Kornimate/medical-research-clean huggingface dataset:
tramadol-paracetamol combination in treatment of patients undergoing spinal surgery

Conditions: Pain, Postoperative

Summary: tramadol-paracetamol combination is studied in patients coming for elective spine surgery. the study drug is started at the day of surgery and continued maximum of five days. before the surgery pain, use of pain medication, satisfaction for pain medication, adverse effects, resilience, depression and life satisfaction were asked. at the discharge and seven days after the surgery use of pain medication and adverse effects were asked. the patients were followed up to 28 days and one year after surgery.


Eligibility criteria:
inclusion criteria: * age 18-75 years, * bmi 18-35 kg/m2, * informed consent obtained, * elective spine surgery exclusion criteria: * age\ 75 years * hypersensitivity to anti-inflammatory drugs, paracetamol, tramadol or their auxiliary substances * acute or recovered hemorrhage in gastrointestinal tract or peptic ulcer * hemorrhagic disease * monoamineoxidase use in past two weeks * epilepsy * tendency to seizure * anti-seizure drugs in use liver or renal failure reduction in lung function alcohol, drug or opioid addiction on record acute intoxication due to alcohol, analgesics, opioids or psychopharmacon pregnancy or breastfeeding investigators estimation
a multicenter, randomized, double-blind, double-dummy trial of azithromycin sr compared with levofloxacin for the treatment of sinus infections in adults

Conditions: Maxillary Sinusitis

Summary: the objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (sr) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.


Eligibility criteria:
inclusion criteria: patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus x-ray (water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage. exclusion criteria: patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.
safety and efficacy of overnight closed loop in children with type 1diabetes mellitus in luxembourg

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (florenced2 system) in children with type 1 diabetes between 6 - 12 years of age in luxembourg .


Eligibility criteria:
inclusion criteria: * between 6 - ≤12 years * with type 1 diabetes for 6 months or more and * pump user for at least 6 months. * hbac1 should be \<11 %. * no medication or physical or psychological disease should be present, which could interfere with the study. exclusion criteria: -none

Keywords: type 1 diabetes mellitus children closed loop cross over overnight florenced2 dana diabecare r pump freestyle navigator ii dexcom g4
acute recanalization of thrombo-embolic ischemic stroke with preset (artesp)

Conditions: Stroke

Summary: artesp is a prospective multicenter study in which the preset thrombectomy system (phenox gmbh\* germany) will be examined. the effectiveness, safety and the long-term success when using the preset to treat acute occlusions of cerebral vessels will be analyzed. \*german: "gesellschaft mit beschränkter haftung", limited liability company

artesp is a prospective multicenter study in which the preset thrombectomy system (phenox gmbh germany) will be examined. the effectiveness, safety and the long-term success when using the preset to treat acute occlusions of cerebral vessels will be analyzed. in this study the market-approved, self-expandable stent retriever (preset, phenox gmbh, germany) will be used to achieve a direct flow recovery. the thrombectomy system will be unfolded directly in the vessel occlusion. in a second step, the system and the thrombus will be pulled back into the guide catheter. it is planned to enroll 100 patients at the age of 18 until 85 years, with a nihss (national institutes of health stroke scale) ≥ 8 and ≤ 30. the preconditions for study enrollment are the written consent of the patient or of the legal representative and the fulfillment of all mentioned inclusion and exclusion criteria. pregnant women are excluded from study participation.the clinical interventions are in accordance with the clinical standard of care for the treatment of this patient population. the mrs (modified rankin scale) on day 30, the nihss on day 90 and an imaging procedure on day 90 may be performed by the study site provided that it corresponds to the clinical standards of the study site.

Eligibility criteria:
inclusion criteria: * patient age ≥ 18 and ≤ 85 years. * patients with acute-onset stroke in the 0-6 hour time window for cerebral onset of symptoms and in angiography with a tici reperfusion (thrombolysis in cerebral infarction) value of 0 or 1 of at least one major cerebral artery (carotid artery, a. media , anterior cerebral artery, basilar artery, vertebral artery, posterior cerebral artery). * nihss (national institutes of health stroke scale) ≥ 8 * signed informed consent by patient / legal representative to participate in the study. exclusion criteria: * pregnancy * demarcated infarcted area in the initial cranial ct or intracranial haemorrhage, * rapid improvement of neurological symptoms * nihss \> 30 * anticoagulation with warfarin with inr (international normalized ratio) \> 3.0, * platelets \<30,000, * glucose \<50mg/dl, * life expectancy \<90 days

Keywords: ischemic, acute
comparing telepractice and conventional face-to-face voice therapy

Conditions: Dysphonia; Aged; Speech Therapy

Summary: people over 55 years are high-risk with voice disorders. voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. however, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. the purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in taiwan. the investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.

randomization: per mutated block, 40 patients on each arms (experimental and control) allocation: sealed envelope indicating either of the 2 groups intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment primary outcome: 10-item voice handicap index secondary outcome: acoustics and aerodynamic parameter

Eligibility criteria:
inclusion criteria: * patient equal or older than 55 years old * voice handicap index-10 (vhi-10) score \>10 point * accessibility to a network connection exclusion criteria * neurologic disorders * active pulomanory disease * mental disorder
a study assessing the safety, tolerability, and efficacy of galegenimab (fhtr2163) in participants with geographic atrophy secondary to age-related macular degeneration (amd)

Conditions: Macular Degeneration, Age-Related; Geographic Atrophy

Summary: this study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (fhtr2163) administered every 4 weeks (q4w) or every 8 weeks (q8w) for approximately 76 weeks in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd) compared with sham control. after completing the study's last visit (week 76), eligible participants will have the option to enroll in open-label extension study nct04607148 (gr42558) and receive open-label galegenimab (fhtr2163) injections.


Eligibility criteria:
inclusion criteria: * age \>/= 60 years at time of signing informed consent form; * visual acuity: best-corrected visual acuity (bcva) letter score \>/= 24 letters (snellen equivalent of 20/320 or better). if the study eye bcva letter score is \>/= 69 letters (snellen equivalent of 20/40 or better), the non-study eye must have a bcva letter score of \>/= 44 letters (snellen equivalent of 20/125 or better); * well-demarcated area of ga secondary to amd with no evidence of prior or active choroidal neovascularization (cnv) in either eye. exclusion criteria: ocular exclusion criteria, study eye: * history of vitrectomy surgery, submacular surgery, or any surgical intervention for amd; * previous laser photocoagulation or itv anti-vascular endothelial growth factor (anti-vegf) for cnv, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy. ocular exclusion criteria, both eyes: * ga in either eye due to causes other than amd; * active uveitis and/or vitritis (grade trace or above) in either eye; * active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; * retinal pigment epithelium (rpe) tear that involves the macula in either eye; * previous participation in interventional clinical trials for ga or dry amd, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.
pharmacokinetics of ago178 in participants with liver impairment

Conditions: Hepatic Impairment

Summary: ago178 was developed for the treatment of depression. a new formulation is being tested in the present study: a tablet to be placed and dissolved under the tongue (sublingual tablet). the goal of this trial was to study the pharmacokinetics of agomelatine given as sublingual tablet in participants with liver impairment and to compare the results to those of healthy volunteers who receive the same treatment.


Eligibility criteria:
inclusion criteria: * participants with liver disease confirmed within 3 months of screening. * if liver impairment is caused by alcohol use, participants must have abstained from alcohol use within 3 months of study start. * participants must satisfy criteria for child- pugh class a or b. exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * pregnant or nursing (lactating) women. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study. * donation or loss of 400 millilitres (ml) or more of blood within eight (8) weeks prior to initial dosing. * significant illness within the two weeks prior to the dosing. * participants with child-pugh alterations due to a non-liver disease (e.g. cancer or treatment related weight loss). other protocol-defined inclusion/exclusion criteria may apply.

Keywords: liver impairment major depression disorder sublingual tablet
magnevist® injection enhanced mra compared to non contrast mra for the detection of structural abnormalities of the aortic arch and cerebral branches

Conditions: Cardiovascular Abnormalities

Summary: the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of magnevist (the study drug) used for mri of the aortic arch and cerebral branches. the results will be compared to the results of mri taken without magnevist, and with the results of your x-ray angiography.

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc.is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * has known or suspected disease of the aortic arch and cerebral branches * is scheduled for x-ray angiography exclusion criteria: * has any contraindication to magnetic resonance imaging * is scheduled for any procedure before the x-ray angiography * had previous bilateral intervention (surgery, bypass) of the arteries of interest

Keywords: structural abnormalities of the aortic arch and cerebral branches
evaluation of a behavioural intervention using app technology in cf

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a lifelong condition which causes the lungs and digestive system to become clogged with thick, sticky mucus. this leads to recurrent chest infections and reduced nutrient absorption from food. the average age at death is 31 years, usually from respiratory failure. the nutritional status of people with cf (pwcf) is important to help them live healthier and longer. it is recommended that adults with cf achieve a bmi of 23 for males and 22 for females. however, fewer than 50% of adults with cf achieved that target bmi despite effective nutritional support to help weight gain. there is a clear need for a behavioural intervention that can help pwcf use the available nutritional support. this is a feasibility study to try out a multi-component behavioural intervention supported by a nutrition app. the intervention is designed to help pwcf use their nutritional support to gain weight. it will focus on testing the methods and procedures to be used on a larger scale, improving the behavioural intervention and estimating how many people are needed for the larger trial. eligible patients will be invited to participate, and the investigators anticipate recruiting 6 participants. the participants will have 6 weeks of intensive intervention, which will include a mix of clinic visits, home visits and telephone calls followed by 6 weeks of maintenance phase. data will be collected during clinic visits at baseline, week 6 and week 12 along with weight monitoring at home. the investigators will interview each participant at the end of the study period to improve the intervention and study processes based on participant feedback. the investigators hypothesised that using a nutrition app, along with regular input from a dietitian, will help pwcf to use the available nutritional support.


Eligibility criteria:
inclusion criteria: * adult people with cf looked after at the sheffield adult cf centre * best bmi of \<23 for males and \<22 for females between june 2018 and november 2018 exclusion criteria: * patients in palliative phase of disease * patients who are pregnant * patients who have no capacity to consent to participate in the study * patients who are unable to communicate by telephone for coaching

Keywords: nutrition weight bmi behaviour change
safety and immunogenicity of codavax-rsv in seropositive and seronegative children

Conditions: Respiratory Syncytial Virus Infections

Summary: this study is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to codavax-rsv in healthy children. they will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 rsv season. 18 children aged 2 to 5 years who are rsv-seropositive (have antibodies to rsv) and 33 children aged 6 months to \< 2 years who are rsv-seronegative (do not have antibodies to rsv) will be enrolled in escalating-dose cohorts. a safety committee will review the safety profile of each dosing group before the next dose-escalation. children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart. a parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. the parent/guardian will be contacted by telephone on the day after dose 1 for safety assessment and review of the diary data. children will return to the clinic 3, 7, 14, and 28 days after each dose. the parent/guardian will then be contacted by telephone monthly until 1 year after the second dose. study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.


Eligibility criteria:
inclusion criteria: 1. age at the time of informed consent: * part a: 2 to 5 years, inclusive * part b: 6 months to \< 2 years 2. rsv status at screening: * part a: rsv-seropositive * part b: rsv-seronegative 3. good general health status 4. product of normal full-term pregnancy (36 to 42 weeks gestation) exclusion criteria: 1. household contact with any of the following groups of individuals for the period up to 14 days after each dose: * pregnant women * infants \< 6 months of age * with hospitalization for asthma or other chronic respiratory disease in the past 5 years * immunocompromised individuals, which includes, but is not limited to, those with the following conditions: * aids * receipt of chemotherapy within the past 6 months * current receipt of immunosuppressive agents * solid organ or bone marrow transplant 2. enrolled in the same classroom at full-time day care with infants \< 6 months of age for 14 days after each dose 3. household contact of another child enrolled into the study 4. inadequate venous access for repeated phlebotomy 5. height and weight ≤ 5th percentile for age and sex (according to cdc growth charts for children in part a, according to world health organization child growth standards for children in part b)

Keywords: rsv live-attenuated vaccine respiratory infection pediatric codon-deoptimized
multiple dose study of ucb4940 as add-on to certolizumab pegol in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety, efficacy and body distribution of bimekizumab (ucb4940) when added to certolizumab pegol treatment in patients with rheumatoid arthritis. neither the patient nor the doctor will know the treatment group.


