Kornimate/medical-research-clean huggingface dataset:
a prospectivetrial using video images in advance care planning in hospitalized seriously ill patients with advanced cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to compare the decision making of hospitalized subjects with advanced cancer having a verbal discussion about cpr compared to subjects using a video.

aim 1: to recruit 150 subjects with advanced cancer admitted to the inpatient oncology ward with an overall prognosis of one year or less and randomly assign these subjects to: 1. a video visually depicting cpr preferences or 2. the current standard of care without the use of video (control). hypothesis 1: it is feasible to recruit and randomize 150 hospitalized subjects with advanced cancer and an overall prognosis of one year or less. aim 2: to compare the care preferences for cpr and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video. hypothesis 2: subjects randomized to the video intervention will be significantly more likely to opt against cpr and intubation compared to those who do not see the video. aim 3: to compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video. hypothesis 3: subjects randomized to the video are more likely to have their code status documented in the electronic medical records compared to those who do not see the video. aim 4: to compare the decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video. hypothesis 4: when compared to subjects randomized to the current standard of care, subjects in the video intervention group will have lower decisional conflict (lower decisional conflict scores) when asked to choose cpr and intubation preferences. aim 5: to compare knowledge assessment of cpr of subjects randomized to video and subjects randomized to current standard of care without the video. hypothesis 5: when compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge assessment scores when asked questions regarding their understanding of cpr. aim 6: to compare code-status (cpr, and intubation) preferences in the electronic medical record on future hospitalizations up to one year post-hospital discharge of subjects randomized to video and subjects randomized to current standard of care without the video. hypothesis 6: subjects randomized to the video are more likely to opt against cpr and intubation in the future compared to those who do not see the video.

Eligibility criteria:
inclusion criteria: * potential subjects will be identified by the research assistant. the specific eligibility criteria include: 1. over the age of 60 2. the ability to provide informed consent 3. the ability to communicate in english 4. an established diagnosis of metastatic cancer with a prognosis of one year or less confirmed with the attending physician on service.
cognitive-behavioral therapy (cbt) in children with diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. development of adaptive coping strategies may be improved by focused parent and children training. this study assesses a cognitive behavioral treatment (cbt) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. the investigators main aim is to verify that the cbt program improves overall balance of glycaemia better than phone contact without cbt content (control group). secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.


Eligibility criteria:
inclusion criteria: * children and teenagers from 6 years-old to 18 years-old * having diabetes treated by insulin for at least 1 year * followed in pediatric diabetology department of arnaud de villeneuve hospital in university hospital of montpellier * study inform consent signed by both children and parents exclusion criteria: * children with developmental delay, severe mental disorders or language delay * non french-speaking family * children who does not live with at least one of his/her parents * children whose residence is not compatible with frequent visits at university hospital of montpellier * clinical status not compatible with study questionnaires assessment.

Keywords: diabetes mellitus glycaemia cognitive-behavioral treatment coping parents children
a study of tmc435 in genotype 1, hepatitis c-infected patients who relapsed after previous interferon (ifn)-based therapy

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of tmc435 in combination with peginterferon alfa-2a (pegifnα-2a) and ribavirin in genotype 1 hepatitis c virus (hcv)-infected participants who relapsed after previous interferon (ifn)-based therapy in japan.

this is a single-arm study to evaluate the efficacy and safety of tmc435 in combination with the standard of care (soc), pegifnα-2a (p) and ribavirin (r), in adult, genotype 1 hcv-infected participants who relapsed after previous ifn-based therapy in japan. the study objective is to evaluate the efficacy of tmc435 by the percentage of participants with undetectable hcv ribonucleic acid (rna). participants will receive 12 weeks of treatment with tmc435 (100 mg) once daily plus pr followed by 12 or 36 weeks of treatment with pr. tmc435 is a 100-mg capsule and will be taken orally (via the mouth). treatment with pr will last 24 or 48 weeks. pegylated interferon is supplied as a vial containing 1.0 ml solution with 180 µg pegifnα-2a and will be injected by a syringe under the skin once weekly. ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg), taken orally two times a day after meals. the participants will receive oral capsules of tmc435 (100 mg) once daily up to week 12.

