Kornimate/medical-research-clean huggingface dataset:
evaluating intensive group behavioral treatment for children with selective mutism

Conditions: Selective Mutism

Summary: this goal of this study is to evaluate an intensive group behavioral treatment (igbt) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day igbt over the summer or to a waitlist control condition, with the opportunity to participate in igbt 4 weeks later. all children that participate in treatment will be followed up 8 weeks into the following school year.


Eligibility criteria:
inclusion criteria: * meets diagnostic criteria for selective mutism * verbal with at least 1 parent or caregiver * child fluent in english exclusion criteria: * any mental health difficulty significantly more impairing than selective mutism

Keywords: selective mutism treatment anxiety intensive treatment cbt group treatment
comparative effectiveness of different techniques for repeat ablation of atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: atrial fibrillation (af) is the most common type of irregular heartbeat doctors see. people with af sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. however, this treatment doesn't always work. this study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (la) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years on date of consent * one prior pvi ablation procedure for persistent af * recurrent paroxysmal or persistent symptomatic af confirmed on ecg despite prior pvi * eligible for repeat ablation procedure * willingness to comply with all post-procedural follow-up requirements and to sign informed consent exclusion criteria: * inability to undergo af catheter ablation (e.g., presence of a left atrial thrombus) * prior ablation that included non-pvi la ablation, or more than one prior pvi ablation procedure for persistent af * prior surgical ablation for af * contraindication to systematic anticoagulation * la diameter on echocardiogram \> 6.0 cms * lv ejection fraction \< 35% * nyha class iii-iv congestive heart failure * acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date * enzyme-positive myocardial infarction within the past 3 calendar months prior to consent * severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures * prior valve replacement with mechanical prosthesis * angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a cabg or pci in the next 3 calendar months following consent date * stroke within 3 calendar months prior to consent date * any medical condition likely to limit survival to \< 1 year * renal failure requiring dialysis at time of consent * pregnancy * history of non-compliance to medical therapy * participation in other clinical trials (observational/lead registries are allowed) without approval from the ccrc * inability or unwillingness to provide informed consent * resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult * does not anticipate residing in the vicinity of the enrolling site for the duration of the trial

Keywords: atrial fibrillation irregular heart beat posterior wall isolation pulmonary vein isolation ablation repeat-af
surgical and medical emergencies on board of european aircraft carriers

Conditions: Circulatory Collapse; Chest Pain; Diarrhea

Summary: the goal of this retrospective study is to describe emergency relevant illnesses occurring in airline passengers.

an epidemiologic database documenting medical and surgical emergencies across european airlines will provide access to data potentially valuable for further flight-epidemiological research. data on medical emergencies / per rpk (revenue passenger kilometres) are sparse and often based on data from a single airline. while handling the data the regulations of the data protection act of the ethic commission of the ruhr-university bochum are fully respected. as noted, evaluation of the data will be completely anonymized without any information regarding the airline or other details than the passengers illness. preview: the results of the study specified above will be submitted for publication in a peer review and medline listed journal. study design: retrospective, epidemiological study for the evaluation of medical and surgical emergencies on board airliners. patients: in the context of a retrospective study approximately 20,000 patient data from 32 european airlines are collected and statistically evaluated. documentation: the direct documentation takes place through project responsible person into an electronic statistical data base.

Eligibility criteria:
inclusion criteria: * men, women, adolescent, children and babies who have suffered from an emergency on board an european airline. exclusion criteria: * none

Keywords: in-flight emergency
economic evaluation of treatment modalities for position dependent obstructive sleep apnea

Conditions: Positional Obstructive Sleep Apnea

Summary: objectives: to evaluate the effect and cost-utility of a combination therapy of spt+mad compared with continuous positive airway pressure (cpap) in patients with moderate positional obstructive sleep apnea (posa). hypothesis: the spt+mad combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (ahi), quality of life and compliance, compared with cpap. study design: a multicenter randomized clinical trial (rct) will be performed with a follow-up of 12 months per patient. patients will be randomized for cpap or the combination spt and mra. all outcomes will be measured at baseline, month 3, 6 and 12. study population: patients diagnosed with moderate posa according to polysomnography (psg) results. intervention / standard intervention to be compared to: the spt trains posa patients to sleep in non-supine positions, cpap uses positive airway pressure to open the airway; mra is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events. outcome measures: ahi, compliance, quality-adjusted life year (qaly), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (icer) sample size / data analysis: 100 subjects in each treatment group, total of 200 patients. cost-effectiveness analysis / budget impact analysis: the spt is expected to improve the cost-effectiveness of overall treatment of posa patients, and will save annually approximately 35-150 million euros.