Eligibility criteria:
inclusion criteria to be eligible to participate in this study, all of the following criteria must be met: * subject is informed and given approved written informed consent form (icf). * subject is considered reliable and capable of adhering to the protocol. * subject must have a diagnosis of adult-onset moderate-to-severe ra of at least 6 months' duration as defined by acr/eular 2010 classification criteria. * subject must have: * ≥6 tender joints (out of 68) * ≥6 swollen joints (out of 66) * crp≥10.0mg/l . * subject must have had inadequate response to at least 1 synthetic dmard. * subject is at least 18 years and less than 70 years of age at visit 1 (screening). * female subjects must either be: * postmenopausal * permanently sterilized or, * if of childbearing potential, must be willing to use at least 2 effective methods of contraception, * male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug. exclusion criteria subjects are not permitted to enroll in the study if any of the following criteria is met: * subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (imp) under investigation in this study (ucb4940 and/or czp). * subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens. * subjects with known tuberculosis (tb) infection, at high risk of acquiring tb infection, or latent tb infection are excluded. * subject is at high risk of infection. * subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at week 0. * subject has renal or liver impairment. * subject has a current or past history of gastrointestinal ulceration. * subject has active neoplastic disease or history of neoplastic disease. * subject has a concomitant diagnosis of any other inflammatory condition. * subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.
neprilysin inhibition to reduce myocardial fibrosis in heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction; Myocardial Fibrosis

Summary: cardiac magnetic resonance imaging (mri) measures of myocardial interstitial fibrosis (mif) are elevated in heart failure with preserved ejection fraction (hfpef) patients and associated with poor prognosis. extracellular volume (ecv) is the most reproducible and best validated cardiac mri measure of mif. sacubitril/valsartan reduces histological mif in mice and levels of some extracellular matrix regulatory proteins in humans with hfpef. however, the effect of sacubitril/valsartan on robust measures of mif in humans is unknown. demonstrating reductions in ecv with sacubitril/valsartan would clarify the mechanism of this approved medication. given the borderline reduction in heart failure hospitalizations with sacubitril/valsartan and the heterogeneity of hfpef pathophysiology, this result would suggest that neprilysin inhibition may particularly benefit hfpef patients with greater mif. the investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition (sacubitril/valsartan vs valsartan alone) on cardiac mri measures of fibrosis (principally ecv) and circulating protein levels.


Eligibility criteria:
inclusion criteria: * adults aged 50 years or older * able to provide informed consent, as assessed by a physician investigator, and willing to comply with the study * clinically confirmed diagnosis of heart failure * left ventricular ejection fraction greater than or equal to 45% within 1 year by echocardiogram, cardiac mri, or nuclear scan exclusion criteria: * contraindication to mri (metal prosthesis, implantable cardiac device, or severe claustrophobia) * systolic blood pressure \< 100mm hg, or \<110 mm hg for patients not taking an ace inhibitor or angiotensin receptor blocker * symptomatic hypotension * egfr \< 30 ml/min/1.73m2 within 60 days of enrollment * serum potassium \>5.2mmol/l within 60 days of enrollment, or \>5.0 mmol/l for patients not taking an ace inhibitor or angiotensin receptor blocker * myocardial infarction within 6 months of enrollment * infiltrative or hypertrophic cardiomyopathy * history of cirrhosis, biliary cirrhosis, or cholestasis * history of angioedema * pregnancy, planning pregnancy, or breastfeeding * active treatment with lithium or a direct renin inhibitor