Kornimate/medical-research-clean huggingface dataset:
impact of local anesthesia type on cancer detection rate in transrectal ultrasound guided prostate biopsy

Conditions: Adenocarcinoma of Prostate

Summary: transrectal ultrasound guided prostate biopsy (trus-bx) is the gold standard method for prostat cancer diagnosis. cancer detection rate is an important issue in trus-bx. effective biopsy protocol is necessary to enhance cancer detection rate during the procedure. patient tolerance may improve the protocol effectiveness and quality. adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in trus-bx.

in transrectal ultrasound guided prostate biopsy ultrasound's probe manipulation is necessary for effective biopsy. patient discomfort and pain frequently occurs with manipulation of probe during transrectal ultrasound guided prostate biopsy and this situation may qualify of the achievement of this procedure. in this study, we aimed to describe the impact of different two local anesthesia types on cancer detection rate in transrectal ultrasound guided prostate biopsy.

Eligibility criteria:
inclusion criteria: * patients who underwent transrectal ultrasound guided prostate biopsy because of elevated serum psa levels and/or suspicious rectal examination of prostate. exclusion criteria: * previous trus-bx and prostatic operations(tur-p, open prostatectomy, etc..) history, treatment for prostate carcinoma, usage of finasteride and dutasteride.

Keywords: prostate biopsy, local anesthesia, cancer detection rate.
evaluation of cork splint materials instead of plaster splint for children

Conditions: Wrist Fractures; Forearm Fractures; Elbow Fractures; Ankle Fractures; Foot Fractures; Wounds and Injuries

Summary: this is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).


Eligibility criteria:
inclusion criteria: * fractures of the wrist, forearm, elbow, ankle, foot * distortions of the wrist, elbow, ankle * wounds without tendon injuries

Keywords: fractures of the wrist, forearm, elbow, ankle, foot distortions of the wrist, elbow, ankle wounds without tendon injuries
diabetes mellitus and vulvovaginal candidiasis

Conditions: Diabetes Mellitus; Vulvovaginal Candidiasis

Summary: clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.

a high proportion of vulvovaginal candidiasis is due to c.glabrata that responds poorly to fluconazole therapy. we assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a randomized trial. fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.

Eligibility criteria:
inclusion criteria: * consecutive patients with diabetes mellitus attending endocrine opd of all india institute of medical sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of candida species on culture of high vaginal swab (hvs). exclusion criteria: * patients with vaginal discharge in whom candida growth was not detected on fungal culture were excluded. * subjects also excluded were those with pregnancy, * sexually inactive girls, * age \> 65 years, renal failure and steroid therapy. * patients who did not give consent for pelvic examination, * those who were treated for any kind of vaginal discharge during the past three months and who did not comply with boric acid therapy or did not report on 15th day for repeat examination excluded.
effect of the dpp-4 inhibitor sitagliptin on islet function after mixed meal in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous glp-1 and gip on islet cell function in men with type 2 diabetes. to this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).

in men subjects with type 2 diabetes treated with diet and exercise with or without metformin treatment as an antidiabetic agent, a standardized mixed meal test will be served with or without administration of sitagliptin (100mg).

Eligibility criteria:
inclusion criteria: * caucasian men with type 2 diabetes diagnosed according to icd10 * ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. metformin therapy should not exceed 2 grams daily * age 20-75 years * hba1c ≤80 mmol/mol * bmi: 20-40 kg/m2 exclusion criteria: * liver disease or alat three times above upper reference range * diabetic nephropathy (gfr \< 50 ml/min/1.73 m2 or albuminuria) * proliferative diabetic retinopathy * treatment with any glucose-lowering medication except metformin * previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months. * previous surgery on the gastrointestinal tract * larger surgical intervention during the last 12 weeks * treatment with oral steroids or thiazide diuretics * treatment with digoxin * smokers * participation in another study the last 4 weeks * paracetamol intolerance

Keywords: glp-1, gip, dpp-4 inhibition, iset function
evaluation of carina microphone sensitivity and maximum stable gain in adult recipients

Conditions: Hearing Impairment

Summary: this investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the cochlear carina system.

the totally implanted carina system is an active middle ear implant where all components are implanted under the skin. placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. software is now available to enable non-intrusive microphone measurements in existing patients with the carina device, through a wireless link to the implant. detailed knowledge of the acoustic sensitivity of the implanted microphone and objectively measured maximum stable gain, and its inter-individual variability, will allow more accurate calculation of overall system performance, and thereby more accurate prediction of clinical outcomes. subjects will attend one scheduled study visit to be assessed; several objective acoustic measurements will be performed that do not require active participation from the subject. no data monitoring committee will be used for this clinical investigation.

