Kornimate/medical-research-clean huggingface dataset:
epidural analgesia versus iv analgesia in lumbar spine fusions

Conditions: Lumbar Spine Fusion; Pain; Back Pain

Summary: 1. protocol title - a comparison of epidural analgesia with standard care following lumbar spinal fusion: a prospective randomized study 2. purpose of the study - this prospective randomized study will enroll 200 patients undergoing elective lumbar spinal fusion at duke university hospital. the primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia. hypothesis: the investigators hypothesize that patients undergoing lumbar spinal fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.


Eligibility criteria:
inclusion criteria: * adult patients who are scheduled for elective transforaminal lumbar interbody fusion surgery exclusion criteria: * baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the study investigators. * inability to follow directions or comprehend the english language. * females who are pregnant as determined by positive pregnancy test on or before the day of surgery. * prisoners. * patient refusal to provide informed consent. * allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).
digital cognitive behavioral therapy for insomnia in china

Conditions: Primary Insomnia

Summary: digital cognitive behavioral therapy for insomnia (dcbt-i) is found to be effective but is rarely used in china. hence, the investigators developed an automated chinese dcbt-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.


Eligibility criteria:
inclusion criteria: * were aged 18 or older; * had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the sleep condition indicator (sci); * had stable access to the internet via a smartphone. exclusion criteria: * additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea); * psychosis or mania; * serious physical health concerns necessitating surgery or with prognosis \<6 months; * undergoing medical or psychological treatment for insomnia with a health professional; * habitual night shift, evening, or rotating shift-workers.
duration of coldzyme® ii

Conditions: Common Cold

Summary: the objective of this investigation is to verify that coldzyme® is deposited onto the throat and estimate the half-life of the coldzyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (lmm).

the study is an open label, non-comparative study intended to verify the method used to measure the duration of coldzyme®. each participant will be his own control as samples are taken before application of coldzyme and used as an internal control. samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.

Eligibility criteria:
inclusion criteria: * healthy male or female subjects between 18-70 years. the investigator judges the definition of healthy by medical history. * no reported symptoms of sore throat. * readiness to comply with trial procedures. * females of childbearing potential: should use reliable method of birth control. * participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. exclusion criteria: * known allergy or hypersensitivity to the components of the investigational product * history and/or presence of clinically significant condition/disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject. * any current cold symptom such as sore throat, sneezing, rhinorrhea, malaise, nasal obstruction or cough. * use of products, drugs, or food containing glycerol that may influence the study outcome, or concomitant medication with pharmaceuticals that might cause dry mouth (xerostomia), e.g. but not restricted to, morphine or morphine derivates, diuretics, antidepressants or other drugs with anticholinergic effect. * females: pregnant or breast-feeding * history of (in the past 12 months prior to study start) or current abuse of drugs, alcohol or medication * inability to comply with study requirements according to investigator's judgement * participation in another clinical study in the 30 days prior to enrolment and during the study
beta glucan and acetate production

Conditions: Pre Diabetes; Obesity

Summary: based on our hypothesis that orally administered resistant starch and beta glucan will be fermented into a scfa pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: to investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.


Eligibility criteria:
inclusion criteria: * lean (bmi ≥ 20kg/m2 and ≤ 24.9kg/m2) * normoglycemic * aged 30 - 65 years or * overweight/obese (bmi ≥ 25kg/m2 and ≤ 34.9kg/m2) * pre-diabetes * aged between 30 - 65 years. exclusion criteria: * diabetes mellitus * gastroenterological diseases or major abdominal surgery (allowed i.e.: ---appendectomy, cholecystectomy) * lactose intolerance and other digestive disorders * cardiovascular disease, cancer, liver or kidney malfunction (determined based on alat and creatinine levels, respectively) * disease with a life expectancy shorter than 5 years * use of antibiotics 3 months prior inclusion * use of probiotics or prebiotics
a randomized, open, prospective clinical research of fluorouracil implant to improve surgical gallbladder cancer and bile duct cancer

Conditions: Gallbladder Cancer; Bile Duct Cancer

Summary: through clinical practice, to explore if the application of fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.

major objective through clinical practice, to explore if the application of fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer. secondary objective 1) if fluorouracil implants application in clinical surgery could lead to the incidence of complications increased in biliary-enteric anastomosis. 2）assess drug safety according to drug-related clinical and / or laboratory adverse events. 3）observe the postoperative complication rate of fluorouracil implants. 4）observe the quality of life of patients used fluorouracil implants.

