Kornimate/medical-research-clean huggingface dataset:
general practice research database seroquel xr safety study

Conditions: Schizophrenia; Major Depressive Disorder; Bipolar Disorder

Summary: the main objective of this observational study is to characterize new users of quetiapine xr as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine xr as well as in other study drugs.

epidemiology study to assess the safety of a new slow-release form of seroquel (quetiapine) in the post-marketing phase in the uk.

Eligibility criteria:
inclusion criteria: * episodes of new use (\>/=1 prescription) of quetiapine xr or other study drugs exclusion criteria: * less than two years of recorded history before the start of the marketing of quetiapine xr (or cohort entry date) * if the duration and dose of the antipsychotic drug cannot be determined

Keywords: atypical antipsychotics quetiapine
hydroxychloroquine or diltiazem-niclosamide for the treatment of covid-19

Conditions: Sars-CoV2

Summary: no optimal antiviral intervention has been yet validated to treat covid-19 disease. comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis. this study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (soc), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented sars-cov-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. participants will be randomized to receive soc alone or soc + hydroxychloroquine 200 mg three times a day during 10 days or soc + association of niclosamide 2 g at j1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.


Eligibility criteria:
inclusion criteria: * positive sars-cov-2 test on nasopharyngeal swab * onset of symptoms \<8 days prior to randomization * news score\<4 and no item ≥2 * at least one comorbidity among: age ≥ 70 years old, history of cardiac disease, diabetes, obesity, chronic kidney disease, chronic respiratory failure, immunosuppression, neoplasia, liver failure (stage ≥ child-pugh b) * fully able to understand the challenges of the trial * signed informed consent * covered by health insurance exclusion criteria: for all patients: * inability to decide to participate * pregnancy or breath feeding * hypersensitivity to any of the test drugs * stage 4 or 5 chronic kidney disease (dfg \<30 ml/min/1.73 m²) for hydroxychloroquine arm: * long qt syndrome or qtc space \>500 ms * treatment with piperazine, halofantrine, dasatinib, nilotinib, citalopram, escitalopram, hydroxyzine, domperidone * hepatic porphyria, retinopathy, known glucose-6-phosphate dehydrogenase deficiency, * heart rate \<50/min * hypokaliemia \< 3.5 mmol/l for diltiazem arm: * heart rate\<40/min * sinus bradycardia, second- or third-degree atrioventricular block * left heart insufficiency with pulmonary stasis * treatment with dantrolene, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, esmolol, bêta-blockers (bisoprolol, carvedilol, metoprolol, nebivolol), fingolimod

Keywords: covid-19 hydroxychloroquine dilitazem niclosamide
new prospective expanded german registry of incidental gallbladder carcinoma (persuasion)- a permanent platform including all kind of biliary tract cancers (btc)

Conditions: Biliary Tract Cancer; Neoadjuvant, Adjuvant and 1st Line

Summary: permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and qol for all types of biliary tract cancers.

permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and qol for all types of biliary tract cancers. the registry does not define any medical intervention and does not evaluate the efficacy or safety of the treatment decision made by the investigator. every adverse event whether related to a treatment or not, will neither be documented in the trial´s ecrf nor be reported to the leading investigators of this study. objectives: • to establish a registry with a representative btc-patient population in german-speaking europe (mainly dach region) for current and future research. the study registry is not based on a primary endpoint. the data collection includes (among basic patient-/tumor-/treatment- characteristics) the survey of quality of life (eortc-c30), a so-called patient-reported outcome (pro) and - if available - the collection of tissue samples for translational accompanying projects. * clinical data: * to analyse potential risk factors associated with btc-cancer addressing clinical and biological predictors of treatment success and survival * to determine the course of disease and qol throughout all applied therapy lines for patients with btc * to measure progression-free, disease-free and overall survival in different btc sub-groups, mortality and morbidity for perioperative and palliative therapy procedures * recording of the therapy regimens and therapy sequences used across all treatment lines * molecular data (data- and biobanking): * to establish a sample collection for future molecular/genetic biomarker characterization to enable for e.g. assessment of the frequency of targetable mutations and associated therapy decisions or progression analysis in baseline and follow-up investigations

Eligibility criteria:
inclusion criteria: * known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder carcinomas * age ≥18 years * signed informed consent form * planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy exclusion criteria: * patients who are unable to consent because they do not understand the nature, significance and implications of the registry and therefore cannot form a rational intention * patient under 18 years of age * patient's inability to complete qol questionnaire or answer the questions. * second-line or further palliative therapies if the patient's first-line therapy was not documented within the study.

