Kornimate/medical-research-clean huggingface dataset:
safety study about the mrna vaccines against covid-19 in children (pedivacov-hcsc)

Conditions: COVID-19 Vaccine Adverse Reaction

Summary: drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes. the use of covid-19 vaccines (mrna vaccines) is worldwide spread as a safety measure against the pandemic. although clinical trials have shown that vaccines are safe in the general population, specific real-life monitoring is needed to address the special situation that applies to children.

drug-related side effects are an important health problem causing an increase in health costs. most of the related research is focused on the adult population, therefore evidence in pediatric patients is scarse. this situation remains true in the clinical trials of the mrna vaccines against covid-19, with most studies suggesting the need of a greater follow up and specific research that address the pediatric population. even though vaccines seem to be a safe and effective ways to protect the population against the covid-19 pandemic, more information is needed regarding the safety profile for pediatrics in the short and long term.

Eligibility criteria:
inclusion criteria: * patients of both sexes between 5 and 12 years old. * pediatric patients with data included in the clinico san carlos' hospital available for consultation. * acceptance by the parents/legal guardians for the participation and follow up. exclusion criteria: * none

Keywords: covid19 vaccine pharmacovigilance drug-related side effects and adverse reactions
therapeutic effects of robotic exoskeleton-assisted gait re-habilitation and predictive factors of significant improvements in stroke patients

Conditions: Stroke Sequelae

Summary: investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.


Eligibility criteria:
inclusion criteria: * patients aged from 30 to 80 years * hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months exclusion criteria: * with a significant history of pain or injury of lower limbs that affected their walking ability, * with cardiopulmonary diseases that prohibited exercise training * with impaired cognitive function * unable to complete the timed up-and-go test * able to complete the timed up-and-go test in \<20 seconds using walking device

Keywords: robotic rehabilitation stroke quality of life walking speed
prospective comprehensive molecular profiling in neuroendocrine tumors

Conditions: Neuroendocrine Tumors; Pancreatic Neuroendocrine Tumors

Summary: prospective study to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (nets) or well-differentiated pancreatic neuroendocrine tumors (pannets) for molecular profiling.

in this prospective study the aim is to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (nets) or well-differentiated pancreatic neuroendocrine tumors (pannets). eligible population includes: nets and pannets patients who have undergone or are undergoing treatment with targeted therapies and have shown prolonged clinical benefit, and nets and pannets patients who have been treated with these agents and just recently progressed. rna and dna from fresh tumor biopsies and from mononuclear blood cells will be subjected to transcriptome sequencing and dna sequencing analyses to evaluate possible genes of interest and related targetable pathways. moreover, archived tumor samples will be requested from all patients to perform additional genomic testing. remaining rna and dna will be banked for additional exploratory analyses (e.g. further genomic testing, or dna copy number analysis, or epigenetic evaluations).

Eligibility criteria:
inclusion criteria: * age \> 18 years. * histological or cytological proof of nets or pannets. * at least one biopsiable lesion deemed medically accessible and safe to biopsy. * current/recent treatment with targeted therapies with confirmed clinical benefit; confirmed progression disease to targeted therapies at the time of study enrollment. * fulfills local institution's laboratory parameters for tumor biopsy. * willingness and ability of patient to provide signed voluntary informed consent. exclusion criteria: * any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment. * any contraindication to undergoing a biopsy or blood collection procedure.

Keywords: net pannet molecular profiling transcriptome sequencing
motivate: a web-based intervention

Conditions: Eating Disorders

Summary: the aim of this study is to test whether motivate can increase attendance at assessment. this will be done using a single-consent zelen randomised control trial, with all non-emergency adult clients referred to the kimmeridge courte eating disorder service over a one year period being randomised to either treatment as usual (tau) or tau plus access to the motivate intervention prior to their assessment appointment.

motivate is a web-based intervention intended to be delivered at the point of referral to an eating disorder (ed) service. the intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. this is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with eds spread across four 15-20 minute modules. these modules have been evaluated by service-users who have an ed. the aim of this study is to test whether motivate can increase attendance at assessment. this will be done using a single-consent zelen randomised control trial, with all non-emergency adult clients referred to the kimmeridge courte eating disorder service over a one year period being randomised to either treatment as usual (tau) or tau plus access to the motivate intervention prior to their assessment appointment. routine audit data will be collected to compare the number of people who attend their assessment appointment in the motivate group verses the control group. usage data generated by the intervention will also be assessed. twenty participants from the motivate group will be invited to give qualitative feedback about their experience of the intervention.

