Kornimate/medical-research-clean huggingface dataset:
special drug use surveillance of entresto tablets (hypertension)

Conditions: Hypertension

Summary: this is a single arm, multicenter, observational study to evaluate the safety and efficacy of entresto tablets during the first 52 weeks of treatment in japanese patients with hypertension.

this study is a special drug use surveillance to collect information on the safety specifications under the actual clinical practice of entresto tablets in patients with hypertension in japan to confirm the occurrence and timing of onset of events related to the safety specifications and investigate their risk factors.

Eligibility criteria:
inclusion criteria: 1. patients who have given written consent to participate in this study before the start of treatment with entresto 2. patients who used entresto for the first time for the indication of hypertension exclusion criteria: 1. patients who have received a formulation containing the same ingredient as entresto (including investigational product or post-marketing clinical study drug) 2. the following patients for whom administration of entresto is contraindicated in the package insert: * patients with a history of hypersensitivity to any of the ingredients of entresto * patients who are receiving angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, and lisinopril hydrate) or who discontinued these drugs within 36 hours. * patients with a history of angioedema (angioedema due to angiotensin ii receptor antagonists or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.) * patients with diabetes mellitus who are receiving aliskiren fumarate * patients with severe hepatic impairment (child-pugh class c) * pregnant or possibly pregnant women 3. patients with a history or complication of cardiac failure 4. patients who have been hospitalized at the start of treatment with entresto

Keywords: hypertension entresto entresto tablets actual clinical practice japan sacubitril/valsartan sacubitril valsartan sodium hydrate
efficacy of aspirin and l-arginine in high risk preeclamptic

Conditions: High Risk Pregnancy

Summary: worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. the world health organization (who) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). in mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; moreover, it has been observed that l-arginine lowers blood pressure in this population. it is for this that is of interest to know the efficacy and safety of the combination of l-arginine low dose, which is known as an important enos in no production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.

it will conduct a clinical trial, double-blind, randomized and placebo control group female patients with 12 weeks of gestation have one or more risk factors for developing preeclampsia. 2 groups will be formed with 82 patients each, chance will determine the intervention (acetylsalicylic + l-arginine acetylsalicylic acid or acid + placebo). at the beginning and end of the intervention clinical and laboratory determinations, the end will be determined in both groups the incidence of preeclampsia, severity and number needed to treat is made. the data obtained were analyzed using spss statistical software version 22. it was considered statistically significant at p \<0.05.

Eligibility criteria:
inclusion criteria: * pregnant before 12 weeks of gestation * high risk of preeclampsia * signature of informed consent in writing exclusion criteria: * noncompliance \> 20% of drug intake * lack of tolerability l-arginine or acetylsalicylic acid * compliance with at least one non-inclusion criteria during the course of the study * serious adverse event * withdrawal of consent

Keywords: preeclampsia l-arginine
early dieting in girls: a longitudinal cohort study

Conditions: Eating Behavior; Dietary Habits; Weight, Body

Summary: this longitudinal observational cohort followed the growth and development of non-hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake.

this longitudinal observational cohort followed the growth and development of non-hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake. data was collected biennially from girls and their mothers and fathers. measures included anthropometrics, questionnaires and laboratory measures of eating behavior, dietary recalls, psychosocial characteristics, and parenting measures.

Eligibility criteria:
inclusion criteria: * living with both biological parents exclusion criteria: * severe food allergies * chronic medical conditions affecting food intake
mantra meditation in major depression

Conditions: Depression

Summary: to evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to increased spirituality as a potential mediating factor of positive mental health.

primary objective to measure the difference in efficacy between treatment as usual (tau) + mantra meditation (mam) 20min per day and tau + progressive muscle relaxation (pmr) 20min per day in the treatment of depressive symptoms in patients with major depression after inpatient treatment, after 3 months and after 6 months of treatment as assessed by the montgomery-åsberg depression rating scale (madrs). secondary objectives (exploratory) 1. differences between and within groups in self-rated depression, rumination, automatic negative thinking or trait-anxiety. 2. differences between and within groups in measures of spirituality. 3. correlation between measures of spirituality and change of psychometric scores. 4. change in stress response and relaxation response after inpatient treatment, compared to baseline. 5. difference in adherence and depth of practice between groups and within groups and correlation to psychometric outcomes.

