Kornimate/medical-research-clean huggingface dataset:
a study of nivolumab in relapsed/refractory primary central nervous system lymphoma (pcnsl) and relapsed/refractory primary testicular lymphoma (ptl)

Conditions: Lymphoma

Summary: the purpose of this study is to determine whether nivolumab is effective in the treatment of relapsed/refractory primary central nervous system lymphoma (pcnsl) and relapsed/refractory primary testicular lymphoma (ptl)


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * pathologically confirmed pcnsl or ptl who failed or did not respond to at least 1 line of systemic therapy * measurable disease requirements on scans: pcnsl subjects should have at least one measurable extranodal brain lesion; ptl subjects should have at least 1 measurable extranodal lesion or nodal lesion * have tumor tissue for pd-l1 expression testing * must have a karnofsky performance status of 70-100 exclusion criteria: * a) intraocular pcnsl without evidence of brain disease b) pcnsl patients who cannot undergo mri assessments c) pcnsl patients with systemic disease * patients with certain diseases such as active autoimmune disease, type i diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder * prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways pcnsl, and ptl subjects with brain or spinal cord lesion who have received doses of more than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first dose of nivolumab are excluded other protocol defined inclusion/exclusion criteria could apply
effects of a new botanical extracts combination on quality of life in menopausal spanish women

Conditions: Menopause; Dietary Supplements; Quality of Life

Summary: this study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on health-related quality of life in healthy spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported and validated cervantes scale.

fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from april 2018 to april 2019 in the context of a prospective, placebo-controlled, double-blind study. women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. at the beginning and end of the study, health-related quality of life was assessed using the cervantes scale.

Eligibility criteria:
inclusion criteria: * women in the climacteric phase under medical criteria based on health questionnaire, blood and urine test. * informed consent to participate in the study. exclusion criteria: * hormone-related pathologies. * menopause from surgery origin. * family or personal history of endocrine cancer. * known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise. * vegetarian diet or daily consumption of soya rich-products during the last year. * anovulatory treatment. * hormone replacement treatment.

Keywords: menopause hot flushes isoflavones aframomum melegueta extract punica granatum extract cervantes scale
systematic treatment after successful surgical treatment for primary hyperparathyroidism with strontium ranelate

Conditions: Primary Hyperparathyroidism; Osteopenia; Osteoporosis

Summary: patients with primary hyperparathyroidism (phpt) with osteopenia and osteoporosis are treated with strontium ranelate/ca+vitamin-d or placebo/ca+vitamin d after successful surgical treatment of phpt. strontium ranelate/ca + vitamin-d helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for phpt and results in higher gain of bmd than placebo treated patients.

the chronic excessive hypersecretion of parathyroid hormone (pth) has significant impact on bone remodeling. in primary hyperparathyroidism (phpt) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density. after successful surgical treatment of phpt bone metabolism switches from catabolic state to anabolic state again. however studies show that especially postmenopausal women regain significantly less bmd but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. the optimal state would be to reach normal bmd again. although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. the only drug combining these qualities known so far is strontium ranelate. therefore the hypothesis is that strontium ranelate/ca + vitamin-d helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for phpt and results in higher gain of bmd than placebo treated patients.

Eligibility criteria:
inclusion criteria: * biochemically proven phpt, ptx planned * osteopenia (t-score \ -2.5) or osteoporosis (t-score ≤ -2.5) according to who criteria \[27\] exclusion criteria: * premenopausal women * cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma \>1cm) * persisting or recurrent phpt (postoperative hypercalcemia) * four-gland hyperplasia * multiple endocrine neoplasia (men) or hereditary phpt * familial hypocalciuric hypercalcaemia (ca/creatinine ratio \< 0.01) * anamnestic pulmonal embolism or deep venous thrombosis * blood coagulation disorder or coagulopathy * phenylketonuria * renal impairment (creatinine clearance \<30ml/h) * severe hepatic disorder * severe systemic disorder * thyroid dysfunction * immobilisation * intake of drugs with potential effects on bmd like glucocorticoids, lithium, estrogen-replacement therapy, selective estrogen-receptor modulators (serms), bisphosphonates in the last three months * known allergy against any component of the study medication

Keywords: primary hyperparathyroidism osteopenia osteoporosis
efficacy of combined low- and high- frequency stimulation in peripheral muscle function during hemodialysis

Conditions: Chronic Kidney Diseases

Summary: chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. objective: assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. methods: a randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (lf) ; high frequency (hf); low and high frequency (lhf); and sham electrical stimulation. the groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. in the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. the individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.

patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the informed consent term. on the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, medical research council (mrc) and biochemical markers. on the second day, anthropometry, body composition and functional capacity will be performed. on the third day, the muscular function will be assessed by isokinetic evaluation. after completing the evaluations, patients will be allocated into four groups: low frequency (lf), high frequency (hf), low and high frequency (lhf), and sham.

