Kornimate/medical-research-clean huggingface dataset:
a pilot study of boredom in a community sample of adolescents and a clinical sample of adolescents

Conditions: Mental Disorders; Affective Disorders; Anxiety Disorders; Attention Deficit and Disruptive Behavior Disorders; Psychotic Disorders

Summary: the aim of the following pilot study is to examine boredom in a community sample of adolescents and a clinical sample of adolescents. this is important in order to examine differences among healthy adolescents and adolescents with mental illness.

boredom has been recognized as a significant problem in a wide variety of areas. however, limited research has been focused on this construct (vodanovich \& watt, 1999). research into boredom in adolescents is especially lacking in the psychological literature. this is surprising given that adolescence is a time marked by change, stress, and identity issues. the aim of the following pilot study is to examine boredom in a community sample of adolescents and a clinical sample of adolescents. this is important in order to examine differences among healthy adolescents and adolescents with mental illness, such as depression, anxiety, and adhd. this has implications for both prevention and intervention strategies and programs, such as the assessment and treatment of adolescents with mental illness. hence, the results of this study will be important in providing an evidence-based practice in the treatment of mental illness in adolescents. participants will be asked to complete one survey, the boredom proneness scale (farmer \& sundberg, 1986), and a demographic background form to measure gender, date of birth, country of birth, etc. the community sample of adolescents will be recruited from secondary schools in victoria. the clinical sample of adolescents will be recruited from the alfred child and adolescent mental health service. it is envisaged that about 100 adolescents from each sample will be recruited to participate.

Eligibility criteria:
inclusion criteria: * 13-18 years of age * has consenting guardian exclusion criteria: * unable to sufficiently understand self report measure * iq \< 70

Keywords: boredom adolescent mental illness depression anxiety
impact of the use of a weighted jacket on the balance of patients with a balance disorder.

Conditions: Balance; Distorted

Summary: the aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies. the center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. weights will be placed accordingly in a jacket in order to correct the imbalance. in the experimental group, weights will represent 1.5 to 2% of the patient body mass. in the control group, the investigators will use weights of 200 grams maximum, placed evenly on both sides of the jacket. patients will wear the jacket for 2 consecutive hours. after wearing the jacket for 2 hours, data similar to those recorded at the beginning of the experiment will be taken again, namely the determination of the center of mass and of the deviations caused by the imbalance. a final series of tests will take place approximately one week after wearing the jacket, to determine if there are any residual effects.


Eligibility criteria:
inclusion criteria: * good level of french understanding * be able to walk a minimum distance of 10 meters with or without rod/walker * walk 10 meters in more than 12 seconds. * have a diagnosis of multiple sclerosis, parkinson's, or any other neurological pathology that could cause balance disorders * be able to endure at least 2 hours of tests, interviews or medical care. * score of more than 8 seconds at the time up and go (tug), less than 24 points out of 28 in the tinetti test exclusion criteria: * the patient underwent a period of exacerbation of his pathology in the last two months (especially for multiple sclerosis patients) * chronic back pain * poor eyesight (not be able to perform the tests) * osteoporosis

Keywords: weighted jacket balance disorder equilibrium disorder
a study in japan of the safety and antiviral activity with chronic hepatitis b infection

Conditions: Chronic Hepatitis B

Summary: the objectives of this study are to demonstrate that entecavir has antiviral activity with undetectable at week 48, and to assess the safety and the pharmacokinetic in japanese patients given entecavir at each dose of 0.1 and 0.5 mg for 52 weeks


Eligibility criteria:
inclusion criteria: * documentation of chronic hepatitis b infection by all of the following: 1. positive for hbsag or, negative for igm core antibody and confirmation of chronic hepatitis b on liver biopsy 2. positive for hbeag or negative for hbeag 3. documented hbv viremia on 2 or more occasions and at screening visit: viremia on sample drawn and hbv dna of ≥ 10\*5\* copies/ml by pcr assay at the screening visit * alt in the range of 1.3 to 10 x uln
orlistat induced modulation on the fatty acid composition in obese females