Eligibility criteria:
inclusion criteria: 1. inpatients of open psychiatric ward 2. written informed consent by patients who are competent to consent to study participation 3. diagnosis of current episode of major depression as defined by dsm-iv criteria and diagnosed via structured interview (skid) by a trained psychiatrist or psychologist. dsm-iv codes: 296.22, 296.23, 296.32, 296.33. corresponding icd-10 codes: f32.1, f32.2, f33.1, f33.2. 4. male or female ≥18 years of age 5. bdi-ii \>= 20 6. patients must be able to sit in a chair for at least 20 minutes 7. patients live in the catchment area of the hospital exclusion criteria: patients will be excluded for any one of the following reasons: 1. any other current major psychiatric disorder is an exclusion criterion except for the following: * abuse of nicotine or dependence of nicotine; * agoraphobia with or without panic disorder, generalized anxiety disorder, posttraumatic stress disorder, specific phobia, social phobia * hypochondriasis, pain disorder, somatization disorder, undifferentiated somatoform disorder * sexual and gender identity disorders * eating disorders 2. psychotic symptoms that are not compatible with diagnosis of unipolar depression 3. acute suicidality 4. diagnosis affecting cortisol levels such as type i diabetes mellitus, cancer, asthma, chronic hepatitis, chronic fatigue syndrome, or regular use of medications having an immuno-modulary effect (e.g. cytotoxic chemotherapy, corticosteroids, interferons); 5. current practice of other forms of mantra repetition such as the rosary, chanting, or transcendental meditation 6. current participation in another trial

Keywords: mantra meditation
study of aoc 1044 in healthy adult volunteers and participants with duchenne muscular dystrophy (dmd) mutations amenable to exon 44 skipping

Conditions: Duchenne Muscular Dystrophy; Exon 44

Summary: aoc 1044-cs1 (explore44) is a phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of aoc 1044 in healthy adult volunteers and participants with dmd mutations amenable to exon 44 skipping. part a is a single dose design with multiple cohorts (dose levels) in healthy adult volunteers. part b is a multiple-ascending dose design with 3 cohorts (dose levels) in participants with duchenne.


Eligibility criteria:
part a: key inclusion criteria: * aged 18 to 55 years, inclusive, at the time of informed consent * body mass index (bmi) of 18.5 to 32.0 kg/m2 key exclusion criteria: * clinically significant abnormalities in laboratory results, ecgs, or vitals * current or recent use of prescription or nonprescription drugs * positive drug/alcohol test at screening or day -1 * elevated blood pressure (bp) \>130/80 mmhg at screening * participation in a clinical study in which an investigational product was received within 1 month of screening or 5 half-lives of the investigational product * blood or plasma donation within 16 weeks of planned aoc 1044 administration note: other protocol defined inclusion/exclusion criteria may apply part b: key inclusion criteria: * aged 7 to 27 years, inclusive, at the time of informed consent * clinical diagnosis of dmd or clear onset of dmd symptoms at or before the age of 6 years * confirmation of dmd gene mutation amenable to exon 44 skipping * weight ≥ 23 kg * ambulatory or non-ambulatory * ambulatory participants: lvef ≥50% and fvc≥50% * non-ambulatory participants: lvef ≥45% and fvc≥40% * pul 2.0 entry item a ≥3 * if on corticosteroids, stable dose for 30 days before screening and throughout the study key exclusion criteria: * biceps brachii muscles unsuitable for biopsy * serum hemoglobin \< lower limit of normal * uncontrolled hypertension or diabetes * prior treatment with any cell or gene therapy * prior treatment with another exon 44 skipping agent within 6 months prior to informed consent * recently treated with an investigational drug * history of multiple drug allergies

Keywords: explore44 avidity biosciences avidity aoc 1044
development and testing of a pediatric cervical spine injury risk assessment tool

Conditions: Cervical Spine Injury

Summary: cervical spine injuries (csi) are serious, but rare events in children. spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with csi, but are poorly studied. in contrast, spinal precautions for pediatric trauma patients without csi are common and may be associated with harm. spinal precautions result in well-documented adverse physical and physiological sequelae. of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ed) to evaluate children for csi and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. most children who receive spinal precautions and/or are imaged for potential csi, and particularly those imaged with computed tomography (ct), are exposed to potential harm with no demonstrable benefit. therefore, there is an urgent need to develop a pediatric csi risk assessment tool that can be used in the prehospital and ed settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for csi.