Eligibility criteria:
inclusion criteria: * chronic kidney disease * classical hemodialysis * over 18 years old * no pace maker * without cognitive or motor deficit * no regular physical activity in the last six months exclusion criteria: * abstention for more than two consecutive sessions or four in total * inability to perform the tests

Keywords: chronic kidney disease electrical stimulation
shift hospital in motion (pilot study)

Conditions: Hospitalized Patients; Physical Inactivity

Summary: the goal of this monocentric observational study involving acute hospitalised patients is to develop a classification algorithm for the detection of various movements parameters.

patients in hospitals spend the majority of their time inactive, sitting or lying down. not being active is a common problem for patients in hospitals, often causing complications and impairing recovery, as it can lead to issues such as reduced blood volume, unsteady blood pressure when standing, weaker muscles, and a higher risk of infections, blood clots, and other health issues. the inactivity-related changes in the body in combination with the natural ageing process, the stress of being in the hospital, a poor nutritional status, and possibly troubles with thinking, memory, and understanding or depression diminish the ability to regenerate with overall compromised physiological resilience. in order to quantify the amount of physical activity of hospitalised patients, the ability of activity sensors to distinguish between lying, sitting, standing and walking is an important requirement. the primary objective of this observational, single center study is to develop an algorithm for the detection of various movements parameters. therefore, enrolled patients, wearing a sensor on either ankle, wrist, or upper thigh, perform a fixed set of movements to generate acceleration and movement data. the secondary objective is the evaluation of the best suited position of wearing the sensor. the results of this pilot study will provide information about the feasibility and effectiveness of using activity sensors in clinical settings and will advance healthcare by developing an algorithm that accurately determines the activity patterns of hospitalized patients, thereby enhancing monitoring and understanding of patient mobility in hospital settings.

Eligibility criteria:
inclusion criteria: * patient must have been able to walk before hospitalisation (with or without aids) * patient must be cognitively able to follow instructions (if a cognitive assessment has been carried out, this cut-off value counts, if no assessment is available, no cognitive impairment is assumed) * ≥ 18 years * signed informed consent exclusion criteria: * patient unable to move prior to hospital admission * prior inclusion in the study * discharge on the same day * inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), speech problems, mental disorders, or cognitive impairments isolated patient (unable to complete the test battery completely)

Keywords: movement detection activity sensors sensor positioning algorithm development
evaluation of d-chiro-inositol treatment in women with endometriosis

Conditions: Endometriosis

Summary: to date, the treatment for endometriosis is represented by the surgical removal of the lesions. nonetheless, in the years following surgery, the lesions can recur, often due to excessive estrogen production. to balance estrogen, progestin- or estrogen-progestin-based medications are generally prescribed. on the other hand, progestins and estrogen-progestins act as contraceptives, preventing the onset of a pregnancy. at the same time, these can have side effects that can affect up to 30% of patients. for these and other reasons, some women refuse therapy with progestins or estrogen-progestins, preferring to resort to no treatment. considering the need to research effective molecules in the prevention of relapses that can maintain fertility and avoid unwanted effects, the research focuses on natural molecules, well tolerated by the body. d-chiro-inositol (dci) is a polyol normally present in human cell membranes, where, from a metabolic point of view, it acts as a second messenger of insulin, while from a hormonal point of view, it exerts an on the biosynthesis of androgens. this effect on steroidogenesis can be attributed to more than one mechanism. in the ovary, dci stimulates direct testosterone production. furthermore, it stimulates the accumulation of testosterone by reducing the activity of the aromatase enzyme, responsible for the conversion of androgens into estrogens. considering the responsiveness of endometriosis to estrogens, and that these constitute a risk factor for recurrences following surgical removal, the use of dci could be interesting from a clinical point of view. the study plans to verify whether d-chiro-inositol dietary supplementation can be effective in reducing systemic estrogen levels in women with endometriosis, thus also reducing the risk of relapses and associated symptoms.


Eligibility criteria:
inclusion criteria: * women affected by endometriosis (regardless of the stage) exclusion criteria: * treatment with hormones in the previous three months or during the study * treatment with inositol and/or other insulin-sensitizers in the previous three months * obesity * diabetes * cancer (any site/stage)

Keywords: d-chiro-inositol endometriosis
oral and systemic levels of tff-1 and ttf-3 in periodontal diseases

Conditions: Periodontal Diseases

Summary: trefoil factor family (tff) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. interleukin (il)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. this study aimed to investigate the levels of tff-1, tff-3 and il-1β in gingival crevicular fluid (gcf), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.

a total of one hundred participants were enrolled for the study. all individuals were assessed clinically and radiographically. full-mouth clinical periodontal examinations were performed by the measurements of probing depth (pd), clinical attachment level (cal), gingival index (gi), plaque index (pi) and bleeding on probing (bop). all these measurements were recorded at six sites around each tooth with a manual periodontal probe. the participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. tff-1, tff-3 and il-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.