Eligibility criteria:
inclusion criteria: * participants must have chronic genotype 1 hcv with hcv rna level \>= 5.0 log10 iu/ml * participant relapsed after previous ifn-based therapy * participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication. exclusion criteria: * co-infection with any other hcv genotype or co-infection with the human immunodeficiency virus (hiv) * diagnosed with hepatic cirrhosis or hepatic failure * a medical condition which is a contraindication to pegifn or ribavirin therapy * history of, or any current medical condition, which could impact the safety of the patient in the study

Keywords: hepatitis c, chronic hepatitis c virus interferon alfa-2a ribavirin viral rna
step down colon cancer risk

Conditions: Adenomatous Polyps

Summary: hypothesis 1: exercise will decrease serum markers in a dose response manner. hypothesis 2: participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.

primary aim: to conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. the major outcomes are changes in serum levels of four risk-related biomarkers: insulin, c-peptide, il-6 and pge-2. secondary aim. to compare changes in the secondary outcome of physical activity over three months.

Eligibility criteria:
inclusion criteria: * aged 50 to 80 * no personal cancer history * found to have an adenomatous polyp upon colonoscopy at bjh/wusm in the previous six months * no contraindications to beginning an exercise program * no previous diagnosis of familial polyposis syndromes * no previous diagnosis of ulcerative colitis or crohn's disease; exclusion criteria: * participants who are regular nsaid users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other nsaid 5 or more days of the week.
spine deformities in juvenile idiopathic arthritis

Conditions: Scoliosis; Juvenile Idiopathic Arthritis; Awareness

Summary: juvenile idiopathic arthritis (jia)is the most common chronic rheumatic disease in childhood. while jia usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. the aim of this study was to perform scoliosis screening in children with jia and to evaluate families' awareness of scoliosis.

juvenile idiopathic arthritis (jia)is the most common chronic rheumatic disease in childhood. while jia usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. the aim of this study was to perform scoliosis screening in children with jia and to evaluate families' awareness of scoliosis. aged 4-16 years will include in the study. trunk rotation measure with scoliometer by applying forward bending test. children with more than 5 rotations will send to the x-ray. 28 questions will asked, which evaluate the demographic characteristics of children, their educational status, their participation in sports activities, and the physical appearance of families about their children. these questions will asked if the parents had heard of scoliosis before, where they heard it, and whether anyone had scoliosis in the family. families who complained of posture disorder will asked which shoulder is high without looking at their children and whether they see any height when they leaned forward and the pain situation in their children. statistical analysis of the data using the spss 24.0 (statistical package for social sciences) program. in all analyzes, p≤0.05 consider statistically significant.

Eligibility criteria:
inclusion criteria: * having been diagnosed with rheumatology age between 6-16, * to be diagnosed at least 6 months ago; * ability to walk independently; ability to read and write in turkish; able to follow simple instructions * no pathology in visual ability and hearing exclusion criteria: * a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder); * severe musculoskeletal, neurological or cardiovascular disorders that limit mobility; * use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines * participate in scoliosis rehabilitation in the lasts 6-months.

Keywords: scoliosis juvenile idiopathic arthritis awareness spine
effectiveness of oxymetazoline added on nasal steroid in rhinitis with persistent nasal obstruction