Eligibility criteria:
inclusion criteria: * age 0-17 years * known or suspected exposure to blunt trauma at least one of the following applies to the patient: * undergoing trauma team evaluation * transported from the scene to participating facility by ems * undergoing cervical spine imaging at participating facility * transferred to participating facility with cervical spine imaging exclusion criteria: * exposed to solely penetrating trauma (e.g. a gunshot or stab wound)
memory training versus yogic meditation training in older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the purpose of this pilot study is to test whether 6 months of supervised weekly kundalini yoga classes and a brief daily meditation homework assignment can improve memory and thinking in older adults with mild memory complaints when compared to weekly classes of memory training with daily homework assignments.

the purpose of this pilot study intervention is to investigate brain mechanisms of response to memory enhancement training (met) compared to kundalini yoga and "kirtan kriya" meditation using functional magnetic resonance imaging (fmri) that will be acquired from each subject at baseline and at 12 weeks (post-randomization). overall, the investigators anticipate recruiting 66 adults with memory complaints and diagnosed with mci for adults 55 years old and older. subjects will either receive: (1) met class for 60 minutes per week; or (2) kundalini yoga and "kirtan kriya" meditation class for 60 minutes per week. all assessments will be completed immediately after the interventions for a total of 10 visits in 12 weeks and a follow-up visit at 6 months (24 weeks)to monitor the overall benefit of the intervention.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment amnestic type * clinical dementia rating scale score of 0.5 * sufficientenglish proficiency and 8th grade or higher reading level as determined by the word reading subtest of the wide range achievement test-iv * capacity to provide informed consent. exclusion criteria: * any current or past psychiatric disorders, or recent unstable medical or neurological disorders * any disabilities preventing their participation in the memory enhancement training (met) (e.g. severe visual or hearing impairment) * insufficient english proficiency * diagnosis of dementia * mini mental health examination score of 24 and below * psychoactive medications * participation in a psychotherapy that involves cognitive training * do not meet criteria for mild cognitive impairment subtype * prior or current training in yoga.

Keywords: memory impairment meditation yoga memory training mild cognitive impairment mci geriatric fmri
to evaluate the technique and effects of separating the prostate and rectum with hyaluronic acid during radiotherapy

Conditions: Prostatic Cancer

Summary: the dominating problem after local radiotherapy of prostate cancer is rectal toxicity. if the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. in this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (ha) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.


Eligibility criteria:
inclusion criteria: * histologically verified prostatic cancer * low or intermediate risk prostatic cancer * lymph node negative * suitable for radiotherapy exclusion criteria: * earlier treatment for prostatic cancer * unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment

Keywords: prostatic cancer radiotherapy hyaluronic acid
impact of interventions with a diet and exercise on the cardio-metabolic status in multi-risk population

Conditions: Cardiovascular Diseases; Metabolic Syndrome x; Mediterranean Diet

Summary: the diseases derived from metabolic syndrome caused 75% of the total deaths. it is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. several institutions consider prevention as one of the main priorities in public health. patients with metabolic syndrome, undergoing mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise. objective: to evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a mediterranean diet program and / or controlled physical activity. design: experimental, longitudinal design, controlled clinical trial, randomized. population with metabolic syndrome in which the effect of mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of metabolic syndrome. * patients diagnosed with overweight. * patients diagnosed with obesity. * patients with a diagnosis of systemic arterial hypertension. * patients diagnosed with type 2 diabetes mellitus. * patients with dyslipidemia. exclusion criteria: * recent myocardial infarction * pregnancy * lactation * in pharmacological treatment for weight loss. * cancer. * chronic kidney disease * liver failure * heart failure. * chronic obstructive pulmonary disease * depression * malabsorption syndrome * chronic diarrhea
opioid sparing effect of sphenopalatine ganglion block in functional endoscopic sinus surgery: a randomized controlled clinical trial.

Conditions: Sinus Surgery

Summary: functional endoscopic sinus surgery (fess) is widely recognized as a safe and preferred treatment option for various conditions, particularly nasal polyps and rhinosinusitis . this technique has been shown to improve postoperative symptoms by 86.3% in patients with chronic inflammatory paranasal sinus diseases . the aim of this study is to evaluate the effect of adding of mgso4 to bupivacaine via spgb block for postoperative pain for 24 hours in patients scheduled for fess as opioid free anaesthesia.

however, managing postoperative pain remains a significant challenge. research suggests that 86% of surgical patients experience pain, with 75% enduring moderate to severe levels . the sphenopalatine ganglion block (spgb) is an effective, safe, and well-tolerated method for managing craniofacial pain. the ganglion comprises both sensory and autonomic nerves, which innervate the nasal cavity, palate, and certain areas of the nasopharynx and oropharynx . spgb involves the administration of analgesic agents into the nasal cavity, typically through an endoscopic approach due to the challenges of transnasal injection . some complications, such as postoperative nosebleeds, and temporary numbness of the palate, have been observed following the blockade with endoscopic intervention, but these are generally temporary . studies evaluating the effects of the sphenopalatine block in endoscopic sinus surgery suggest that patients who received the ganglion block experienced reduced postoperative pain compared to those in the placebo group when combined with general anaesthesia .

Eligibility criteria:
inclusion criteria: * • patients programmed for elective fess * american society of anaesthesiologists (asa) physical state i-ii * age over 18 years and less than 60-years-old. exclusion criteria: * • known hypersensitivity to the study drugs. * inability to accurately describe postoperative pain to investigators. * opioid tolerance or dependence. * patient refusal * history of renal, liver, cardiac, neuropsychiatric disorder problems. * bleeding or coagulation abnormality. * infection at the site of injection

Keywords: sphenopalatine ganglion block
a efficacy and tolerability study of tegafox sequential s-1 in the treatment of adjuvant chemotherapy for gastric cancer

Conditions: Gastric Cancer

Summary: this study is designed to compare the three chemotherapy regimens(tegafox sequential s-1 or sox sequential s-1 or sox non-sequential s-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.


Eligibility criteria:
inclusion criteria: * 75≧age≧18 * histologically or cytologically confirmed gastrointestinal cancer * stage ⅱ or ⅲ or ⅳ * ecog ≦2 * accept the gastric cancer radical resection * life expectancy of at least three months * written informed consent to participate in the trial exclusion criteria: * history of severe hypersensitivity reactions to the ingredients of s-1\\tf\\5-fu/calcium folinate or oxaliplatin * inadequate hematopoietic function which is defined as below: * white blood cell (wbc) less than 5x10\^9/l * absolute neutrophil count (anc) less than 2x10\^9/l * platelets less than 100\*10\^9/l * inadequate hepatic or renal function which is defined as below: * serum bilirubin greater than 2 times the upper limit of normal range * alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the uln if no demonstrable liver metastases or greater than 5 times the uln in the presence of liver metastases * blood creatinine level greater than 2 times uln * presence of peripheral neuropathy * receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug * women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (including male) * psychiatric disorder or symptom that makes participation of the patient difficult; * concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months * severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes

Keywords: s-1 adjuvant chemotherapy tegafox
myofascial release and sustained stretching in spastic cp children

Conditions: Cerebral Palsy

Summary: the aim of this research was to find and compare the effects of myofascial release technique and passive sustained stretching on hamstrings flexibility in children with spastic cerebral palsy.

randomized clinical trials done at dhq sahiwal. 26 spastic cp children of age 6-12 years were taken by random sampling technique from dhq sahiwal. 13 were allocated to each group. study duration was of 6 months. sampling technique applied was non probability convenience sampling technique group a received passive sustained stretching along with conventional treatment. whereas group b received mfr along with conventional treatment. both these groups received treatment for 6 weeks. the baseline and post treatment score of mas, goniometer (aket to measure popliteal angle) and gmfcs -88 were evaluated. data analysis was done by using the spss version 21.

Eligibility criteria:
inclusion criteria: * age range from 6 to 12 years were included. * both genders were included. * ambulatory subjects with or without ambulatory aids. * diagnosed children with spastic cp. * cp patients with grade 3 on modified ashworth scale for hamstrings were included exclusion criteria: * children with visual or auditory defects. * children with cognitive dysfunction. * subjects who had severe limitations in passive range of motion at lower extremities specially hamstrings due to surgery or any other complication. * children with other types of cerebral palsy such as ataxic cp, dyskinetic cp etc.

Keywords: spastic cerebral palsy passive sustained stretching myofascial release mas goniometer