Eligibility criteria:
inclusion criteria: * the patients with gallbladder and bile duct cancer diagnosis by surgical exploration, or intraoperative frozen biopsy (annex 2). * aged 18 to 70 years old, male or female, body condition score generally ecog 0～2, expected survival ≥ 3 months. * subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators: blood: wbc count \> 3.0 × 109 / l, platelet count\> 100 × 109 / l, hb \> 8.0g/dl. liver function：serum bilirubin less than 1.5 times the upper limit of normal; alt and ast less than 3 times the upper limit of normal. renal function: creatinine less than 1.5 times the upper limit of normal. * participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test. * patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past. * patients who can understand the circumstances of this study and signed informed consent. exclusion criteria: * currently is receiving effective treatment； * pregnancy, breast-feeding patients； * primary brain tumors or central nervous system metastatic tumor is not controlled; * patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment. * patients with purulent and chronic infected wounds which delayed healing. * patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease; * patients has a history of mental illness and difficult to control; * patients who was considered inappropriate to participate in the trials by the researchers.
prognosis of patients with aggressive b-cell lymphoma, treated with rituximab+anthracycline regimen

Conditions: B-Cell Lymphomas

Summary: this study is a retrospective analysis of an homogeneous population of patients with aggressive b-cell lymphoma and treated upfront with r-chop or r-chop like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed newly diagnosed aggressive b-cell lymphoma according to the current world health organisation classification, from 2001 to 2007. 2. any stage of disease. 3. treatment with r-chop or r-chop like regimens (+/- transplant). 4. age at least 18 years. 5. availability of tissue biopsy at diagnosis for a possible centralized revision. 6. availability of data on clinical involvement, laboratory, treatment and follow up. exclusion criteria: * none

Keywords: aggressive b-cell lymphoma r-chop
natural orifice transgastric endoscopic surgical removal of the gallbladder

Conditions: Cholecystitis

Summary: hypothesis: natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. patient benefits will include less pain and scaring.

in this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. a flexible endoscope will be inserted through the mouth and into the stomach. using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. the flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. once dissected free, the gall bladder will be removed through the stomach and out of the mouth. commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed. patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. during the hospital stay severity of pain and use of pain medications will be recorded. length of time spent in the recovery room and in the hospital will also be collected. patients will return and be evaluated by their surgeon two weeks following their procedure. at this visit, any complications will be noted in the patient's medical record. additionally at this visit and at the preoperative visit, patients will complete a standardized quality of life (qol) assessment (i.e., sf-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.

Eligibility criteria:
inclusion criteria: 1. ability to undergo general anesthesia 2. age \> 18 years of age and \< 80 years of age 3. ability to give informed consent exclusion criteria: 1. acute cholecystitis 2. body mass index (bmi) \> 40 3. contraindicated for esophagogastroduodenoscopy (egd) 4. gallstones \> 2.5cm in diameter 5. gall bladder more than 15cm in length on u/s 6. presence of common duct stones 7. presence of esophageal stricture 8. altered gastric anatomy

Keywords: notes cholecystectomy endoscopic
prolonged pulsatile kisspeptin administration in hypogonadotropic hypogonadism

Conditions: Hypogonadotropic Hypogonadism

Summary: the goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (hh) through the use of exogenous kisspeptin.

* assignment: each study subject will serve as their own control. the order of kisspeptin doses will be randomized within each set/exposure. * delivery of interventions: * prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. subjects will also wear a gonadotropin releasing hormone (gnrh) pump prior to the inpatient study visit. * on the day of the inpatient study, the subjects will * undergo q10 min blood sampling for 6 hours, * receive kisspeptin intravenous (iv) boluses from hour 6 to hour 44 (20 boluses total), * undergo q10 min blood samplings for another 6 hours, * receive a single gnrh iv bolus at hour 51.

Eligibility criteria:
inclusion/exclusion criteria: * age 18 years and older, * confirmed diagnosis of hh with * low testosterone or estradiol, * low or low-normal gonadotropin levels, * thyroid stimulating hormone (tsh) and prolactin within the reference range, * absence of abnormal pituitary or hypothalamic findings on magnetic resonance imaging (mri), * all other medical conditions stable and well controlled, * no prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition, * no history of a medication reaction requiring emergency medical care, * no illicit drug use, * no excessive alcohol consumption (\<10 drinks/week), * normal blood pressure (bp), (systolic bp \< 140 mm hg, diastolic \< 90 mm hg), * white blood cell, platelet counts, and tsh between 90% of the lower limit and 110% of the upper limit of the reference range, * prolactin below 110% of the upper limit of the reference range, * hemoglobin * women: no less than 0.5 gm/dl below the lower limit of the reference range for normal women, * men: on adequate testosterone replacement therapy: normal male reference range, * blood urea nitrogen (bun), creatinine, aspartate aminotransferase (ast), alanine transaminase (alt) not elevated, * for women, * negative serum human chorionic gonadotropin (hcg) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration), * not breastfeeding and not pregnant.

Keywords: hypogonadotropic hypogonadism, kisspeptin
outcome of urs in fresh versus recurrent cases of stone ureter

Conditions: Stone Ureter

Summary: comparison of ureteroscopy in fresh versus recurrent cases of stone ureter

urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either eswl, ureteroscopy or open surgery according to location, site, size, and density. ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. semirigid urs is the gold standard of treatment for ureteral stones. high success rates and low morbidity have been reported in semirigid urs. but complications still occur in some cases. the possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful urs as age, gender, previous eswl, and stone character. in addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful urs only seen in very few original articles as second-time urs after any procedure decreases the rate of success, so it is a point of research that amr moustafa aims to clarify. amr moustafa will conduct a prospective study to evaluate the outcomes of urs for stones in the fresh and recurrent cases.

Eligibility criteria:
inclusion criteria: * • all cases with middle and lower ureteric stone candidate for endoscopy. * stone 15mm or less. exclusion criteria: * • patients with a ureteral stent. * patient refusing participation. * pregnant woman. * active urinary tract infection. * comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.

Keywords: urs
the effects of creative dance therapy on motor and executive functions in children with dyslexia

Conditions: Dyslexia; Dance Therapy; Motor Skills; Executive Function

Summary: although some benefits of dance have been described for motor and cognitive skills, the effects on individuals with dyslexia are unclear. the purpose of this study was to investigate the effects of creative dance training on the motor and executive skills of children with dyslexia.

although some benefits of dance have been described for motor and cognitive skills, the effects on individuals with dyslexia are unclear. the purpose of this study was to investigate the effects of creative dance training on the motor and executive skills of children with dyslexia. the randomized controlled trial was conducted between august 2019 and december 2020 in the occupational therapy department of hacettepe university. the sample consisted of 51 children with dyslexia aged 8-10 years. while 26 of the participants received routine literacy training, the other 25 also received creative dance training three times a week for 4 weeks. motor functions were assessed using the "bruininks-oseretsky motor competence 2 test- short form", and executive functions were assessedusing the "executive function and occupational routines scale".

Eligibility criteria:
inclusion criteria: * an age between 6 and 10 years * a diagnosis of dyslexia according to dsm-v criteria * continued formal education in elementary school * participation in routine literacy training in a special education and rehabilitation center * voluntary participation in the study. exclusion criteria: * having additional physical or psychological problem accompanying the dyslexia * using of psychotic drugs * participating in sports regularly.
study to investigate the efficacy and safety of gl2702 glars-nf1tablet and harnal-d - tablet in bph patients with luts

Conditions: Benign Prostatic Hyperplasia

Summary: study to investigate the efficacy and safety of gl2702 glars-nf1tablet and harnal-d - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic

gl2702 glars-nf1 tablet is controlled released formation which is made by gl pharm tech

