Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of ciclesonide administered with or without different spacers in patients with asthma (12 to 75 y) (by9010/m1-145)

Conditions: Asthma

Summary: the aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. the study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).


Eligibility criteria:
main inclusion criteria: * written informed consent * history of persistent bronchial asthma for at least 6 months * good health with the exception of asthma main exclusion criteria: * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * smoking history with ≥10 cigarette pack years * pregnancy * intention to become pregnant * breast feeding * lack of safe contraception * previous enrolment into the current study

Keywords: asthma ciclesonide
immune biomarker study for salivary gland carcinoma

Conditions: Salivary Gland Tumor; Benign Salivary Gland Tumor

Summary: aims of this study are analyses of tumor metabolome, tumor transcriptome and tumor proteome as well as of the immune infiltration, separated by histological entity. these data will subsequently be compared with the with the detailed immune status determined in the patient's peripheral blood and saliva using machine learning techniques, among others, to create a biomarker cluster for salivary gland tumors. these can be used in clinical routine. in addition, the investigators would like to study a subset of patients from freshly resected tumor organoids from freshly resected tumor tissue according to already established methods in order to mechanistic investigations of prognostic parameters.


Eligibility criteria:
inclusion criteria: 1. observational group * initial diagnosis of a primary salivary gland carcinoma in the head and neck region (no squamous cell carcinomas) * specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired 2. control group 1 * initial diagnosis of a benign salivary gland tumor in the head and neck region * specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired 3. control group 2 * functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) * specimen collection with sufficiently large resectate during a functional nose surgery for all groups: * willingness of patients to collect blood, saliva and stool and consent to the preservation of all samples for study purposes. * age ≥ 18 years * sufficient cognitive ability of the patients to understand the purpose of the study and to understand the purpose of the study and agree to it exclusion criteria: * distant metastasis at the time of diagnosis and simultaneous second cancers, i.e. at study inclusion * malignancy in the last 5 years regardless of location (except basal cell carcinoma or cis of the uterine cervix) * carcinomas for which specimen collection is not possible or likely without compromising the compromise the pathological evaluation * persistent drug or medication abuse * patients who are unable or unwilling to comply with protocol and to be treated * patients who are represented by a legal guardian * patients who are not suitable for participation in the study due to a language barrier
comparison study of usual care vs. usual care plus community intervention to manage type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; NIDDM; Non-insulin Dependent Diabetes Mellitus

Summary: the overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with type 2 diabetes mellitus and multiple chronic conditions and their family caregivers. once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.

research goal to examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with t2dm and multiple chronic conditions and their family caregivers. objectives 1. to determine if a 6-month, ip, community-based intervention improve self-management compared with usual primary care services? 2. to compare the effectiveness of the intervention on hrqol, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels \[hba1c, hypoglycemic episodes\]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services? 3. to determine the effectiveness of the intervention on hrqol of family caregivers compared with usual primary care? 4. to assess whether or not the intervention improves clinical practice behaviours? 5. to determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective? 6. to identify which subgroups of older adults with t2dm and mcc benefit most from the intervention? 7. to determine the effectiveness of the intervention based on sex/gender and region? 8. to determine the overall feasibility and acceptability of an ip community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?

Eligibility criteria:
inclusion criteria: * older adults aged 65+ * live in the local vicinity of a participating diabetes education program * were referred to their diabetes education program within the past 24 months * competence in english (or access to a translator) * intention to continue living in the area for the next 6 months * two reported chronic conditions in addition to t2dm. individuals with newly diagnosed t2dm as well as those who were already receiving treatment for t2dm will be eligible for inclusion in the study. exclusion criteria: * score of 20 or less in montreal cognitive assessment (moca) test and without access to a substitute decision maker to sign consent (score of 20 or less is not in itself an exclusion).