Eligibility criteria:
inclusion criteria: * 18 years and older * ability to speak, read and write dutch * ability to follow up * diagnosis with symptomatic moderate osa (15 \< ahi \< 30) * diagnosis of 10 to 90% supine position during the night * ahi supine is 2 \> as high as ahi non-supine * own a windows pc and ability to install spt connection software and upload research data * expected to maintain current lifestyle (sports, medicine, diet etc.) exclusion criteria: * many dental problems; insufficient teeth for wearing mra * medication used/ related to sleeping disorders * central sleep apnea syndrome * night or shifting work * severe chronic heart failure * medical history of known causes of tiredness by day or severe sleep disruption (insomnia, plms, narcolepsy) * seizure disorder * known medical history of mental retardation, memory disorders or psychiatric disorders * shoulder, neck and back complaints * reversible morphological upper airway abnormalities (e.g. enlarged tonsils) * inability to provide informed consent * simultaneous use of other treatment modalities to treat osa * previous treatment for osa with mra, cpap or spt * pregnancy

Keywords: positional therapy mad oral appliance sleep position trainer posa
treatment of mdes during the course of psychotic disorders with duloxetine

Conditions: Psychotic Disorders

Summary: we evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders

major depressive episodes (mde) frequently occur during the course of schizophrenic psychoses, both as as "post-psychotic" depressions, and also independently from psychotic episodes. a number of clinical studies reported the application of different antidepressive substances, such as imipramine, reboxetine or venlafaxine. in general, the treatment of schizophrenic patients with antidepressive drugs can be considered as necessary and save, resulting in therapeutic guidelines of different psychiatric societies. however, since 5 to 10 % of the schizophrenic patients commit suicide, there is still much effort necessary in order to improve the treatment of affective symptoms in schizophrenic psychoses.the recently introduced antidepressive substance duloxetine selectively inhibits as a ssnri the reuptake of serotonine and noradrenaline from the synaptic cleft. duloxetine was proven as antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled investigations. based on these considerations and on successful experiences in single case reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime diagnoses of the schizophrenic spectrum.

Eligibility criteria:
inclusion criteria: * major depressive episode, severity: cdss at least 8 points or hamd at least 15 points, indication for the treatment with duloxetine * lifetime diagnosis of a psychotic disorder (panss positive scale below 15 points) * age between 18 and 65, * informed consent exclusion criteria: * no informed consent, * contraindications with respect to duloxetine, * gravidity or missing anticonceptive safety * substance dependance (excluded nicotin)

Keywords: schizophrenia, schizoaffective disorder, major depressive episode, combination, duloxetine
a study to determine eligibility for cah-301 (a study of gene therapy for classic congenital adrenal hyperplasia (cah) [nct04783181])

Conditions: Congenital Adrenal Hyperplasia

Summary: this pre-screening study is designed to determine potential eligibility of adults with classic cah due to 21-hydroxylase deficiency (21-ohd) for participation in the cah-301 \[nct04783181\] gene therapy trial with bbp-631.

adult participants diagnosed with classic cah due to 21-ohd and who are taking glucocorticoids as treatment for cah will undergo assessments to determine their potential eligibility for participation in the adult cah-301 treatment trial with bbp-631.

