Kornimate/medical-research-clean huggingface dataset:
prevalence of bacteriuria, antibiotic susceptibility, and treatment response in symptomatic benign prostatic hyperplasia

Conditions: Bacteriuria in Symptomatic Benign Prostate Hyperplasia; Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia; Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia

Summary: the goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic bph and to assess severity of luts in patients with symptomatic bph using ipss score before and after antibiotic therapy.

this was a hospital-based prospective observational study. all patients with symptomatic bph attending the urology out-patient department (opd) of the study site were enrolled. informed and written consent was obtained from all participants. demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of bph, including incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia, and relevant past history. ipss scoring was conducted. a thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. during the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.

Eligibility criteria:
inclusion criteria: * patients with symptomatic bph. exclusion criteria: * patients with indwelling catheters * recent antibiotic use * immunocompromised states (e.g., hiv, hcv) * uncontrolled diabetes mellitus (hemoglobin a1c \> 7%) * steroid therapy * those who declined to provide consent

Keywords: bacteriuria benign prostate hyperplasia urinary tract infection
real life weight bearing after tibial fractures

Conditions: Tibial Fractures; External Fixation Pin Site Infection

Summary: in this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.

ten patients treated with a large external fixator after tibial fracture will be enrolled for this prospective case series. patients will be equipped with the ao fracture monitor (a data logger device) attached post-operatively to a connection rod of the external fixator. the device continuously measures deformation of the fixator frame due to normal weight bearing for up to 12 months by means of a strain gauge. the strain signal is processed on-board and several parameters related to the loading characteristics of the fracture are stored. simultaneously, patients will be equipped with a fully integrated sensor insole (opengo insole, moticon gmbh, münchen). this product offers long-term weight bearing data (recording and storage) and allows non-invasive documentation of real life loading in patients without affecting the daily life activity of the patient. recording of weight-bearing data will be obtained for a maximum of 4 months.

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of tibial fracture (ao 41-43) * external fracture fixation with large external fixator * capable of at least partial weight-bearing * bone segment transport (if applicable) must be completed * informed consent obtained, i.e.: * ability to understand the content of the patient information/ informed consent form (icf) * willingness and ability to participate in the clinical investigation according to the clinical investigation plan (cip) * signed and dated ethics committee (ec) exclusion criteria: * external fixation as temporary stabilization * bone fragment compression * joint-bridging external fixation * any not medically managed severe systemic disease * recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * pregnancy or women planning to conceive within the study period * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
efficacy of split-dose of oral mms for bowel preparation in elderly patients

Conditions: Colonic Adenoma; Bowel Preparation

Summary: adequate bowel preparation is critical for successful colonoscopy and a large volume of peg was required for bowel preparation in patients undergoing colonoscopy. the investigators conducted a a prospective, randomized, controlled study to compare low dose of oral magnesium sulfate solution with high dose peg. the investigators found that patients who took low dose of oral magnesium sulfate solution had similar bowel preparation quality to patients who took peg,but accompanied with fewer adverse events and better tolerance.


Eligibility criteria:
inclusion criteria: * patients who underwent colonoscopy exclusion criteria: * known or suspected bowel stricture or obstruction; * history of colorectal surgery; * significant gastroparesis or gastric outlet obstruction; * toxic colitis or megacolon; * severe acute inflammatory bowel disease; * active gastrointestinal bleeding; * suspected or confirmed chronic renal insufficiency and heart illness; * disturbance of electrolytes ; * unable to provide informed consent

Keywords: bowel preparation oral magnesium sulfate solution polyethylene glycol solution
effect of ketogenic diet on muscle hypertrophy

Conditions: Healthy Nutrition

Summary: the purpose of this study is to investigate the effects of 4 weeks of carbohydrate deprivation (through a ketogenic diet) on hypertrophy signalling after a single bout of exercise in healthy trained male subjects, and the impact on body composition, muscle strength, and blood parameters.


