Kornimate/medical-research-clean huggingface dataset:
fish oil and inflammation in overweight subjects

Conditions: Overweight

Summary: the aim of this study is to investigate the effects of acute and short-term intervention with fish oil on inflammatory markers in overweight subjects.

being overweight is associated with metabolic syndrome, cardiovascular disease, and diabetes mellitus (type 2). adipose tissue can be regarded as an active organ, which produces an array of inflammatory mediators. this creates a state of chronic low-grade inflammation. inflammation has been proven to be a key element in the development of atherosclerotic plaques. the marine n-3 polyunsaturated fatty acids (pufas) have beneficial effects on cardiovascular disease. these effects are partly attributed to the anti-inflammatory effect of the n-3 pufas. previous studies have shown an anti-inflammatory effect of n-3 pufas in overweight subjects, but the studies have been conducted with a high daily dose of n-3 pufa. we want to examine the effect of a lower dose of 1 g n-3 pufa/day (the dose recommended by the danish heart foundation). the study is randomized, placebo-controlled and double blinded. fifty subjects aged 30 - 75 years (postmenopausal women; waist circumference \> 80 cm and men; waist circumference \> 94 cm) will be included. blood samples and fatty tissue biopsies will be collected at baseline, after 1 day and after 6 weeks.

Eligibility criteria:
inclusion criteria: * waist circumference ≥ 80 cm (females) or ≥ 94 cm (males) * postmenopausal (females) exclusion criteria: * daily intake of fish oil capsules * daily intake of nsaids * hba1c ≥ 8% * serum creatinine ≤ 30 ml/min * chronic inflammatory disease * other serious illness * inability to informed consent

Keywords: inflammation fatty acids, omega 3 leukotrienes adiponectin adipose tissue rna, messenger
clinical study to investigate the safety and efficacy of mlc601 in 150 iranian patients after stroke

Conditions: Stroke

Summary: to investigate the safety and efficacy of mlc601 (neuroaidetm) as a traditional chinese medicine on motor recovery after ischemic stroke.

this is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent (less than 3 month) ischemic stroke. all patients will give either mlc601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard medication of post stroke for 3 months. motor improvement will be monitored using fugl-meyer assessment fma.

Eligibility criteria:
inclusion criteria: * age between 30-72 yars, * \< one month after stroke, * ischemic cerebral stroke, * signed informed consent form. exclusion criteria: * treatment with thrombolytic after stoke, * ischemic stroke combined with hemorrhage, severe renal or liver failure, dementia, psychosis and history of seizure disorder, history of previous stroke, and hemoglobin level less than 10mg/dl on admission.

Keywords: safety efficacy mlc601 motor recovery
a study of cisapride in patients with symptomatic gastro-oesophageal reflux disease

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (gord).

this is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (gord) (also referred to as gastroesophageal reflux disease \[gerd\[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of gord based on protocol-specified characteristics * failed the 1st of 5 stepwise treatments for gord recommended by the european society of pediatric gastroenterology, hepatology and nutrition (espghan) * caregiver able to complete the i-gerq-r questionnaire exclusion criteria: * protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable) * cause of vomiting/regurgitation other than gord * prior history of cisapride intake

Keywords: cisapride (prepulsid) placebo gastroesophageal reflux disease (gerd) gastro-oesophageal reflux disease (gord)
long-term follow-up prognosis of atrophic gastritis after 3 years

Conditions: Gastric Neoplasm; Gastric Cancer; Gastric Adenoma; Gastric Atrophy; Intestinal Metaplasia

Summary: serum pepsinogen (pg) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum pg i level or pg i/ii ratio. a combination of serum pg levels and helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on correa's hypothesis. the investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. all the participants will be followed for an expected average of 3 years.

according to the correa's hypothesis, the combination method using serum pepsinogen levels and serum helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. however, in endemic regions of h. pylori infection such as in east asian countries (korea, japan, and china), most of the aged population are have current or had past h. pylori infection. therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/h. pylori(-) group followed by atrophy(+)/h. pylori(+), atrophy(-)/h. pylori(+), and atrophy(-)/h. pylori(-) groups. in addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with lauren's diffuse type are more commonly developed in the subjects without atrophy. taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.