Conditions: Nasal Obstruction Present Finding

Summary: background allergic rhinitis is a common health problem with a worldwide prevalence is 10-25%, and poses significant impact on the quality of life of the patients. in thailand, the prevalence of allergic rhinitis in the general population is 13.5%, of which the frequency of allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the graduate students. despite intranasal steroid being the current first-line treatment of patients with allergic rhinitis, only 60% of patients achieve excellent control. persistent nasal congestion is the major symptom which is difficult to control in these patients. data are limited about efficacy and safety of the additional use of 0.05% intranasal oxymetazoline hydrochloride (oxy) for persistent nasal congestion that does not adequately respond to recommended doses of intranasal steroid (ins) and oral antihistamine(oah). objective to determine the efficacy and safety of the additional use of oxy for persistent nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately controlled by combination treatment with ins and oah. methods the investigators performed a 6-week, randomized, double blind, placebo controlled, clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom inadequately controlled by combination treatment with ins and oral antihistamine (oah). after an initial screening, qualified individuals were randomized into 2 groups including the treatment group and the control group. the treatment group received the ins (2 puffs in each nostril twice daily) and oah (1 tablet once daily) plus oxy (2 puffs in each nostril twice daily) the control group received ins (2 puffs in each nostril twice daily) and oah (1 tablet once daily) plus placebo (2 puffs in each nostril twice daily).

all participants will continue medications for 4 weeks, then stop using interventional medication and still take ins (2 puffs in each nostril twice daily) and oah (1 tablet once daily) for 2 more weeks. then, all participants will come for the last visit to see whether rebound nasal symptoms occur. participants will be asked to record nasal symptom diary card, and nasal peak inspiratory flow. rhinoconjunctivitis quality of life questionnaire (rcq) will be recorded during visit.

Eligibility criteria:
inclusion criteria: * patient 18 years of age or greater * diagnosis with allergic or nonallergic rhinitis with persistent nasal obstruction * being treated with intranasal steroid and oral antihistamine exclusion criteria: * underlying disease of hypertension * use oral or nasal decongestant 7 days prior to entering the study * nasal polyp or significant deviated nasal septum * respiratory tract infection 14 days prior to entering the study

Keywords: rhinitis oxymetazoline
study of the efficacy and safety of nebivolol in younger patients (18 - 54 years)

Conditions: Hypertension

Summary: the purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.


Eligibility criteria:
inclusion criteria: * male and female outpatients, of age 18 - 54 years * patients diagnosed with stage 1 or stage 2 essential hypertension * normal physical examination findings and electrocardiogram (ecg) results or abnormal findings judged by the investigator to be not clinically significant exclusion criteria: * secondary hypertension or severe hypertension * history of type 1 diabetes mellitus * a medical contraindication to discontinuing a current antihypertensive therapy * clinically significant respiratory disease that prohibit use of a beta blocker

Keywords: stage 1 stage 2 hypertension
quality project to evaluate and validate the fast-o rating scale

Conditions: Acute Psychotic Symptoms

Summary: the purpose of this project is to test the reliability of the fast-o rating scale in patients at acute wards or psychiatric intensive care units.


Eligibility criteria:
inclusion criteria: * patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit exclusion criteria: * not applicable

Keywords: psychotic symptom assessments observational assessments of patients with acute psychotic symptoms
a post-market study evaluating the safety of infinity dbs system with mr conditional labeling

Conditions: Movement Disorders; Parkinson Disease; Essential Tremor; Tremor; Dystonia

Summary: the infinity mri pmcf was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (pmcf) study. the study evaluated the safety of the infinity dbs system with mr conditional labeling when an mri procedure was performed according to the approved guidance. subjects were followed for 1 month after the mri procedure. participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.


Eligibility criteria:
inclusion criteria: 1. subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure. 2. subject has been implanted, or is scheduled to be implanted, with a commercially available infinity dbs system with mr conditional labeling per locally approved indications for use. 3. subject is scheduled to undergo a mri procedure in compliance with the mri procedure information clinician's manual. anxiolytics and patient's regular medications may be administered, provided instructions for use (ifu) criteria are met. 4. subject is willing and able to comply with study requirements. exclusion criteria: 1. subject has another implanted device (active or passive implanted device) that prohibits safe scanning. 2. subject has previously experienced an mri-related adverse event or cannot undergo mri for any other reason. 3. subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period. 4. subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 5. subject is currently participating in another clinical investigation that may confound the results of this study.