Eligibility criteria:
inclusion criteria: * at least 2 years of resistance-training experience * body mass index: more than 18 kg/m2 and less than 30 kg/m2 exclusion criteria: * metabolic diseases or noncommunicable diseases (cardiovascular, liver, respiratory, cancer, etc) * experience with the ketogenic diet (last six months) * acute inflammatory status * treatment with steroids in the past 3 months
epidemiology of acute otomastoiditis in pediatric age

Conditions: Otomastoiditis

Summary: it was decided to conduct this study because there are no standardized guidelines. regarding the management of acute otomastoiditis. the aim of the study is to describe the epidemiology of otomastoiditis in order to outline the scientific and rational basis necessary to standardize the diagnostic and therapeutic approach to this condition in order to reduce the diagnostic delay and improve the therapeutic outcome. it also aims to evaluate the effectiveness of different treatment modalities and identify possible risk factors associated with complications.

acute otomastoiditis is the main suppurative complication of acute otitis media (oma) and is secondary to the extension of the inflammatory process from the middle ear to the mastoid process of the temporal bone through a narrow canal, termed aditus ad antrum, which in the youngest child is more likely to be obstructed (due to the absence of pneumatization of the mastoid).1,2 rarely, mastoiditis can occur even in the absence of signs and symptoms suggestive of oma.3 currently, risk factors leading to the evolution of oma into otomastoiditis are not known in the literature, so the debate on the proper management of the single episode of otitis as a preventive strategy is still very much alive, also in light of the extreme frequency of oma in pediatric age, its frequent self-resolution and the rarity of its complications. in particular, acute otomastoiditis remains a rare complication; in fact, it is estimated that the percentage of oma that goes on to evolve into otomastoiditis is 0.24%. the annual incidence of acute mastoiditis has been greatly reduced since the introduction of antibiotic therapy and is estimated to be between 1.2 and 4.2 cases per 100,000 children in industrialized countries. over the past decades, several scientific societies have updated guidelines for the management of oma in order to reduce the overprescription of antibiotics and the consequent increase in drug resistance.in the latest italian guidelines, the strategy of watchful waiting, i.e., clinical observation for the first 48-72 hours after symptom onset, has been confirmed only in children older than 2 years with mild monolateral, severe monolateral, and mild bilateral oma. according to some authors, this treatment choice did not impact the incidence of complications, particularly otomastoiditis, but conflicting opinions exist in the literature. in recent years, numerous studies have documented an increasing trend in the incidence of acute otomastoiditis, in particular, a study conducted from 2002 to 2013 at 25 hospitals in our country documented an increase in the annual number of acute otomastoiditis in patients older than 4 years.

Eligibility criteria:
inclusion criteria: * patients aged ≤14 years with an established diagnosis of acute otomastoiditis exclusion criteria: * na
safety study of f2695 sr in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the long- term safety of f2695-sr in the treatment of adults with major depressive disorder.


Eligibility criteria:
inclusion criteria: * completed 1 of the lead-in studies lvm-md-01, lvm-md-02, or lvm-md-03 * have normal examination findings at the final visit of the lead-in study * have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential exclusion criteria: * any exclusionary psychiatric or medical condition that developed during the lead in study * patients considered a suicide risk * women who are pregnant, breastfeeding, or planning to become during the study or are sexually active and not currently using a medically acceptable method of contraception

Keywords: depression major depressive disorder
evaluation of chronic pain after nerve section during thoracotomy

Conditions: Lung Cancer

Summary: the purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.


Eligibility criteria:
inclusion criteria: * patients included for anterior or lateral thoracotomy exclusion criteria: * unable to give consent due to age, cognitive reduction or otherwise * neurological disease or symptoms affection thoracic area * chronic pain prior to surgery * inability to supply the patient with an epidural catheter * pneumonectomy * prolonged infection at surgical site * invasive tumor growth * need for repeated surgery at site

Keywords: thoracotomy nerve section qst quantitative sensory test muscle sparing posterolateral thoracotomy chest wall surgical incision tumors or cancer of the lung
single dose pharmacokinetic study of gb221 in comparison with herceptin ®

Conditions: Breast Cancer

Summary: this is a single center, randomized, blind, parallel controlled clinical trial. the primary objective is to evaluate the single dose pharmacokinetics of recombinant humanized anti-her-2 monoclonal antibody injection gb221 in comparison with herceptin ® in chinese healthy adult volunteers. the main aim is to study the pharmacokinetic similarity between gb221 and herceptin ®.

subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of gb221 or herceptin ®, and accept observation for 42 days. throughout the course, safety data will be collected.