Eligibility criteria:
inclusion criteria: * korean adults older than 18 year-old * subjects who agreed on serum pepsinogen tests, h. pylori serology, and upper gastrointestinal endoscopy on the same day exclusion criteria: * subjects who had past history of gastric surgery * abnormal endoscopic or laboratory finding that require further treatment * any evidence of malignancy other than gastric neoplasm

Keywords: gastric atrophy helicobacter pylori pepsinogen gastric cancer gastric adenoma
remote outpatient temperature monitoring for early detection of febrile neutropenia after chemotherapy

Conditions: Acute Myeloid Leukemia (AML)

Summary: febrile neutropenic patients are at high risk for developing sepsis and other infections which often necessitates acute admission to the intensive care unit (icu) and are associated with high mortality. neutropenic fever is a medical emergency and early detection of fever allows for prompt infectious work up. in this study, the investigators will collect pilot data from outpatients utilizing a remote outpatient continuous temperature monitoring device to compare the incidence of icu admission and severe sepsis to historical data for prior patients who did not receive at home monitoring device.


Eligibility criteria:
inclusion criteria: patients who have acute myeloid leukemia (aml) and are candidates for consolidation chemotherapy with high dose cytarabine (hidac) after successful remission induction chemotherapy * both male and female * age 18 years and older exclusion criteria: patients who have already developed febrile neutropenia during their hospitalization for their consolidative cycle of chemotherapy will not be eligible for monitoring for that cycle; however, these patients will be able to participate in subsequent cycle if they do not develop febrile neutropenia during their subsequent hidac hospitalization. • if a patient is admitted to the hospital between cycles of chemotherapy for reasons other than febrile neutropenia or its sequelae, they will be taken off study for that cycle and data not collected while they are admitted

Keywords: hidac neutropenia fever aml leukemia
comparison of post facilitation stretch versus reciprocal inhibition in quadratus lumborum syndrome: a randomized controlled trial

Conditions: Quadratus Lumborum Syndrome

Summary: this study is a randomised control trial and the purpose of this study is to determine the effects post facilitation stretch versus reciprocal inhibition on pain, lumbar range of motion, apparent leg length discrepancy and lumbar lordotic angle in quadratus lumborum syndrome.

the purpose of this study is to determine the difference between post facilitation, stretch versus reciprocal inhibition on pain, lumbar range of motion, apparent leg length discrepancy and lumber lordotic angle in quadratus lumborum syndrome. the individual of age 18-35 years among both genders, who experiences pain of 3 ≤ on nprs from at least 3 months and whose pain decreases on supine lying; along with any two of the following findings positive of quadratus lumborum on physical examination i.e., taut bands, local tenderness, patient's pain recognition, pain referral to greater trochanter, local twitch response \& jump sign will be recruited in the study as patients of quadratus lumborum syndrome. pain levels will be assessed using the numeric pain rating scale (nprs). inclinometer will be used for measuring lumber ranges. to assess apparent leg length discrepancy measuring tape will be used. the lumbar lordotic angle will be measured using 60 cm flexible ruler. participants of interest would be approached and explained about the research. informed written consent will be taken. it is a non-blinded study and randomization will be done through sealed envelope. both groups will receive conventional intervention. additionally, group a will receive quadratus lumborum post facilitation stretches while group b will receive reciprocal inhibition. baseline and post intervention scores would be recorded for both groups.

Eligibility criteria:
inclusion criteria: * age 18-35 years * both genders * having pain of ≤ 8 on nprs from at least 3 months * pain decreases on supine lying * any two of the following findings positive of unilateral quadratus lumborum on physical examination: 1. taut bands 2. local tenderness 3. patient's pain recognition 4. pain referral to greater trochanter 5. local twitch response exclusion criteria: * painful isometric muscle testing of hip flexors, abductors, adductors, and extensors * previous surgery of lower limb * centralization/peripheralization * lower back trauma * positive slr * radiculopathy * fracture/surgery of pelvic and/or hip region * diagnosed fibromyalgia or other rheumatic diseases. * lactating women * intrauterine device * pregnant women * use of psychiatric medications
long-term outcome after edoxaban versus vitamin k antagonists for acute vte

Conditions: Venous Thromboembolic Disease; Post Thrombotic Syndrome; Chronic Thromboembolic Pulmonary Hypertension; Quality of Life

Summary: the hokusai post vte study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (pts) and chronic thromboembolic pulmonary hypertension (cteph) respectively. our aim of the study is to compare the long term outcomes along with the quality of life assessment of vte in a group treated with heparin+vka versus a group treated with heparin+edoxaban in the acute setting.