Eligibility criteria:
inclusion criteria: * eighteen years of age or older at the time of enrolment in the study * current recipient of a cochlear carina system. exclusion criteria: - unwillingness or inability of the candidate to comply with all investigational requirements as determined by the investigator.

Keywords: cochlear implantation
screening and brief intervention for substance misuse following traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: this study is investigating one way to improve health and healthy habits after traumatic brain injury (tbi). the primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe tbi is effective in reducing alcohol misuse during the year following injury. it is hypothesized that an adapted screening, education and brief intervention (adapted sbi) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a screening and education attention control condition (sea control).


Eligibility criteria:
inclusion criteria: * sustained a tbi, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings * history of alcohol misuse within the year prior to injury * be at least 18 years old * english-speaking * have cleared post-traumatic amnesia * able and willing to provide informed consent exclusion criteria: * language impairments that would preclude participation in interview * has not cleared post-traumatic amnesia before discharge

Keywords: traumatic brain injury
drain placement for seroma prevention after mammosite/savi catheter removal

Conditions: Infected Seroma After Surgical Procedure

Summary: the proposed study is randomised controlled trial where informed and consenting patients who have a mammosite/savi device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will have a penrose drain placed under sterile conditions at the time of removal of their device. the drain will be placed in the same site used for the apbi device and no additional surgery will be performed. the drain will remain for 2-3 days and it will be removed by the patient at home. they will return for their routine follow-up appointments and be monitored for development of a seroma with the use of standard ultrasound and physical exam. hypothesis: based on the null hypothesis there will be no difference in the rate of seroma formation after the apbi device removal if a drain is placed.

the proposed study is randomised controlled trial where informed and consenting patients who have an apbi device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and a experimental group that would have a penrose drain placed under sterile conditions at the time of removal of their device. the procedure will be performed at the msu surgery outpatient clinic by residents, the senior investigator or a trained nurse/pa. additional data will be collected on each patient from their medical record including demographic data, cancer diagnosis, lesion size, date of procedure, date mammosite/savi was inserted and removed, total dose of radiation, er, pr, her2neu status, and any chemotherapy or hormone therapy being administered. drains will remain in place for 2-3 days and will be removed by the patient upon removing the dressing. patients will continue their antibiotic regimen prescribed while the apbi device was in place for the 2-3 days the drain is in place for infection prophylaxis. patients will be followed for 4 weeks to determine if a seroma or other complication has developed. patients in both the experimental and control groups will have the same standard follow up and monitoring for seroma development with the use of ultrasound. all postop cancer care will be standard and this study will not alter or delay any aspect of breast cancer treatment. statistics will be performed and reported based upon data collected.

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer * received accelerated partial breast irradiation exclusion criteria: * any metastatic breast cancer * infection * skin with radiation injury

Keywords: seroma accelerated partial breast irradiation (apbi) breast lumpectomy breast cancer
correlation between the analgesic effect of fentanyl transdermal patches and nutritional status in cancer pain patients

Conditions: Cancer Pain; Nutrition Disorders

Summary: the goal of this observational study is to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status.

cancer-related pain is one of the most common and unbearable symptoms among patients with malignant tumors. opioids are commonly used to treat moderate or severe cancer pain. among them, fentanyl is a synthetic opioid with analgesic adjuvant with a 50\~100 times higher potency than morphine. due to its small molecular weight, high lipid solubility, and low irritation to the skin, transdermal fentanyl (tdf) is formulated, which is more convenient for patients with intestinal obstruction, swallowing difficulties, and intolerance to oral opioids. according to some research, the tdf demonstrated good cancer pain control for patients switching from morphine or oral oxycodone preparations, and was well tolerated. however, a part of patients still go through increased breakthrough pain, sleep disturbances, and even accompanied by anxiety and depression when using tdf. therefore, early identification of cancer pain patients using tdf at risk of ineffectiveness is an essential step in increasing analgesic effectiveness, and improving quality of life. some studies discovered different clinical factors such as age, gender, serum albumin, glomerular filtration rate, kidney disease, body mass index (bmi), total protein, alanine aminotransferases have some influence on fentanyl serum concentration and the dose of tdf. furthermore, the clinical factors seem to have a greater impact on the effectiveness of tdf than the genetic factors which may affect the liver metabolism of fentanyl. based on these results, we aim to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status. our purpose is to help clinicians recognize and increase the analgesic effect of tdf according to the patient's risk level.