Eligibility criteria:
inclusion criteria: * systemically healthy individuals * no history of smoking * individuals between the ages of 25-50 years * having at least 20 natural teeth exclusion criteria: * any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer) * a history of smoking * pregnancy or lactation * a history of surgical/non-surgical periodontal therapy in the past 1 year * drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 6 months
overnight and in-house 3d-printed patient-specific casts for non-operative treatment of distal radius fractures

Conditions: Radius Fracture Distal

Summary: the aim of this prospective randomized trial is the acquisition and evaluation of data to assess the relevance, feasibility and safety of forearm casts based on 3d-printing technology in the nonoperative treatment of distal radius fractures.

the study design is planned according to similar studies investigating the treatment of distal radius fractures. upon the patient's arrival at the emergency unit, the distal radius fracture is examined following the same scheme as before. the wrist is x-rayed in two planes. if there is a distal radius fracture and none of the exclusion criteria apply, the patient is included in the study after giving their consent in writing. the patients are then assigned to the "conventional cast" group (group a) or the "3d print cast" group (group b) in randomized trial, either immediately during the emergency consultation or within a week during hand surgery consultation hours. for initial immobilization, a thermoplastic cast splint is used as before. depending on the randomization, the cast is changed to a scotchcast cast (group a) or a 3d printed cast (group b). further treatment of both groups occurs based on the same algorithm as before (see below). the cast for group b are produced using 3d print technology based on software by a belgian company, our collaborators: the patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment. the patients are examined after 1, 6, 12, 26 and 52 weeks in the outpatient clinic. follow up x rays, patient satisfaction and clinical efficacy questionnaires and clinical examinations are conducted.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * undisplaced or minimally displace distal radius fractures exclusion criteria: 1. age \< 18yrs. 2. dorsal dislocation (dp angle) \>20° 3. palmar dislocation 4. ad latus dislocation 5. radio-/ulnar angulation in the coronary plane 6. symptoms of neurologic affection (median nerve) 7. bilateral fractures 8. previous ipsilateral distal radius fracture 9. the patient is unable to give informed consent due to physical or mental impairment 10. the patient is unavailable for follow-up examinations (foreign country, polytrauma, etc) 11. the patient is under legal custodianship 12. c2- or drug-abuse or expected incompliance 13. hypersensitivity/allergy to one or more components of the used casts 14. pregnancy/intention to become pregnant during the course of the study

Keywords: distal radius fracture, 3d-printing
eslicarbazepine acetate as add-on treatment to one baseline antiepileptic drug (esladoba)

Conditions: Epilepsy

Summary: this is a multicenter, non-interventional, prospective study. the observation period comprises at least 6 months, from the initiation of esl add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one aed, until the first visit that occurs between 6 and 9 months of follow-up. the observation period will end after 9 months of follow-up even if the final assessment is not performed.

to ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive esl has to be made before and independently of his/her decision to include the patient in the study. at all circumstances during the study the patients will be treated and followed according to routine clinical practice. esl and concomitant medication should be managed by the neurologist according to the respective summary of product characteristics (spc).in order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.

Eligibility criteria:
inclusion criteria: * male or female outpatient, 18 years or older; * the patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive esl; * the patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive esl; * the neurologist's decision to prescribe esl has been made before and independently of his/her decision to include the patient in this study; * the patient's treatment is in accordance with the spc of esl; * written informed consent from the patient (or legally acceptable representative, if the subject is unable to provide informed consent). exclusion criteria: * known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients; * patient with 2nd or 3rd degree atrioventricular block; * patient treated with an experimental drug within four weeks prior to the introduction of esl; * female patient who is pregnant, lactating, or who is planning to become pregnant during the study period; * patient starting esl outside the approved spc at enrolment.

Keywords: partial-onset seizures eslicarbazepine acetate esl bia 2-093 bial
long-term safety and efficacy of empagliflozin as add on to glp-1 ra

Conditions: Diabetes Mellitus, Type 2

Summary: this is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to glp-1 ra in japanese patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * male and female patients on diet and exercise regimen who are pre-treated with liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be \>=7.0% and \<=10.0% at screening * male and female patients on diet and exercise regimen who are pre-treated with liraglutide at 0.9 mg/day and one of oral antidiabetic drug (oad) for at least 10 weeks prior to visit 1 must be \>=7.0% and \ =7.0% and \<=10.0% at placebo run-in * male and female patients on diet and exercise regimen who are pre-treated with oad alone for at least 10 weeks prior to visit 1 must be \>=7.0% and \<=10.0% at both screening and placebo run-in * age at informed consent must be \>=20 years * bmi at screening must be \<=40 kg/m2 * further inclusion criteria apply exclusion criteria: * uncontrolled hyperglycaemia with a glucose values \>270 mg/dl (\>15.0 mmol/l) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement * patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (sglt-2) inhibitor within 10 weeks prior to informed consent. * acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent * indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period * impaired renal function, defined as estimated glomerular filtration rate (egfr) \<45 ml/min/1.73m2 (japanese equation) as determined during screening and/or switch/washout/placebo run-in period * further exclusion criteria apply