Eligibility criteria:
inclusion criteria: * participant in the hokusai vte trial exclusion criteria: * none

Keywords: post thrombotic syndrome edoxaban vitamin k antagonist chronic thromboembolic pulmonary hypertension quality of life
hyperglycemic profiles in obstructive sleep apnea: effects of pap therapy

Conditions: Sleep Apnea; Diabetes

Summary: this is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to pap therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.

research over the last decade has shown that obstructive sleep apnea (osa) is a common condition in people with diabetes. observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in osa may alter glucose metabolism and worsen glycemic control. however, the impact of treating osa with positive airway pressure (pap) therapy on glycemic variability and control is not well defined. adequately powered randomized clinical trials have yet to be performed to demonstrate whether pap therapy for osa in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. the overarching goal of this study is to determine whether pap therapy for osa in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.

Eligibility criteria:
inclusion criteria: * type 2 diabetics * age \> 21 and ≤ 75 years exclusion criteria: * inability to consent or commit to the required visits * use of insulin or other injections for diabetes * weight change of 10% in last six months * use of oral steroids in the last six months * pulmonary disease (i.e., copd) * renal or hepatic insufficiency * recent mi or stroke (\< 3 months) * sleep-related hypoventilation * obesity-hypoventilation syndrome * morbid obesity * occupation as a commercial driver or operator of heavy machinery * active substance use * untreated thyroid disease * pregnancy * any history of seizures or other neurologic disease * poor sleep hygiene or sleep disorder other than sleep apnea * central sleep apnea * variants of obstructive sleep apnea (e.g., rem-related osa) * participants not suitable for the study based on the clinical judgment * use of any investigational drug within the past 30 days * participating in another study
pharmacokinetics,pharmacodynamics,efficacy and safety of hrg2010 in parkinson's disease patients with motor fluctuations

Conditions: Parkinson's Disease

Summary: the study is a multicenter, randomized, open-label, active-controlled, phase ii clinical study. the aim of this trial is to evaluated the pharmacokinetics, pharmacodynamics,efficacy and assessed the safety of hrg2010 compared with a sustained-release cabridopa-levodopa formulation in parkinson's disease patients with motor fluctuations.


Eligibility criteria:
inclusion criteria: 1. male or female participants diagnosed at age ≥ 40 years with pd, consistent with the international parkinson and movement disorder society clinical diagnostic criteria and who are being treated with stable regimens of ddci+ld but experiencing motor fluctuations. 2. mini mental state examination (mmse) ≥ 25 at screening visit. 3. hoehn and yahr stage ii-iv when "on" at screening visit. 4. at screening, the participant has predictable "off" periods. 5. able and willing to provide a written informed consent. exclusion criteria: 1. diagnosed with atypical or secondary parkinsonism. 2. history of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage. 3. had prior functional neurosurgical treatment for pd or if such procedure(s) are planned or anticipated during the study period. 4. female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method. 5. in the opinion of the clinical investigator, subjects who should not participate in the study.
interpersonal psychotherapy in adolescents with polycystic ovary syndrome

Conditions: Interpersonal Psychotherapy; Polycystic Ovary Syndrome

Summary: the main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (ipt) program designed to improve mood and lessen stress in girls with pcos will improve depression, unhealthy eating behaviors, weight, and insulin resistance.


Eligibility criteria:
inclusion criteria: * diagnosed with pcos duration \> 3 months * 12-17 years old * bmi \> 75th percentile * cesd \> 16 exclusion criteria: * weekly or bi-weekly therapy with licensed behavioral health provider * inability to speak, read, or write in english (teen) * major medical conditions * hba1c \> 7.0% * hormonal contraception \< 3 months * metformin \< 3 months * antidepressants/psychotropic medications \< 4 weeks
the effect of probiotics on maintenance of health in pregnancy and infants

Conditions: Pregnancy

Summary: this phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. in addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.

throughout pregnancy women undergo many biological changes, including alterations in their microbiota. these infections can exacerbate pregnancy complications and increase the risk of preeclampsia and preterm birth. the present study aims to evaluate the potential effects of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a healthy pregnancy. potential infections include but are not limited to influenza/colds, bacterial vaginosis, mastitis, candidiasis, urinary tract infection and gingivitis. additionally, the benefits of probiotic intake by the mother on the infant during pregnancy and breastfeeding will be evaluated.

