Kornimate/medical-research-clean huggingface dataset:
mirtazapine for chronic insomnia in older adults

Conditions: Chronic Insomnia

Summary: insomnia is highly prevalent in the older adult population. the pharmacolgical management of chronic insomnia includes benzodiazepines and z-drugs (zolpidem, zopiclone). although these drugs are indicated for insomnia, they are not without side effects. these drugs are associated with cognitive impairment, rebound insomnia, falls and addiction. mirtazapine has a hypnotic and sedative effect related to the blocking of histamine-1 receptors. no clinical trials has evaluated the efficacy and safety of mirtazapine for insomnia in the older population. the goal of the study is to assess the efficacy and safety of mirtazapine compared to a placebo in older adults with chronic insomnia. this prospective double-blind placebo controlled trial will be conducted in adults 65 years and older with chronic insomnia. the treatment group will receive mirtazapine 7.5 mg at bedtime for 28 days and the control group will receive a matching placebo for 28 days. the sample size for the pilot study will be 60 subjects, 30 subjects in the treatment group and 30 subjects in the control group. the efficacy of mirtazapine will be measured using the insomnia severity index and the pittsburgh sleep quality index. safety will be monitored during the study


Eligibility criteria:
inclusion criteria: * age 65 years and older * a report of sleep initiation or maintenance problems * an adequate opportunity and circumstances to sleep, * to have at least one daytime consequence in relation to sleep complaint. * sleep disorder and daytime consequences occur at least 3 times a week. * duration of sleep disorder and daytime consequences for at least 3 months * sleep complaint cannot be explained by a sleep disorder other than chronic insomnia. exclusion criteria: * contrindication to mirtazapine * use of drug for insomnia * cognitive behavioural therapy for insomnia * use of melatonin * active psychiatric illness * parkinson's disease * major neurocognitive disorders * more than one fall in the last 3 months

Keywords: insomnia mirtazapine aged
tahini and dermatitis in breast cancer

Conditions: Breast Cancer

Summary: this study aimed to investigate the effect of tahini on acute radiation dermatitis in breast cancer (bc) patients undergoing radiotherapy (rt). 50 eligible bc patients will randomly assign to consume tahini 48 gr per day during and 1 week after rt or with no intervention (control group). the radiation dermatitis will be assessed weekly according to the radiation therapy oncology group/ european organization for research and treatment of cancer (rtog/eortc) scales.


Eligibility criteria:
inclusion criteria: * women with brest cancer undergoing adjutant radiation therapy exclusion criteria: * previous history of rt, mrm, * concomitant presence of two or more malignant tumors * metastasis to other areas * allergy or intolerance to tahini * skin diseases and wounds * severe liver and renal disease * autoimmune diseases * pregnant and lactating women * those who treated with hypo fraction rt
investigation of pupillometry as guide for extubation readiness in anesthetized children

Conditions: Anesthesia; Laryngospasm on Emergence

Summary: investigation of pupillometry as guide for extubation readiness in anesthetized children.

can a pupil metric be used to make extubation more safe in anesthetized children?

Eligibility criteria:
inclusion criteria: * children undergoing general anesthesia and endotracheal intubation for surgery. * american society of anesthesiologists physical status class i and ii patients. exclusion criteria: * central nervous system abnormality. * ophthalmologic abnormality.

Keywords: pediatric anesthesia extubation pupillometry
raman spectroscopy and endometriosis

Conditions: Endometriosis; Endometrioma

Summary: we aimed to use raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

endometriosis is a chronic disease whose molecular basis is still unknown and diagnostic methods are controversial. the diagnosis is still invasive and there are no accepted ways which are molecular-based and noninvasive. raman spectroscopy is a vibrational spectroscopy technique which can analyze specific spectral patterns, substances and molecular changes with high specificity. we aimed to use raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

Eligibility criteria:
inclusion criteria: * proven endometriosis exclusion criteria: * having additional health conditions

Keywords: endometriosis raman analaysis
the application of comprehensive prevention and treatment strategy of placenta accreta spectrum disorders

Conditions: Placenta Accreta Spectrum

Summary: placenta accreta spectrum (pas) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. pas can lead to severe postpartum hemorrhage or even maternal death. prenatal diagnosis of pas is essential for optimal obstetric management to improve the pregnancy outcomes. however, in some low resource regions in china, less than 20% pas are detected before delivery. to explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. we will conduct a regional, cluster-randomized trial to assess a multicomponent pas management strategy to improve the prepartum detection rate of pas.