Eligibility criteria:
inclusion criteria: * over 50 years old, bph diagnosted, adult male subject * ipss ≥ 13 point * psa \< 4ng/ml * 5ml/sec \< qmax ≤ 15ml/sec exclusion criteria: * prostatic cancer * 250ml \< pvr * alt or ast \> 2 times (upper normal range) * total bilirubin \> 1.5 times (upper normal range) * treated with α-adrenalin receptor blocker within 2weeks before screening * treated with 5alpha-reductase inhibitor within 6 months before screening * treated with phytotherapy within 2weeks before screening * treated with anabolic steroid within 6 months before screening

Keywords: lower urinary track syndrome harnal tamsulosin hcl 0.4mg
efficacy and safety of adding alisporivir (deb025) to peginterferon (ifn) alfa-2a (peg-ifn alfa-2a) and ribavirin in chronic hcv genotype 1 patients who relapsed or did not respond to previous treatment

Conditions: Hepatitis C

Summary: the study is to investigate whether participants with hepatitis c virus (hcv) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (peg) and ribavirin (rbv) may benefit from treatment with triple therapy alisporivir (alv; deb025) with peg and rbv versus placebo with peg and rbv.


Eligibility criteria:
inclusion criteria: * chronic hcv genotype 1 viral infection * hcv rna ≥ 1,000 iu/ml assessed by quantitative polymerase chain reaction (qpcr) or equivalent at screening * previous non-responders/relapsers to peg and rbv after treatment for at least 12 weeks exclusion criteria: * treatment with any anti-hcv drug (whether approved or investigational) within 3 months prior to screening * women of child-bearing potential unless using highly effective * any other cause of relevant liver disease other than hcv * other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic hepatitis c cyclophilin inhibitor
comparison between the use of phentolamine versus glyceryl trinitrate for their effect on renal function in pre-eclampsia patients in icu

Conditions: Pre-Eclampsia; Complicating Pregnancy; Pre-eclampsia Aggravated

Summary: severe pre-eclamptic toxemia has a high incidence of renal complications. rapid diagnosis and termination of pregnancy are still the gold standard main treatment for pre-eclampsia. rapid control of blood pressure showed to provide protection against many adverse effects of preeclampsia as intracranial hemorrhage, subcapsular hepatic hematoma and acute kidney injury (aki). in assiut university hospital icu regimen, glyceryl trinitrate (gtn) was used primarily for this purpose. but it was accused in many cases as a cause for aki without any other organ damage along with the severe preeclampsia disease. some previous studies supported this assumption as , ying-hsuan .t. et.,al during their study of gtn on renal outcome during cardiopulmonary bypass in cardiac surgery. phentolamine infusion is a new rising alternative for an old drug with a high safety profile. in this research protocol the researchers will study comparative effect of glyceryl trinitrate (gtn) versus phentolamine on renal outcome in severe pre-eclampsia patients during their stay in obstetric icu.


Eligibility criteria:
inclusion criteria: * severe preeclampsia defined by presentation of 2 or more of the following criteria: 1. blood pressure more than 160/100 2. proteinuria 3. pitting edema 4. with or without organ dysfunctions exclusion criteria: 1. patient relatives' refusal 2. recent active internal hemorrhage 3. chronic renal impairment or failure on dialysis for any other etiology
red light intervention for myopia prevention

Conditions: Myopia

Summary: to explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.


Eligibility criteria:
inclusion criteria: * students of grade 1-4 in the participating schools; * students' eyes have no myopia, that is the cycloplegic spherical equivalent（se） \>-0.50d, and at least one eye accords with the pre-myopic state, that is -0.50d \<cycloplegic se≤0.50d; * students whose mother and/or father are in myopia status (se \< -3.0d for either of eyes); * students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys. exclusion criteria: * students whose parents do not sign informed consent; * students who have strabismus and/or other binocular vision abnormality; * students who have other eye diseases and/or systematic diseases; * students who have dc \<=-1.5d; * students whose difference of se between the two eyes \>=1.5d; * students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.

Keywords: children and adolescents myopia prevention and control red light