity), thoracic cancer (including esophageal), abdominal cancer (including retroperitoneal sarcoma), or pelvic cancer. * planning to undergo palliative radiotherapy to a lesion ≥ 4.5 cm as measured with radiographic imaging or with calipers by clinical exam. * ecog performance status ≤ 2 * at least 18 years of age. * radiotherapy is known to be teratogenic. for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study * ability to understand and willingness to sign an irb approved written informed consent document exclusion criteria: * prior high-dose radiotherapy that overlaps with any planned site of protocol radiotherapy. patients where the lattice sbrt fields may overlap with the low dose (\<10 gy) region of prior radiotherapy treatments are eligible and may be treated if this is determined to be safe by the treating physician. * patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture. * currently receiving any cytotoxic cancer therapy regimens or vegf inhibitors that will overlap with the lattice sbrt administration. \*cytotoxic chemotherapy and vegf inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. this includes continuing a treatment plan which was initiated prior to the start of radiotherapy. a 2-week washout is recommended, but not required. * pregnant. women of childbearing potential must have a negative pregnancy test within 20 days of study entry. * patients with hiv are eligible unless their cd4+ t-cell counts are \< 350 cells/mcl or they have a history of aids-defining opportunistic infection within the 12 months prior to registration. concurrent treatment with effective art according to dhhs treatment guidelines is recommended. recommend exclusion of specific art agents based on predicted drug-drug interactions (i.e. for sensitive cyp3a4 substrates, concurrent strong cyp3a4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).
weight loss prior mamma reduction - a pilot study

Conditions: Weight Loss; Hypertrophy

Summary: due to a higher risk of complications, obese and overweight patients with macromastia are in denmark prohibited mammoplasty , as bmi must be within normal range, i.e. bmi \< 25 kg/m2. the study is a pilot study with a diet intervention group and no control group. the intervention is a 12 week low energy diet pre-operative weight loss program investigating if this will result in weight loss making the overweight and obese patients eligible for breast reduction surgery i.e. bmi \< 25.


Eligibility criteria:
inclusion criteria: * entitled to mammoplasty, * motivated towards participation in a weight loss program * bmi within the range 25.5 to 35 kg/m2 exclusion criteria: * more than 65 years of age * insulin-dependent diabetes * chronic heart, liver or kidney failure
comparison of 18f-fluorodeoxyglucose positron emission tomography and coronary computed tomography in assessing vascular inflammation

Conditions: Atherosclerosis

Summary: vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18f-fluorodeoxyglucose (fdg) positron emission tomography (pet) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row ct can provide measurements of coronary artery calcium (cac), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. therefore, the purpose of the investigators study is to compare the usefulness of 18 fdg-pet and mdct in assessing the vascular inflammatory status and vulnerability.


Eligibility criteria:
inclusion criteria: * healthy patients for visiting routine medical check in our clinic exclusion criteria: * history of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) * diabetes * stage 2 hypertension (resting blood pressure, ≥ 160/100 mmhg) * malignancy * severe renal or hepatic disease * subjects taking medications that might affect inflammation such as nsiad and statin

Keywords: atherosclerosis vascular inflammation mdct 18fdg-pet
diet and physical activity changes among latina breast cancer survivors

Conditions: Breast Cancer

Summary: the investigators will conduct a 2x2 factorial randomized controlled trial to test the separate and synergistic effects of an in-person hands-on dietary and physical activity change curriculum (i.e., mi vida saludable program) and e-communication strategies (text messaging, emailed newsletters and an interactive website) on changing dietary and physical activity behaviors among a diverse population of latina breast cancer survivors who have completed breast cancer treatment. participants will be evenly randomized to 4 arms: in-person education alone, e-communication alone, in-person education plus e-communication, or control.

there are clear diet and physical activity guidelines for cancer survivors: eat a diet high in fruits/vegetables and low in energy-dense foods and engage in 150 minutes of moderate-to-vigorous physical activity each week. however, cancer survivors are provided with few, if any, resources to meet these guidelines and there are limited data supporting how cancer survivors can achieve sustained dietary change. there are even fewer behavioral change resources available to minority cancer survivors. few studies have examined the separate and synergistic effects of in-person education and electronic or "e-"communication strategies in changing and maintaining health behaviors.

Eligibility criteria:
inclusion criteria: 1. female. 2. 21 years of age or older. 3. self-identify as hispanic/latina. 4. speak spanish or english. disease related criteria 5. medical history of histologically confirmed stage 0, i, ii, iii breast cancer, with no evidence of metastatic disease. prior/ current therapy criteria 6. at least 90 days post chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery. current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors). accessibility criteria 7. have access to computer or smartphone. clinical/ laboratory criteria 8. no history of smoking within the past 30 days. 9. no uncontrolled diabetes mellitus defined as hgb a1c \>7% 10. consume \<5 servings of fruits and vegetables per day and/or engages in \<150 weekly minutes of moderate to vigorous physical activity. exclusion criteria: any criterion not met under inclusion.

Keywords: breast cancer cancer survivor e-communication diet and physical activity fruits/vegetables daily servings energy density
home based exercise program for brain injury children

Conditions: Brain Injury; Cerebral Palsy

Summary: the purpose of this study is to examine whether simple home-base aerobic exercise program have beneficial effect on walking abilities and balance performance in children with brain damage


Eligibility criteria:
inclusion criteria: clinical diagnosis of cp or abi must be able to stand with or without aid. exclusion criteria: can not follow simple commands