Kornimate/medical-research-clean huggingface dataset:
study comparing a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago

Conditions: Acute Lumbago

Summary: the purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

to assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the same components alone. some eligibility criteria: have a normal x-ray of the lumbar spine for the age; have a baseline score in the vas higher than or equal to 40 mm

Eligibility criteria:
inclusion criteria: * sign, initial and date the informed consent form (icf); * be between 18 and 75 years old; * have acute lumbago with onset in less than 72 hours; * have a normal x-ray; * have a baseline score in the vas higher than or equal to 40 mm; exclusion criteria: * use of triptans; * use of monoamine oxidase inhibitors; * use of nsaids within the last week; * previous use of narcotics; * have any rheumatologic disease; * conditions of chronic pain; * have any significant chronic comorbidity; * previous history of gastrointestinal bleed or ulcers; * history of allergy to any of the components of study medications; * recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure; * female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study; * have participated in another clinical trial within the last 12 months.
medication focused outpatient care for underutilization of secondary prevention

Conditions: Diabetes; Hyperlipidemia; Hypertension; Cardiovascular Disease

Summary: the study tested whether a pharmacist-run cardiovascular risk service (cvrs) at the university of iowa can increase use of national standards of care in clinics

this project conducted a multicenter, cluster-randomized study utilizing a centralized cvrs for medical offices with large geographic, racial and ethnic diversity to determine the extent to which the cvrs model will be implemented. twenty primary care offices were randomized to either the cvrs arm or a usual care arm, and 18 continued in the study. each clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186 represented racial minorities. subjects in the intervention arm clinic had regular contact by phone, email or text with a cvrs clinical pharmacist housed at the university of iowa. the pharmacist communicated with the subject, with the site clinical pharmacist and, as needed, with the site provider to optimize both the subject's pharmaceutical regimen and lifestyle behaviors. the cvrs intervention lasted for 12 months. a complex algorithm was used to calculate the degree to which the subject's care and medical regimen follows national guidelines for reducing the risk of developing cardiovascular risk. post-intervention telephone interviews are being conducted with 20 intervention subjects in order to assess their experience with the intervention and barriers and facilitators to the intervention.

Eligibility criteria:
inclusion criteria: * english speakers age 55 or greater * must have a medical history of at least one of the following: * coronary artery disease * myocardial infarction * stroke * transient ischemic attack * atrial fibrillation * systolic heart failure * peripheral vascular disease/claudication * carotid artery disease * diabetes with either: low density lipoprotein (ldl) 100 or greater and/or systolic blood pressure 140 or higher or diastolic blood pressure 90 or higher exclusion criteria: * signs of acute angina, stroke, heart failure or renal failure * systolic blood pressure 200 or greater or diastolic blood pressure 115 or greater * significant hepatic disease, including: cirrhosis, hepatitis b or c infection, alanine aminotransferase (alt) or aspartate aminotransferase (ast) 3 times control or higher, or total bilirubin 2.0 mg/dl or higher

Keywords: diabetes hyperlipidemia hypertension cardiovascular disease
platelet aggregation in diabetic patients with acute coronary syndrome treated with different doses of aspirin

Conditions: Acute Coronary Syndrome; Diabetes Mellitus

Summary: diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. the aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.


Eligibility criteria:
inclusion criteria: * diabetic patients with acute coronary syndrome after 24 hours from the coronarography exclusion criteria: * patients with a family or personal history of bleeding or thrombophilic disorders; * platelet count \>600000/mmc or \<150000/mmc * hematocrit \>50% or \<25% * creatinine clearance \<30 ml/min

Keywords: platelet aggregation acute coronary syndrome diabetes
aklief evaluation in acne-induced post-inflammatory hyperpigmentation

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the efficacy and safety of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (pih) after 24 weeks of treatment in facial acne participants