Eligibility criteria:
inclusion criteria: * adult male and non-pregnant females with classic cah (simple virilizing or salt-wasting) due to 21-ohd * screening/baseline 17-ohp levels \> 5-10 × uln * is on a daily regimen of glucocorticoid * naïve to prior gene therapy or aav-mediated therapy exclusion criteria: * positive for anti-aav5 antibodies * history of adrenalectomy and has no significant liver disease

Keywords: cah
virtual cycling environments for persons with parkinson disease

Conditions: Parkinson Disease

Summary: this study asks three questions about persons with parkinson disease that use a bicycle for exercise. 1. does the use of virtual reality increase the intensity and and enjoyment of the experience compared to bicycling without virtual reality? 2. does the way in which the bicycling (interval compared to continous) is performed affect the experience? 3. how does the way the virtual reality is delivered (with goggles or projected on a screen) affect the experience?

participants attend two sessions. they complete movement assessments and questionnaires about physical activity. during the first session they bicycle in a semi-immersive (projected on a screen) and an immersive (with googles) virtual environment. after each bout they completed a questionnaire about the experience. in the second session they bicycle four times with and without a virtual environment using both a continous and interval mode. their oxygen consumption is measured during cycling. they complete questionnaires after each exercise bout.

Eligibility criteria:
inclusion criteria: 1. diagnosis of parkinson's disease 2. hoehn and yahr stages ii-iii, 3. 45-75 years old 4. able to ride a stationary upright bicycle 5. able to sign informed consent. exclusion criteria: 1. have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than parkinson disease. 2. are unable to follow directions or sign a consent form 3. do not have adequate vision or hearing ability to see or hear a television 4. have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle 5. have any other medical condition that prevents bicycling 6. have moderate depression

Keywords: virtual reality exercise cardiovascular intensity neuromuscular intensity enjoyment
efficacy and safety study of dietary supplements in chronic smokers having mild to moderate hyperlipidemia

Conditions: Chronic Smokers; Hyperlipidemia

Summary: the purpose of this study is to investigate the efficacy and safety of dietary supplements (bioturmin, bioturmin-wd and maqxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.

in a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (bioturmin, bioturmin-wd and maqxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 30 days. the efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Eligibility criteria:
inclusion criteria: men \> 20 years chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (ldl ranging 160-189 mg/dl, tc \>200 mg/dl and/or hdl-c \<40 mg/dl) being mentally competent and able to understand all study requirements and sign the informed consent form. exclusion criteria: patients with chronic obstructive pulmonary disease (copd) women patients with severe liver, renal, cardiac or brain diseases. unable to complete follow up. subjects on any medication like diuretics. allergic to any medication. with a history of alcohol and/or drug abuse.

Keywords: dietary supplements cotinine level malondialdehyde chronic smokers hyperlipidemia
study of complication rates associated with picc for left vs right

Conditions: Bacterial Infections

Summary: peripherally inserted central catheter (picc) are catheters that are placed mainly in the arms, but which pass in the veins to beside the heart. they are associated with occasional complications due to infection or blockage of the vein that they are in. the investigators want to investigate whether piccs in the right arm have lower complications than those in the left. this difference in complication rates has been noticed in most other forms of central venous access.


Eligibility criteria:
inclusion criteria: * referral for in-patient picc placement at centre carrying out study. exclusion criteria: * out of hospital referrals for picc placement; previous picc placement; previous long term central catheter/pacemaker; unable to give valid consent; presence of pre-existing medical preventing randomisation.

Keywords: catheterisation, central venous catheters, indwelling
a study to learn about the effects of multiple doses of sisunatovir on people with respiratory syncytial virus (rsv) infection

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (called sisunatovir/rv521) for the potential treatment of respiratory syncytial virus (rsv). sisunatovir will be given as multiple doses during the treatment period. rsv is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant. this study is seeking healthy participants who are: 1. aged 18 to 45 years old and will agree to the use of highly effective methods of contraception. 2. with a body mass index (bmi) of 18.0 to 30.0 kg/m2 this study will consist of 2 cohorts of 33 participants each. in both cohorts participants will be exposed to the challenge virus on study day 0. cohort 1 will receive either 200 mg of sisunatovir or placebo (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5 days. cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5 days. participants will start taking the study medicine upon confirmation of rsv infection (or evening of day 5 if not positive to rsv). the study medicine will be administered 12 hours apart (or twice daily). each participant will remain in the quarantine unit until discharge on day 12.


