Kornimate/medical-research-clean huggingface dataset:
ursodiol 500 mg tablets under fed conditions

Conditions: Healthy

Summary: the objective of this study was to evaluate the comparative bioavailability between ursodiol 500 mg tablets (test) and urso forte™ 500 mg tablets (reference)after a single-dose in healthy subjects under fed conditions.

criteria for evaluation: fda bioequivalence criteria statistical methods: fda bioequivalence statistical methods

Eligibility criteria:
inclusion criteria: * healthy, non-smoking male and female subjects, 18 years of age or older. * bmi ≥ 19 and ≤ 30. * negative for: 1. hiv. 2. hepatitis b surface antigen and hepatitis c antibody. 3. using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). 4. urine cotinine test 5. serum hcg consistent with pregnancy (females only) * no significant diseases or clinically significant findings in a physical examination. * no clinically significant abnormal laboratory values. * no clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ecg). * be informed of the nature of the study and given written consent prior to receiving any study procedure. * females who participate in this study are: 1. unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) or 2. willing to remain abstinent \[not engage in sexual intercourse\] or 3. willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide or iud) * females who participate in this study are not pregnant and/or non-lactating. exclusion criteria: * known history or presence of any clinically significant medical condition. * known or suspected carcinoma. * known history or presence of: 1. hypersensitivity or idiosyncratic reaction to ursodiol and/or any other drug substances with similar activity. 2. alcoholism within the last 12 months. 3. drug dependence and/or substance abuse. 4. use of tobacco or nicotine-containing products within the last 6 months. * on a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet). * participated in another clinical trial or received and investigational product within 30 days prior to drug administration. * donated up to 250 ml of blood within the previous 30 days or donated from 251 to 499 ml of blood in the previous 45 days or donated more than 499 ml of blood in the previous 56 days (based on the canadian blood services guideline for blood donation. * females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing. * females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing. * requirement of any non-topical medication (prescription and/or over-the-counter, with systemic absorption) on a routine basis. * difficulty fasting or consuming the standard meals. * do not tolerate venipuncture. * unable to read or sign the icf.

Keywords: bioequivalence healthy subjects
preoperative anxiety and music therapy

Conditions: Anxiety State

Summary: music can reduce anxiety in adult patients awaiting surgical interventions. the study was designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory enzymes, skin resitance between surgical patients listening music vs no sound.

patients undergoing elective surgical intervention will be allocated in two groups: group m will listen prerecorded music through an individual headset for 30 min before the induction of anesthesia; group c will listen no sound through an individual headset for 30 min before the induction of anesthesia the degree of stress and anxiety the patients will be assessed using questionnaire. laboratory enzymes will be measured. heart rate, non invasive arterial pressure, pulse oximetry,skin resistance will be recorded. all the patients will receive continuous ecg holter recording . to assess the effect of music therapy on the degree of autonomic modulation, hrv will be analyzed with traditional time and frequency measures.

Eligibility criteria:
inclusion criteria: * elective surgical patients \>18 years old, after obtaining informed consent exclusion criteria: * patients with hearing impairment, * any known psychiatric or memory disorder * thyroid disease. * atrial fibrillation * pace-maker
novolet® surveillance study on using human insulin system in indonesia

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to investigate the safety and efficacy of novolet® human insulin delivery system in an outpatient setting.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * type 2 diabetes mellitus * other types of diabetes mellitus (gestational, drug induced \[thiazide\] or metabolic syndrome-related)
impact of prokinetic use after emergency intestinal anastomosis on postoperative clinical outcomes

Conditions: Prokinetic Use After Emergency Intestinal Anastomosis

Summary: prokinetic drugs used to accelerate healing of intestinal anastomosis of urgent cases which not prepared preoperative by increase intestinal motility and gastric emptying and decrease postoperative adhesions they are many types of prokinetics as cholinergic agonists, dopamine antagonist, serotonergic agonists and macrolides agents of prokinetics administered immediately post operation and at the time of hospitalization

by evaluation the effect of prokinetic use versus non use after emergency intestinal intestinal anastomosis on short and long term clinical outcome it will be prospective cohort study which conducted in sohag university hospital study will include patients presented with urgent anastomosis inclusion criteria: all adults underwent emergency intestinal anastomosis exclusion criteria: pediatrics, patients with comorbidities and patients with electively resection and anastomosis. primary goals are to detect effect of prokinetics on incidence of leakage rate secondary outcomes include early bowel opening, enteral feeding, post operative pain, wound infection and adhesion formation rate.