Eligibility criteria:
inclusion criteria: * pregnant women who have regular prenatal examination at the research hospitals * pregnant women diagnosed with pas before or after delivery exclusion criteria: * pregnant women who have never been diagnosed with placental implantation disease throughout the pregnancy * pregnant women who were lost to follow-up during the study period

Keywords: placenta accreta spectrum disorders
validation of a smartwatch in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study is designed to validate the accuracy of steps detected by a commercially available smartwatch in persons with multiple sclerosis. specifically, the investigators examine whether a smartwatch can detect steps accurately during slow, comfortable and fast overground walking. the total steps counted by the smartwatch will be compared to those counted by an accelerometer commonly used in clinical studies and the actually walked steps.

multiple sclerosis (ms) is a chronic inflammatory disease of the central nervous system. it is one of the most common neurological diseases in young adulthood. the main symptoms of ms are gait and mobility impairments, which also determine the severity of the disease. currently, subjective clinical functional tests are commonly used to evaluate therapy outcomes. due to advancing mechanization, body-worn accelerometers have been established as a potential instrument for the objective detection of mobility in clinical research. the accuracy of these devices for determining the mobility is therefore essential. however, current studies, especially in people with altered gait, show large deviations in step detection accuracy. in the present study we want to investigate: i) whether a commercially available smartwatch (polar m600) counts steps in persons with multiple sclerosis (pwms) accurately and ii) whether it counts steps as accurately as an accelerometer commonly used in clinical research (actigraph wgt3x-bt). in addition, the accuracy of the step detection by the algorithms of the manufacturer of the two devices (polar m600 and actigraph wgt3x-bt) will be compared with an own-developed algorithm. for this purpose, 63 pwms with low to severe functional restriction (edss: 0 - 6.5) will participate in this validation study. the validation protocol consists of three walking tests with different walking velocities. during these three conditions the participants will wear the polar m600 on the wrist and the actigraph wgt3x-bt with a belt over the hip. in the first walking test, the subjects will complete 250 steps with comfortable walking velocity (cwv). after a sufficient break, the participants will be randomly assigned to either a fast walking velocity condition (fwv: cwv + 20%) followed by a sufficient period of rest and a slow walking velocity condition (swv: cwv - 20%) or vice versa. each of the walking tests with modified walking velocity also consists of 250 steps. to analyze the accuracy of step detection, the measured steps of the devices will be compared with the actually walked 250 steps.

Eligibility criteria:
inclusion criteria: * multiple sclerosis with expanded disability status scale between 0 - 6.5 * ability to walk 250 steps with or without an assistive device exclusion criteria: * clinically relevant cardiovascular or orthopaedic disease * severe polyneuropathy * cognitive impairment

Keywords: multiple sclerosis motion sensors smartwatch steps walking validation
preservation of ovarian function via lot in squamous cell carcinoma of the cervix

Conditions: Cervical Cancer

Summary: the purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma


Eligibility criteria:
inclusion criteria: * newly diagnosed stages ib-iiib squamous cell carcinoma of the cervix exclusion criteria: * evidence of ovarian involvement on mri * evidence of uterine involvement on mri * evidence of distant mets on mri

Keywords: cervical cancer squamous cell laparoscopy ovarian function
evaluation of a new program for carers of people with anorexia nervosa

Conditions: Anorexia Nervosa; Carer Stress Syndrome

Summary: carefree is a 12-session carer's programme for carers of adults with moderate to severe anorexia nervosa. this programme was developed to provide carers with an opportunity to develop an understanding of anorexia from a biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. the carefree programme is unique in its focus on providing a framework for understanding an from a schema -compassion focused framework, incorporating psychoeducation in regard to both anorexia nervosa and carer burnout. the programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. the carefree programme is open to carers from across scotland and runs online. outcomes (including carer and patient quality of life, family communication, patient motivation to change) will be analysed and published at the end of the 24-month period. one of the key benefits of this programme is that as it is a cross-regional-nhs project.

