Kornimate/medical-research-clean huggingface dataset:
long term study of fingolimod in ms patients from the fty clinical program

Conditions: Multiple Sclerosis

Summary: the purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.


Eligibility criteria:
inclusion criteria: * patients who are prescribed fingolimod as part of their routine medical care * patients who have participated in a prior fingolimod clinical trials exclusion criteria: * restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label * any patient who has prematurely discontinued from the previous fingolimod trial other protocol-defined inclusion/exclusion criteria may apply

Keywords: fingolimod fty720 relapsing forms of multiple sclerosis multiple sclerosis ms safety efficacy
results of progressive resistance training in older type 2 diabetic patients with sarcopenia

Conditions: Sarcopenia; Diabetes

Summary: a randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. the intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks.

sarcopenia, prevalent among geriatric populations, involves the progressive loss of muscle mass and decline in muscular function. this age-related condition is associated with higher susceptibility to falls, comorbidities, and mortality. resistance training emerges as a non-pharmacological intervention proven to alleviate and potentially delay the progression of sarcopenia. however, there are still few studies investigating its effects on outcomes in older patients with diabetes mellitus.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients diagnosed using american diabetes association 2022 criteria * hba1c ≥ 7.0 and ≤ 8.5% * sarcopenia diagnosed using criteria from the asian working group for sarcopenia 2019 * age ≥ 60 and ≤ 80 exclusion criteria: * acute diabetic complications * patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis. * patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders. * patients have been bedridden due to illness for more than 1 month within the past 3 months up to the recruitment time. * patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160/100 mmhg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy. * renal failure with estimated glomerular function rate (modification of diet in renal disease equation) \< 60 ml/min/m3 or serum creatinine ≥ 130 µmol/l * on treatment with sodium-glucose cotransporter 2 inhibitors (sglt2i)

Keywords: sarcopenia diabetes resistance training
a 24 month phase 2a open label, randomized study of avastin®, lucentis®, or eylea® (anti-vegf therapy) administered in combination with fovista® (anti-pdgf bb pegylated aptamer)

Conditions: Age-Related Macular Degeneration

Summary: to evaluate the safety of intravitreal (ivt) fovista® administered in combination with anti-vegf therapy.

60 subjects randomized 1:1:1 and treated with ivt fovista® 1.5 mg/eye in combination with anti-vegf therapy as follows: * avastin® 1.25 mg/eye (20 subjects) * lucentis® 0.5 mg/eye (20 subjects) * eylea® 2.0 mg/eye (20 subjects) subjects will be stratified by lesion size (≤2 da vs. \>2 da). subjects will be treated with "combination therapy" of ivt fovista® and ivt anti-vegf therapy every month for the first 5 months (day 1, months 1,2,3,4), followed by q12w (every 12 weeks) administration (months 7,10, 13,16, 19 and 22), for a total of 24 months. when administered, ivt fovista® will be given first, followed by ivt anti-vegf (same day).

Eligibility criteria:
inclusion criteria: * subjects of either gender aged ≥ 50 years. * active subfoveal choroidal neovascularization (cnv) due to amd. exclusion criteria: * any intraocular surgery or thermal laser within three (3) months of trial entry. any prior thermal laser in the macular region, regardless of indication. * subjects with subfoveal scar or subfoveal atrophy * any ocular or periocular infection in the past twelve (12) weeks. * history of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Keywords: wet amd subfoveal choroidal neovascularization fovista® avastin® lucentis® eylea®
quality control of ce-certified phonak hearing aids - 2017_13

Conditions: Hearing Loss, Bilateral Sensorineural, Progressive

Summary: a methodical evaluation of new ce-labelled phonak hearing systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. the aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding phonak hearing systems.

phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). this will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * central hearing disorders
pemf in the treatment of fresh distal radius fractures

