Kornimate/medical-research-clean huggingface dataset:
drug use-results survey of betanis tablets in japan

Conditions: Overactive Bladder

Summary: this study is to determine the following information. 1. the occurrence of adverse drug reactions in clinical settings. 2. factors potentially impacting safety, effectiveness, and other aspects.

this survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using betanis (generic name: mirabegron): 1. the occurrence of adverse drug reactions in clinical settings. 2. factors potentially impacting safety, effectiveness, and other aspects. items of particular interest: * safety and effectiveness in patients with hepatic impairment and patients with renal impairment. * safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent cyp3a4-inhibiting effect, drugs with a cyp3a4-inducing effect, drugs metabolized primarily by cyp2d6, and other frequently used drugs). * the occurrence of cardiovascular adverse events. * the occurrence of adverse events related to increased intraocular pressure. * the occurrence of urinary retention

Eligibility criteria:
inclusion criteria: * patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Keywords: overactive bladder mirabegron occurrence of adverse events overactive bladder symptom score
efficacy study for development and use of neurofeedback-trainings for patients suffering from chronic tinnitus

Conditions: Tinnitus, Subjective

Summary: chronic tinnitus affects about 10-15% of the population in industrialized countries. investigations of the brain activity by using electroencephalography (eeg) showed that in localized regions of the hearing system brain activity was decreased. this reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. by using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. the purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. in order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. before and up to 6 month after the training eeg-recordings are performed.


Eligibility criteria:
inclusion criteria: * age 18-75 * chronic tinnitus \> 0.5 years * informed consent * fluent in german language exclusion criteria: * psychological and neurological disorders other than tinnitus * drug- or alcohol abuse * tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake * impairing hearing loss or cochlea implant

Keywords: adult aged alpha rhythm auditory cortex chronic electroencephalography female humans male neurofeedback prospective studies questionnaires tinnitus treatment outcome
resistance mechanisms and sequential treatment strategies following first-line lorlatinib in alk-positive nsclc

Conditions: ALK-Positive NSCLC

Summary: this is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in china, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with alk-positive locally advanced or metastatic nsclc, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.


Eligibility criteria:
inclusion criteria 1. age: patients aged 18 years or older; 2. histologically or cytologically confirmed locally advanced or metastatic nsclc 3. documened alk resrrangemen by approved test (eg.. fish,ihc. .r ngs). 4. first-line loelaninab treatment fom apr2023-apr-2027. 5. evidenoe of popression to first-line lorlztinib within 2 weekes. exclusion criteria 1. previous treatment with other alk-tkis: patients who have previously received any alk tki other than lorlatinib; 2. concomitant medications: patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.
patient reported experience in endoscopic ultrasound

Conditions: Pancreatic Diseases; Bile Duct Diseases

Summary: the evaluation of the patient's experience is becoming increasingly important as a better patient experience can improve the quality of the delivered health service. patient-reported experience measures (prems) are self-reported assessment tools provided by patients about their experience during any health event. there are few prems's instruments in the field of gastrointestinal endoscopy, and none is specific for endoscopic ultrasound (eus). the aim of this study is to develop a questionnaire to evaluate the experience of patients undergoing eus, identifying and prioritizing the factors related to the patient's experience. in order of it, expected results are developing a valid tool of question to value patients experience during eus and, for ranking, it is iphotized that will be more correlation with patients's and nurses's answer that clinicians's one. in literature is described that nurse's view and patient's view are more similar especially in those aspects concerning empatics and psychological aspects.

the study will consist of several phases: 1) tool creation: a "patient reported measure of eus" (preus) questionnaire will be created based on literature review; 2) face and content validity: the preus tool will be submitted to 7 experts in the field (physicians, nurses, psychologist, communication expert, patients' advocacy representative) for a two-round evaluation and to "expert" patients who had already undergone eus at least once. content validity index (cvi) will be calculated and questions with a cvi \< 0.70 will be excluded; 3) questionnaire creation: based on the results of phase 2, a modified "preus" tool will be then evaluated by ranking the relevance of the identified questions in the previous phase (from 0 to 10) by 50 outpatients undergoing eus and cronbach's alpha will be calculated to determine reliability; 4) ranking: tool of phase 3 will be also evaluated by 6 physicians and 13 nurses working in irccs ospedale san raffaele endoscopy unit to measure the agreement between patients and health care professionals (hcps) by the spearman-brown coefficients.

Eligibility criteria:
inclusion criteria: * age \> 18 years; * outpatients undergoing eus in i.r.c.c.s. san raffaele hospital (milan, lombardy, italy); * written informed consent signed exclusion criteria: -

Keywords: patient reported experience measures endoscopic ultrasonography pancreatic questionnaire
three-year clinical evaluation of class ii posterior composite restorations

Conditions: Dental Caries

Summary: the aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated class ii cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.

forty-seven pairs class ii (mesio-occlusal or disto-occlusal) composite restorations were placed in 37 patients. in all cavities, adper single bond 2 was used. in one of the cavities of each pair, a conventional flowable composite, aelite flo, was applied in approximately 2mm thick, and the remaining cavity was restored incrementally with grandioso. in the second cavity, a bulk-fill flowable composite, x-tra base, was applied in approximately 4 mm thick in bulk increments and the remaining 2mm occlusal part of the cavity was restored with grandioso. all cavities were restored with open-sandwich technique by the same operator. at baseline and after 6-month, 1-, 2- and 3-year follow-up visits, restorations were evaluated by modified usphs criteria.

