Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of two treatments in the treatment of acne vulgaris on the face

Conditions: Acne Vulgaris

Summary: to compare the safety and efficacy of perrigo's product to an fda approved product for the treatment of acne vulgaris


Eligibility criteria:
inclusion criteria: 1. signed irb approved written informed consent/assent 2. 12 to 40 years of age, inclusive. 3. clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose. 4. baseline investigator's global assessment score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4. 5. females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at visit 1/day1(baseline), must be willing to use an acceptable form of birth control during the study. exclusion criteria: 1. pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. 2. presence of more than 2 facial nodulocystic lesions. 3. presence of any other facial skin condition that, in the investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations 4. any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments 5. excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris. 6. history of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy. 7. currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family. 8. history of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication. 9. use of medications known to exacerbate acne 10. start or change within 3 months (90 days) of visit 1 and throughout the study 11. use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study 12. subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. 13. subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
the effect of vitamin c on growth hormone secretion

Conditions: Obese; Disorder of Vitamin C; Growth Hormone Secretion Abnormality

Summary: obesity is associated with reduced growth hormone (gh) secretion. gh secretion is regulated by nutritional stimuli including fasting, insulin, glucose and free fatty acids. however, the role of micronutrients, such as vitamins, on gh secretion has not been investigated in much detail. vitamin c levels are also reduced in obesity, and the investigators recently demonstrated a possible role for dietary vitamin c intake in the regulation of gh secretion in two preliminary retrospective studies. the investigators therefore propose a more detailed prospective physiological study to examine the effects of increasing dietary vitamin c intake on gh secretion in a physiologic, intervention study. the investigators hypothesize that increasing vitamin c concentrations in obese subjects with sub-optimal plasma vitamin c levels and reduced gh secretion will increase gh secretion.


Eligibility criteria:
inclusion criteria: 1. men and women age 18-60 2. bmi ≥ 30 kg/m2 3. waist circumference ≥ 102 cm in men and ≥ 88 cm in women 4. plasma vitamin c concentration ≤ 23 µmol/l 5. peak stimulated gh ≤ 4.2 µg/l upon ghrh-arginine stimulation test exclusion criteria: 1. history of hypopituitarism, pituitary surgery, pituitary/brain radiation, recent traumatic brain injury or any other condition known to affect the gh axis. 2. history of severe chronic illness including anemia, chronic kidney disease, liver disease, oxygen dependent copd or hiv 3. subjects on testosterone, glucocorticoids, anabolic steroids, ghrh, gh or igf-1 within 3 months of enrollment 4. use of dietary supplements including vitamin c or once daily multi-vitamins 5. subjects with hgb \ 2.5x upper limit of normal or creatinine \> 1.5 mg/dl 6. subjects with poorly controlled diabetes, defined as hba1c \> 8%. 7. changes in lipid lowering or anti-hypertensive regimen within 3months of screening 8. subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit 9. any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.

Keywords: low vitamin c reduced growth hormone secretion
effect of dihydromirycetin on glycemic control, insulin sensitivity and insulin secretion in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: dihydromyricetin has demonstrated promising effects in glycemic control, insulin sensitivity and insulin secretion, that above mentioned findings show that dihydromyricetin has an excellent potential effect in the treatment of type 2 diabetes mellitus patients.

a double-blind, randomized clinical trial of three pharmacological groups in 36 patients with a diagnosis of type 2 diabetes mellitus in accordance with the american diabetes association (ada) without treatment. they will be assigned randomly two groups of 12 patients, each one will receive dihydromyricetin 300 mg or metformin 850 mg, two times per day before having break-fast and before having dinner during 12 weeks. the area under the curve of glucose and insulin will be calculated, total insulin secretion (insulinogenic index), first-phase of insulin secretion (stumvoll index) and insulin sensitivity (matsuda index). this protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. qualitative variables will be analyzed by x2, will be used for differences inter-group mann-whitney u test and wilcoxon test for the within-groups differences. it will be considered statistical significance p ≤0.05.