Conditions: Overweight

Summary: orlistat is a popular drug approved for long-term use which produces weight loss by inhibiting triglycerides, main components of fats in the diet and reducing dietary fat absorption by up to 30%. the effect of this drug on human blood fatty acid profile has not been described yet. the fa composition of rbcs, plasma and platelets can be used to monitor of many pathological processes. this study presents alteration of fa composition in rbcm and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.

obesity treatment requires lifestyle changes such as diet, exercise, and behavioral therapy. orlistat is a popular drug approved for long-term use which produces weight loss by inhibiting triglycerides, main components of fats in the diet, from binding to the lipase enzyme active sites thus halting their subsequent breakdown into monoglycerides and free fatty acids necessary for fat digestion, reducing dietary fat absorption by up to 30%. the effect of this drug on human blood fatty acid profile has not been described yet. the fa profile is typical of each lipid and tissue, however, alterations in diets, pathological processes, drugs intervention, cigarettes and alcohol consumption can alter the fa profile. the fa composition of rbcs, plasma and platelets can be used to monitor these processes. this study presents alteration of fa composition in rbcm and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.

Eligibility criteria:
inclusion criteria: * obesity bmc (body mass index) between 30 to 40 kg/m2 women 18 to 45 years premenopausal stage exclusion criteria: * relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopathy or neoplasm in the last three years) * chemical or natural laxatives * weight variation greater than 5% in the preceding 3 months * surgery for weight reduction * drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months

Keywords: fatty acids orlistat lipase bmc (body mass index) between 30 to 40 kg/m2 women 18 to 45 years premenopausal stage
pharmacokinetics & tolerability study of map0004 in smoking and non-smoking adult volunteers

Conditions: Healthy Subjects

Summary: compare the pharmacokinetics of dihydroergotamine mesylate (dhe) delivered by oral inhalation (map0004) or intravenous (iv) dhe in smokers versus non-smokers. identify whether there are clinically significant differences in the tolerability of map0004 between smokers and non-smokers.


Eligibility criteria:
major inclusion criteria: 1. able to provide written informed consent 2. male or female subjects 18 to 45 years old 3. female subjects who are practicing adequate contraception or who are sterile 4. stable cardiac status 5. normal rhythm or arrhythmia deemed clinically insignificant on ecg major exclusion criteria: 1. contraindication to dihydroergotamine mesylate (dhe) 2. use of any excluded concomitant medications within the 10 days prior to visit 1 (see section 5.5) 3. history of hemiplegic or basilar migraine 4. participation in another investigational trial during the 30 days prior to visit 1 or during this trial
diaphragmatic speckle tracking to guide diaphragm-protective ventilatory support: a study of feasibility and efficacy.

Conditions: Respiratory Failure

Summary: the goal of this clinical trial is to evaluate the effectiveness of diaphragmatic speckle tracking ultrasound in guiding diaphragm-protective ventilation in mechanically ventilated patients, and to assess its impact on extubation success rates and diaphragmatic function preservation. the main research questions include: can diaphragmatic speckle tracking ultrasound improve diaphragmatic function and reduce the risk of complications associated with mechanical ventilation? can real-time adjustment of ventilation parameters based on speckle tracking feedback improve extubation success rates? researchers will compare the peep strategy guided by diaphragmatic speckle tracking ultrasound with conventional peep settings in mechanical ventilation to evaluate the effectiveness of this novel approach in preserving diaphragmatic function and improving patient outcomes. participants will: receive either ultrasound-guided ventilation or conventional ventilation daily during mechanical ventilatory support. keep a daily record of symptoms, ventilation adjustments, and extubation outcomes.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. clear diagnosis of respiratory failure requiring respiratory support. 3. expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours. 4. voluntary participation in this study and signed informed consent. if the participant is unable to read or sign the informed consent form due to incapacity (e.g., unconsciousness), the legal guardian must act as a proxy in the informed consent process and sign the form. if the participant cannot read the consent form (e.g., illiterate participants), a witness must observe the informed consent process and sign the form. exclusion criteria: 1. severe chest wall deformities or diaphragmatic paralysis. 2. end-stage disease with a predicted life expectancy of less than 24 hours. 3. inability to acquire ste (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations). 4. vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.