Eligibility criteria:
inclusion criteria 1) referrals to the eating disorders service during the study period. exclusion criteria 1. inpatients or emergency and urgent cases. 2. patients who have already been randomised into the study. 3. non english speakers

Keywords: motivation attendance
prevention of acute kidney injury - molecular mechanisms of dietary pre-conditioning in human

Conditions: Chronic Kidney Disease

Summary: the key objective of this pilot study is to assess the molecular mechanisms of renal pre-conditioning by a one-week low-calorie diet in humans. the protective effect of the low-calorie diet and also of the protein-restriction in donor on transplant qualities and functions in receptor will also be investigated. analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome through tissue samples as well as blood samples for comparison of low-calorie diet, protein-restriction and no-diet groups.


Eligibility criteria:
inclusion criteria: * age ≥18 years * competent patients * planned living kidney transplantation * provision of informed consent * bmi ≥ 18,5 kg/m² exclusion criteria: * none

Keywords: living kidney transplantation chronic kidney disease acute kidney injury
dusquetide for the treatment of behcet's disease

Conditions: Behçet Disease

Summary: this is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by behcet's disease. study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks.


Eligibility criteria:
inclusion criteria: * participants must have a clinical diagnosis of behcet's disease meeting the international study group criteria. * participants must have at least two oral ulcers and/or one genital ulcer on the day of randomization. * participants willing to follow the clinical protocol and voluntarily give their written informed consent. * female participants not pregnant or nursing and willing to undergo a pregnancy test prior to treatment initiation and at the end of the treatment period. exclusion criteria: * pregnancy or mothers who are breast-feeding. * all women of childbearing potential (wocbp) and males with female partners who are wocbp not willing to agree to the use of effective contraception during the trial. * evidence of significant renal, hepatic, hematologic or immunologic disease. * use of any investigational medication within 4 weeks prior to enrollment or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer). * having received concomitant immune modulating therapy (except colchicine or azathioprine) within: 1. ten days prior to enrollment for mycophenolate mofetil 2. four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone 3. oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment 4. at least 5 terminal half-lives for all biologics including, but not limited to, those listed below; within: i. four weeks prior to enrollment for etanercept; ii. eight weeks prior to enrollment for infliximab; iii. ten weeks prior to enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab; iv. six months prior to enrollment for secukinumab. * having received oral or parenteral corticosteroids within 6 weeks (42 days) prior to enrollment. * having received apremilast (otezla) within 4 weeks prior to enrollment. * presence of non- behcet's disease related genital ulcers, including both infectious and non-infectious etiologies. * active organ involvement requiring immunosuppressive treatment.

Keywords: dusquetide
qualitative analysis of photoplethysmography waveforms for the detection of cardiac arrhythmias

Conditions: Cardiac Arrhythmia

Summary: single-lead electrocardiography (ecg) technologies and photoplethysmography (ppg) deriving smartphone apps are gaining interest in the heart rhythm detection space since these apps have the potential to capture and assess heart rhythms. proprietary arrhythmia detection algorithms are proven to be reliable and accurate. however, insights into the readability of ppg waveforms by human reviewers remain limited. to the investigators' knowledge, there are no publications available regarding the readability of ppg waveforms by human reviewers. the objective of the study was to assess the readability of ppg and single-lead ecg analysis by medical professionals, with respect to the gold-standard 12-lead ecg diagnosis, and investigate whether additional information positively impacts ppg analysis.