Eligibility criteria:
inclusion criteria: * healthy pregnant women * less than 28 weeks of gestation (3rd trimester) * ≥18 to \<40 years old * singleton gestation * availability and willingness to come in for morning visits * planning to breastfeed * willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits * willing to discontinue consumption of fermented foods (e.g. foods that contain probiotics such as kefir, pickles, etc.) or probiotics (e.g. yogurts with live active cultures or probiotic supplements) * able to provide informed consent exclusion criteria: * known gestational diabetes or diabetes type 1 or 2 * known blood/bleeding disorders * known liver and kidney disorders * known unstable cardiovascular diseases * women with a personal history of or currently diagnosed with preeclampsia * suffering from neurological diseases (e.g. alzheimer's disease, parkinson's disease, epilepsy, etc.) * suffering from gastrointestinal diseases (e.g. gastric ulcers, crohn's disease, ulcerative colitis, etc.) * current symptoms of depression or experienced depressive symptoms in the past 2 years * maternal history of second trimester loss * women diagnosed hiv positive or with hepatitis b or c * known fetal abnormality * daily use of probiotic product within 2 weeks of the screening visit. the potential participant could be eligible to participate after a 2-week wash-out period * use of any antibiotic drug within 1 month of screening. the potential participant could be eligible to participate after a 2-week wash-out period * smoking, alcohol consumption or drug use during pregnancy * history of alcohol or substance abuse six months prior to screening * allergies to milk, soy, or yeast

Keywords: probiotics infections bacterial vaginosis
verisee software for diabetic retinopathy screening

Conditions: Diabetic Retinopathy

Summary: the investigators aim to improve the diagnostic accuracy and the clinical referral rate for diabetic retinopathy by using a deep learning-based software.

diabetic retinopathy (dr) is the leading cause of blindness among working-age patients with type 2 diabetes. according to previous studies, early screening and timely treatment can reduce the risk of worsening dr and blindness. international guidelines recommend that screening for dr be performed at least once every year for patients with type 2 diabetes. the investigators will implement a validated deep learning-based software, verisee®, in clinics, and evaluate the benefits on diagnostic accuracy and the clinical referral rate for diabetic retinopathy after implementation of this software.

Eligibility criteria:
inclusion criteria: * adults * patients with diabetes * cooperation to fundal scopic examination exclusion criteria: * diabetic duration \< 5 years in patients with type 1 diabetes * pregnancy
assessment of utility of exhaled nitric oxide measurement for treatment monitoring in children with asthma

Conditions: Asthma

Summary: the aim of this study is to assess the utility of exhaled nitric oxide measurement (feno) in treatment monitoring in children with asthma. according to the aim of the study following assumptions are formulated: 1. comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with feno monitored treatment (study group), and group of children with treatment monitored by gina's grade of disease clinical control (control group) 2. assessment of corelation of feno (ppb) with symptom score (points)and lung function (fev1) 3. comparison of values of non-specific bronchial hyperresponsiveness with methacholine (pc20m)between both study groups after 12. months of treatment.

asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on both children and adults. what needs to be kept in mind, especially in assessing treatment effect of allergic inflammation in children with asthma, is that symptom score and spirometry measures have limitations, mainly their subjectivity (symptom scores), wide variability, and lack of stability in short time period (symptom scores and spirometry measures). monitoring allergic inflammation in the course of asthma in children with exhaled nitric oxide measurement (feno) may allow to titrate the dose of inhaled glucocorticosteroids more precisely, depending on individual patients requirements. the aim of this study is to assess the utility of feno in treatment monitoring in children with asthma. according to the aim of the study following assumptions are formulated: 1. comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with feno monitored treatment (study group), and group of children with treatment monitored by gina's grade of disease clinical control (control group) 2. assessment of corelation of feno (ppb) with symptom score (points)and lung function (fev1) 3. comparison of values of non-specific bronchial hyperresponsiveness with methacholine (pc20m)between both study groups after 12. months of treatment.

Eligibility criteria:
inclusion criteria: * feno values above the norm for age and inadequate asthma control (based gina guidelines) exclusion criteria: * presence of other perennial and seasonal allergies * presence of other chronic diseases * excluded medications: systemic glucocorticosteroids 3 months before enrollment

Keywords: exhaled nitric oxide asthma children inhaled glucocorticosteroids