Keywords: diaphragm speckle tracking peep
multiple dose ethnobridging pk study in healthy subjects

Conditions: Inflammatory Bowel Diseases; IBD

Summary: a phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult japanese and caucasian subjects.


Eligibility criteria:
inclusion criteria: for all subjects: * male or female between 18 to 55 years old * female subjects must have documentation of a negative serum pregnancy test, * female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method * male subjects must be vasectomized with documented medical assessment of the surgical success, or use acceptable contraception * all male subjects must agree to refrain from sperm donation during the study and for at least 7 days after the last dose of study drug. * body mass index (bmi) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less than 90 kg * willing and able to give informed consent * additional inclusion criteria apply for japanese subjects only: * subject must have been born in japan, with 2 japanese biological parents and 4 japanese grandparents as confirmed by interview. * subject has lived no longer than 10 years outside of japan. * subject had no significant change in lifestyle, including diet, since leaving japan. for caucasian subjects only: * subject has 2 caucasian biological parents and 4 caucasian grandparents as confirmed by interview. * subject has lived no longer than 10 years outside of europe and/or north america. exclusion criteria: for all subjects: * subject is a female who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study or within 7 days after the last dose of study drug. * subject is a male who is planning to father a child during the study or within 7 days after the last dose of study drug. * is positive for hepatitis a, b or c, and/or hiv * has clinically significant abnormalities in baseline laboratory evaluations * subject has a clinically significant abnormal electrocardiogram (ecg) * participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device) additional exclusion criteria apply

Keywords: healthy japanese subjects healthy caucasian subjects ethnobridging
powering up stroke rehabilitation through hiit

Conditions: Stroke

Summary: objectives: to investigate the effects of high-intensity interval training (hiit) on musculoskeletal fitness in chronic stroke survivors. hypothesis to be tested: hiit, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (mict) design and subjects: assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors. interventions: participants will be randomly allocated to one of three groups: the hiit group, the mict group, or a stretching group (active control). each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions. main outcome measures: assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). the primary outcome measure will be muscle power. secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, cardio-autonomic response, and psychosocial response.


Eligibility criteria:
inclusion criteria: * men and postmenopausal women aged 50-80 years * 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography * able to walk 10 meters independently with or without a walking aid * class i or ii according to the new york heart association functional classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity) exclusion criteria: * presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months * undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months * participation in ongoing stroke rehabilitation services or structured exercise programme * cognitive or communication issues that could limit the ability to follow instructions * contraindications to hiit, graded exercise testing, or failure to pass medical clearance from a specialist
effectiveness of six sessions cbt for adolescents with emotional problems in community clinics

Conditions: Generalized Anxiety Disorder; Social Phobia; Agoraphobia; Depression; Panic Disorder

Summary: background: there is need for more effectiveness studies concerning treatment of emotional symptom problems indicating anxiety and depression in adolescents. smart is the only treatment manual for combined emotional disorders developed in norwegian. purpose: to find the best individualized treatment for adolescents with emotional difficulties by: finding criteria for the selection of appropriate patients for treatment with cognitive-behavior therapy program smart in an outpatient population (14-18 years). finding predictors of completion of treatment program smart. examining the effects of treatment with the smart program at 6 months follow-up. design: a randomized controlled study in six outpatient clinics in the north of norway. n= 160 referred adolescents (14-18 years) with score above 6 on the emotional problems scale of the strength and difficulties questionnaire (sdq). two thirds are treated according to the smart-manual immediately, while the waiting list control group is treated with smart after six weeks. hypothesis: the smart treatment is an effective treatment for emotional symptom problems. publication: the results sought published internationally and nationally and will be communicated to clinicians.


