Kornimate/medical-research-clean huggingface dataset:
deworming and vitamin a (devta) prepilot study

Conditions: Malnutrition; Worm Infestation; Under-Fives

Summary: background. more than a third of the world's population is infected with intestinal nematodes. a majority of these infections occur in children. current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrensetting: within the integrated child development system (icds) infrastructure in urban lucknow (up), indiadesign: open labeled randomised trialhypothesis: our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenintervention one group will receive usual health care by the existing health care staff, which included six monthly administration of vitamin a concentrate. the other group will receive, in addition, 400 mg of albendazole (zentel, smith kline \& beecham) in 10 ml syrup form. five such doses will be given at six monthly intervals for 2 years.main objective: to assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age main outcomes measures: weight gain in 2 yearsinclusion criteria: children 1 to 5 years, whose guardians give written informed consent. exclusion criteria: those not consentingsample size: sample size was calculated for a continuous outcome. for a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.


Eligibility criteria:
inclusion criteria: * local residents * aged 1-5 years * informed written parental consent exclusion criteria: * refusal to give consent * prior enrollment in the study

Keywords: deworming malnutrition children community india
the application of zishen yutai pill in aged women undergoing ivf-et

Conditions: Infertility, Female

Summary: to explore the application of zishen yutai pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.

this will be a multi-center double-blind randomized controlled trial, which aims to explore the application of zishen yutai pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.the target population will be infertile women aged between 35 and 42 years, bmi\<28kg/m2 and bilateral ovaries who undergo ivf-et (long or antagonist protocol). qualified 1,466 patients are randomized into either of two groups.they will be randomized to receive either zishen yutai pill or the placebo. the pregnancy test results and pregnancy complications will be followed up by checking medical records and telephone calls.

Eligibility criteria:
inclusion criteria: * infertile women aged ≥35 and ≤42 years; * intend to undergo ivf/icsi-et (gnrh-a long protocol or gnrh-ant protocol); * bmi\<28kg/m2; * bilateral ovaries exist; * patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol. exclusion criteria: * repeated implantation failure (previous three times or more ivf/icsi-et failure); * adenomyosis, uterine line constricted by uterine fibroid; * untreated bilateral hydrosalpinx; * endometrial diseases that have not been cured ; * known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy; * patients who have taken traditional chinese medicine or chinese patent medicine for infertility treatment in the last month(30 days). exit criteria: * subjects who have adverse events cannot be tolerated; * severe breach of the protocol; * for subjects who exit due to personal or unpredictable reasons, please describe specific details; * subjects considered inappropriate to continue to participate in the study for other medical reasons.

Keywords: ivf-et infertility aged women
impact of vitamin c on biomarkers of neurologic injury in survivors of cardiac arrest

Conditions: Heart Arrest, Out-Of-Hospital; Biomarkers; Oxidative Stress; Neurological Injury

Summary: out-of-hospital cardiac arrest (ohca) is one of the leading cause of death in the world. in slovenia approximately 25% of resuscitated patients survives to discharge from hospitals, usually with poorer functional status. one of key pathophysiological process responsible for poorer functional status is global hypoxic-ischemic injury, which is two-stage. primary stage occurs immediately after cardiac arrest due to cessation of blood flow. with return of spontaneous circulation a secondary injury occurs, of which the leading process is an imbalance between oxygen delivery and consumption. reperfusion exposes ischemic tissue to oxygen, resulting in the formation of large amounts of highly reactive oxygen species (ros) within minutes. ros lead to oxidative stress, which causes extensive damage to cell structures and leads to cell death. consequently, necrosis and apoptosis are responsible for organ dysfunction and functional outcome of these patients. such injury of neural tissue causes brain damage, which is ultimately responsible for poor neurological and thus functional outcome of ohca survivors. the extent of brain damage can be determined in several ways: clinically by assessing quantitative and qualitative consciousness and the presence of involuntary movements in an unconscious patient, by assessing activity on electroencephalographic record, by imaging of the brain with computed tomography and magnetic resonance imaging, as well as by assessing levels of biological markers of brain injury. of the latter, the s-100b protein and neuron-specific enolase have been shown to be suitable for such assessment. oxidative stress is counteracted by the body with endogenous antioxidants that balance excess free radicals and stabilize cellular function. vitamin c (ascorbic acid) is the body's main antioxidant and is primarily consumed during oxidative stress. large amounts of ros rapidly depletes the body's vitamin c stores. humans cannot synthesise vitamin c and enteral uptake of vitamin c is limited by transporter saturation. on the other hand, parenteral (venous) dosing of vitamin c can achieve concentrations of vitamin c above physiological and thus produce a stronger antioxidant effect. the beneficial effect of parenteral dosing of vitamin c has been establish in several preclinical and clinical studies in patients with ischemic stroke and cardiac arrest. the investigators hypothesize that there is a similarly beneficial effect of vitamin c in survivors of ohca.


