Kornimate/medical-research-clean huggingface dataset:
investigating if interferon-beta can be used in patients with ms after they have developed neutralizing antibodies

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this study is to find out if interferon-beta can recover its effectiveness in patients with multiple sclerosis who have previously developed neutralizing antibodies to interferon-beta.

this is a multi-center, open label, non-comparative phase iv trial. eligible patients will receive treatment with interferon-beta-1a (avonex) 30mcg i.m. once weekly for up to 12 months. in the wash-out period prior to commencing treatment with avonex, patients will receive treatment with intermittent methylprednisolone 500 mg po daily for three consecutive days at monthly intervals. the patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months. neutralizing antibody(nab)titres and binding antibody(bab)titres as well as mxa protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.

Eligibility criteria:
inclusion criteria: * relapsing remitting multiple sclerosis according to poser criteria (cdms or ldms) or multiple sclerosis according to mcdonald criteria * disability equivalent to edss of 6.0 or less * clinical activity defined as at least one relapse rate within the last 12 months * nab titre \>20 (measured at least 48 hours after last interferon-beta injection * has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (rebif) for at least 24 hours before enrollment exclusion criteria: * any condition that might give rise to similar symptoms as ms * immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial * treatment with glucocorticoids or acth less than one month prior to inclusion into the trial * history of major depression * alcohol or drug dependency * cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv) * hypertension (bp \> 180/110 mmhg) * renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit * any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability * gastro-intestinal ulcers, gastritis, or dyspepsia * women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. to avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives

Keywords: multiple sclerosis antibody neutralizing antibody binding antibody mxa protein
three dimensional virtual reconstruction (3d) in percutaneous nephrolithotomy

Conditions: PNL; Stone, Kidney

Summary: the aim of our study is to investigate the effect of 3d imaging technique on the pcnl learning curve in specialist training.


Eligibility criteria:
inclusion criteria: * patients with kidney stones larger than 2 cm and those with pcnl indication. exclusion criteria: * patients with missing ct images, missing clinical information, or inaccessible
the role of surgical approach on residual limping after total hip arthroplasty

Conditions: Hip Osteoarthritis; Muscle Weakness; Muscle Atrophy; Muscle Injury; Arthroplasty Complications

Summary: residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. the purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.

the use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. however lateral approach remains a widespread technik because it provides a decreased risk of dislocation. in litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. in the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. the purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. moreover it will validate ultra sound (u/s), magnetic resonance imaging (mri) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty. 580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (trendelenburg sign) and patient.-reported outcome measures. patients with a positive trendelenburg sign at 3 months will undergo u/s and mri examination as well as gait analysis and reassessed at one year with physical examination. the first 40 patients with negative trendelenburg sign at 3 months will also undergo u/s, mri and gait analysis. the specificity and sensitivity of u/s, mri and gait analysis for positiv trendelenburg sign will be calculated.

Eligibility criteria:
inclusion criteria: * primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty. * ability to understand and write swedish. exclusion criteria: * impaired funktion of the contralateral hip or knees causing limping. * neuromuscular diseases * postoperative leg length discrepancy excceding 1 cm * postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.

Keywords: abductor approach limp trendelenburg gluteus medius
gelatin in icu and sepsis

Conditions: Hypovolemia

Summary: this prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * women of child bearing potential must test negative on standard pregnancy test (urine or serum) * patients with body weight ≤ 140 kg * patients diagnosed severe sepsis / septic shock at admission on intensive care unit who can be enrolled within 90 min after admission or patients diagnosed severe sepsis / septic shock during intensive care unit stay who can be enrolled within 90 min after diagnosis * patients where antibiotic therapy has already been started (prior to randomization) * patient who are fluid responsive. fluid responsiveness is defined as increase of \> 10% in mean arterial pressure (map) after passive leg raising (plr) * signed informed consent by patient, legal representative or authorized person or deferred consent exclusion criteria: * administration of hes, dextrane solutions or \> 500 ml of gelatin solutions within the 24 h prior to randomization * death expected within the next 48 h (moribund patients as defined by asa ≥ class v) * patients for whom the need of pressure infusions are expected * patients with confirmed acute sars-cov-2 (covid-19) infection (as available from routine medical records/ patient chart) * requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration) * patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e. partial thromboplastin time \> 60 sec) * acutely burned patients * contraindications according to summary of product characteristics of investigational test and reference product * simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
flexible gnrh antagonist vs flare up gnrh agonist protocol in poor responders

Conditions: Infertility; Premature Ovarian Failure

Summary: the purpose of this study is to compare ovulation induction using a flexible gnrh antagonist protocol and flare up gnrh agonist protocol in ivf patients with poor response to ovarian stimulation. our hypothesis is that the antagonist protocol provides better ivf outcomes compared to the flare up protocol in this group of patients.

poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an ivf cycle. it seems that a diminished ovarian reserve is the principal factor of poor ovarian response. several strategies have been proposed for the management of poor responders, including flare up gnrh agonist regimens and the gnrh antagonist, which presents a new hope in this group of patients. comparisons: poor responder patients (see inclusion criteria) commencing an ivf treatment cyle will receive ovarian stimulation treatment either using a gnrh antagonist (ganirelix) or flare up agonist (arvekap) protocol. primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

Eligibility criteria:
inclusion criteria: * regular menstrual cycle * 1 or more failed ivf attempts with poor response * 5 or fewer oocytes retrieved * fsh\>12 iu/l on day 3 exclusion criteria: * pcos * normal responders

Keywords: poor responders gnrh antagonist gnrh agonist flare up short protocol
microbiome sampling in gi disease with a focus on small intestinal microbial assessment

Conditions: Healthy; IBS - Irritable Bowel Syndrome; Inflammatory Bowel Diseases

Summary: gi disorders are influenced by the gut microbiome. to date, sampling of the small intestine in gi disorders has been limited. the investigators plan to sample the small intestinal contents during endoscopy for research purposes.

current guidelines (aga clinical practice update, 2020) report the definition of sibo as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine. to date, there is unlimited knowledge regarding the diagnostic criterion which has been limited by nonspecific and nonsensitive testing such as breath tests. breath tests have a limited use in patients with ibs-d who inherently have increased gut transit time rendering the testing invalid for accurately measuring small intestinal bacteria. additionally, the relationship between sibo and symptoms in patients without obvious risk factors (such as anatomical changes due to surgery) is unknown. the investigators study aims to investigate the microbial landscape of the small intestine in healthy patients and those with gi disease (suspected or diagnosed) undergoing an upper endoscopy by collecting an aspirate of patient small intestinal fluid and studying it.

Eligibility criteria:
inclusion criteria: * age \>18years * patients seen at stanford university digestive health center who are scheduled for an upper endoscopy as part of their standard of care exclusion criteria: children (under age 18years) pregnant women and fetuses neonates (0 - 28 days) impaired decision making capacity
study of hypo-fractionated proton radiation for low risk prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma within 365 days prior to randomization. * history/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization. * histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material;gleason score must be in the range of 2-6. \> 6 cores are strongly recommended. * psa values \< 10 ng/ml within 90 days prior to randomization. either done prior to biopsy or at least 21 days after prostate biopsy. * clinical stages t1a-t2a n0 m0 (ajcc criteria 7th ed.). staging must be done by treating investigator. * no pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative. * patients must be at least 18 years old. * ecog performance status 0-1 (appendix i) documented within 90 days prior to randomization. * ipss score \<= 16. * patients must give irb approved, study specific, informed consent. * patients must complete all mandatory tests listed in section 4.0 within the specified time frames. * patients must be able to start treatment within 56 days of randomization. exclusion criteria: * previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery. * previous pelvic radiation for prostate cancer. * androgen deprivation therapy prior to radiation is allowed. however, it is not acceptable if continued during radiation or as adjuvant therapy. * active rectal diverticulitis, crohn's disease affecting the rectum, or ulcerative colitis. * prior systemic chemotherapy for prostate cancer. * history of proximal urethral stricture requiring dilatation. * current and continuing anticoagulation with warfarin sodium (coumadin, heparin, low-molecular weight heparin, clopidogrel bisulfate (plavix),or equivalent. (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement). * any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. consent by legal authorized representative is not permitted in this study. * evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).

Keywords: proton radiation prostate cancer
study comparing mri/ultrasound fusion-guided prostate biopsy versus systematic transrectal ultrasound-guided biopsy

Conditions: Prostate Cancer

Summary: patients will be submitted to a multiparametric mri examination of the prostate. subsequently, all participants will be randomized (1:1) into both study arms. in study arm a patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. in study arm b patients will be submitted to targeted prostate biopsy based on the multiparametric mri findings.

in men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (psa) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. the hypothesis of this study is that targeted mri/ultrasound fusion-guided biopsy improves the detection rates of significant prostate cancers compared with systematic transrectal ultrasound-guided prostate biopsy. men with at least one previously negative transrectal ultrasound-guided biopsy and persistently elevated psa values (\> 3 ng/ml) or psa velocity \>0.75 ng/ml/p.a. will be submitted to a multiparametric mri examination of the prostate. subsequently, all participants will be randomized (1:1) into both study arms. in study arm a patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound--guided prostate biopsy. in study arm b patients will be submitted to targeted prostate biopsy based on the multiparametric mri findings. targeted biopsies will be performed using mri/ultrasound fusion-guided.