Keywords: infinity dbs system abt-cip-1026 deep brain stimulation magnetic resonance imaging
a self-controlled study of the effect of partial spectral absence of visible light on the pupil

Conditions: Full Spectrum

Summary: previous studies have shown that the spectrum of light influences myopia. led lights with a partially absent light spectrum increase the risk of myopia progression compared to leds with a full spectrum, potentially mediated by the excitability of the parasympathetic nervous system. this study intends to compare pupil size and area, as well as parameters regulated by the autonomic nervous system (such as skin bioelectrical activity and heart rate), between leds with a full visible spectrum and leds with a partially absent spectrum around 470nm and 730nm. we aim to elucidate the physiological mechanism underlying the effect of light spectrum on pupil changes and myopia.


Eligibility criteria:
inclusion criteria: * 1. age 7-45 years 2. able to wear multi-channel physiological measurement devices and cooperate with experimental procedures. 3. binocular? spherical power between -0.50 to -5.00 diopters, and cylinder power no more than -1.50 diopters. 4. voluntarily participate in this study with informed consent form signed. exclusion criteria: * 1. history of diseases affecting autonomic nervous system function, such as depression and anxiety. 2. history of eye diseases such as strabismus, amblyopia, keratitis, and glaucoma, which are unsuitable for eye movement test. 3. history of major systemic diseases or surgeries such as cranial surgery, myocardial infarction, or stroke. 4. systemic medication history that may affect autonomic nervous system function, including but not limited to antidepressants, antihistamines, anticholinergics, antipsychotics, and sedative-hypnotic drugs like diazepam or lorazepam. 5. use of eyedrops such as mydriatics or miotics that will affect pupil size. 6. having difficulty in understanding and cooperating with the trial, such as those with disabilities, communication barriers, or those unable to undertake examinations. 7. other contradictions that the physician may consider inappropriate for enrolment.

Keywords: myopia,spectrum,vegetative nerve,pupil
multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing tbi and chemotherapy

Conditions: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Summary: this clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradiation (tbi) and chemotherapy. using multi-modality imaging and collecting biospecimen samples may help doctors know more about how tbi and chemotherapy can change the bone marrow.

primary objectives: i. temporal assessment of treatment impact on bone marrow. ii. relative assessment of bone marrow status between total marrow and lymphoid irradiation (tmli) and conventional tbi. secondary objectives: i. correlation of dual energy computed tomography (dect), magnetic resonance imaging (mri) imaging with biological samples for cellularity/adiposity. ii. feasibility of fluorothymidine f-18 (flt) positron emission tomography (pet) imaging biomarker as a predictor of treatment response. iii. correlation of flt pet imaging with biological correlate for leukemia. iv. characterize relative distribution of leukemia in bone marrow (bm) environment. outline: patients are assigned to 1 of 2 cohorts. cohort i (tlmi+flt/tmli): patients may undergo optional fluorothymidine f-18 pet scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. patients undergo dect and water-fat mri scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. patients undergo fluorothymidine f-18 pet, dect, and water-fat mri as in tmli+flt. cohort ii (tbi): patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.

Eligibility criteria:
inclusion criteria: * cohort tmli+flt: aml patients eligible for and enrolling on coh 14012 or irb 17505 that agree to participate in optional flt pet imaging * note: patients enrolling on irb 19518 cannot enroll onto this cohort, but they may enroll on cohort tmli (below) * cohort tmli: aml or all patients eligible for and enrolling on coh 14012, irb 17505 or irb 19518 * cohort tbi: first or second remission aml or all patients that will receive tbi (13.2 gy) plus chemotherapy (etoposide \[vp16\] 60 mg/kg or cyclophosphamide \[cy\] 60 mg/kg for two days) as part of their standard of care * cohort tbi: documented written informed consent of participant * cohort tbi: age \>= 18 to =\< 60 years * cohort tbi: patients who have not received a prior transplant
systemic pharmacokinetics following intravitreal injections of anti-vegf

Conditions: Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Summary: comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. in the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (vegf) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent for participation in this study * subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection exclusion criteria: * subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy * subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year * subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion * subjects with history of vitrectomy

Keywords: macular degeneration diabetic macular edema vein occlusion vascular endothelial growth factor