Keywords: biliary tract cancer registry molecular profiling
acute effects of neonatal hydrokinesiotherapy in newborn preterm hospitalized

Conditions: Newborn Preterm

Summary: this study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. salivary cortisol samples were collected, pain applying the neonatal infant pain scale scale (nips), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.

newborns have the neurological maturity to perceive pain, including preterm. in the environment of the neonatal intensive care unit newborns are subject to environmental stress and numerous painful interventions. based on the physiological properties of water, it is known that the hydrotherapy promotes comfort, reduces stress, and as a resource for treatment of various diseases. this study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit.

Eligibility criteria:
inclusion criteria: * gestational age above 37 weeks * clinically stable * without ventilatory support exclusion criteria: * access deep below the shoulders * umbilical catheterization * neurological and cardiac disorders * clinically unstable
nidek gonioscope gs-1 for glaucoma

Conditions: Glaucoma

Summary: the gonioscope gs-1 is an ophthalmic camera with gonioscopic prism that is intended to capture, display and store images of the anterior chamber angle and its peripheral part. this study evaluates the efficiency of gonioscope gs-1 in glaucoma patients.with the captured images, the glaucoma diagnosis and post-operative observation are enabled.


Eligibility criteria:
inclusion criteria: * diagnosed with glaucoma or glaucoma suspect glaucoma suspect * glaucomatous optic neuropathy as described in the glaucoma patients below * and/or ocular hypertension (iop \> 21 mm hg) * normal visual field glaucoma patients * clinical characteristics of glaucoma: onh abnormalities: global rim thinning, rim notch, or disc hemorrhage; rnfl defect * typical glaucomatous field loss in reliable vf, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests. * both eyes will be included, except in cases where only one eye meets study criteria exclusion criteria: * corneal opacities (scars, edema, etc.) * pregnant or planning to become pregnant * inability to fixate gaze
thermal pulsation versus warm compress treatment for meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: this study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.

this prospective, single-center, single-masked, randomized, controlled clinical trial compared the systane ilux handheld thermal pulsation system with a warm compress mask (bruder moist heat eye compress, bruder healthcare, alpharetta, ga, usa) for the treatment of meibomian gland dysfunction (mgd). subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. enrollment criteria included ocular surface disease index (osdi) score \>23, total meibomian gland secretion (mgs) score \< or =12 in the lower lid of each eye, and tear break-up time (tbut) \< 10 seconds. tbut, mgs, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. symptoms were evaluated using the osdi questionnaire at baseline, 2 weeks, and 8 weeks.

Eligibility criteria:
inclusion criteria: * history of self-reported dry eye symptoms for 3 months prior to study enrollment * baseline osdi score of 23 or greater ( * mgs score of 12 ior less in the lower eyelid of each eye * tbut \<10 seconds * willing and able to abstain from using any new ocular lubricants exclusion criteria: * diagnosis of thyroid dysfunction or rheumatoid arthritis * history of laser-assisted in situ keratomileusis (lasik); any other ocular surgery within the previous 12 months * abnormal lid anatomy or active lid lesions * use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month * active ocular infection * pterygium * planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops * cdva worse than 0.2 logmar
iui vs. ivf/icsi in women aged 38-42 years: a prospective randomized controlled trial.

Conditions: Infertility

Summary: prospective randomised controlled trial: 3 iui cycles versus 1 ivf/icsi cycle in women aged 38-42 years.

study design: prospective randomised controlled trial: 3 iui cycles versus 1 ivf/icsi cycle in women aged 38-42 years. . group 1: 3 consecutive gonadotrophin stimulated iui cycles (follitropine bèta, puregon, msd). vs. group 2: 1 ivf/ icsi cycle - recombinant fsh (follitropine bèta, puregon, msd) - antagonist protocol.

Eligibility criteria:
inclusion criteria: women aged between 38 and 42 years. sperm: use of donor sperm or husband sperm reaching who criteria 2010. exclusion criteria: * tubal infertility (even one tube). * major uterine or ovarian abnormalities * metabolic abnormalities

Keywords: age (38-42 years) pregnancy rates 3 iui cycles 1 ivf/icsi cycle
performance study of the thermodiag solution for body temperature measurement

Conditions: Temperature Change, Body; Emergency Department Visit

Summary: the goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the thermodiag® medical device, compared with reference methods, for continuous measurement of core temperature in critical care patients. the main question it aims to answer is to develop non-invasive alternatives to the current methods of measuring core body, to reduce health risks, and overcome various other limitations (as infection, bleeding, thrombosis and local reactions).


Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years; * female or male patients; * patients hospitalised in a critical care unit as defined by the public health code of the republic of france, article r6123-33: 'the critical care activity consists of the care of patients who present or are likely to present one or more acute failures directly threatening the vital or functional prognosis and which may require recourse to one or more methods of substitution'. * patients affiliated to the social security system or beneficiaries of such a system, where applicable, in accordance with local regulations; * voluntary patients - or trusted person/family member/relative who have given oral and written consent after being informed by the investigator of the research. exclusion criteria: * patients with a corpulence or physical characteristics responsible for a 'tourniquet' effect: arm circumference greater than 47 centimetres; * patients with burns on the arm (location for thermodiag® measurement); * patients with particularly sensitive or affected skin in the biceps or armpit (left and right); * patients undergoing an mri examination; * patients undergoing extracorporeal circulation; * patients with a history of allergy to silicone; * patients with active implantable medical devices such as pacemakers, defibrillators, etc. ; * patients undergoing dialysis; * patients with a tattoo in the area where the investigational device will be worn (arm); * patients currently excluded from another protocol or taking part in another interventional research study; * pregnant or breast-feeding women.

Keywords: temperature body temperature monitoring temperature multisensors actimetry actigraphy heart rate continuous measurement contextualized measure dedicated machine learning model machine learning
quantiferon access clinical performance study protocol

Conditions: Tuberculosis (TB)

Summary: approximately 225 samples, obtained from participants with varying risk factors for tb infection and disease, will be tested using the qft access kit and the comparator device qft-plus.


Eligibility criteria:
inclusion criteria: * 1. be ≥ 18 years of age, * 2. have received no tb treatment or received treatment for less than 14 consecutive days. * 3. provide informed consent. exclusion criteria: * 1. they do not meet the inclusion criteria, * 2. blood handling was not completed using qft-plus * 3. incubation was \ 24 hours * 4. improperly collected and/or stored samples per instructions for use
effect of consumption of supplements and enriched olive paste on bone metabolism indices

Conditions: Osteopenia or Osteoporosis

Summary: it was a prospective randomized controlled trial. a sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups and received supplements of ca, vitamin d and mg with or without enriched olive paste and with or without vitamin c. changes in calciregulatory hormone were evaluated at the beginning of the study, at 5 and 12 months . blood levels of vitamin d, vitamin c, ca, mg, the lipid profile, anthropometric indices and bone density were assessed at the beginning and at the end of the study.

: it was a prospective randomized controlled trial. a sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups: (i) nutritional intervention group(n=40) received daily 1000mg vitamin c, 500mg vitamin d3, 500mg calcium(ca) and 300mg magnesium (mg); (ii) control group(n=42) received daily 500mg vitamin d3, 500mg ca and 300mg mg; (iii) nutritional intervention group (n=18) received daily 150mg bisphosphonates, 500mg vitamin d3, 500mg ca and 300mg mg; and (iv) nutritional intervention group (n=15) received daily about 364 mg polyphenols via an innovative functional food (50g olive paste enriched with mountain tea extract) along with 500mg vitamin d3, 500mg ca and 300mg mg. groups i -iii received supplementation for a year whereas group iv for 5 months. changes in calciregulatory hormone parathormone (pth) were evaluated at the beginning of the study as well as at 5 and 12 months intervals. blood levels of vitamin d, vitamin c, ca, mg and the lipid profile were assessed at the beginning and at the end of the study. anthropometric indices (weight, body fat(kg), body mass index(bmi) and bone mineral density(bmd) were evaluated at the beginning and at the end of the study.

Eligibility criteria:
inclusion criteria: * age 45 to 75 years old * screening for osteoporosis (t-score ≤ - 1 normal bone density, t-score ≤ 2.5 osteoporosis ) and osteopenia of the femur strength or spine (t-score between -1 and -2.5 ) exclusion criteria: * age \> 75 y.o. and \<45 y.o * diagnosed with chronic diseases including cancer, diabetes, coronary heart disease and stroke

Keywords: postmenopausal osteopenia osteoporosis supplements functional olive paste
validity and reliability of vo2-max measurements in persons with parkinson's disease