Eligibility criteria:
inclusion criteria: * at least one negative transrectal ultrasound-guided prostate biopsy * psa \> 3.0 ng/ml or psa velocity \>0.75 ng/ml/p.a. exclusion criteria: * known prostate cancer * psa \>50 ng/ml * previous mri-targeted prostate biopsy

Keywords: primary disease multiparametric mri targeted prostate biopsy mri/ultrasound fusion-guided prostate biopsy systematic transrectal ultrasound-guided prostate biopsy
a model for risk prediction of fracture in diabetic patients with osteoporosis

Conditions: Healthcare; Risk Prediction; Diabetic Patients With Osteoporosis

Summary: the fracture risk of diabetic patients proves to be higher than those without diabetesdue to thehyperglycemia, usage of diabetes drugs, the changes in insulin levels and excretion, and this risk begins as early as adolescence.many factors may be related to bone metabolism in patients with diabetes, including demographic data (e.g. age, height, weight, gender), medical history (e.g. smoking, drinking, menopause) and examination (e.g. bone mineral density, blood routine), urine routine).however, most of existing methods are qualitative assessments and do not take the interactions of the physiological factors of humans into consideration. in addition, the fracture risk of diabetic patients with osteoporosis has not been further studied before. in order to investigate the effect of patients' physiological factors on fracture risk, in the paper, we used a hybrid model combining xgboost with deep neural network to predict the fracture risk of diabetic patients with osteoporosis.


Eligibility criteria:
inclusion criteria: * patients in hospital's outpatient and inpatient his database between july 2012 and november 2022, diabetic patients were combined with osteoporosis. exclusion criteria: * patients with fractures before diagnosis of diabetes; patients with fractures before diagnosis of osteoporosis; patients with hyroid disease and other diseases that seriously affect bone metabolism.
international multisite transcatheter tricuspid valve therapies registry

Conditions: Severe Tricuspid Regurgitation

Summary: for a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. if treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. hence, physicians tend to refer patients more aggressively to surgery (1). transcatheter procedures are an attractive alternative in high-risk patients. the field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied. the main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.


Eligibility criteria:
inclusion criteria: * all the patients undergoing transcatheter tricuspid valve intervention. general inclusion criteria: * minimal age: 18 years * patient is able to give written informed consent to the procedure exclusion criteria: * patients not fulfilling the indications for transcatheter tricuspid intervention

Keywords: tricuspid valve tricuspid regurgitation transcatheter tricuspid regurgitation
efficacy and safety of madalena association in the treatment of type ii diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of madalena association in the treatment of type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * participants with 18 years of age or greater; * participants presenting the diagnosis of type ii diabetes mellitus, and who did not reach the therapeutic goals of hba1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy); * hba1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \> 100 mg/dl at the screening visit; * bmi (body mass index) \> 19 kg/m2 and ≤ 45 kg/m2. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * history of alcohol abuse or illicit drug use; * participation in a clinical trial in the year prior to this study; * pregnancy or risk of pregnancy and lactating patients; * known hypersensitivity to the formula components used during the clinical trial; * type 1 diabetes mellitus; * fasting blood glucose \> 300 mg/dl; * risk factors for volume depletion; * impaired renal function and end-stage renal disease; * participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent; * impaired hepatic function; * medical history of pancreatic diseases that may suggest insulin deficiency; * bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome; * condition that, in the investigator's judgment, may favor clinically significant changes in cpk levels; * medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent; * current medical history of cancer and/ or cancer treatment in the last 5 years; * medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis; * medical history of blood dyscrasia or any other hemolytic disorders; * participants using sulfonylureas and/or insulin therapy; * treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.

Keywords: type 2 diabetes mellitus
investigating the effects of smartphone use on the masseter muscle

Conditions: Smartphone Addiction; Masseter Muscle Hypertrophy; Masseter Muscle Spasm

Summary: the aim of this study was to determine the short- and long-term effects of smartphone use on the masseter muscle. in the short term, to investigate whether repetitive thumb movements during phone use will cause a spontaneous muscle activation and/or tenderness in the masseter muscle; in the long term, to investigate the relationship between strength change and tenderness of the tenar and masseter muscles depending on the intensity and duration of phone use.

a total of 120 healthy university students aged 18-30 years at bandırma onyedi eylül university will be included in our study. descriptive data form, smartphone addiction scale - short form, edinburg hand preference inventory, pressure pain threshold, muscle activity, lateral grip strength, hand grip strength will be evaluated in the participant students.

Eligibility criteria:
inclusion criteria: * smartphone users students between the ages of 18-30 years * students whose voluntary informed consent was obtained exclusion criteria: * individuals undergoing masseter botox application * individuals diagnosed with tmj disorder and/or bruxism * individuals with musculoskeletal problems with evidence of a systemic, specific pathologic condition such as fracture of the hand, finger, upper extremity and/or tmj, rheumatoid disease * individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or tmj problem * individuals with less than 6 months of physiotherapy and rehabilitation services related to hand, finger, upper extremity and/or tmj * individuals with facial paralysis * individuals with diagnosed psychiatric illness.

Keywords: smartphone addiction masseter thenar