Eligibility criteria:
inclusion criteria: * patients both sexes * age between 30 and 60 years * diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \>126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \>200 mg/dl; or glycosylated hemoglobin between \>6.5%) * informed consent signed exclusion criteria: * women with confirmed or suspected pregnancy, or under lactation and/or puerperium * previous treatment for glucose * fasting glucose ≥250 mg/dl * body mass index ≥34.9 kg/m2 * known uncontrolled renal, hepatic, heart or thyroid diseased * hypersensibility to ingredients of intervention * triglycerides ≥500 mg/dl * total cholesterol ≥240 mg/dl * blood pressure ≥140/90 mmhg

Keywords: dihydromyricetin metformin type 2 diabetes mellitus
clinical implications of three-vessel ultrasonic flow ratio measurement in patients with coronary artery disease

Conditions: Coronary Artery Disease (CAD)

Summary: this is a prospective, observational, single-center study. the main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (ufr) in predicting functionally significant three coronary stenosis with conventional pressure wire-based fractional flow reserve (ffr) as the standard reference. the study will be conducted in fuwai hospital, and a total of at least 495 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (ivus) followed by ffr examination. ivus imaging will be sent to an independent core laboratory for ufr calculation. ufr analyses were performed offline in a blinded fashion without awareness of ffr measurement. using ffr≤0.80 as the gold standard, the sensitivity and specificity of ufr in the functional significance of all the three coronary artery stenoses will be analyzed.


Eligibility criteria:
inclusion criteria: stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction; age ≥18 years; written informed consent; angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery); patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (pci) prior to study enrollment. exclusion criteria: ineligible for diagnostic ivus examination; prior coronary artery bypass grafting (cabg); myocardial infarction within 72 hours of coronary angiography; severe heart failure; serum creatinine levels \>150 umol/l, or glomerular filtration rates \<45 ml/ kg/1.73 m2; allergy to the contrast agent or adenosine; life expectancy \< 2 years; severe coronary artery disease requiring cabg identified during angiography; extreme vascular tortuosity precluding ivus catheter advancement; suboptimal ivus image quality impairing quantitative analysis.
acute pancreatitis and thrombosis (pathro)

Conditions: Acute Necrotizing Pancreatitis; Portosplenomesenteric Venous Thrombosis

Summary: severe acute pancreatitis (ap) is a pathology with high morbidity and mortality. portosplenomesenteric vein thrombosis is a well-known local complication of ap with a variable incidence, which can reach up to 50% in case of severe ap. however, there is no specific recommendation regarding the management of portosplenomesenteric vein thrombosis. by analogy to all venous thrombosis, the european society of gastroenterology recommends curative anticoagulation. however, the efficacy of curative anticoagulation has never been evaluated by prospective studies. in addition, bleeding complications during ap occur in approximately 10% of patients and are associated with a poor prognosis. the investigators wish to conduct an observational multi-center study with epidemiologic aims, including all patients admitted for ap and with a diagnosis of portosplenomesenteric vein thrombosis. the aim of this study is to evaluate the therapeutic management of these patients, the efficacy and safety of anticoagulant treatment for the treatment of portosplenomesenteric vein thrombosis, and their outcomes.

the investigators will include prospectively all patients admitted for ap with a computed tomography diagnosis of portosplenomesenteric vein thrombosis.

Eligibility criteria:
inclusion criteria: * adult patients (age \> 18 years) with acute pancreatitis * and a diagnosis on ct injected with portal time of portosplenomesenteric vein thrombosis or laminated veins (without passage of blood flow through the vessel but without visible intraluminal thrombus) will be included. exclusion criteria: * patient under guardianship * refusal to participate in research * pregnancy

Keywords: acute necrotizing pancreatitis acute pancreatitis pancreas disease anticoagulation anticolagulant therapy bleeding portosplenomesenteric vein thrombosis splanchic venous thrombosis
evaluation of performances and safety of the medical device blueback® physio for patients with chronic low back pain

Conditions: Low Back Pain, Recurrent

Summary: the main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of blueback® physio compared to a rehabilitation without the use of blueback® physio in terms of reducing the time needed for a patient to control the voluntary contraction of the transversus abdominal muscle and to return to autonomy.

the blueback® physio is a wireless device for indicating, for a given patient, the relative level of contraction of the transversus abdominal muscle. blueback® physio is a ce marked class i medical device. this medical device allows to measure and visualize in real time the activity of the transversus abdominal muscle, one of the deepest muscle of the abdominal wall. it is placed on the patient, during a rehabilitation session with a mhysiotherapist. the objective is to optimize the three key phases followed by the healthcare professional: teaching his patient to feel the contraction of the muscle, learning to control this contraction, then learning to master this contraction when the patient is in double task (movements rehabilitation targeting other muscles, cognitive tasks or other tasks of everyday life that strain the spine). in the abc-tracc study, the objective is to compare the time needed for patient to get a good motor control on his transversus abdominal muscle if he is using the blueback® physio during his sessons or not.