Eligibility criteria:
inclusion criteria: * permanent premolars and molars without any restorations were included in the study. every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth. exclusion criteria: * patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.

Keywords: composite resin bulk-fill teeth endodontically-treated
physiotherapy, nutritional supplement and anabolic steroids in rehabilitation of patients with hip fracture.

Conditions: Hip Fractures

Summary: this pilot trial investigates the preliminary effect and safety of a 12 week multi-modal intervention initiated during admission in the acute ward after hip fracture surgery. the intervention under investigation is a combination therapy consisting of physiotherapy, protein-rich nutritional supplement and nandrolone decanoate (deca-durabolin) supplement. the investigators expect the combination therapy to be a preliminary effective and safe treatment in elderly patients with hip fracture and that this combination therapy intervention program is more efficacious in improving muscle strength, and physical function 14 weeks after hip fracture surgery, compared to physiotherapy, protein-rich nutritional supplement plus placebo.


Eligibility criteria:
inclusion criteria: * patients who have undergone surgery for a hip fracture at amager-hvidovre university hospital and admitted at the hip fracture unit at the hospital * age \>=60 years * ability to speak and understand danish and with a danish social security number * able to give written informed consent * residing at home and with an independent pre-fracture indoor walking ability (nms≥2) exclusion criteria: * postoperative weight-bearing restrictions * multiple fractures * active cancer or suspected pathological fracture * patients unable/unwilling to cooperate to testing and rehabilitation * planned/elective hospitalization within the trial period. * cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (disoriented, dementia, active delirium) * uncontrolled blood pressure (systolic \> 150 mmhg, or diastolic \> 100 mmhg) * heart disease in the form of peri-, myo- or endocarditis. * history of stroke with motor disability. * heart failure (nyha class iii and iv) * evidence of kidney failure or renal impairment (estimated glomerular filtration rate \ 200μmol/l) * abnormal liver function tests (alanine aminotransferase, γ-glutamyltransferase, bilirubin, or alkaline phosphatase \>2 times the upper limit of normal) or history of hepatic tumor. * elevated hematocrit ≥ 50% * history of breast or prostate cancer * abnormally elevated serum psa assesed at the 3 week control corresponding to psa \ 70 years). * allergic to any ingredient in the deca-durabolin solution (nandrolone, benzyl alcohol, arachis oil (peanut-oil) and allergy to peanuts or soya) or milk protein allergy (related to the nutritional drink).

Keywords: rehabilitation physiotherapy strength training anabolic steroids nutritional supplement
comparison of nn5401 with insulin glargine, both in combination with oral antidiabetic drugs, in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe and the united states of america (usa). the aim of this clinical trial is to compare nn5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (oads). subjects continued their ongoing treatment with oads in the trial.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine hagedorn \[nph\] insulin) once daily (od), for at least 3 months * ongoing treatment with: metformin with or without other oral antidiabetic drugs (oads) for at least 3 months prior to randomisation * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis * bmi maximum 40.0 kg/m\^2 exclusion criteria: * treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or nph insulin) od within 3 months prior to visit 1 * treatment with glucagon-like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1 * current rosiglitazone users * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * impaired liver function, defined as alanine aminotransferase (alat) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
evaluation of the crestal bone expansion obtained with the magnetic mallet® during the preparation of the implant site

Conditions: Edentulous Alveolar Ridge

Summary: the purpose of the study is to evaluate the use of a magnetodynamic instrument (magnetic mallet®, metaergonomica, turbigo, italy) to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.

from october 2019 to may 2022, a sample of 15 patients, 11 men and 4 women, age between 39 and 78 years, was analyzed. a total of 18 conical-shaped implants with a diameter of 3.80 mm and a length between 10 and 11.5 mm were inserted in the maxillary region in the area between the lateral incisor and the first upper molar. the patients were treated by two different surgeons.