during the study, the readability of ppg and single-lead ecg waveform analysis will be investigated. the objective of the study is to determine the readability of ppg and single-lead ecg measurements, with respect to the gold-standard 12-lead ecg, and investigate whether additional information positively impacts the readability of ppg. medical professionals (cardiologists and cardiology residents), blinded for the patients' characteristics and history, are instructed to separately analyse the following signals, obtained from 30 patients. * 30 outputs with ppg waveforms * 30 outputs with ppg waveforms with tachogram and poincaré * 30 outputs with ppg waveforms with tachogram, poincaré, and algorithm interpretation * 30 outputs with single-lead ecg waveforms * 30 outputs with 12-lead ecg waveforms participants report the results of the qualitative analysis via a digital questionnaire with multiple-choice questions. medical professionals classify each rhythm trace as regular rhythm, one or more ectopic/missed heartbeats, atrial flutter, atrial fibrillation, unreadable, or other. the tachogram, poincaré, and the algorithm interpretation are subsequently added to investigate whether the additional information improves the readability of ppg. based on the provided answers, the study team will determine the readability of ppg and single-lead ecg analysis interpretation, with respect to the gold-standard 12-lead ecg diagnosis.

Eligibility criteria:
inclusion criteria: * cardiologist or cardiology resident * able to understand dutch or english

Keywords: qualitative analysis photoplethysmography single-lead electrocardiography
use of black cohosh and red clover for the relief of menopausal symptoms

Conditions: Hot Flashes; Menopause

Summary: this phase ii study, a follow-up to a phase i trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. it will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (cbc and chemistry lab values) at baseline and 1 year.


Eligibility criteria:
inclusion criteria: * menopausal women with intact uterus * must be experiencing hot flashes * no menstrual periods for at least 6 months and no longer than 3 years * non-smoker * must have intact uterus (no hysterectomy) exclusion criteria: * contraindications for hormone replacement therapy * diabetes mellitus * pregnancy or breast-feeding * obese (bmi \>35 excluded) * history of endometrial hyperplasia/neoplasia/malignancy * history of breast or reproductive cancer * history of severe recurrent depression, or severe psychiatric disturbance * history of stroke/cva, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart) * history of abnormal vaginal bleeding of unknown cause * untreated or uncontrolled high blood pressure/hypertension * use of any medication or supplement containing estrogen, progestin, serm, st. john's wort, bisphosphonates, or phytoestrogens * history of hormone-associated migraines * history of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders * participation in a clinical trial within 30 days * abnormal endometrial biopsy or mammogram * abnormal transvaginal ultrasound defined as \>7mm thickness * vegan

Keywords: menopause hot flashes red clover black cohosh sexual dysfunction
a single-dose pharmacokinetics and safety study of tmc278 in healthy adult japanese participants

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of tmc278 after a single oral dose of tmc278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy japanese adult male participants.

this is a single center, open-label (all study staff and participants will know the identity of the treatment assigned), single dose study in healthy japanese adult male participants. the study consists of 3 phases: a screening phase up to 26 days; an inpatient phase from day -2 to day 8; and a follow-up assessment phase that occurs on day 15 (± 2 days) or at the time of the participant's early withdrawal from the study. participants who meet the selection criteria will be admitted to the investigational institute on two days before the dose (day -2). all enrolled participants will receive orally (by mouth) a single dose of one tmc278 25 mg tablet on day 1 within 10 minutes after completion of the standardized breakfast. enrolled participants will remain in the investigational institute for the entire duration of the inpatient phase. participants will be discharged on day 8 after the completion of all required assessments. blood samples for determination of plasma concentrations of tmc278 will be collected over a period of 168 hours (7 days). the maximum study duration for each participant is 45 days, including the screening phase, in-patient period, and follow-up visit.