Eligibility criteria:
key inclusion criteria: * participant with clinical diagnosis of acne vulgaris, defined by: 1. moderate acne on the face (acne investigator's global assessment \[iga\] =3); and 2. with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose); and 3. moderate to marked pih on the face (overview of pigmentation disorders hyperpigmentation scale 4-6); and 4. no more than one acne nodule or cyst (greater than \[\>\] 1 centimeter \[cm\]) on face (excluding the nose) * participant with any fitzpatrick skin type i to vi (target patient enrollment according to fst) * female participants of childbearing potential must have a negative urine pregnancy test (upt) at baseline visit * female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study * female participant of non-childbearing potential * other protocol defined inclusion criteria could apply key exclusion criteria: * participant with severe acne (iga \> 3) * participant with more than 1 nodule/cyst on the face (excluding the nose) * participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne, acne requiring systemic treatment * participant with damaged facial skin that may interfere with study assessments * female participant who is pregnant, lactating or planning a pregnancy during the study * female participant of childbearing potential using combined oral contraceptives approved as acne treatments, in whom the dose has not been stable for at least 6 months prior to the baseline visit * participant with known impaired hepatic or renal functions * participant with active or chronic skin allergies

Keywords: acne vulgaris trifarotene aklief cd5789
relationship of obesity with gerd among nigerians

Conditions: Gastro-esophageal Reflux Disease With Ulceration.

Summary: obesity is a strong risk factor for gerd. this study assessed the role of obesity among patients having erosive gerd and controls.

a case control study of patients with erosive gerd. patients with erosive gerd who had upper gastro-intestinal endoscopy were graded using the los angeles classification. patients and controls had measurements of body mass index (bmi), wc (waist circumference), waist hip ratio (whr), and hip circumference (hc). bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. a p value of equal to or less than 0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * patients with dyspepsia exclusion criteria: * patients that refused consent. * patients with gastric cancer * patients with gastric outlet obstruction * pregnant women * active gastrointestinal bleeding * cigarette smokers * patients on naso-gastric tube.

Keywords: gastroesophageal reflux disease women nigeria obesity
linear growth study (0476-097)(completed)

Conditions: Asthma

Summary: the purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.


Eligibility criteria:
inclusion criteria : * boys (aged 6 to 8 years at visit 1) at tanner stage i (prepuberty) * girls (aged 6 to 7 years at visit 1) at tanner stage i (prepuberty * with at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists) exclusion criteria : * patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to visit 1
enhancing sleep duration: effects on children's eating and activity behaviors-renewal

Conditions: Obesity; Sleep

Summary: enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (cv) disturbance. observational studies with children demonstrate that short sleep increases risk of obesity and other cv risk factors. randomized controlled trials with children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes in eating and activity behaviors and weight status, particularly for children who enhance their sleep the most. enhancing sleep may be particularly important for racial minority children and those from lower socioeconomic backgrounds given their increased risk for short sleep, obesity and cv risk factors. in this study two active obesity preventive interventions will be evaluated: a) enhancing sleep alone (optimize sleep \[os\]), and b) enhancing sleep along with eating and activity behaviors that have demonstrated efficacy for obesity prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy dense snack foods and beverages, tv viewing, and physical activity) (os-plus). two hundred four children 6-11 years old who are primarily african american/black, primarily from low socioeconomic backgrounds, and who sleep \< 9.5 hours/night into a 12-month study will be enrolled. children will be randomly assigned to either os or os-plus. over the 6-month treatment phase, all children will attend an 8-session treatment; monthly phone contacts will occur during maintenance (6-12 months). primary aim is to determine the efficacy of os-plus relative to os on change in body mass index z-score (bmiz) at end of treatment. secondary aims will assess efficacy of os-plus relative to os on additional cardiometabolic risk factors, eating and activity behaviors. exploratory aims will assess maintenance of effects at 12 months.


Eligibility criteria:
inclusion criteria: 1. caregiver-reported child age of 6-11 years 2. \< 9.5 hours time-in-bed for sleep most days/week 3. bmi for age and gender \> 25th percentile (but no greater than 100% overweight) 4. understanding of and ability to complete protocol 5. self-reported caregiver age of 18 years and primary caregiver at bedtimes/wake times 6. likes food used in the eating regulation paradigms 7. willingness to be randomized to either treatment condition. exclusion criteria: 1. diagnosable sleep disorder 2. medication use or diagnosis of medical or psychiatric condition that may impact sleep/weight status 3. current or planned treatment for weight control 4. allergies or dietary restrictions that would prevent consumption of foods used in the study

Keywords: obesity prevention sleep behavioral intervention
brain (biomarker rapid assessment of ischemic injury)

Conditions: Stroke; Stroke Mimic(Conditions Presenting With Stroke-like Conditions)