Eligibility criteria:
inclusion criteria: * age 18 to 45 years, inclusive * in good health with no history of major medical conditions * a total body weight ≥ 50 kg and a body mass index (bmi) of \>/=18kg/m2 and \</=30kg/m2 exclusion criteria: * evidence of any clinically significant or currently active major medical condition * positive for human immunodeficiency virus, active hepatitis a, b or c test * significant nose or nasopharynx abnormalities * abnormal lung function * history or currently active symptoms suggestive of upper or lower respiratory tract infection
preventive drug-coated balloon angioplasty in vulnerable atherosclerotic plaque (restore trial)

Conditions: Acute Coronary Syndrome (ACS)

Summary: the objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (dcb) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (gdmt) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.


Eligibility criteria:
inclusion criteria: 1. subjects must be between 18 and 80 years of age 2. subject must present with acute myocardial infarction or unstable angina planned for pci 3. successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., qfr equal or less than 0.8) 4. subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and qfr \>0.8 5. target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm 6. target lesion must have any two of the intravascular imaging criteria of pb \>65%, mla \ 180° 7. subject must provide written informed consent before any study-related procedure exclusion criteria: 1. subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, p2y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated 2. subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.) 3. hypotension, shock, or need for mechanical support or intravenous vasopressors; 4. creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by mdrd formula for estimated gfr) 5. left ventricular ejection fraction\<30% by the most recent imaging test within 30 days before procedure (echo, mri, contrast left ventriculography or others) 6. life expectancy \<2 years for any 7. subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint 8. presence of 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. 9. the target lesion is located within 10 mm of the proximal or distal of stent 10. the target lesion cannot be in the left main coronary artery 11. the target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is \>2 mm with \>50% of stenosis) 12. the target lesion is located in severe calcification or tortuosity of vessels 13. the target lesion involved in the ostium of lad, lcx or rca (within 3 mm of the ostium) 14. the target lesion is located within the bypass graft artery
effect of a new combination bronchodilator on exercise in gold stage ii moderate copd

Conditions: COPD

Summary: preliminary information from our laboratory indicated that even patients with milder chronic obstructive pulmonary disease (copd) can have significant physiological derangements which become more pronounced during exercise, leading to intolerable dyspnea at lower levels of ventilation than in health. this study will explore pathophysiological mechanisms of dyspnea and activity limitation in gold stage ii copd and will determine if there is a sound physiological rationale for the use of dual long-acting beta2-agonist (laba)/long-acting muscarinic antagonist (lama) therapy (gsk573719/ gw642444 inhalation powder) versus lama alone (gsk573719) as treatment for dyspnea and exercise intolerance in this subpopulation. objectives of this study are to determine if: 1) neuromechanical uncoupling of the respiratory system contributes to exertional dyspnea in milder copd, and 2) treatment with laba/lama improves dyspnea and exercise endurance compared with lama by improving neuromechanical coupling. the investigators hypothesize that: 1) dyspnea is related to excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of central respiratory neural drive to tidal volume displacement, a measure of neuromechanical uncoupling of the respiratory system, and 2) laba/lama will improve dyspnea and exercise endurance, which will be explained by partial reversal of the above mechanical abnormalities. the investigators will conduct a randomized, double-blind crossover study and compare the effects of once-daily laba/lama over 4-weeks with lama on dyspnea, exercise endurance and ventilatory mechanics in gold stage ii copd.


Eligibility criteria:
inclusion criteria: * stable moderate copd * post-bronchodilator fev1/fvc\<0.7 and 50%≤fev1\<80% predicted * baseline dyspnea index ≤ 9 and mrc dyspnea scale \>2 * cigarette smoking history at least 20 pack-years exclusion criteria: * presence of a significant disease other than copd that could contribute to dyspnea and exercise limitation * important contraindications to clinical exercise testing * use of daytime oxygen * history of asthma

Keywords: copd combination therapy anticholinergic beta2-agonist exercise dyspnea respiratory mechanics