Eligibility criteria:
inclusion criteria: * 1. signed informed consent form; * 2. healthy adult volunteers aged between 18 and 45, male or female; * 3. medical examination as required within 28 days, body mass index (bmi) 19.0 \~ 24.0, weight≥50 kg for men, ≥45 kg for women, and≤ 75 kg for both; * 4. agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months; * 5.subject can communicate well with the investigators and complete the study according to the study regulations. exclusion criteria: * 1. pregnant or lactating women, or positive in either blood or urine pregnancy test; or unwilling to take effective contraceptive measures during the trial and within 6 months after the end of the trial at fertile age; * 2. allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin e (ige) test; * 3. history of drug abuse, or positive urine test for drug; * 4. history of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. history of high blood pressure, or clinically significant systolic blood pressure≥140 mmhg/diastolic blood pressure≥90 mmhg; * 5. family history of cancer, or tumor markers (male: cea, afp, psa, ca-125; female: cea, afp, ca-153, ca-125) positive. * 6. participated in other clinical trials of drug or used drugs harmful to major organs within 3 months; * 7. blood donation within 3 months; * 8. used prescription or otc drugs within 14 days; * 9. left ventricular ejection fraction (lvef) \< 60%; * 10. alt or ast \> 1.5 uln, cr \> uln; * 11. wbc \ 1.2 uln; anc \< 0.8 lln; plt \< 0.8 lln; hgb \< 0.9lln. * 12. hbs-ag, hcv-ab, anti-hiv or tp-ab positive; * 13. anti-drug antibody (ada) test positive; * 14.history of psychosis; * 15. history of postural hypotension; * 16. more than 5 cigarettes per day; * 17. more than 28 units of alcohol per week; or alcohol breath test positive within 24 hours before pre-dose; * 18. history of dizziness of blood or needle; * 19. unsuitable for other reasons.

Keywords: breast cancer pharmacokinetics anti-her-2 human monoclonal antibody herceptin gb221
use of in vivo 3t mr to characterize carotid plaque in patients and correlate mr findings with symptoms

Conditions: Carotid Plaque Hemorrhage Appearance

Summary: to compare two competing newly designed 3d sequences for black blood carotid plaque imaging techniques with the industry standard 2d sequnce for black blood.

to utilize a 3d sequence instead of the usual 2d commonly standard industry sequence that is supplied by the various manufacturers. patients with greater than 50% stenosis that are 3t compatible are imaged using the two sequences to compare which sequences better visualize the plaque and it's characteristics the purpose is to validate the ability of the new 3d sequence to detect and measure any plaque hemorrhage as well as to identify region sof type 1 hemorrhage.

Eligibility criteria:
inclusion criteria: * patients with 50% stenosis of the carotid arteries that are safe to undergo mri imaging exclusion criteria: * patients that are determined to no be safe to undergo mr imaging due to implants
placebo-controlled proof of concept study of epelsiban in women with adenomyosis

Conditions: Adenomyosis

Summary: the primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis. this is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (tid), 200 mg of epelsiban tid, or placebo tid. the study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.


Eligibility criteria:
inclusion criteria: * eighteen to 55 years of age, inclusive * pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining. * females with adenomyosis confirmed on magnetic resonance imaging (mri), - females with heavy menstrual bleeding . * willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up. * not pregnant as confirmed by a negative serum human chorionic gonadotropin exclusion criteria: * a female subject will not be eligible for inclusion in this study if any of the following criteria apply: * abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start * abnormal endometrial biopsy within six months of starting study treatment. * history of an endometrial ablation within 12 months of starting study treatment. * uterine artery embolization within six months of starting study treatment. * prior major uterine procedures or any other significant uterine abnormalities on mri (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted). * confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy. * active pelvic infection or current use of an intrauterine device within three months of screening. * women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage. * any uterine dimension \>20 centimeter (cm). * other major causes of heavy menstrual bleeding - * use within 3 months or anticipated use of medications that modify reproductive function * use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid. * use of daily opioid pain medications other than with menses. * hemoglobin \<8 grams (g)/deciliter. * history of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).

