Kornimate/medical-research-clean huggingface dataset:
modeling mood course to detect markers for effective adaptive interventions- aim 3

Conditions: Bipolar Disorder; Psychosocial Intervention

Summary: this study is a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. its long-term objective is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (bp) into an effective and evidence-based adaptive intervention. in this aim of the study, investigators will evaluate how individuals with bp respond to a microintervention based in acceptance and commitment therapy (act) that is delivered with a mobile app.

bipolar (bp) disorder is a chronic illness of profound shifts in mood ranging from mania to depression. bp is successfully treated by combining medication with psychosocial therapy, but care can prove inadequate in practice. with gaps in coverage and medication, along with imprecise guidelines on when, where, and how to intervene, promising psychosocial therapies require adaptive strategies to better address the specific needs of individuals in a timely manner. however, to accomplish this, evidence based practices are needed. this project aims to address this knowledge gap by establishing a mobile health platform for translating a psychosocial therapy in bp into an effective adaptive intervention. the research to be conducted under this protocol falls under the general heading of a micro-randomized trial. it investigates feasibility of a study on how to tailor an intervention based on acceptance and commitment therapy (act) when delivered via a smartphone app. long-term objective of this study is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (bp) into an effective adaptive intervention. in this particular part of the study, the investigator will assess the feasibility of a mobile health and wearable device platform for the translation of a bp psychosocial therapy into an evidenced-based adaptive intervention. to answer this question, investigator will study how individuals with bp respond to a microintervention delivered via a mobile app. primary outcome of this study is to evaluate the feasibility of a micro-randomized trial in act in terms of completion of assessments (interview and self-report), wearing of fitbit, and completion of microintervention questions. secondary outcome of the study is to detect a linear effect in time of the microintervention on symptom levels of mania and depression in individuals with bipolar disorder. the estimated linear effect would be used to power a larger study.enrollment is by invitation only; participants in the study will be recruited from the prechter longitudinal study of bipolar disorder (hum606).

Eligibility criteria:
inclusion criteria: * individuals diagnosed with bipolar disorder * have agreed to be contacted for future research * have a smart-phone * have a diagnosis of bipolar disorder. exclusion criteria: -

Keywords: mood stress sleep circadian rhythm medical adherence acceptance and commitment therapy microintervention
a study of switching avatrombopag and rh-tpo in itp

Conditions: Corticosteroid-resistant or Relapsed ITP

Summary: thrombopoietin receptor agonists (tpo-ras) represent a highly effective and well-tolerated second-line itp treatment that provides excellent responses.if there is cross-resistance between 2 drugs for the treatment of adult itp is still unkonwn.the purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-tpo in adults with itp.

thrombopoietin receptor agonists (tpo-ras) are novel treatments for patients with chronic primary immune thrombocytopenia (itp). according to the findings of mechanism-based studies, rhtpo competes with endogenous tpo for binding to tpo-r while avatrombopag has an additive effect with endogenous tpo, indicating that the treatment mechanism and side-effect profiles could be somewhat different between these drugs. if there is cross-resistance between 2 drugs for the treatment of adult itp is still no answer. the purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-tpo in adults with itp.this is a non-interventional study. patients who fail previous steroids and receive rh-tpo and then switch to avatrombopag or vice versa will be enrolled. the reason for switch will be recorded. the efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.

Eligibility criteria:
inclusion criteria: 1.18 years or older 2.primary itp 3.failed initial glucocorticosteroid treatment, 4.applying rhtpo or eltrombopag as subsequent treatment 5.switch from rh-tpo to eltrombopag or vice versa 6.normal neutrophils 7.available follow-up at least 6 weeks after switching exclusion criteria: 1. hiv positive status, or active infection of hbv or hcv 2. suffering from a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk for participation in this study (i.e. cancer or pre-cancer, immunocompromised, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (i.e. stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure \[classified as nyha iii-iv\], severe lung dysfunctions, etc)) 3. history of thrombosis plus two or more risk factors as defined in caprini thrombosis risk assessment model 4. lactating or pregnant women, or wocbp who are unwilling to use highly effective contraceptive measures during the study period 5. abnormal liver and renal functions: ast or alt or total bilirubin ≥1.5 × uln, and/or creatinine ≥176.8 μmol/l 6. women of childbearing potential (wocbp) that are pregnant or wish to become pregnant during the prospective phase of the study. 7. other conditions which the investigator considers inappropriate for enrollment

Keywords: immune thrombocytopenia recombinant human thrombopoietin avatrombopag switching
association between dietary habits and gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) is defined as carbohydrate intolerance of varying severity with onset or first recognition during pregnancy. the diagnosis of gestational diabetes is important, because of the increased risk of adverse maternal and feto-neonatal outcomes. in addition, gdm also confers a future risk of type 2 diabetes to mothers and their fetus. dietary components associated with gdm risk include macronutrients, micronutrients, and individual foods, such as refined carbohydrates, saturated fats, soft drinks and processed meats. the pre-pregnancy dietary patterns may affect women risk of developing gdm. a diet high in red and processed meat was associated with a significantly elevated risk.