Eligibility criteria:
inclusion criteria: * included in the presdo program, * suffering from chronic low back pain (= low back pain installed for more than 2 months), * beneficiary of a social security, * for which his consent has been obtained in writing with regard to his participation in the protocol. exclusion criteria: * bedridden or using a wheelchair, * having a contraindication to performing the muscular exercises provided for in the protocol, * having any other condition which, in the opinion of healthcare professionals, could affect its ability to complete the study or could present a significant risk, * simultaneously participating in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.
a clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients (i-rosette study)

Conditions: Hypercholesterolemia

Summary: a phase ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.


Eligibility criteria:
inclusion criteria: 1. 19 \~ 79 years old 2. patients who confirmed hypercholesterolemia. 3. patients who requiring drug therapy according to ncep atp(national cholesterol education program adult treatment panel) iii guideline at visit2. 4. patients with triglyceride\< 400 at visit 2. 5. patients who have a wash-out period over 4 weeks for other drugs that can affect lipid profile.(patients who have lipid regulators should have washout period over six weeks) 6. patients who agreed to participate in the trial exclusion criteria: 1. patients who have a history of myopathy or rhabdomyolysis by statin treatment or hypersensitivity to statin hmg coa(3-hydroxy-3-methylglutaryl-coenzyme) reductase inhibitors) or ezetimibe. 2. a heavy alcohol consumer. (alcohol \> 25 units/week) 3. patients with severe renal disease. (creatinine ≥ 2.0 mg/dl) 4. patients with active liver disease and ast(aspartate transaminase) or alt(alanine transaminase) \> 2 times of upper limit of normal range. 5. patients with cpk(creatine phosphokinase) \> 2 x upper limit of normal range. 6. patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein. 7. patients with hiv(human immunodeficiency virus positive. 8. patients who have a acute arteriopathy. 9. patients with uncontrolled hypertension. 10. patients who have hereditary problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. 11. patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder. 12. patients with tumor. 13. patients who have hormonal therapy. 14. pregnancy or breastfeeding patients who don't agree to use adequate contraception. 15. patients who are judged unsuitable to participate in this study by investigator. 16. patients taking other clinical trial drugs within 30 days from the time of visit for screening.
antenatal tranexamic acid in women with symptomatic placenta previa

Conditions: Placenta Previa

Summary: 200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending ain shams university maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).


Eligibility criteria:
inclusion criteria: * gestational age 28 weeks of gestation. * definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan. * haemodynamically stable pregnant women. * maternal age:20-40years old. * pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage. exclusion criteria: * multiple pregnancy. * women with bleeding tendency due to any medical disorder (itp, thrombocytopenia, coagulopathies),or on anticoagulants . * severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. * women have hypersensitivity or any contraindication to use of tranexamic acid. * pregnant women with placenta previa with doppler showing morbidly adherent placenta.
aspirin versus aspirin+clopidogrel as antithrombotic treatment following tavi

Conditions: Aortic Valve Disease; Myocardial Infarction; Stroke; Bleeding

Summary: the purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following tavi for the prevention of major ischemic events (mi, ischemic stroke) or death without increasing the risk of major bleeding events.

transcatheter aortic valve implantation (tavi) has emerged as an alternative to standard aortic valve replacement for the treatment of patients considered to be at very high or prohibitive surgical risk. nowadays the procedure is associated with a very high success rate (\>95%) but major peri-procedural ischemic complications such as myocardial infarction (mi) or ischemic stroke occur in about 2% (0% to 17%) and 3% (2% to 7%) of the cases, respectively. the recently published partner trial showed a stroke rate as high as 6.5% within the 30 days following tavi, with most (77%) of these events diagnosed as major strokes. in order to avoid such ischemic complications full dose anticoagulation (usually intravenous heparin) is administered during the tavi procedure, whereas aspirin (long-term) + clopidogrel (1 to 6 months) have been the recommended antithrombotic treatment following the procedure. however, this antithrombotic regime has been recommended on an empirical basis, and no studies have as yet shown the efficacy of aspirin + clopidogrel vs. aspirin alone or no antithrombotic treatment in preventing ischemic events following tavi procedures. also, patients undergoing tavi nowadays are usually octogenarians and very frequently exhibit comorbidities such as hypertension, abnormal renal function or prior cerebrovascular disease, which significantly increase the risk of major bleeding. indeed, tavi procedures can also be associated with major vascular complications which in turn can complicate with life-threatening or major bleeding. it is well know that clopidogrel on top of aspirin is associated with a higher rate of major bleeding complications, especially in elderly patients. it would therefore be of major clinical relevance to determine the risk/benefit ratio of using a dual antithrombotic therapy following tavi procedures in order to recommend the most appropriate antithrombotic treatment in this high-risk population. the arte trial is a multicenter randomized study to evaluate the efficacy and safety of aspirin/acetylsalicylic acid versus aspirin/acetylsalicylic acid+ clopidogrel as antithrombotic treatment after tavi.

Eligibility criteria:
inclusion criteria: * patients undergoing a tavi procedure with the edwards valve. exclusion criteria: * need for chronic anticoagulation treatment * major bleeding within the 3 months prior to the tavi procedure * prior intracranial bleeding * drug-eluting stent implantation within the year prior to the tavi procedure * allergy to clopidogrel and/or aspirin/acetylsalicylic acid

Keywords: transcatheter aortic valve implantation antithrombotic treatment clopidogrel aspirin/acetylsalicylic acid myocardial infarction ischemic stroke major bleeding
implementation of strength at home for military couples

Conditions: Intimate Partner Violence

Summary: the strength at home couples program is designed to enhance intimate relationships and prevent intimate partner violence (ipv) among service members and their partners in light of the unique stressors and experiences of this population.

a hybrid type-i implementation-effectiveness research design will allow the research team, comprising investigators with expertise in treatment development, efficacy and effectiveness research, and implementation science, to simultaneously investigate the effectiveness of sah-c in a military population while identifying any barriers to implementation that would need to be addressed before sah-c could be successfully implemented on a larger scale. sah-c derives from a unique fusion of interventions for trauma and ipa, integrating elements of cognitive processing therapy for ptsd,39 couples therapy for ptsd,40 and a cognitive behavioral intervention for ipa.41 sah-c consists of 10 two-hour weekly sessions, co-led by two therapists. this was the minimum length deemed necessary to incorporate components addressing the proposed ipa mechanisms and is consistent with the briefest ipa interventions.42 during each session, couples are provided assignments to practice skills together and to assist with the consolidation of material. a group couples format is used because group cohesion among clients appears to be associated with ipa prevention.43 group interventions also use less time and resources than individual-based interventions.

Eligibility criteria:
inclusion criteria: * couples must be in an intimate relationship * must be over the age of 18 * both members of the couple report no occurrence of physical ipa in the past 3 months and no severe aggression in the past 12 * at least one member reports at or below a score of 100 on the dyadic adjustment scale * both members must provide research consent exclusion criteria: * will be excluded on the basis of reading difficulties that preclude valid completion of the assessment instruments

Keywords: prevention domestic violence military couples veterans marital relationship trauma ptsd implementation
performance evaluation of ani in patients under general anesthesia with remimazolam

Conditions: Pain Measurement

Summary: the purpose of this study is to determine whether analgesia nociception index (ani) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.


Eligibility criteria:
inclusion criteria: patients * aged 20-79 years under general anaesthesia with remimazolam * scheduled to undergo robotic surgery * in american society of anesthesiologists physical class 1, 2 or 3 * voluntarily agree in writing to participate in this clinical study exclusion criteria: * conditions affecting the autonomic nervous system * other conditions or disease that may cause acute or chronic pain * the nrs before induction of anesthesia is 1 or over * when taking medications that may affect the autonomic nervous system * in other cases where the investigator deems the subject unsuitable for this trial

Keywords: remimazolam remifentanil analgesia nociception index (ani)