Conditions: Distal Radius Fracture

Summary: distal radial fractures (drf) are the most common fractures encountered in health care. annualized estimates in the united states alone suggest an incidence of approximately 640,000 cases, and rising, per year. most fractures may be treated in a plaster cast, but unstable fractures tend to displace without a surgical procedure. 1 pulsed electromagnetic field (pemf) is one modality commonly used to stimulate bone generation throughout various clinical settings including orthoapedic surgery. pemf has been shown to primarily effect vascular generation, formation and neovascularization2,3. this may help decrease time to healing and allow patients to return to normal activities sooner. additional study demonstrated that pemf exposure increased cell proliferation, adhesion and the osteogenic commitment of mscs, even in inflammatory conditions. in this in-vitro model pemfs increased the expression of anti-inflammatory cytokines, such as il-10, and reduced the expression of the pro-inflammatory cytokine il-1 4. the distal radius fracture was chosen as the model to test the effects of pemf treatment because it includes both trabecular and cortical bone, is accessible for radiographs, has little soft tissue that can distort the radiograph, and is amenable to multiple functional endpoints. the purpose of the study is to determine whether the use of fhp by means of pulsed electromagnetic fields in acute distal radius fractures will accelerate healing both clinically and radiotralogically


Eligibility criteria:
inclusion criteria: 1. subjects with closed unilateral dorsally angulated fracture of the distal radius (colles') visible by x-ray. 2. subjects treated conservatively by immobilization ± closed reduction 3. age \>18 years 4. subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. exclusion criteria: 1. subjects with intra articular fracture or extra-articular fracture that meets the criteria for operative fracture fixation. 2. subjects with pins or plates in the wrist 3. sustained previous fractures or bone surgery in the currently fractured distal forearm 4. synovial pseudarthrosis 5. subjects with multiple trauma (several fractures at once) 6. subjects suffering from joint diseases that affect the function of the wrist and/or hand of the injured arm. 7. pregnancy 8. women who are breast-feeding. 9. women of childbearing potential and not using a medically accepted form of contraception when sexually active. 10. presence of a life supporting implanted electronical device
assessment of physical functioning and handling of spiolto respimat in patients with copd (otivacto)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this non interventional study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in copd patients on treatment with spiolto® respimat® in routine daily treatment after approximately 6 weeks. a secondary objective is to evaluate the patient's general condition (physician's evaluation) from visit 1 (baseline visit at the start of the study) to visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with spiolto® respimat® at visit 2.


Eligibility criteria:
inclusion criteria: 1. written informed consent prior to participation 2. female and male patients = 40 years of age 3. patients diagnosed with chronic obstructive pulmonary disease (copd) and requiring long-acting dual bronchodilation (lama + laba) treatment according to approved spiolto® respimat® smpc and copd gold guideline recommendation exclusion criteria: 1. patients with contraindications according to spiolto® respimat® smpc 2. patients who have been treated with a long-acting beta2 adrenoceptor agonist\\long-acting muscarinic antagonist (laba/lama) combination (free and fixed dose) in the previous 6 weeks. 3. patients continuing long-acting beta2 adrenoceptor agonist inhalative corticosteroids (laba-ics) treatment should not be additionally treated with spiolto® respimat® in order to avoid a double dosing of long-acting beta-agonists 4. patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. pregnancy and lactation 6. patients currently listed for lung transplantation 7. current participation in any clinical trial or any other non-interventional study of a drug or device further exclusion criteria apply
evaluation of the diagnostic and prognostic value of immunohistochemical markers in precancerous lesions of the cervix

Conditions: Cervix Cancer

Summary: the study aims to evaluate the expression of certain proteins and their diagnostic and prognostic value in precancerous lesions of the cervix.