Eligibility criteria:
inclusion criteria: * all adult patients exclusion criteria: * pediatrics * patients associated with comorbidities * patients with electively resection and anastomosis
oral administration of dci to women with pcos

Conditions: Polycystic Ovary Syndrome

Summary: to determine if oral dci administration to women with pcos increases the total dci content in urine and blood, and, if so, if that change is accompanied by i) an increase in dci-ipg release in blood (as determined by bioactivity) during an oral glucose challenge and ii) an increase in whole-body insulin sensitivity.

a total of 46 women will be studied. we will study 23 obese and 23 non-obese women. there will be no bmi restriction. twenty-three women will be randomly assigned to receive dci (experimental group) and 23 women to receive placebo (control group). the women will be studied during the equivalent of the follicular phase of the cycle, as documented by a serum progesterone concentration of 2 ng/ml. pcos will be defined using criteria developed at the 1990 nichd conference on pcos3 - i.e., all women will have oligomenorrhea (eight or fewer menstrual periods annually) and hyperandrogenemia (elevated serum total or free testosterone concentration), and secondary causes of hyperandrogenism or ovulatory dysfunction will be excluded (see below: entrance criteria). all women will undergo a standard oral glucose tolerance test (ogtt) to screen for diabetes mellitus,16 but impaired glucose tolerance (igt) will not be an exclusion criteria because of the high prevalence of igt in this population.8,17-19 we intentionally will not screen the women for the presence of insulin resistance. women with pcos who have disorders associated with insulin resistance - such as hypertension21-23 or dyslipidemia21-23 - will not be excluded as long as they have been on a stable dose of medication for 6 months.

Eligibility criteria:
inclusion criteria:- (1) non-obese and obese women with pcos between 18-40 years of age. (2) oligomenorrhea ( 8 menstrual periods annually), (3) biochemical hyperandrogenemia (elevated total or free testosterone), (4) normal thyroid function tests and serum prolactin, and (5) exclusion of 21 -hydroxylase deficiency by a fasting 17 -hydroxyprogesterone \<200 ng/dl.41 (6) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (cbc, sma20, urinalysis). (7) signed, witnessed informed consent. (8) ability to comply with study requirements. exclusion criteria: - (1) diabetes mellitus by fasting glucose or ogtt, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). (2) current use of oral contraceptives, depoprovera or norplant.. (3) documented or suspected recent (within one year) history of drug abuse or alcoholism. (4) ingestion of any investigational drug within two months prior to study onset.
comparing postoperative analgesic techniques for umbilical hernia repair: a randomized trial of ultrasound guided caudal, erector spinae, and external oblique interfascial plane blocks

Conditions: Regional Anesthesia

Summary: the aim of this study is to evaluate the efficacy of ultrasound guided erector block versus caudal block versus external oblique intercostal plane block perioperatively

umblical hernia repair surgeries have been performed in the practice of pediatric surgeries, ensuring adequate perioperative analgesia is crucial for perioperative care as pain in pediatric patients can cause functional recuperation and lead to negative behavioral changes and family dissatisfaction. (1) various studies are made to improve postoperative analgesia and facilitate recovery in pediatric patients.(1) day-case surgery is defined as the planned day admission of a patient to hospital for a surgical procedure, after which there is subsequent successful and safe discharge back home on the same day in a safe and timely manner instead of spending prolonged periods within the hospital.(2) this has significant implications, including reducing hospital stay, hospital-acquired infection, and healthcare-related costs while also improving patient experience and service efficiency. surgical, anesthetic, and patient factors should be considered for successful day case surgery.(2) external oblique intercostal plane block (eoipb) is a novel fascial plane block which aims to provide upper midline and lateral abdominal wall analgesia thereby reducing perioperative opioid consumption , la is deposited into the fascial plane beneath the external oblique muscle (eom) and superficial to the sixth rib or external intercostal muscle. it targets anterior and lateral cutaneous branches of the thoracoabdominal nerves from the ventral rami of spinal nerves.(3) caudal block is the most frequently performed regional technique for pain management in children undergoing lower abdominal surgeries. ultrasound guidance has resulted in enhanced reliability and safety profiles for caudal blocks.(4) the erector spinae plane block (espb), multiple studies demonstrated its potential as a practical approach for managing postoperative pain in the last decade, involves an ultrasound-guided injection of a relatively large volume of local anesthetic into the fascial plane beneath the erector spinae muscle. (5)

Eligibility criteria:
inclusion criteria: * pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to asa i or ii. exclusion criteria: * parents refusal. * coagulopathy. * allergy to local anesthesia. * local infection at the site of injection. * neurological anomalies.
fire and ice re-ablations (retrospective data collection)

Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Summary: retrospective data collection on re-ablations performed within the fire and ice trial.

the purpose of this retrospective data collection on re-ablations performed in both treatment arms (cryo arm and radiofrequency arm) of the fire and ice trial is to gain insight into re-occurrence of atrial arrhythmias resulting in a re-ablation after a performed index ablation procedure. data to be collected from subject charts include pulmonary vein anatomy, documented atrial arrhythmias prior to re-ablation, pulmonary vein reconnection, pulmonary vein ablation lesion gaps and gap location, ablation lesions performed during the re-ablation, procedure parameters of the rf or cryo catheter utilized during the re-ablation, and success of re-ablations performed.

Eligibility criteria:
n/a - no new patients will be enrolled within this project. inclusion criteria for the fire and ice trial included: * symptomatic paroxysmal atrial fibrillation (paf) with at least two episodes and at least one episode documented (30 seconds episode length, documented by electrocardiogram (ecg) within last 12 months * documented treatment failure for effectiveness of at least one anti-arrythmic drug (aad type i or iii, including beta-blocker and aad intolerance) * 18 to 75 years of age * patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol * patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard radiofrequency (rf) ablation technique. the exclusion criteria were grouped as follows in the fire and ice trial: * general exclusion criteria * exclusion criteria related to the cardiac condition * exclusion criteria based on laboratory abnormalities
protection against benzene toxicity

Conditions: Leukemia; Aplastic Anemia

Summary: we are investigating the role of an enzyme (nqo1) in protection against the bone marrow toxicity of the occupational and environmental toxicant benzene. all of the proposed studies involve use of human bone marrow cells in-vitro to define mechanisms of nqo1-mediated protection. cells are obtained from healthy volunteers and protocols have undergone irb review and approval.


Eligibility criteria:
healthy adult volunteers with blood counts in normal ranges and without evidence of hepatitis or hiv infection.

Keywords: nqo1 dt-diaphorase benzene leukemia aplastic anemia
effect of propofol on internal anal sphincter pressure during arm

Conditions: Chronic Constipation

Summary: background and aim: an anorectal manometry (arm) is a common test in the evaluation of outlet obstruction in constipation. in children under 6 yo, anesthesia is often used for patient comfort and compliance. the choice of anesthesia for arm varies from center to center and includes the use of ketamine, inhalation agents, and propofol. with the increased use of propofol, our aim is to determine the effects of propofol on resting anal sphincter pressure while performing an arm under general anesthesia. hypothesis: propofol administration leads to a decrease in internal anal sphincter pressure. methods: this is a prospective, single center, observational study of the effect of propofol on the internal anal sphincter pressure. pediatric patients between the ages of 2-6 years who require an anorectal manometry for chronic constipation will be offered enrollment. anesthesia was required for patient compliance and comfort and conducted by an anesthesiologist. sevoflurane was the inhalational agent used for induction. at massachusetts general hospital (mgh), 1 mg/kg of propofol bolus is routinely given at completion of the arm test to reduce emergence delirium. the manometric probe was kept in place with continuous measurement of baseline internal anal sphincter pressure while propofol was administered. we measured changes to internal anal sphincter pressure and time to return to baseline. results: the primary outcomes will be change of internal anal sphincter pressure from baseline and time to return to baseline. discussion: the proposed investigation may demonstrate that propofol has an effect on the internal anal sphincter pressure which may affect its utility as an anesthetic for anorectal manometry.


Eligibility criteria:
inclusion criteria: * ages 2 - 6 years * chronic constipation * requires anorectal manometry exclusion criteria: * ages 0-2 or \> 6 years * abnormal anorectal anatomy * known history of hirschsprung's disease
pregabalin as treatment for alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (lyrica) in the treatment of alcohol use disorder. the primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

the proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (lyrica) in the treatment of alcohol use disorder. pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. we plan to enroll 20 participants in an 8-week trial.the ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with alcohol use disorder (aud). the primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