\*aim of the work: to investigate associations between maternal dietary patterns and gdm. * patients and methods: * study design: a cross sectional study was conducted. * study site: gdm outpatient clinic of assiut university hospital. * study population: the study will include all pregnant women at 24th to 28th gestational age, who attending to gdm outpatient clinic during the period of the study. * inclusion criteria include pregnant women at 24th to 28th age of gestation. * exclusion criteria include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation. * instrument: structured designed questionnaire: which consists of socio-demographic characteristics, medical and obstetric history and other risk factors for gdm including previous gdm, family history of diabetes, twins in current pregnancy, history of pco and macrosomic baby in current or previous pregnancy, also contains information about regularity and frequencies of daily meals taken by the women, and information about food group frequencies per week, food groups like vegetables, fruits, fast food , red and processed meat, fish and seafood, whole grains, cereal fiber, sweetened beverage, dessert food and use of multivitamins. * data collection: direct interview will be done with each participant separately for filling the food frequency questionnaire by the researcher himself during the period from january 2017 to june 2017 * clinical examination: * bp (mmhg) * pulse * body weight (kg) * height (cm) * bmi laboratory examination * ogtt (75gm) 2hr * hba1c (if bl. glucose ≥ 200mg/dl).

Eligibility criteria:
inclusion criteria: * include pregnant women at 24th to 28th age of gestation. exclusion criteria: * include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
a study to assess feasibility of using clinician-directed and digital application supported cognitive behavior therapy (cbt) in conjunction with esketamine in participants with treatment-resistant depression

Conditions: Depression

Summary: the purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (cbt) supplemented with the mindset app with esketamine therapy in participants with treatment-resistant depression.


Eligibility criteria:
inclusion criteria: * medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) performed at screening. any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator * participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (dsm-5) diagnostic criteria for single-episode major depressive disorder (mdd) or recurrent mdd, without psychotic features, based upon clinical assessment confirmed by the mini international neuropsychiatric interview (mini) * participant must have had nonresponse to greater than or equal to (\>=) 2 different oral antidepressant treatments of adequate dose and duration in the current episode of depression * participant must be currently taking an oral antidepressant. * participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided exclusion criteria: * participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ect) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ect * participant has a current or prior dsm-5 diagnosis of a psychotic disorder or mdd with psychotic features, bipolar or related disorders (confirmed by the mini), obsessive compulsive disorder (current only), intellectual disability (dsm-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder * participant has a history of moderate or severe substance or alcohol use disorder according to dsm-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. a history (lifetime) of ketamine, phencyclidine (pcp), lysergic acid diethylamide (lsd), or 3, 4-methylenedioxy-methamphetamine (mdma) hallucinogen-related use disorder is exclusionary * participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug * participant has known allergies, hypersensitivity, intolerance, or contraindications to esketamine/ketamine and/or its excipients
mhealth hiv prevention for transgender women

Conditions: HIV

Summary: this study aims to inform the development of an acceptable and usable smartphone app for transgender women (tgw) in malaysia to deliver an integrated hiv prevention intervention that incorporates screening and guidance for hiv testing and pre-exposure prophylaxis compared to treatment as usual.

this study aims to inform the development of an acceptable and usable smartphone app for transgender women (tgw) in malaysia to deliver an integrated hiv prevention intervention that incorporates screening and guidance for hiv testing and pre-exposure prophylaxis (prep) compared to treatment as usual. a new clinic-affiliated app (to be called mylink2care) will be developed (by adapting an existing app) and tested to deliver an integrated hiv prevention intervention that incorporates tailored hiv prevention and gender affirming care (gac) services to tgw in malaysia. the specific aims of the study include: * aim 1: guided by the modified im adapt model, an existing mobile app will be adapted, expanded, and refined. focus groups will be conducted with tgw (n=20) and clinical stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the mylink2care app (alpha version), which will undergo usability testing (n=10), followed by full development of the app (beta version). * aim 2 conduct beta testing of the fully developed version of the mylink2care app (n=15) to assess its usability and acceptability. * aim 3: assess preliminary feasibility and acceptability of the mylink2care app within a pilot, randomized controlled trial, compared with treatment as usual for engagement in the hiv prevention cascade (n=50). together, these aims will address multilevel barriers to hiv testing and prep uptake in malaysian tgw. feasibility is high based on the investigators extensive experience with hiv prevention in tgw, theory-guided behavioral interventions, mhealth expertise, and longstanding work in malaysia.