cervical cancer is the second most common malignancy in women and the most common gynaecological cancer worldwide. numerous risk factors are associated with the development of cervical cancer; in particular, human papilloma virus (hpv) infection plays a decisive role in the development of the neoplasm. almost all cervical cancers are caused by persistent human papilloma virus (hpv) infections. in particular, squamous cell carcinoma accounts for about 70% of cervical cancers; its precursor is called 'cervical intraepithelial neoplasia' (cin) or 'squamous intraepithelial lesion' (sil) and is classified according to the degree of dysplasia. the 'cin' classification system defines three categories: cin1 (dysplasia limited to the lower third of the epithelium), cin2 (dysplasia extending into the middle third of the epithelium) and cin3 (dysplasia extending into the upper third of the epithelium). more recently, the 'cin' system has been replaced by the 'sil' system, which appears more reproducible and biologically relevant. the 'sil' system reduces the categories from three to two: low grade - sil (l - sil, overlapping cin1) and high grade - sil (h - sil, grouping cin2 and cin3 together). several diagnostic markers have been proposed, such as athanogene 3 associated with bcl - 2 (bag3) and others with prognostic value such as topoisomerase 2a (top2), minichromosome maintenance protein 2 (mcm 2), ki-67, p16ink4, p-53 associated with cervical cancer. however, there is no strong evidence for the association of these markers with precancerous lesions. our study therefore aims to investigate the diagnostic and prognostic value of bcl-associated athanogene 3 - 2 (bag3) in patients diagnosed with cin/sil undergoing colposcopic cervical biopsies or conization. this clinical trial is therefore a tissue-based, diagnostic and prognostic accuracy, retrospective cohort, single-center, non-profit, pilot study and foresees that histological sections obtained at the time of initial diagnosis will be re-evaluated in blinded fashion by two pathologists regarding histological diagnosis, histotype, histological grading, lymphocytic infiltrate. they will then be subjected to immunohistochemistry according to the specific protocol for bag3.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of cin/sil undergoing cervical biopsy/concussion whose tissue sample is archived at the operative unit of pathological anatomy and histology * obtaining written informed consent for the use of biological samples * patients aged 18 years and over exclusion criteria: none

Keywords: cervix cancer gynaecology
effect of physiotherapy in patients presenting to the emergency department with nonspecific lower back pain

Conditions: Lower Back Pain

Summary: physiotherapy is a long established therapy in lower back pain. it is unknown if physiotherapeutic interventions in patients presenting to the emergency department (ed) with nonspecific lower back pain are beneficial. the aim of this study is to assess whether patients presenting to the emergency department with non-specific low risk low back pain would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at time of ed presentation.


Eligibility criteria:
inclusion criteria: * written informed consent * experiencing nonspecific lower back pain * presentation to the emergency department (ed) of the university hospital basel exclusion criteria: * inpatient disposition after ed work-up * "red flags" at time of ed-presentation: 1. major trauma in all patients 2. fractures leading to immobilization 3. severe or progressive sensory alteration or weakness 4. bladder or bowel dysfunction 5. evidence of neurological deficit on physical examination 6. severe chronic disease, such as metastasized cancer, palliative care * epidural steroid injections in the last 3 months * inability or contraindications to undergo the investigated intervention or to follow the study procedures, e.g. due to certain neurological disorders, language problems, psychological disorders, cognitive impairment, physical inability etc. * prior enrolment in this trial

Keywords: physiotherapy intervention oswestry disability index (odi) nonspecific lower back pain
evaluation of prostate specific membrane antigen positron emission tomography-computed tomography in active surveillance for prostate cancer

Conditions: Prostate Cancer

Summary: this study will be assessing the ability of psma-pet ct to determine the absence of clinically significant prostate cancer in patients on active surveillance (as) with low risk and favorable intermediate-risk prostate cancer.

this is a prospective, multicenter, nonrandomized single-arm study assessing the diagnostic accuracy of psma-pet ct (prostate specific membrane antigen positron emission tomography-computed tomography) in determining the absence of clinically significant prostate cancer in patients on active surveillance (as).the trial will enroll 200 subjects for low and favorable intermediate-risk prostate cancer patients per nccn guidelines who have elected to pursue active surveillance.