Eligibility criteria:
inclusion criteria: - comatose survivors of out-of-hospital arrest exclusion criteria: * patients with trauma, asphyxia, drowning or electrocution as a cause of cardiac arrest * history of oxalate nephropathy or nephrolithiasis, glucose-6-phosphate dehydrogenase deficiency, and hemochromatosis * pregnancy

Keywords: vitamin c biomarkers brain injury cardiac arrest
a study on the effects of interventional therapy in patients with lower extremity arterial occlusive disease and its risk factors(eilrf)

Conditions: PAD

Summary: along with the improvement of living standard, the prevalence of lower extremity arterial occlusive disease (leaod) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. currently, percutaneous transluminal angioplasty (pta), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for leaod. the therapeutic effects of lower extremity interventional treatment, varied in different reports. it was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. more risk factors are still unknown. the difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on leaod and explore its risk factors.


Eligibility criteria:
inclusion criteria: * male or female, age between 40-90 years old. * ankle-brachial index(abi)\<0.9. * lower extremity arterial ct shows that the arterial stenosis\>50% exclusion criteria: * type 2 diabetes with acute complications. * type 1 diabetes. * cerebrovascular diseases in the last 3 months. * cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months. * hemorrhagic disease. * hypohepatia (ast or ast is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy. * history of dialysis. * chronic obstructive pulmonary disease (copd), chronic respiratory failure or hypoxemia. * acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. * fertile woman without contraceptives. * allergic to iodine. * unable to understanding and follow the study protocol orientations.

Keywords: lower extremity arterial occlusive disease interventional therapy
efficacy of cognitive behavioral therapy and hair cortisol concentration

Conditions: Cognitive Therapy; Control

Summary: stress is considered as a risk factor for physical and mental health. for this reason, interventional programs focused on stress management have been developed. these programs have proven to be efficacious modifying emotional variables and psychopathological symptoms. however, there are no studies showing how these interventions modify objective measures of stress. for example, measures reflecting hipotalamic-pituitary-adrenal (hpa) axis activity, the main system involved in the stress response. the activity of hpa axis is also altered by illness and psychopathology. hair cortisol technique allows for changes assessment of hpa axis activity during months. therefore, hair cortisol may be considered as an useful tool to measure changes of emotional variables related to stress in the long term. this measure of change over time of hpa axis activation together with related emotional variables assessment could be useful to evaluate the efficacy of interventional programs. for this reason, the aim of this research is to assess the effects of a cognitive-behavioral treatment (cbt) on perceived stress, resilience, worries, psychopathology and hpa axis activity through hair cortisol analysis.


Eligibility criteria:
inclusion criteria: * member of university of granada, complete dominance of spanish, high levels of perceived stress. exclusion criteria: * psychopathology, being under psychological treatment.

Keywords: cognitive behavioral therapy hair cortisol hypothalamic pituitary adrenal axis stress psychopathology
insulin glargine in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: primary: * to investigate the efficacy of insulin glargine (in terms of change in a1c from baseline to endpoint a1c \< 7%) secondary: * to investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia) * to investigate whether beta cell function is preserved if this therapy is initiated before 2nd oad (oral anti-diabetic drug) failure