Summary: this project is designed to evaluate the clinical utility of a novel blood test, the triage stroke panel, as an aid in the diagnosis and assessment of stroke. the triage stroke panel test device, used with the triage meterplus, is a rapid, point-of-care immunoassay. the test measures the concentration of various analytes present in edta-anticoagulated whole blood or plasma, specifically b-type natriuretic peptide (bnp), fibrin degradation products containing d-dimer, matrix metalloproteiase-9 (mmp-9), and s-100b. the test utilizes a proprietary algorithm for the automatic calculation of a single multimarker index (mmx) result from the individual biomarker values. the mmx result is being evaluated for use as an aid in the assessment and diagnosis of stroke.

to date, there is no commercially available blood test approved in the united states for use as an aid in the assessment and diagnosis of stroke. there have been various reports in the scientific literature describing the ability of various biomarkers to predict or identify stroke, with varied success. a biomarker panel approach, similar to that used for the evaluation of chest pain patients (troponin i, ck-mb, and myoglobin) enhances diagnostic accuracy, particularly when the panel includes protein markers associated with various components of the disease pathophysiology. this study involves a retrospective analysis of data collected from patients that present with an acute focal neurological deficit, suspected cerebral ischemia, or suspected intracranial hemorrhage within 24 hours of symptom onset or last known well time will be enrolled into the study. blood samples will be collected at enrollment and serially up to 72 hrs. from the time of onset or last known well time. the study population will also include a subset of patients with subarachnoid hemorrhage, who will have additional samples collected daily from day 3 through day 14 (at clinical sites participating in the vasospasm substudy) for the evaluation of cerebral vasospasm. the patient's participation in the study is complete when all samples have been collected or when they are discharged from the hospital, whichever occurs first. all blood sample will be analyzed using the triage stroke panel test. measurements will be performed at each clinical site and at biosite (subject to test device availability). in order to minimize bias and eliminate significant risk to the patient, physicians will be blinded to all triage stroke panel results during the course of the study. completed case report forms (crfs) and frozen plasma samples will be transferred to biosite.

Eligibility criteria:
inclusion criteria: age 18 and above cerebral ischemia or intracranial hemorrhage suspected enrollment within 24 hrs from symptom onset or last well-known time exclusion criteria: none
robotic natural orifice specimen extraction surgery versus robotic transabdominal specimen extraction surgery for early-stage rectal cancer

Conditions: Rectal Cancer; Robotic Surgery; Natural Orifice Specimen Extraction Surgery

Summary: a retrospective cohort study, conducted nationwide（china） and across multiple centers, aimed to compare the surgical quality and short-term outcomes of r-noses （robotic natural orifice specimen extraction surgery）with r-tses （robotic transabdominal specimen extraction surgery） for early-stage rectal cancer.

in this retrospective cohort study, data from 1086 patients who underwent r-noses or r-tses for early-stage rectal cancer between october 2015 and november 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. the study was aimed to compare the surgical quality and short-term outcomes of r-noses with r-tses for early-stage rectal cancer.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed rectal adenocarcinoma 2. robotic tme for rectal adenocarcinoma 3. postoperative pathological staging of t1-2n0m0 4. complete surgical and postoperative follow-up information exclusion criteria: 1. body mass index (bmi) ≥ 35 kg/m2 2. history of abdominal surgery 3. history of pelvic surgery 4. presence of another primary cancer 5. previous endoscopic submucosal dissection (esd) or endoscopic mucosal resection (emr) 6. anal or vaginal disease 7. ileostomy or transverse colostomy 8. conversion to open operation 9. tumor distant metastasis
early versus delayed artificial rupture of membranes (arom trial)

Conditions: Induction of Labor Affected Fetus / Newborn

Summary: this randomized controlled trial of consenting women undergoing induction of labor with combined combination foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. this project will include 157 women presenting at christiana care health system. women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a foley catheter combined with either misoprostol or pitocin. following admission, women will be randomized into either early or delayed amniotomy women will be randomized with equal probability to the intervention group using block randomization stratified by party. prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review