Eligibility criteria:
inclusion criteria: * meets dsm-5 criteria for current alcohol use disorder * reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days * between the ages of 18 and 65 * able to provide informed consent and comply with study procedures exclusion criteria: * subjects with any current psychiatric disorder as defined by dsm-5, other than aud, that in the investigator's judgment might require intervention over the course of the study. * subjects receiving psychotropic medication treatment * evidence of moderate-to-severe alcohol withdrawal (ciwa-ar \> 13) * history of alcohol withdrawal seizures or alcohol withdrawal delirium * history of allergic reaction to candidate medication (pregabalin) * pregnancy, lactation, or failure in females patients to use adequate contraceptive methods * unstable physical disorders which might make participation hazardous * subjects who have a current dsm-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine use disorders. a diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol. * are legally mandated to participate in alcohol use disorder treatment program * cognitively impaired

Keywords: alcohol use disorder alcohol abuse treatment lyrica
the effect of gastric antrum ultrasonography on early stage of enteral nutrition in critically ill patients.

Conditions: Critically Ill

Summary: the purpose of this study is to investigate the effect of gastric antrum ultrasonography on early stage of enteral nutrition in critically ill patients.


Eligibility criteria:
inclusion criteria: all patients who need enteral nutrition (through the nose) in icu ; the length of stay in icu \> 3 days; exclusion criteria: \ 90 years old; gastrointestinal surgery history； small blow nutrition； bmi\>30kg/m2; pregnancy; prone position\>4hours a day
determination of a safe dose of optison in pediatric patients with solid tumors

Conditions: Abdominal Neoplasms; Pelvic Neoplasms

Summary: st. jude children's research hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body. researchers are studying a contrast agent (like a dye) called optison™. st. jude children's research hospital researchers want to learn the best and safest dose of this ultrasound "dye."


Eligibility criteria:
inclusion criteria: * age: 2-20 years old * subject has a known or suspected solid soft tissue tumor in the abdomen or pelvis. * subject is scheduled for other imaging or is already scheduled for an ultrasound or has already had adequate imaging performed at an outside institution. * subject is able to lie still for the exam without sedation. exclusion criteria: * known or suspected hypersensitivity to albumin, blood or blood products. * history of open heart surgery, cyanotic congenital heart disease or an axygen saturation of less than 96% as determined by pulse oximetry.

Keywords: ultrasound abdominal tumors pelvic tumors
transvaginal diverticulum wall filling and coverage technique for treating female circumferential urethral diverticulum

Conditions: Circumferential Female Urethral Diverticulum

Summary: the goal of this clinical study is to learn if a new surgical technique called transvaginal diverticular wall filling and covering is effective and safe for treating circumferential urethral diverticulum (ud) in female patients. the main questions it aims to answer are: does this technique reduce the risk of postoperative complications, such as fistula formation or stress urinary incontinence (sui)? does it improve urinary symptoms and sexual function? what are the recurrence rates after surgery using this approach? researchers will follow two groups of patients: one group includes patients who had this surgery in the past 5 years (retrospective group). the other group includes patients who are newly treated with this technique and followed prospectively. participants will: undergo the transvaginal wall filling and covering surgery. have regular follow-up visits to assess symptoms, complications, and quality of life. complete questionnaires about urinary and sexual function.

circumferential ud is a rare and complex subtype that surrounds the urethra and is associated with a higher risk of surgical complications when treated with conventional diverticulectomy. to address these challenges, this study utilizes a modified surgical approach in which the demucosalized diverticular wall is preserved, folded, and used to obliterate the diverticular cavity and reinforce the closure of the ostium. this technique aims to reduce surgical trauma, preserve urethral function, minimize dead space, and improve postoperative urinary and sexual function. all enrolled patients will undergo this standardized surgical intervention. follow-up assessments will be conducted at predefined timepoints (1 month and 6 months postoperatively). evaluations will include physical examinations, symptom assessments, and validated questionnaires addressing urinary symptoms, sexual function, and overall quality of life. primary and secondary outcome measures include: improvement or resolution of ud-related symptoms (e.g., dysuria, dyspareunia, urgency) incidence of postoperative complications (e.g., urethrovaginal fistula, de novo stress urinary incontinence) clinical and imaging-confirmed recurrence patient-reported outcomes regarding urinary and sexual function this study aims to provide clinical evidence on the feasibility, safety, and potential advantages of this novel technique for managing circumferential urethral diverticulum in women.

Eligibility criteria:
inclusion criteria: female patients with imaging-confirmed circumferential urethral diverticulum (ud). availability of complete medical records. minimum of 6 months postoperative follow-up. exclusion criteria: presence of uterine prolapse. diagnosis of vaginitis. presence of vaginal tumors. abnormal coagulation function.

Keywords: circumferential female urethral diverticulum transvaginal surgery recurrence