Eligibility criteria:
inclusion criteria: * japanese healthy men * body mass index (bmi) between 18.5 and 25.0 kg/m², inclusive and a body weight of not less than 50 kg exclusion criteria: * history of or current medical illness considered by the investigator to be clinically significant and should exclude the participant or that could interfere with the interpretation of the study results * laboratory abnormality of grade 2 or greater (defined by the world health organization adult toxicity table) or clinically significant abnormal values as assessed by the investigators * clinically significant abnormal physical examination and vital signs at screening as assessed by the investigators * use of any prescription or nonprescription medication (including vitamins and herbal supplements), within 14 days before the dose of tmc278 25 mg tablet * history of clinically significant drug or food allergies, especially known hypersensitivity and/or known allergy to tmc278 or any of the excipients of the formulation

Keywords: healthy pharmacokinetics japanese
observational study of dydrogesterone in cycle regularization

Conditions: Observational Study; Dydrogesterone; Irregular Menstrual Cycle; Abnormal Uterine Bleeding

Summary: dydrogesterone has been widely used worldwide for various gynecological and obstetric indications: * dydrogesterone is effective in cycle regulation treatment. * dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (hpo) axis in the recommended dosage. * dydrogesterone might have non-negative effect on glucose and lipid metabolic.

the current study is designed as a prospective, non-interventional, observational study. patients with irregular cycle diagnosed as aub-o will be prescribed dydrogesterone as per physician's clinical practice.

Eligibility criteria:
inclusion criteria: * women aged 16 years or above with menses * patient who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as aub-o (irregular cycle is defined as cycle duration \ 35 days) * physicians have decided to prescribe dydrogesterone 10mg for cycle regulation treatment, orally taking dydrogesterone 10mg twice daily, from day16 to day 25 of each cycle, being consecutive at least 3 cycles * patient who is willing to sign written authorization exclusion criteria: * hyperprolactinemia and thyroid dysfunction. * patient took cycle regulation treatment including oral contraceptives, sex hormone or glucocorticoid in the past 1 month * women with estrogen deficiency related symptom * patient who meets the contraindications listed in chinese label of dydrogesterone * pregnant and lactating patients * patient who is not suitable for the study according to physician's discretion
study of the analytical performance of allegro™ instrument

Conditions: Diabetes

Summary: a new analyser has been developed (allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. this means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. it is obviously important that this analyser performs to a similar degree of accuracy to the laboratory analyses.

blood and urine tests are used in the assessment of diabetes and to guide clinical management. in the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit. a new analyser has been developed (allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. this means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. it is obviously important that this analyser performs to a similar degree of accuracy to the laboratory analyses. the aim of this research study is to assess the accuracy of the allegro™ analyser compared to laboratory analyses on finger prick capillary blood samples and urine samples. fifty (50) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. the venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the allegro™ analyser and laboratory analyses and the results compared. the allegro™ results will not be used in the management of the patients' diabetes.

Eligibility criteria:
inclusion criteria: * diabetes patients attending altnagelvin area hospital clinics or primary care in western trust area aged 18-80 years of age exclusion criteria: * patients who are less than 18 years or over 80 years of age
it-based training in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and it-based training on the outcome of patients with metabolic syndrome.

the study settles in the field of primary prevention and aims to change lifestyle of patients with metabolic syndrome with a new combination of personal and it-based training specially designed für obese people with risk factors. procedures that are similar for all participants are summarized in a training program whereas individual aspects of physical activity like initial education and exercise tests are still performed by doctors and trainers. before and after three months of training anthropometric parameters, laboratory and exercise capacity are examined and analyzed. the intervention group is characterized by a predetermined exercise program whereas the control group is allowed to practise without detailed instructions. the practicability and the effect on health status of the combined personal and it-based training in the intervention group is compared with the independent training of the control group. after 6 months and again after 12 months the measurements are repeated to evaluate a lasting effect of the program.

Eligibility criteria:
inclusion criteria: * males and females between 20 and 60 years * staff of the fa. bmw * written informed consent after detailed education * bmi 25-35 kg/m2 * ≤ 1x/week sport respectively exercise * metabolic syndrome (at least 3 of 5 criteria) exclusion criteria: * \> 1x/week physical activity * bmi \ 35 kg/m2 * florid acute or chronic disease of any kind prohibiting regular physical activity * diabetes mellitus * pregnancy or lactation * drug or alcohol abuse

Keywords: metabolic syndrome physical activity overweight malnutrition prevention