Conditions: Parkinson Disease

Summary: each participant would complete four test days and each test day is separated by 7-10 days. at each test day the participants would complete a graded maximal exercise test (vo2max-test), a chair rise (linear encoder) as well as measuring of basic demographic outcomes (weight, fat%,blood pressure etc.). the first test day would further include a motor (mds-updrs iii) and cognitive examination (moca), a questionnaire about quality of life (pdq-39) and one about depression (bdi-ii). furthermore, the first test day would include two test of walking performance (6 minutes walk test and time up and go). two of the test days would be completed while the participants are off their parkinson disease medication for at least 12 hours, while the other two test days would be completed while on their parkinson medication. the order of the tests would be randomized. it is hypothesized that the vo2max test would be reliable and valid when participants are on medication, while off-medication would affect the reliability and validity.


Eligibility criteria:
inclusion criteria: * age ≥ 40 year * written informed consent * diagnosed with idiopathic parkinson's disease * hoehn \& yahr ≤ 3 * taking dopaminergic medication * able to complete a maximal aerobic test on a bicycle exclusion criteria: * dementia * alcohol abuse * pacemaker * serious cardiovascular, respiratory, orthopedic or other comorbidities excluding maximal exercise participation. * pregnancy
insomnia and wake up and recovery from anesthesia

Conditions: Insomnia

Summary: 18-55 years old 100 patients, who are planned to undergo for planned ureteroscopy will be participated in the study. in the preoperative room patients will be asked to participate to the study. if they accept 4 item jenkins-sleep questionaire will be asked to them.patients will be divided to two groups , with or without insomnia according to their answers to the questionaire. general anesthesia will be performed to all patients. at the end of operation anesthesia time,operation time, time of eye opening, time of transfer to the recovery room will be recorded in the operating room. pain scores and recovery scores will be evaluated in the recovery room.

18-55 years old 100 patients with american society of anesthesiology (asa) physical status i-ii,who are planned to undergo for elective ureteroscopy will be participated in this study.in the preoperative room patients will be asked to participate to the study and will be asked to answer the 4-item jenkins-sleep questionaire.if they accept to participate, written informed consent will be taken from the patients. according to their answers to the questionaire , patients will be divided into two groups :those with or without insomnia.general anesthesia will be performed to all patients. after anesthesia induction with propofol 2mg/kg and rocuronium 0.6 mg/kg, patients will be ıntubated and mechanically ventilated. maintenance of anesthesia will be achieved with 4-6 % desflurane in nitrous oxide/ oxygen (50%/50%) concentrations with the flow 5l/min. tramadol 1 mg/kg and metoclopramid 1 ampul will be administered intravenously after intubation. hemodynamic parameters( systolic blood pressure, diastolic blood pressure, heart rate and peripheral oxygen saturation), end tidal carbon dioxide values, the concentrations of inspired and exhaled desflurane will be recorded on the surgery start time and on the 5th, 15th,25th,35th,45th,60 th minutes of surgery. at the end of operation ,neuromuscular blockage will be reversed with neostigmine (0,05 mg/kg)and atropine sulphate 0,015 mg/kg i.v. anesthesia time, surgery time, time of eye opening,time of transfer to the recovery room will be recorded in the operating room. in the recovery room pain score will be evaluated with visual analogue scale. modified aldrete recovery score will be used for evaluating recovery.

Eligibility criteria:
inclusion criteria: * 18- 55 years * asa 1-2 patients * patients undergoing elective ureteroscopy exclusion criteria: * renal failure * obstructive sleep apnea syndrome, * thyroid dysfunction * neurologic and physiatric dysfunctions, * morbid obesity * anticonvulsant, antidepressant, anxiolytic drugs usage

Keywords: anesthesia recovery insomnia
study of recombinant modified process hepatitis b vaccine in older adults (v232-059)(completed)

Conditions: Hepatitis B

Summary: the purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis b vaccine and a currently licensed hepatitis b vaccine (recombivax hb™).


Eligibility criteria:
inclusion criteria: * healthy male and female older adults greater than or equal to 50 years of age exclusion criteria: * any adult with a history of previous hepatitis b infection * a history of vaccination with any hepatitis b vaccine * recent (\<72 hours) history of febrile illness (oral temperature =37.8ºc/=100.0ºf) * known or suspected hypersensitivity to any component of recombivax hb™ or engerix-b™ (e.g., aluminum, yeast) * recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product * receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine * receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine * receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine * known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). does not include topical and inhaled steroids * pregnant women, nursing mothers, and women planning to become pregnant within the study period * any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives