Kornimate/medical-research-clean huggingface dataset:
a care empowerment program using virtual reality for family caregivers of people with dementia

Conditions: Dementia Family Caregiver

Summary: this study aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy, empathy and caregiver burden of family caregivers of people with dementia.

the majority of patients with dementia live at home and cared by their families in taiwan. most of family caregivers have limited knowledge and care skills of dementia, therefore they experience great stress and caregiver burden which may have negative impact on their physical and mental health. this two-group cluster randomised controlled trial aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy, empathy and caregiver burden of family caregivers of people with dementia. the family care empowerment program consists of dementia care e-books, dementia virtual reality activity and family support group. the interventional group will receive the care empowerment program using dementia care e-books, dementia virtual reality activity and family support group. the control group will only receive dementia education manual and family support group with no dementia virtual reality activity. both groups will be assessed for their dementia knowledge, attitudes, care self-efficacy, empathy and caregiver burden at baseline, month 3, and 4.

Eligibility criteria:
inclusion criteria: * age 20 to 90 years, * taiwanese nationality, * have provided care for relatives with dementia or cognitive impairment for at least three months, * able to read chinese and communicate in chinese or taiwanese, * have a mobile phone or tablet and regular access to the internet, * provide informed consent to participate in the study. exclusion criteria: * family members who do not meet the inclusion criteria, * can not provide informed consent.

Keywords: family caregiver dementia virtual reality empowerment
secondhand smoking in asthmatic children

Conditions: Asthma in Children; Wheezing

Summary: this study will investigate the interaction between gstp1 / tnfa polymorphisms and passive smoking in children with asthma/wheezing. contemporary second hand-smoke exposure will be confirmed by laboratory testing.


Eligibility criteria:
inclusion criteria: * subjects 1-18 years old with doctor diagnosed asthma/wheezing exclusion criteria: * premature birth (\< 36 gestation weeks) * asthma-like symptoms due to other conditions (infectious, congenital, mechanical)

Keywords: asthma wheezing gstp1 tnfa secondhand smoking passive smoking intrauterine smoking
biopsychosocial impact on caregivers in patients undergoing joint and spine surgery

Conditions: Pain, Postoperative

Summary: the purpose of this study is to describe the biopsychosocial impact of caregivers in patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spine surgery.defining such impacts may offer opportunities to enhance caregiver capability to provide care following surgery on a loved one.

this is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical subgroup, with a total of 150 subjects. caregivers for patients undergoing the above surgeries will be administered patient reported outcome measurement information system (promis) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1 month postoperatively. promis item banks will include global health, anxiety, fatigue, depression, self efficacy, social satisfaction, and sleep disturbance. if the caregiver reports the presence of persistent pain, pain interference and physical function will be administered.

Eligibility criteria:
inclusion criteria: * 18 years old or older * are the primary person helping in the recovery of a patient undergoing one of the following surgeries below with in the first 30 days after surgery total knee arthroplasty total hip arthroplasty cervical/thoracic/lumbar spine surgery * able to understand english and can verbalize their pain level exclusion criteria: * younger than 18 years old * refuse participation * cannot understand english * has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)
the effect of interactive music therapy applied for women during the perioperative period for ivf on their stress levels

Conditions: Infertility

Summary: the purpose of this study is to investigate the effect of music therapy on stress levels in female patients applying for in vitro fertilization.

if the patients participate in the study, when they apply to the in vitro fertilization center, they will meet with their anesthesiologist, anesthesia assessment will be done face to face and asked some questions about the diseases that may affect the procedure. . if patients are included in the study, their blood pressure, blood oxygen value and heart rate will be measured and recorded, as in every patient. subsequently, a test will be administered to assess stress and anxiety levels of the patients. the patients involved in the study will be randomly divided into two groups. one group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. the music will continue to be played through the headphones during the procedure. the other group will be taken to the operating room without any procedure, and this process will be applied to both groups. when patients are brought to the operating room, blood pressure, blood oxygen levels, and heart rate will be measured and recorded once again. routine anesthesia procedures, applicable to all, will be carried out. after patients are fully awake, their pain condition will be assessed using a visual test.

Eligibility criteria:
inclusion criteria: * 18 years and older, * american society of anesthesiologists (asa) scores i-iii. exclusion criteria: * patients who did not provide informed consent, * used anxiolytics, alcohol, or drugs before the procedure, * refused to participate in the study, * lost their hearing ability for any reason.
virtual reality as a new therapeutic tool for chronic pain

Conditions: Fibromyalgia

Summary: chronic pain is a major health problem and it has been estimate to account for approximately 40% of all medical visits, costing more than $600 billion annually in the united states alone. given that pharmacological and non-pharmacological treatments for chronic pain are often difficult and may be associated with limiting side effects, technology-based interventions using virtual reality (vr) may be a promising alternative treatment option. recent findings from cognitive neuroscience show that it is possible to manipulate the body schema and to induce a range of well-controlled illusory bodily experiences by exposing participants to conflicting multisensory bodily inputs using vr, that are associated with changes in pain perception and somatosensory processing in healthy subjects and chronic pain patients. in the current project the investigators plan to follow up on these findings in patients suffering from chronic pain affecting the whole body, e.g. fibromyalgia. the project is planned as a single center clinical study at the department of neurology and psychosomatic medicine, inselspital bern, in cooperation with the pain center inselspital bern, the department of biomedical engineering; university bern and the department of psychology, university of bern. the investigators want to explore the analgesic effect of a specific multisensory illusion (e.g. the cardio-visual illusion) in patients suffering from chronic pain as compared to a control condition (single-blinded, randomized clinical trial) using psychometric and algometric methods. moreover, the investigators would like to assess the physiological changes associated with pain reduction, study the reduction of psychological distress and improved well-being and assess the subjective acceptance of vr as a possible treatment option for patients with chronic pain. importantly, the investigators plan to develop and test an easy to use, mobile vr setup as a long-term treatment option for patients with chronic pain. given that chronic pain is a major health problem, the investigators believe that there is a huge market potential for an easy to use, noninvasive and effective treatment option and a possible technology transfer.


Eligibility criteria:
inclusion criteria * a diagnosis of fibromyalgia according to current diagnostic criteria * aged \> 18 years old * capable of judgement * willing to participate in the study (by signing the informed consent form) * able to follow the study protocol exclusion criteria * presence of psychosis or major depression with suicidal risk * history of alcohol or drug abuse * inability to follow the procedures of the study, e.g. due to language problems, inability to wear head-mounted display * arrythmia, such as atrial fibrillation
an evaluation of 9mw1911 injection in healthy subjects

Conditions: Asthma; COPD; Atopic Dermatitis

Summary: this study is a randomized, double-blind, dose-escalating phase i clinical study to evaluate the safety, tolerability and pharmacokinetics of 9mw1911 injection in healthy subjects.


Eligibility criteria:
inclusion criteria: - 1. male or female subjects aged 18 to 65 years (including 18 and 65 years). 2. weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (bmi) in the range of 19.0 \~ 26.0 kg/m2 (including cut-off value). 3. female subjects must have a negative β-hcg pregnancy test (screening and baseline); subjects(including their partners) will take effective contraceptive measures voluntarily. exclusion criteria: * 1. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. 2. the clinical laboratory tests show any clinical abnormalities, or abnormalities with clinical significance (including but not limited to diseases of digestive tract, kidney, liver, nervous system, blood, endocrine system, cancer, lung, immune system, mental, heart) , and judged by the investigator to affect participation in this study. 3. subjects with prolonged qtcf interval (\> 450 ms) on electrocardiogram (ecg) examination, or family history of prolonged qtc syndrome or sudden death. 4. subjects received any biological treatment (including all vaccines except the coronavirus vaccine) within 3 months before screening, or planned to take biological treatment during the study period, or received the new coronavirus vaccine within 1 month before screening. 5. subjects received any prescription drugs or traditional chinese medicines, including vitamins, trace elements or dietary supplements within 14 days before screening; except for topical products without systemic absorption. 6. subjects with a history of smoking within 6 months before screening, or unwilling to stop smoking during the study, or willing to use products containing nicotine during the study. 7. subjects who have lost blood or donated blood ≥200ml within 3 months before screening, or those who plan to donate blood within 3 months. 8. subjects positive screening for viral hepatitis (including hepatitis b and c), hiv antibodies, and treponema pallidum antibodies. 9. subjects who paticipated any clinical trial within 3 months before screening. 10. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
influence of fluid challenge on end-expiratory lung impedance in mechanically ventilated patients monitored with electrical impedance tomography

Conditions: Respiratory Failure; Circulatory Failure; Fluid Responsiveness; Fluid Overload

Summary: the study investigates the influence of a clinically indicated fluid challenge on end-expiratory lung impedance, assessed by electrical impedance tomography (eit). eit data will be collected before, during and after infusion of 500 ml of crystalloid solution in mechanically ventilated patients on an operative intensive care unit.


Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation * clincial decision to monitor regional ventilation with electrical impedance tomography * clinical indication for fluid challenge * established cardiac output monitoring with transpulmonary thermodilution exclusion criteria: * age \< 18 years * open lung injuries * instable injury of spine or cranium * thoracic metal implants * body mass index \> 35
clinical study of eye001 for wet-type amd (age-related macular degeneration)

Conditions: Macular Degeneration

Summary: this study will examine the efficacy and safety of pegaptanib sodium in japanese patients with wet-type amd, in order to establish that there is no large difference in the efficacy and the safety of the drug between western and japanese patients.


Eligibility criteria:
inclusion criteria: * wet amd, visual acuity from 20/320 to 20/40 exclusion criteria: * diabetic retinopathy, laser coagulation history
investigating the accuracy of the home glucose monitors in hypoglycemia

Conditions: Hypoglycemia

Summary: the purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; optium xceed, contour ts, accu-chek go, one touch select and ez smart in an adult population.


Eligibility criteria:
inclusion criteria: * being under investigation for pituitary- adrenal functions exclusion criteria: * diabetes mellitus or any other chronic metabolic disease * taking medicine for any reason * anemia * polyctemia * compromised circulation * hypoxia

Keywords: hypoglycemia home blood glucose monitoring subjects are being investigated for the integrity of pituitary-adrenal functions by insulin hypoglycemia test.
exercise amenorrhea stress and bone health in adolescents

Conditions: Healthy

Summary: this study investigates the role of energy balance and stress in the regulation of hypothalamic-pituitary-gonadal axis in adolescent girls across the fitness spectrum.


Eligibility criteria:
inclusion criteria: * healthy adolescent girls not taking any medications exclusion criteria: * hormonal preparation or birth control within 12 months prior to enrollment * galactorrhea * clinical depression
clinical study of tbf regimen in allo-hsct in patients with cns leukemia

Conditions: Central Nervous System Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation

Summary: central nervous system (cns) leukemia is a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-hsct). thiotepa can penetrate the blood-brain barrier and has immunosuppressive effects and similar effects to irradiation in allo-hsct. this project aims to investigate whether the tbf regimen is superior to the traditional modified bucy2 regimen to improve the long-term survival of the cns leukemia patients.

central nervous system (cns) leukemia is a common extramedullary leukemia and a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-hsct). there is a blood-brain barrier (bbb) in the cns. the treatment effect of cns leukemia is seriously limited by the low penetration of conventional chemotherapy drugs into cerebrospinal fluid. thiotepa can penetrate the bbb and has immunosuppressive effect and myeloablative effect similar to irradiation in transplantation. therefore, it is speculated that cestipide has certain advantages as a conditioning regimen in transplantation for cns leukemia. this project aims to investigate whether the tbf regimen is superior to the traditional modified bucy2 regimen to improve the long-term survival of the cns leukemia patients.