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients with first oad (sulfonylurea \[su\] or metformin) failure * patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week) * serum creatinine ≤ 1.5mg/dl * bmi: 21-41 kg/m² * 7.5%\< a1c \<11% * fasting plasma glucose \> 7.5mmol/l * on diet and exercise therapy and stable oad treatment (su or metformin \> ½ maximal dose)for more than 1 month prior to enrolment * women not of childbearing potential (sterilization procedure done or menopausal \> 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study * able and willing to monitor blood glucose * able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week * understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin exclusion criteria: * type 1 diabetes * acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma * pregnancy, breast-feeding * people who work night shifts * hypersensitivity to investigational drugs or its additives, or intolerability to metformin * need for use of medications prohibited by the protocol during the study for treatment purpose * significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis * drugs or alcohol abuse the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
hit on hypoglycemic risk in type 1 diabetes (t1d)

Conditions: Type1diabetes

Summary: there is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. however, many people with type 1 diabetes do not exercise regularly. the primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. this loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. recent work (unpublished) from our lab suggests high intensity interval training (hit) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn. therefore, the aim of this study is to determine the effects of hit on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise. 24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. during these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.


Eligibility criteria:
inclusion criteria: * t1d diagnosis more than 6 months ago (to ensure participants are out of the honeymoon period), * using a basal bolus insulin regime or insulin pump therapy * bmi ≤ 32 kg.m-2 exclusion criteria: * pregnancy (or planning pregnancy) * disability preventing participation in an exercise regime * angina * autonomic neuropathy * medication that affects heart rate (this will affect estimation of fitness) * major surgery planned within 6 weeks of study * uncontrolled blood pressure * significant history of hyperglycaemia * history of severe hypoglycaemia requiring third party assistance within the last 3 months * severe non-proliferative and unstable proliferative retinopathy
paroxetine-mediated grk2 inhibition to reduce cardiac remodeling after acute myocardial infarction

Conditions: Cardiac Remodeling; Myocardial Infarction

Summary: this study evaluates the off-target effect of paroxetine to reverse cardiac remodeling and improve left ventricular ejection fraction in patients after acute myocardial infarction. half of the participants will receive paroxetine, while the other half will receive placebo treatment.

cardiac remodeling is characterized by a composite of structural, geometric, molecular, and functional changes of the myocardium, and is an important determinant of heart failure and cardiovascular outcome in survivors of acute myocardial infarction. progression of heart failure secondary to the remodeling process results from dysregulation of the g protein-coupled receptor (gpcr). excessive adrenergic drive in patients with heart failure results in an enhanced activation of gpcr kinases (grks) that is considered to have a central role in adverse cardiac remodeling after ischemic injury. the selective serotonin reuptake inhibitor paroxetine specifically binds to the catalytic domain of grk2 as an off-target effect, and has been shown to reverse cardiac remodeling and increase left ventricular ejection fraction in a mouse model. the effect was observed at serum levels achieved with standard dosages of paroxetine, and was robust in mice with and without concomitant heart failure treatment, respectively.

Eligibility criteria:
inclusion criteria: * anterior wall st-segment elevation myocardial infarction * primary percutaneous coronary intervention (pci) within 24 hours of symptom onset * left ventricular ejection fraction ≤ 45% within 48-96 hours after primary pci (transthoracic echocardiography) exclusion criteria: * female patients at reproductive age (\<50 years) * known intolerance to paroxetine * inability to provide informed consent * currently participating in another trial before reaching first endpoint * current medical therapy with mao-blocker (during, 14 days before, and 14 days after treatment with mao-blocker), lithium, thioridazide, or pimozide * concomitant tamoxifen intake * previous myocardial infarction * previous revascularization procedure (percutaneous coronary intervention or coronary artery bypass grafting). * contraindication to cardiac magnetic resonance imaging * obvious or questionable inability to appropriately cooperate (alcohol, drugs etc.) * relevant nephropathy or hepatopathy

Keywords: paroxetine
japanese phase 1 multiple ascending dose (mad) study

Conditions: Depression

Summary: the purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of bms-820836 in healthy japanese subjects and japanese patients with depression.


Eligibility criteria:
inclusion criteria: * healthy japanese subjects and japanese patients with depression (hamilton rating scale for depression (ham-d) ≥ 14), ages 20 to 55 years. exclusion criteria: * any significant acute or chronic medical illness. * non-compliance, or overall not suitable as determined by the investigator. * history of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence.
medical treatment of peyronie's disease with collagenase clostridium histolyticum

Conditions: Peyronie Disease

Summary: peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. the physiopathology is largely unknown. there is a significant sexual and psychological impact on patients. historically, the only possible treatment was surgical. the only drug treatment that was fda approved for this disease was collagenase from clostridium histolyticum marketed under the name xiapex® until 31/12/2019 by sobi laboratory. marketing was stopped on that date for economic reasons and restricted to the us market only. the investigators propose a retrospective evaluation of the largest french monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * peyronie's disease stable for more than 3 months after 12 to 18 months of evolution * angle of penis deformation ≥ 30° exclusion criteria: * surgery for peyronie's disease before * anticoagulation

Keywords: collagenase clostridium histolyticum xiapex® peyronie's disease questionnaire (pdq) sexual dysfunction
ameliorating contrast induced nephropathy after coronary angiography

Conditions: Coronary Artery Disease; Nephropathy; Toxic, Drugs

Summary: given the limited understanding of the impact of statin and n-acetyl cysteine use before angiography in preventing contrast-induced nephropathy (cin), the objective of this study is to evaluate the effectiveness of atorvastatin in preventing cin among patients undergoing coronary angiography.

a multi armed randomized controlled clinical trial to be conducted from june 2023.according to inclusion and exclusion criteria, all patients presenting to the cardiology department at ain shams university hospitals, will be assessed for eligibility. at least 120 patients subjected to elective ct coronary angiography who are at risk of developing contrast-induced renal failure will be enrolled. the participants will be assigned to three groups (40 patients for each group): * three groups * high-dose atorvastatin group: 40 patients will receive 80 mg atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr) * n-acetyl cysteine group: 40 patients will receive 200mg 3 times daily 2 days before coronary angiography and 2 days after and will receive adequate hydration using (1ml/kg/hr) * control group: 40 patients will receive adequate hydration using (1ml/kg/hr) the blood sample will be collected from all patients before the administration of contrast media and after 24 hours for assessment of the needed parameters.

Eligibility criteria:
inclusion criteria: * undergoing elective coronary angiography who will receive coronary angiography contrast media. * must have at least two consecutive serum creatinine measurements (before and after contrast exposure) exclusion criteria: * pregnant or lactating women * patients with serum creatinine conc of \>2.1 mg/dl * patients undergoing emergency primary percutaneous coronary intervention for st-segment elevation myocardial infarction. * prior exposure to contrast media within 7 days * contraindication for a high-dose statin, n-acetyl cysteine prescription

Keywords: contrast induced nephropathy percutaneous coronary intervention
clinical trial to assess the efficacy and safety of tacrolimus ointment treatment of atopic dermatitis in adult patients

Conditions: Dermatitis, Atopic

Summary: objective: assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. the ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

the study was a one arm non-comparative study. the only study medication was tacrolimus ointment 0.1% (protopic ® 0.1%).

Eligibility criteria:
inclusion criteria: * male or female, any ethnic group, age ≥16 * moderate to severe atopic dermatitis * has given informed consent exclusion criteria: * erythroderma * pregnant or breast-feeding * skin infection on the affected area

Keywords: dermatitis, atopic tacrolimus adult
erector spinae plane block versus serratus anterior plane block

Conditions: Post Operative Pain; Opioid-Related Disorders

Summary: the aim of the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery

breast reduction surgery is a common cosmetic surgical procedure. providing effective analgesia has a crucial role in reducing side effects, catalyzing postoperative recovery, and increasing patient satisfaction. regional anesthesia techniques are generally used for postoperative analgesia to decrease opioid-related side effects. fascial plane block has gained popularity for breast analgesia. the investigator aimed to consider the effects of esp block or serratus anterior plane block on postoperative analgesia in breast reduction surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-ii, * 18-65 years of age, adult, * female patients * undergoing elective breast reduction surgery exclusion criteria: * allergy to amide-type local anesthetics * infection at the block injection site * severe obesity (bmi \> 35 kg/m2) * liver or renal deficiency * patients with anatomical deformities * recent use of analgesic drugs * patient refusal or inability to consent

Keywords: post operative pain opioid consumption erector spinae block serratus anterior plane block