Keywords: heavy menstrual bleeding adenomyosis safety epelsiban tolerability proof of concept
fenofibrate in ulcerative colitis

Conditions: Inflammatory Bowel Diseases

Summary: fibrates, which are specific pharmacological agonists of pparα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia. apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of nf-kappa b signaling and pro-inflammatory cytokine production. 4 fenofibrate, an important peroxisome proliferator-activated receptor-a (ppar- α) agonist, is widely used in clinical as a triglyceride (tg)-lowering agent.

ulcerative colitis (uc) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however the exact underlying mechanisms of uc remain poorly understood. uc is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors. pparα has been proposed as a key lipid metabolism modulator and regulator of inflammation. there are three isotypes of ppar (α, β and ȣ) which have distinct but overlapping functions. fibrates, which are specific pharmacological agonists of pparα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia. apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of nf-kappa b signaling and pro-inflammatory cytokine production. 4 fenofibrate, an important peroxisome proliferator- activated receptor-a (ppar- α) agonist, is widely used in clinical as a triglyceride (tg)-lowering agent

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * both males and females will be included * negative pregnancy test and effective contraception. * mild and moderate uc patients diagnosed and confirmed by an endoscope exclusion criteria: * breastfeeding * significant liver and kidney function abnormalities * colorectal cancer patients * other inflammatory bowel diseases (cd). * patients with severe uc * patients taking rectal or systemic steroids * patients taking immunosuppressives or biological therapies * addiction to alcohol and/or drugs * known allergy to the fenofibrate
indices of severity and prognosis for sickle cell disease

Conditions: Anemia, Sickle Cell; Blood Disease

Summary: to develop a clinical severity index that could prospectively identify sickle cell disease patients who were at high risk for a turbulent clinical course and a poor prognosis.

design narrative: using the database, univariate analysis showed that factors associated with the occurrence of cerebrovascular accident (51 patients) included hematocrit, rate of change of pocked red cell count, and polymer fraction at 40 percent oxygen saturation (pf40). only low hematocrit was predictive of death in the pediatric cohort. there were 45 disease-related deaths. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
efficacy of intravenous levetiracetam in neonatal seizures

Conditions: Neonatal Seizures

Summary: a new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. monitoring for seizure detection will be tested at five (5) us sites and one (1) international site using the internet.

this project aims to improve the treatment of neonatal seizures. current treatments are poorly effective and have significant side effects. levetiracetam (lev) has great potential as a treatment for neonatal seizures but is not approved for use in children less than 2 years of age. this study aims to obtain essential data regarding the efficacy and safety of lev in this vulnerable and under researched population and simultaneously to develop eeg monitoring systems that facilitate seizure detection and research. specific aims are: 1. to determine the efficacy of intravenous lev in terminating neonatal seizures when given as first line therapy. 2. to obtain dose escalation data by studying the additional efficacy of a further dose in non responders. 3. to obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study. 4. to obtain further safety data of lev in neonates. 5. to prove the feasibility of centralized remote monitoring of continuous eeg monitoring in the neonatal intensive care unit (nicu) via the internet and test a promising automated neonatal seizure detection algorithm. the study design is a phase 2b randomized blinded controlled study.

Eligibility criteria:
inclusion criteria: 1. newborns admitted to any of the study sites with electrographic seizures seizures. 2. term infants gestational age \>36 weeks less than 2 weeks of age. 3. greater than 2200 grams. 4. infants for whom parental consent to participate in the study is obtained. exclusion criteria: 1. infants who are already receiving anticonvulsants 2. if serum creatinine is greater than 1.6mm 3. if seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia) 4. subjects in whom death seems imminent, as assessed by the neonatologist.

Keywords: seizures neonates anticonvulsants treatment levetiracetam phenobarbital