Eligibility criteria:
inclusion criteria: * patients diagnosed with central nervous system leukemia by micm meet one of the following conditions: corresponding symptoms and signs of central nervous system involvement; cerebrospinal fluid pressure increased by 200 mm water column; the white blood cell count in cerebrospinal fluid was 0.01×10\^9/l; cerebrospinal fluid protein qualitative test was positive or protein quantification was 45 mg/dl; leukemic cells can be found in the cerebrospinal fluid; cranial imaging suggested central involvement. * aged 14-60 years, male or female. * kps score: ≥80. * signed the informed consent. exclusion criteria: * patients intending to receive autologous hematopoietic stem cell transplantation. * patients with transplantation contraindications. * those who refuse to sign the informed consent form.
more relaxation by deep breath on methacholine

Conditions: Childhood Asthma

Summary: deep inhalation (di) dilates normal airway precontracted with methacholine. the fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. the hypothesis tested was that di induces more relaxation in methacholine induced bronchoconstriction-solely determined by the smooth muscle contraction-than in exercise induced bronchoconstriction, which is contributed to by both smooth muscle contraction and airway wall inflammation.

children were referred to the lung function department by their pediatric pulmonologist. asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or on exercising and a positive response to methacholine or exercise challenge. the response to exercise was considered positive when forced expiratory volume in 1 s (fev1) decreased at least 8% from baseline. the response to methacholine was considered positive when fev1 decreased at least 20% or rrs increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg. bronchodilator medications were discontinued at least 12 hours prior to the testing and provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline fev1 was larger than 70% pred. exercise and methacholine groups were matched for age, height, baseline fev1 z-score, a moderate level of airway response to challenge and di amplitude ranging 40-60% of the predicted forced vital capacity (fvc). written informed consent was obtained from the children and their parents for the procedures. procedures for spirometry, exhaled fraction of no (feno), grsdi (respiratory conductance response to a deep inhalation) and challenges have been described previously. acceptable grsdi's were analyzed at a 10-20% fev1 decrease from baseline. statistics were performed using mann-whitney, chi square tests and multiple regression as required. data are median and interquartile range.

Eligibility criteria:
inclusion criteria: * children referred to the lung function department by their pediatric pulmonologist. * asthma defined by a complaint of wheezing, cough and dyspnoea. * positive response to methacholine or exercise challenge. * bronchodilator medications discontinued at least 12 h prior to the testing * provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline fev1 larger than 70% pred. exclusion criteria: - other respiratory diseases than asthma

Keywords: airway smooth muscle, asthma, bronchial test, lung function
risperidone and divalproex sodium with mri assessment in pediatric bipolar

Conditions: Bipolar Disorder

Summary: the study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

pediatric bipolar disorder (pbd) severely impairs a child's emotional development, and is associated with alarming rates of suicide, school failure, aggression, risk taking behaviors and substance abuse (geller et al, 1998; 2001; carlson et al, 1998). at present, very little is known about the pathophysiology or optimal treatment of pbd. the long range goals of this proposal are threefold: to investigate a range of pharmacotherapeutic agents that are safe and efficacious for pbd, to use fmri techniques to examine abnormalities in brain function in this disorder, as well as any change in brain function after treatment. in contrast to the adult literature, we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample. in one, lithium was found to be moderately effective in pbd with comorbid substance abuse (geller et al, 1998). in the other, divalproex sodium, lithium and carbamazepine produced a maximum of 50% symptom reduction (kowatch et al, 2000). subsequently, kafantaris et al (2001) observed a potentiation of lithium's antimanic effect when combined with risperidone. further, a prospective, open trial of olanzapine for pbd reported a 70% symptom reduction (frazier et al, 2001) with a retention rate of 96% compared to only 7% with classic mood stabilizers (kowatch et al, 2000). thus, parallelling adult studies (sachs et al, 2000), novel antipsychotics are a promising treatment in this population. further, up to 60% of acute pbd episodes present with psychotic features (geller et al, in press). finally, the time to full effect with mood stabilizers is often 4 weeks in children (kowatch et al, 2000; geller et al, 1998; kafantaris et al, 2001), whereas antipsychotics usually have a more rapid response onset (pavuluri et al, in press). given the potential efficacy of novel antipsychotics for pbd, the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer:

Eligibility criteria:
inclusion criteria: * children with bipolar disorder * must be able to swallow tablets exclusion criteria: * children with general medical condition such as head injury, epilepsy, endocrine disorders * those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings. * if we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them. we expect only a small number of children to be excluded from the study due to exclusionary criteria. selection of the subjects is not based on sex, race, or ethnic group.