Eligibility criteria:
inclusion criteria: age 14 to 18 years referred to community mental health clinic for children and adolescents * score above 6 on emotional symptoms scale on the sdq fluent norwegian language exclusion criteria: * indicators for pervasive developmental disorder (pdd) acute suicidal symptoms psycho-active drug treatment start coinciding with start of intervention symptoms indicating psychotic disorder
vitaflow™ transcatheter aortic valve system post-market study-the launch study

Conditions: Aortic Valve Stenosis

Summary: the study objective is to evaluate safety and effectiveness/performance of the microport™ cardioflow vitaflow™ transcatheter aortic valve system for the treatment of severe aortic stenosis in the real world settings.

this is a prospective, single-arm, multi-center, observational, post-market registry study. the purpose is to evaluate the safety, performance, and effectiveness of the vitaflow™ transcatheter aortic valve system in the real world settings.patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.

Eligibility criteria:
inclusion criteria: * age≥70 years; * symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmhg(1 mmhg=0.133kpa), or aortic valve area\<0.8cm² (or eoa index\<0.5cm²/m²); * the patients considered to be not suitable for surgical aortic valve replacement (savr); * the patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement. exclusion criteria: * aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； * vascular diseases or anatomical condition preventing the device access； * previous implantation of mechanical or bioprosthesis valve in the aortic position； * known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements； * ongoing sepsis, including active endocarditis； * estimated life expectancy\< 12 months； * participating in another trial and the primary endpoint is not achieved. * inability to comply with the clinical investigation follow-up or other requirements.
to evaluate real-world safety, effectiveness and appropriate use of micatrio® combination tablets treatment in patients with hypertension

Conditions: Hypertension

Summary: study to evaluate real-world safety, effectiveness and appropriate use of micatrio® combination tablets treatment in patients with hypertension

non-interventional study based on newly collected data. the study will consist of a baseline visit and follow-up visits at week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated micatrio® combination tablets. the patients will be followed up until discontinuation of micatrio® combination tablets treatment or the end of study. all patients administrated micatrio® combination tablets after the launch at the sites contracted with the sponsor will be registered.

Eligibility criteria:
inclusion criteria: * patients who are prescribed with micatrio® combination tablets by the discretion of investigators based on the japanese package insert * patients who have never been treated with micatrio® combination tablets before enrolment exclusion criteria: patients who are participating/planned to participate in a clinical trial
preventing pain after heart surgery

Conditions: Pain; Hyperalgesia; Chronic Illness; Neuropathic Pain

Summary: the use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery


Eligibility criteria:
inclusion criteria: * informed consent * first time sternotomy for all cardiac surgery * patient aged 18 - 80 years exclusion criteria: * emergency surgery (decision to operate taken on the day of surgery) * previous sternotomy * preoperative renal failure (egfr \<60 ml/min) * history of chronic non-anginal pain * chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs * concurrent use of oxycodone, lorazepam, or ethanol. * concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants * allergy to pregabalin, gabapentin or ketamine * pregnancy * limited understanding of numerical scoring scales * previous participation in other trials investigating analgesic agents or any imp in previous three months
non-steroidal anti-inflammatory drugs in axial spondyloarthritis

Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis

Summary: this is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.

patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (q12h); 2) diclofenac 75mg q12h; 3) meloxicam 7.5mg q12h; 4) celecoxib 200mg q12h. the treatment length will be 6 weeks. primary outcome is the change of pain score from baseline to week 4 and to week 6.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of ankylosing spondylitis (as) by treating rheumatologists, or a diagnosis of axial spondyloarthritis (axspa) with a pelvis mri with significant bone marrow edema on stir sequences; * minimum of 18 years old; * are taking nsaids on a regular basis for as or axspa (defined as more than 20 days in the past month) and willing to withhold medication for one week; or having active symptoms that require initiation of nsaids; * concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past three months; * have active disease after initial washout period, defined by basdai \>=4/10, or back pain numerical rating scale (nrs)\>=4/10 exclusion criteria: * patients who have concurrent rheumatic diseases other than as or axspa; * patients who have oral corticosteroid in the past two weeks; patients who have acute peripheral arthritis; * patients with a fibromyalgia score \>= 13; * patient with extensive cardiac history, history of gastrointestinal bleeding that required blood transfusion, chronic kidney diseases, abnormal liver function tests; or female patients who are pregnant. use of low-dose of aspirin (\<100mg daily) is allowed in the study.

Keywords: ankylosing spondylitis spondyloarthritis