Eligibility criteria:
inclusion criteria: * patients with maxillary mono-edentulism between the lateral incisor and the first upper molar with a bone crest measuring between 4-6 mm; * insertion of conical implants with dimensions 3.80 x \> 10 mm; * correct occlusal relationships between upper and lower jaw; * patients willing to cooperate and follow the instructions given by the clinicians. exclusion criteria: * smokers \> 15 cigarettes per day; * patients with systemic diseases; * irradiation to the head/neck region within 12 months prior to surgery; * pregnancy or breastfeeding; * poor oral hygiene and lack of motivation to return for checkups; * edentulous area for less than 1 year; * edentulousness of the lower jaw.
biomarkers of remission in rheumatoid arthritis (biorra)

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis is a common condition affecting approximately 1% of the united kingdom population; it is an autoimmune disease where the body's natural defences (the immune system) attack the body itself resulting, most notably, in joint damage and arthritis. to help prevent this, patients with rheumatoid arthritis need to take disease-modifying anti-rheumatic drugs (dmards). as rheumatoid arthritis is a life-long condition, these drug treatments are prescribed as long-term medications taken for many years. with successful drug treatment, many patients are able to achieve an excellent control of their disease and their arthritis can go in to remission. at present, there are no markers which can reliably predict which of these patients can reduce their drug treatment, and hence benefit from a lower risk of side effects and inconvenience, without an increase in their arthritis activity. we invite patients with stable rheumatoid arthritis to participate in this study conducted by newcastle upon tyne hospitals nhs foundation trust in collaboration with newcastle university and funded by the wellcome trust. patients whose arthritis is confirmed as being in remission will be able to stop their dmard medication and be monitored for a period of 6 months. patients whose arthritis activity increases during this time will be able to restart their dmard medication, whereas those patients whose arthritis remains in remission will be able to stay off dmard medication. the main aim of this study is to identify clinical, ultrasound and blood markers that can predict which patients will remain in remission after stopping dmard medication. if identified, these markers could be a useful guide to doctors and patients in the future when deciding whether to stop dmard therapy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis made by consultant rheumatologist at least 12 months previously * current single or combination use of methotrexate, sulphasalazine and/or hydroxychloroquine * arthritis currently in remission, as judged clinically by referring healthcare professional * willing to consider dmard withdrawal exclusion criteria: * use of biologic therapy within the past 6 months * received steroids within past 3 months (enteral, parenteral or intra-articular) * use of any dmard other than methotrexate, sulphasalazine or hydroxychloroquine within the past 6 months (or past 12 months for leflunomide) * current pregnancy, or pregnancy planned within next 6 months * current participation within another clinical trial * inability to provide informed consent

Keywords: rheumatoid arthritis biological markers remission ultrasonography microarray survival analysis t cell
safety, reactogenicity, and immunogenicity study of a self-amplifying mrna influenza vaccine in healthy adults

Conditions: Influenza, Human

Summary: this is a phase 1, first-in-human, randomized, placebo-controlled, observer blind study. the effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo. the study has a screening period (day -28 to day -1), a treatment period (day 1 to day 43) and a follow-up period (day 44 to day 202).


Eligibility criteria:
inclusion criteria: 1. individuals 18 to 49 years of age or 65 to 85 years of age, inclusive on the day of informed consent. 2. individuals with body mass index (bmi) between 18 and 32 kg/m2, inclusive, at screening . 3. individuals who can comply with study procedures including follow-up . exclusion criteria: 1. female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study. 2. male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner. 3. progressive, unstable, or uncontrolled clinical conditions 4. known hypersensitivity or allergy to any study vaccine component 5. known history of guillain-barré syndrome or other demyelinating disease 6. condition representing a contraindication to vaccination or blood draw 7. abnormal function of immune system due to clinical condition, medications, or radiotherapy. 8. receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mrna-platform vaccine within different timeframes; previous or from study vaccination. 9. baseline abnormal clinically significant ecg, laboratory safety parameters or vital signs. 10. plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.

Keywords: influenza vaccine mrna
tai chi/qigong for subsyndromal depression and cognition in older age bipolar disorder

Conditions: Bipolar Disorder

Summary: it is expected that by 2030, the percentage of patients with bipolar disorder (bd) in canada over 60 years of age will exceed 50%. in this population, poor cognition and persistent sub-threshold depressive symptoms are particularly common, difficult to treat, associated with increased mood episodes, and poor daily functioning. mind-body interventions have increasingly been found to be effective in treating several psychiatric condition including bd. a few pilot studies examining mindfulness-based intervention in younger adult bd have been promising for depressive symptoms, but some pilot research suggest that patients with older age bipolar disorder (oabd) may benefit more from moving mindfulness. the investigators will conduct a 12-week randomized controlled trial to assess whether tai-chi/qigong will be associated with 1) greater reduction in depressive symptoms, and 2) greater improved cognition, in comparison to a light exercise active control condition, 12- and 24-weeks from baseline, in bd patients aged 40+.


Eligibility criteria:
inclusion criteria: * aged greater than or equal to 40 years * history of diagnosis of bipolar i or ii disorder * access to a computer with a functioning camera, microphone, and ability to run zoom software * english or french speaking * ability to give informed consent exclusion criteria: * young mania rating scale score \> 5 * current clinician diagnosis of substance abuse, unless currently in complete remission * risk of suicide as assessed by a score above 3 on item 10 of montgomery asberg depression rating scale * participation or plan to participate in any other concurrent psychosocial group program during course of study * unstable psychiatric medication (less than 4-weeks since commencement)

Keywords: mindfulness older age bipolar disorder tai chi qigong randomized controlled trial