Eligibility criteria:
inclusion criteria: * ≥18 years of age * full term (≥37 weeks) gestations determined by routine obstetrical guidelines * singleton gestation in cephalic presentation * both nulliparous and multiparous women * intact membranes * bishop score of ≤6 and cervical dilation ≤2cm exclusion criteria: * any contraindication to a vaginal delivery or to misoprostol * fetal demise * multifetal gestation * major fetal anomaly * prior uterine surgery, previous cesarean section * women with hiv, hepatitis c, hepatitis b, and women with medical conditions requiring an assisted second stage * additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (hellp) syndrome or eclampsia, growth restriction \<10th percentile (based on hadlock growth curves) with reversal of flow in umbilical artery doppler studies, and growth restriction \<5th percentile with elevated, absent, or reversal of flow in umbilical artery doppler studies.
subcutaneous progesterone supplementation in patients with endometriosis

Conditions: Endometriosis

Summary: the aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; pleyris, ibsa institut biochimique sa) with vaginal progesterone (90 mg / day; crinone, merck serono) administered during the luteal phase in term of pelvic pain reduction in patients with grade i-ii endometriosis and / or endometrioma \<4 cm subjected to time intercourses or cos/iui cycles.

patients with grade i-ii endometriosis and / or endometrioma \<4 cm subjected to time intercourses or cos/iui cycles will be subjected to subcutaneous or vaginal progesterone for their luteal phase supplementation in time intercourses or iui cycles. the aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; pleyris, ibsa institut biochimique sa) with vaginal progesterone (90 mg / day; crinone, merck serono) administered during the luteal phase in term of pelvic pain reduction

Eligibility criteria:
inclusion criteria: * laparoscopic or ultrasonographic diagnosis of endometriosis grade i-ii and / or endometrioma \<4 cm; * menstrual vas score\> 5 cm before the last menstrual period with progesterone treatment * infertility for at least 1 year * body mass index 19 to 30 kg / m2 * basal fsh serum \<15 iu / ml * normal levels of serum prolactin * normal uterine cavity and fallopian patency exclusion criteria: * previous ovarian surgery * endocrine disorders (eg polycystic ovary syndrome, thyroid disease, hyperprolactinemia, hypogonadotropic hypogonadism) * reduced ovarian reserve (basal levels of fsh\> 15 iu / ml) * acute or chronic infectious state * chronic drug intake, alcohol, or drugs that affect cognitive functions, alertness and / or mood * psychiatric disorders * kidney or liver diseases * male factor infertility

Keywords: endometriosis subcutaneous progesterone luteal phase
the impact of epidural fat resection on postoperative outcomes in posterior surgery of lumbar spine

Conditions: Spinal Stenosis

Summary: posterior lumbar epidural fat commonly had been considered a simple space-filling tissue. anatomic studies on posterior epidural space and its contents are few, including semifluid property. in other words, there has not been studied thoroughly regarding the significance and role of posterior epidural fat in lumbar spine. in adults, epidural fat situated in the posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of thecal sac. the fat tissue was covered by a thin membrane of connective tissue, which were free under this layer. the anterior surface of this membrane lay close to the dura mater without any attachment. to date, the epidural fat has been resected routinely by pituitary forcep and suction drainage during posterior lumbar surgery. however, the investigators focused on the role of epidural fat, which might be associated with postoperative outcome. the investigators thought that this peculiar character, epidural fat, should be caused by certain etiologies. in general, each tissue, such as epidural fat, has its inherited features and significance, thereby the epidural fat has also specific role. however, there has not been fully studies regarding it. thus, the investigators aimed to evaluate the impact of the posterior epidural fat on the postoperative outcomes such as pain intensity and functional outcomes by whether the epidural fat would be resected or not during posterior decompressive surgery. the investigators hypothesized that the epidural fat would be associated with postoperative pain intensitive, functional outcomes, and complications of the surgery such as failed back surgery syndrome. in this study, new device for resection of epidural fat was not utilized, but just resected with conventional devices such as pituitary forcep.


Eligibility criteria:
inclusion criteria: * patients with a lumbar spinal stenosis, which were diagnosed using lumbar spine radiographs and magnetic resonance images (mri) that corresponded to clinical manifestations and physical examinations * patients who underwent one-level posterior decompression * patients aging between 20 and 80 years * patients who volunteered for this study with written consent * patient who were followed-up for one year or more exclusion criteria: * fractures, infection, or tumors in the lumbar spine * patients with hemorrhagic disorders such as hemophilia and thrombocythemia * patient with a follow-up period of less than one year * patients who are not suitable for this study judged by the principal investigator

Keywords: epidural fat resection spinal stenosis lumbar spine