Eligibility criteria:
inclusion criteria: * cancer pain patients admitted to our hospital; * cancer pain patients switched from oral sustained-release strong opioid analgesics to fentanyl transdermal patches during the hospital stay. exclusion criteria: * patients who have been switched to fentanyl transdermal patches after titration with an analgesic pump; * patients using fentanyl transdermal patches in combination with other oral sustained-release strong opioid analgesics; * patients using fentanyl transdermal patches in combination with an analgesic pump; * patients who have used fentanyl transdermal patches for less than 3 days; * patients with postoperative pain; * patients with allergies; * patients who are pregnant women; * patients with missing data.
factors associated with mortality in neonates

Conditions: Neonatal Mortality

Summary: the purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. as a result, an improved neonatal mortality classification system may be defined.


Eligibility criteria:
inclusion criteria: * neonates for whom healthcare was provided * born alive * neonate greater than or equal to 22 0/7 weeks estimated gestational age exclusion criteria: * stillborn * fetal demise * neonates less than or equal to 21 6/7 weeks estimated gestational age

Keywords: neonatal mortality preterm birth low gestational age vlbw
migraine medication effects on urinary symptoms

Conditions: Overactive Bladder; Bladder Pain Syndrome; Migraine Disorders; Overactive Bladder Syndrome; Overactive Detrusor; Migraine; Interstitial Cystitis

Summary: a prospective observational cohort trial to study the effects of cgrp inhibitors (cgrpi) on lower urinary tract symptoms (luts) and bladder/pelvic pain. candidates for either cgrpi or an alternative therapy for refractory migraines (onabotulinumtoxina (bonta) extracranial muscle injections) with baseline luts will be recruited. the investigators will assess luts and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

common urinary urgency syndromes may be related to over-activation of bladder afferent pathways involving cgrp signaling. cgrp (calcitonin gene related protein) is a neurotransmitter in afferent pathways also involved in central nociception and hypersensitization. cgrp-targeted therapies, approved for migraine treatment, have the potential to alleviate lower urinary tract symptoms, but these possible effects have not been studied in humans. this is a prospective observational cohort trial to study the effects of cgrp inhibitors (cgrpi) on lower urinary tract symptoms (luts) and bladder/pelvic pain. candidates for either cgrpi or an alternative therapy for refractory migraines (onabotulinumtoxina (bonta) extracranial muscle injections) with baseline luts will be recruited. the investigators will assess luts and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Eligibility criteria:
inclusion criteria: * female patients \> 18 years * refractory migraine, planned treatment with either: * cgrp inhibitors, including: * cgrp small molecule receptor antagonists ("gepants"): ubrogepant, rimegepant, atogepant. * cgrp monoclonal antibodies: eptinezumab, fremanezumab, galcanezumab. * cgrp receptor monoclonal antibodies: erenumab. * bonta extracranial muscle injections * any of the following symptoms during the last month: * urinating too often (frequency). * having a sudden urge to urinate that's difficult to hold back (urgency). * having a sudden urge to urinate and urine leaking before you make it to the toilet (urge incontinence). exclusion criteria: * age \< 18 years * cgrp treatment within the last 12 months or bonta (head / bladder) last 6 months. * patient (or medical decision-maker) unable to provide informed consent or unable to answer questionnaire. * unable to urinate, eg: post cystectomy, indwelling catheter, on intermittent self catheterization, esrd w/ anuria. * prior bladder bonta in last 12 months.
spirulina platensis supplementation and calorie restriction in obese men : a randomized controlled trial protocol study