Keywords: self-management home visits
assessing the feasibility, acceptability and effects of hiv birth testing in maternity settings in zimbabwe

Conditions: HIV/AIDS; Infant Morbidity; Perinatal HIV Infection; HIV Infections

Summary: this study aims to assess the feasibility and, acceptability and effects of implementing hiv testing at birth testing using point-of-care (poc) hiv nucleic acid testing (nat) in maternity settings.

this unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing hiv testing at birth testing using point-of-care (poc) hiv nucleic acid testing (nat) in maternity settings. outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, hiv positivity rate, and timing of art initiation for hiv-positive infants. this study will compare outcomes between hiv-exposed at high vs low risk of maternal hiv transmission. the study will also assess the impact of poc birth testing on retention in care and impact on subsequent testing at 6 weeks.

Eligibility criteria:
inclusion criteria: hiv-exposed infants (hei) * all hei who access maternity/post-natal services within 48 hours of life * tested for hiv at birth using the poc nat platform * caregiver provides informed consent for participation caregivers * mother/caregiver of an hei who was offered poc eid at birth * able to provide informed consent to participate in the study health workers * all health workers working in maternity services in the study sites * provides informed consent to be interviewed key informants (laboratory managers and program leads/focal persons) * health managers working in the field of pediatric hiv services or pmtct * provides informed consent to be interviewed exclusion criteria: hiv-exposed infants (hei) * hei tested for hiv using conventional eid at project sites * hei whose caregivers refuse birth testing * hei where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia) caregivers * caregivers of hei who cannot legally provide consent to participate in the study health workers * healthcare workers who do not make use of eid or results of eid key informants * key informants who cannot legally provide consent to participate in the study

Keywords: hiv poc eid
interactive hand-grip strength game in critically illness patients

Conditions: Critical Illness

Summary: patients admitted to the intensive care units (icus) are an unexpected event that consequently causes physical and psychological problems, including icu acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (ptsd). such consequences may lead to prolonged icu stay, increased health care, and elevated medical costs. therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. investigators aim to design an interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care.

patients admitted to the intensive care units (icus) are an unexpected event that consequently causes physical and psychological problems, including icu acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (ptsd). such consequences may lead to prolonged icu stay, increased health care, and elevated medical costs. therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. investigaters aim to design a interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care. this will be a two-arm, parallel randomized controlled trial which randomly assign patients into the game group and usual care group.

Eligibility criteria:
inclusion criteria: * aged ≥ 20 years * having clear consciousness * independently able to mobilize to complete the intervention and communicate in chinese * richmond agitation-sedation scale (rass) 24 between +1 to -1 if using sedatives exclusion criteria: * suspect neurological deficits * neuromuscular disease * orthopedic injuries with contraindications to mobilize

Keywords: intensive care unit hand-grip strength
a phase 2 study to assess efficacy and safety of lb54640 in patients with genetic obesity

Conditions: POMC Deficiency Obesity; PCSK1 Deficiency Obesity; LEPR Deficiency Obesity

Summary: the purpose of the study was to assess the efficacy of lb54640 in participants with rare genetic disorders of obesity

patients with obesity due to pomc, pcsk1 or lepr deficiency will be enrolled to receive lb54640 by oral administration for 16 weeks. after 16 weeks of treatment, the participant may enter a long term extension phase and receive treatment for up to 1 year.

Eligibility criteria:
inclusion criteria: * participants aged ≥12 years at the time of enrollment and diagnosed with genetic obesity due to pomc, pcsk1, or lepr deficiency mutations. * obesity is defined as bmi ≥30 kg/m2 for participants ≥18 years of age or bmi ≥95th percentile for age and gender for participants \<18 years of age. exclusion criteria: * participants with recent (within 2 months, prior to screening and up to enrollment) intensive diet/exercise regimen that resulted in \>2% weight loss, use of medication to treat obesity (within 3 months of first dose of lb54640 with certain exceptions), or weight loss surgery within 6 months prior to screening or prior surgery which resulted in \>10% weight loss with no evidence of weight regain are excluded * history of major surgical procedure * weight loss surgery within the previous 6 months * any history of a suicide attempt, or any suicidal behavior * hba1c \>10.9% * fasting glucose level \>270 mg/dl
effects of tdcs combined with vr on anxious ruminations in healthy subjects with a vulnerability to rumination

Conditions: Rumination

Summary: this study proposes: to evaluate 1) whether the combination of virtual reality (vr) and active tdcs provides better rumination attenuation than the combination of vr and tdcs placebo 2) the acceptability and experiential experience of combining these two well known medical devices.

inclusion visit: * confirmation of eligibility criteria * written informed consent visit 1 and 2 (or end of study visit) : before first ruminations induction : * completion of brief state rumination inventory (bsri), state-trait anxiety (stai), inventory, visual analogic scale (vas), ruminative response scale - short form (rrs-sf), beck depression inventory (bdi) * eeg recording then procedure for inducing ruminations using a pre-recorded voice listened to in an audio headset alternating statements promoting a positive, neutral and negative introspection and self-judgment attitude (the latter are heard at the end to initiate the rumination process) over 8 minutes then * completion of brief state rumination inventory (bsri), inventory, visual analogic scale (vas), beck depression inventory (bdi), * eeg recording * pulse and blood pressure measurements then immersion in a relaxing virtual environment for 20 minutes with active or sham placebo. • cutaneous conductance measurement and eye-tracking during immersion at the end of immersion : * completion of brief state rumination inventory (bsri), inventory, visual analogic scale (vas), beck depression inventory (bdi), igroup presence questionnaire (ipq) * pulse and blood pressure measurements then again procedure for inducing ruminations . at the end of ruminations induction : * completion of brief state rumination inventory (bsri), state-trait anxiety (stai), inventory, visual analogic scale (vas), beck depression inventory (bdi), tolerance questionnaires * debriefing

Eligibility criteria:
inclusion criteria: * without any particular ethnic and psychosocial criteria * subject to ruminations (personality trait) documented by a rrs-sf score \>30 * subjects with score to bdi scal \<14 assessed during first visit * subjects without psychiatric or addictive disorders. * subjects who do not meet all the diagnostic criteria for an anxiety disorder or characterized depressive episode. exclusion criteria: * contraindication to tdcs (neurosurgical history, intracranial device, skin problems) * current virtual reality intolerance * history of psychiatric or addictive disorders * use of psychotropic drugs * use of non psychotropic treatments significantly influencing mood or level of anxiety * pregnant or breast-feeding women * neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)

Keywords: virtual reality brain stimulation tdcs phenomenology
stress levels and mental well-being among students during e-learning

Conditions: Anxiety; Depression

Summary: introducing restrictions on human contact has been effective in preventing the uncontrolled spread of covid-19, however, it appears to have negatively impacted mental health. psychological problems in different age groups occur with different intensity and duration of the pandemic. this study was aimed to assess the impact of introducing distance learning (e-learning) on the stress levels and mental well-being among polish, slovak and lithuanian students.

the covid-19 pandemic has had the effect of accelerating changes in educational processes around the world. it resulted in a rapid conversion from face-to-face to online classes. this has disrupted the regular pattern of education and standard practices that have been followed for many years. it is a big organizational challenge for the academics but most importantly for the students. remote learning has resulted in long-term social isolation and limitations in interaction with peers. it has also been noted that about 30% of students have symptoms of depression and increased levels of perceived stress, which during the covid-19 pandemic affects about 50% of young people. many factors have an impact on this condition, besides the epidemic situation, the social mood and the numerous restrictions, the prolonged time spent online and the reduced level of physical activity have an additional negative impact on their mental health. due to the dynamic situation of the pandemic, there is a lack of current studies on the mental state of young people especially in the context of ongoing e-learning. therefore, it was decided to investigate what is the prevalence of depressive disorders and the level of perceived stress during the ongoing remote learning in the group of students of 8 european universities among poland, slovakia and lithuania.

Eligibility criteria:
inclusion criteria: * students attending the course cycle exclusion criteria: * inability to self-complete the research questionnaires; * psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;

Keywords: depression anxiety covid-19 e-learning
regulation of branched-chain amino acid metabolism in pre-diabetes

Conditions: Branched-chain Amino Acid Metabolism; Insulin Sensitivity

Summary: elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. this study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. the purpose of this study is to determine how elevated levels of the branched-chain amino acids may contribute to the development of insulin resistance and ultimately diabetes. an additional purpose is to determine whether exercise or gastric bypass (gbp) surgery intervention can correct aberrations in branched-chain amino acid metabolism as insulin sensitivity improves. this information will be used to further our understanding of the development of insulin resistance and type 2 diabetes in at-risk populations and potentially improve clinical treatment of such conditions.