Eligibility criteria:
inclusion criteria: * males aged ≥ 18. * histologically confirmed low or favorable intermediate risk prostate cancer per nccn guidelines. (note: grade group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma). * psa \< 20 ng/ml. * ability to undergo yearly psma-pet ct. * ability to undergo yearly prostate mpmri. * ability to undergo transrectal or transperineal template and fusion prostate biopsy. * ability to complete hrqol surveys (epic, ipss, iief-5). * willingness to undergo yearly prostate biopsies. exclusion criteria: * history of prior treatment for prostate cancer. * history of systemic therapy for prostate cancer. * inability to undergo transrectal ultrasound. * life expectancy less than 10 years. * not interested in pursuing active surveillance. * initial diagnosis of prostate cancer greater than 15 months.
safety and efficacy of intravenous administration of shed-cm for als

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study evaluates the safety and efficacy of stem cell from human exfoliated deciduous teeth conditioned media (shed-cm) in patients with amyotrophic lateral sclerosis (als), using the japanese version of the revised als functional rating scale (alsfrs-r) as an indicator.

the main objective of this study is to evaluate the safety and efficacy of stem cell from human exfoliated deciduous teeth conditioned media in patients with amyotrophic lateral sclerosis (als), particular focus will be placed on improving neurological function, slowing the rate of symptom progression, and improving the patient's quality of life. what are the advantages of this therapy over standard therapy? and for which patients it is most effective ?

Eligibility criteria:
inclusion criteria: patients who meet the following inclusion criteria (1) to (6) at the time of informed consent 1. patients who have provided written informed consent to participate in the study. 2. patients who are at least 20 years of age at the time of obtaining informed consent. 3. patients diagnosed with isolated or familial als and diagnosed as definite, the probable, or the probable laboratory-supported by updated awaji criteria. 4. patients with severity 1 or 2 on als severity criteria. 5. outpatients. 6. patients residing in japan who can communicate in japanese. exclusion criteria: patients who do not meet any of the exclusion criteria (1) to (15) at the time of informed consent 1. patients with a tracheostomy 2. patients with a history of non-invasive respiratory support 3. patients with a percent fvc of 60 or less 4. patients with chronic obstructive pulmonary disease (copd) 5. patients newly treated with edaravone or riluzole (oral) within 4 weeks prior to informed consent 6. patients receiving hal medical leg type treatment 7. patients receiving intravenous edaravone 8. patients with cognitive impairment 9. pregnant women or patients who may be pregnant 10. patients with serious respiratory, cardiovascular, hepatic, or renal disease 11. patients with malignant tumors 12. patients with uncontrolled infection 13. patients who have participated in other clinical trials within 12 weeks prior to obtaining consent 14. patients with a history of drug allergy or severe allergic disease (e.g., anaphylactic shock) or concomitant history 15. patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.

Keywords: als - amyotrophic lateral sclerosis stem cells conditioned medium therapy safety regenerative medicine
a clinical trial to assess the long term safety and tolerability of mk-0653h in japanese participants with hypercholesterolemia (mk-0653h-833)

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Summary: the study will assess the safety and tolerability of ezetimibe 10 mg+ rosuvastatin 2.5 mg and ezetimibe 10 mg+ rosuvastatin 5.0 mg for up to 52 weeks in japanese participants with hypercholesterolemia uncontrolled with monotherapy of ezetimibe 10 mg or rosuvastatin up to 5 mg.


Eligibility criteria:
inclusion criteria: * japanese * outpatient with hypercholesterolemia * female participant who is of reproductive potential has to agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug * will maintain a stable diet that is consistent with the japan atherosclerosis society guideline 2012 (jas 2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study exclusion criteria: * uncontrolled hypertension (treated or untreated) * uncontrolled type 1 or type 2 diabetes mellitus * homozygous familial hypercholesterolemia or has undergone low-density lipoprotein (ldl) apheresis * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * has had a gastrointestinal tract bypass, or other significant intestinal malabsorption * history of cancer within the past 5 years (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer) * human immunodeficiency virus (hiv) positive * history of drug/alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy * consumes more than 25 g of alcohol per day * currently following an excessive weight reduction diet * currently engages in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study * hypersensitivity or intolerance to ezetimibe or rosuvastatin * myopathy or rhabdomyolysis with ezetimibe or any statin * pregnant or lactating * taking any other investigational drugs and/or has taken any investigational drugs within 30 days