Conditions: Obesity

Summary: the goal of this clinical trial is to evaluate the effects of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase (sod) levels, and serum malondialdehyde (mda) levels in men with obesity. the main question it aims to answer are: what is the effect of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase levels, and serum malondialdehyde levels in obese individuals? participants will be respondents were given spirulina supplements for 30 days with a dose of 2x2 capsules 450mg researchers will compare intervention group with placebo group that weren't given spirulina supplementation to see if there is any effects on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase levels, and serum malondialdehyde levels

spirulina supplement intervention on subjects with male gender aged 25-55 years, which will be intervened for 4 weeks / 30 days, before the intervention will be taken anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase levels, and serum malondialdehyde levels. after that, spirulina supplement intervention will be given at a dose of 2x2 / day, and follow-up will be carried out every week, after 30 hours of intervention,spirulina supplement distribution is carried out by research assistants every 2 days. will be taken again to conduct anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase levels, and serum malondialdehyde levels. the aim is to find out if there is an effect of spirulina supplementation on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase levels, and serum malondialdehyde levels.

Eligibility criteria:
inclusion criteria: * male age 25 - 55 years * bmi ≥ 30 kg/m2 * waist circumference \> 90 cm * low physical activity (sedentary life style) * if taking weight loss supplements are willing to stop the dietary supplements, food or drinks. * not undergoing a diet program. exclusion criteria: * history of kidney disease, atherosclerosis, cancer, and acute infections. * post-surgery in the last 3 months. * deficit in daily calorie requirement. * smoking habit and alcohol dependence. * use of hormonal drugs, antidepressant drugs, antibiotics, antidiuretic, glucocorticoids and use of vitamin or mineral supplements in the last three months. * refusal to sign the informed consent and in the study if not completing all stages will be excluded.
itbs for acute ischemic stroke after thrombectomy

Conditions: Ischemic Stroke

Summary: the goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (itbs) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (mt). the study population includes adults aged 18-85 with nihss scores 5-25 post-mt and etici≥2b reperfusion.


Eligibility criteria:
inclusion criteria: * 1) age 18-85 years, regardless of gender. * 2) acute ischemic stroke caused by occlusion of the anterior circulation large vessels (internal carotid artery, m1 or m2 segment of the middle cerebral artery), verified by cta or dsa. * 3) mechanical thrombectomy (mt) performed within 24 hours of symptom onset. * 4) successful reperfusion: post-mt etici score ≥ 2b. * 5) nihss score 5-25 at 24 hours post-mt, with ≥2 points in at least one limb. exclusion criteria: * 1) pre-stroke modified rankin scale (mrs) score ≥2. * 2) ph2-type intracranial hemorrhage on brain ct post-mt. * 3) patients who underwent intracranial stent placement during mt. * 4) contraindications to itbs: history of epilepsy or seizures, implanted cardiac pacemakers, cochlear implants, or other electronic/magnetic-sensitive devices. * 5) severe consciousness impairment, cognitive dysfunction, or psychiatric disorders preventing compliance with itbs. * 6) expected survival \<3 months due to other medical conditions or inability to complete follow-up for any reason. * 7) participation in another interventional study. * 8) any other condition deemed unsuitable for enrollment by the investigator.
a study to evaluate the safety, tolerability, and efficacy of relatlimab in relapsed or refractory b-cell malignancies

Conditions: Hematologic Neoplasms

Summary: the primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (dlts), and maximum tolerated dose (mtd) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory b-cell malignancies. co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory hodgkin lymphoma (hl), and relapsed or refractory diffused large b cell lymphoma (dlbcl)


Eligibility criteria:
inclusion criteria: * must have histologic or cytologic confirmation of chronic lymphocytic leukemia, hodgkin lymphoma, non-hodgkin lymphoma, or multiple myeloma and have relapsed following prior treatment or been refractory to prior treatment * must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-cd20, alemtuzumab, or anti-cd30) therapy. * must be more than 100 days post autologous transplant exclusion criteria: * known or suspected central nervous system (cns) metastases or with the cns as the only site of active disease (controlled cns metastases are allowed) * known or suspected autoimmune disease * history of allergy to anti-pd-1 or anti-pd-l1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components other protocol-defined inclusion/exclusion criteria apply

Keywords: hodgkin lymphoma non-hodgkin lymphoma diffused large b-cell lymphoma indolent lymphoma chronic lymphocytic leukemia relapsed refractory