Eligibility criteria:
inclusion criteria: * age: * lean and overweight pre-diabetic (pd) groups: 40-65 years * obese gastric bypass (gbp) patients: 30-65 years * body mass index (bmi) within desired range for group: * lean group: 18.0 - 24.9 * overweight pd group: 25.0 - 35.4 * gbp group: 35.0 - 50.0 * fasting plasma glucose level within desired range for group: * lean: \< 99 mg/dl * pd: \> 105 - \< 126 mg/dl * gbp: \> 99 * oral glucose tolerance test, 2-hour plasma glucose results within desired range: * lean: \< 139 mg/dl * pd: 140-199 mg/dl * low density (ldl) cholesterol: \< 190 mg/dl * triglycerides: \< 600 mg/dl * resting blood pressure: \<160/90 mmhg * inactive: exercise \< two days/week (gbp and pd only); * peak oxygen use: \> 14.0 - \< 40.0 ml/kg/min (pd only) * medications: stable use of all medications for \> three months * body weight \< 495 lbs exclusion criteria: * smoker: tobacco use within the last 12 months * dieting or intending to diet (excluding intention for gastric bypass procedure in gbp group)- not weight stable for \> six months or weight loss exceeding five pounds in last six months * use of potential confounding medications, e.g. niacin containing drugs * history of diabetes, heart disease or taking medication for those conditions * history of hypertension (high blood pressure) not controlled with medication * pregnant or intending to become pregnant * unwillingness to participate in study visits, submit to skeletal muscle biopsies and all other study testing or continuously participate in the exercise training intervention program for six months if in overweight pd group * orthopedic limitations, musculoskeletal disease and/or injury * allergic to xylocaine * inability to give blood continuously through an intravenous catheter * unwillingness to exercise at least three times per week at the duke center for living during staff supervised times (pd only) * exercise compliance less than 85% in any 6 week period (missing \> 3 exercise sessions in a 6 week period)

Keywords: branched-chain amino acids insulin sensitivity exercise leucine
oral health care in autism spectrum disorder

Conditions: Autism Spectrum Disorder; Autism

Summary: persons with autism spectrum disorder (asd) are characterized by impairments in social interactions, speech and communication, restricted patterns of behaviour, and unusual sensory sensitivities. there are not many studies available reporting oral health status, dental care needs and oral health care protocol for persons with an asd.

despite the fact that there appears to be no known asd specific dental and oral manifestations, there are consistent reports that persons with asd exhibit significantly poorer oral health epidemiological profile when compared to their neurotypical counterparts. in addition to that, it has been reported that persons with asd to substantial extent have a special health care needs and are almost twice as likely to have unmet oral health care needs as their typically developing peers regardless socioeconomic and cultural background. all these oral health related problems might arise because of asd related challenging behaviors such as communication limitations, personal neglect, self-injurious behaviors, dietary habits, effects of medications, resistance to receiving dental care, hyposensitivity to pain, and possible avoidance of social contact. frequently overlooked but very important reason is the lack of oral care providers who are willing to serve this population. as a results, oral health problems and unmet oral health needs transfer from childhood to adult period in persons with asd.the broad, long-term objective of the investigator's proposed research is to describe the oral health status, oral health related behaviors, oral care delivery pattern, limitations of routine dental treatment and requirements for use general anaesthesia for oral health care of patients with asd. oral health status, pattern of oral health care delivery, dental treatment needs met in routine dental treatment and general anaesthesia will be analysed retrospectively on 52 participants with diagnosed asd who were treated and monitored at the paediatric dentistry department, dental clinic of vojvodina, faculty of medicine, university of novi sad during 5 years (2013-2018) observation period. conditions assessed will include, dental caries, missed teeth, filled teeth (dmft index), restorations, bruxism, delayed eruption/missing teeth, oral infection, injuries, general health status, dental treatment acceptance (frankle scale), dental treatment attendance, routine dental treatment and general anaesthesia dental treatment assessment.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * diagnosis of a autism spectrum disorder not confirmed by a physician

Keywords: oral health dental care general anaesthesia tooth loss