Eligibility criteria:
inclusion criteria: * hiv-negative * identify as a transgender woman * condomless sex in the last 30 days * own a smartphone exclusion criteria: * unable to provide informed consent * unable to read and understand english or bahasa malaysia

Keywords: transgender hiv prevention hiv intervention transgender woman
mechanical and electrical dyssynchrony during his-bundle pacing versus his-bundle area right ventricular pacing

Conditions: Bradyarrhythmia

Summary: the aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in his bundle area.

permanent his bundle pacing (hbp) is a well-known method of cardiac pacing which is increasingly used in everyday practice. after lead implantation in his bundle area (hba) capture of various tissues can be achieved: a. right ventricular myocardium near to hbp; b. cardiac conduction system selectively or nonselectively (with concomitant regional myocardium activation). the different excitability and refractory periods decide which tissue, myocardium or/and the conduction system is effectively paced. a lot of clinical trials revealed the advantage of hbp over apical ventricular pacing (avp). hbp improves clinical (nyha, quality of life, hospitalization rate) and echocardiographic (left ventricular dimension and ejection fraction) indicators of heart failure. we are going to compare mechanical and electrical synchrony during the various type of myocardium activation: hbp (nshbp or shbp), rv pacing near hba and native heart rhythm (if possible) in each patient recruited to the study. adequate pacemaker programming will allow achieving different activations as shown above. the mechanical synchrony will be estimated by transthoracic echocardiography and the electrical one by the detailed analysis of ecg.

Eligibility criteria:
inclusion criteria: * all adult patients after implantation of pacemaker system with pacing lead successfully captured his bundle (selectively or/and nonselectively) exclusion criteria: * not willing or incapable to give written informed consent; * previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)

Keywords: his bundle pacing dyssynchrony echocardiography ecg
safety and efficacy study of topic mucopolysaccharide polysulfate in the superficial varicose veins treatment

Conditions: VARICOSE VEINS

Summary: evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the treatment of superficial varicose veins


Eligibility criteria:
inclusion criteria: * patients must be able to understand the study procedures, agree to participate, and give written consent. * patients must be able to follow the study medication regimen. * patients with inflammatory process in superficial veins for more than 72 hours. * presence of symmetric lesions to compare one side to the other. exclusion criteria: * pregnancy or risk of pregnancy. * lactation. * use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study * any alteration at other deep veins. * history of atopy or allergic diseases. * history of allergy to any component of the formulations. * other conditions considered by the investigator as reasonable for non-eligibility.

Keywords: superficial varicose veins
enhancing prospective thinking in early recovery (park)

Conditions: Opioid Use; Opioid Use Disorder; Substance Use Disorders

Summary: the goal of this clinical trial is to demonstrate the commercial potential for a novel virtual reality (vr) intervention in preparation for phase ii development. this clinical trial will test the vr intervention for efficacy in reducing opioid use, increasing abstinence, and other self-reported and behavioral focus on future outcomes in individuals in early recovery from opioid use disorder. * will the vr group, compared to the control group, have a lower number of opioid use days? * will the vr group, compared to the control group, have longer periods of abstinence at the 30-day follow-up? * will the vr group, compared to the control group, have significantly increased opioid abstinence rates? * will the vr group, compared to baseline and the control group, show increased future self-identification post-vr intervention? * will the vr group, compared to baseline and the control group, show increased future orientation post-vr intervention? * will the vr group, compared to baseline and the control group, show an increased preference for delayed rewards in a laboratory delay discounting task post-vr intervention? * will the vr group, compared to baseline and the control group, exceed in behavioral effects (i.e., future self-identification, future orientation, and increased preference for delayed rewards) at the 30-day follow-up? researchers will compare the vr test group and the control group to see if there are differences in the results for the questions outlined above.


Eligibility criteria:
inclusion criteria: * abstinence between ≥14 days and ≤ 1 year * 18-60 years old * verbal endorsement of commitment to recovery * outpatient * psychotropic drugs for sud-comorbidity * mu-opioid drugs * drug/alcohol abstinence ≥ 24 hours at the time of the study day visit * english comprehension exclusion criteria: * unstable medical disorders * outside the age range of 18-60 * habitual drug use * smell/taste disorders * unstable psychiatric conditions * extravagant/elaborate face tattoos
lci and bronchial inflammation in patients with bo

Conditions: Bronchiolitis Obliterans

Summary: the investigators here compare lung function parameters (rv, rv/tlc and fef75) with the results of the lung clearance index (lci) . further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. the investigators will perform a pulmonary function test (body plethysmography with dlco) and compare the results with the lci. further we will measure the fraction of exhaled nitric oxide (feno) and draw a blood sample to determine the level of systemic inflammation. finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. this study will set baseline markers for future interventional studies.

the purpose of this study is to compare lung function values with the lung clearance index of 20 patients with bronchiolitis obliterans aged between 6 up to 28 years. further we aim to compare the bronchial inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies. the sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition. (sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (pcr) (qrt-pcr) and by cytometric bead assay (cba).) methods and work programme: * measurement of nitric oxide in expired air (feno) * lung function testing with spirometry and body plethysmography * lung clearance index (lci) * bronchodilation * blood test: blood count, crp, rast, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system) * induced sputum for inflammatory mediators and microbiological investigations

Eligibility criteria:
inclusion criteria: * informed consent * between 6 and 28 years of age * known bronchiolitis obliterans * no bronchiolitis obliterans(depending on the study group) * ability to perform lung function tests and inhalation exclusion criteria: * acute illness with systemic or bronchial inflammation * every chronic condition or infection (eg hiv, tuberculosis, malignancy) * pregnancy * known alcohol and/ or drug abuse * inability to understand the extent and scope of the study * participation in another study

Keywords: bronchial inflammation bronchiolitis obliterans sputum blood inflammation adaptive immune system innate immune system