moderate to severe anorexia nervosa (an-ms)is characterised by poor treatment outcomes, poor quality of life, low motivation levels and ambivalence about change, with high burden on families and nhs services. this study aims to improve quality of life and relationships amongst those with an-ms and their families/partners/carers, and enhance motivation to recover amongst adults with an-ms, ultimately resulting in enhanced care and reduced inpatient admissions. we will evaluate a new online group intervention for families/carers and partners. this is a two-phase study: phase 1 feasibility trial will evaluate factors such as recruitment and retention of clinicians and participants, collection of assessment measures and acceptability of the intervention. phase 2 will use this information to inform the development of a second more robust feasibility study which will enable us to determine whether this new untested intervention is effective in its own right, as a precursor for a larger definitive trial.

Eligibility criteria:
carer participants inclusion criteria * has a family member, partner or spouse/partner with moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres) * is over the age of 17 * can speak and read english * has access to the internet and is comfortable using an online meeting platform exclusion criteria * cannot speak/read english * is currently suffering from acute psychosis participants with anorexia inclusion criteria * have moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres) * is over 17 years of age * can speak and read english exclusion criteria • is currently suffering from acute psychotic mental health state

Keywords: anorexia nervosa burnout carer burnout carefree
antihypertensive medication exposure as risk for impaired glucose tolerance: a pear sub-study

Conditions: Prediabetic State

Summary: the purpose of this study is to determine if, in a subset of patients treated with a beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour oral glucose tolerance test (ogtt) compared to fasting glucose measurement.

beta-blockers and diuretics have a well-established role in treating hypertension and are frequently used first-line. however, it is increasingly evident that these medications have harmful metabolic effects. the pharmacogenomic evaluation of antihypertensive responses (pear - nct00246519) study was a greater than 700 participant, randomized, parallel assignment trial, aimed at determining the genetic factors that influence response to both a beta-blocker (atenolol) and a diuretic (hydrochlorothiazide \[hctz\]). the pear trial design includes evaluation at baseline, after monotherapy with either medication, and after combination therapy with both medications. this pilot, pear sub-study aims to characterize the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an ogtt) to detect prediabetes development prior to blood pressure medication use, after monotherapy (with atenolol or hctz) and after combination therapy (with atenolol and hctz).

Eligibility criteria:
inclusion criteria: * participation in pear: * an average seated home dbp \> 85 mmhg and home sbp \< 180 mmhg. * subjects must also have an average seated (\> 5 minutes) clinic dbp between 90 mmhg and 110 mmhg and sbp \< 180 mmhg. exclusion criteria: * secondary forms of htn, * patients currently treated with three or more antihypertensive drugs, isolated systolic htn, * other diseases requiring treatment with bp lowering medications, * heart rate \< 55 beats/min, * known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and tia), * diabetes mellitus (type 1 or 2), * renal insufficiency (serum creatinine \> 1.5 in men or 1.4 in women), * primary renal disease, * pregnancy or lactation, * liver enzymes \> 2.5 upper limits of normal, * current treatment with nsaids, * cox2-inhibitors, * oral contraceptives or estrogen.

Keywords: glucose glucose tolerance test insulin resistance metabolic adverse effects hypertension beta-blocker atenolol diuretic hydrochlorothiazide blood pressure
efficacy and safety study of risedronate, cholecalciferol combination tablet in patients with osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the efficacy and the safety of risedronate, cholecalciferol combination tablet in patients with osteoporosis.

the purpose of this study is to evaluate the efficacy and the safety of risedronate with and without cholecalciferol on vitamin d status, bone mineral density (bmd) and bone markers.

Eligibility criteria:
inclusion criteria: 1. male osteoporosis patients over 19 years of age 2. female osteoporosis patients with menopause * definition of osteoporosis * they had a bmd t-score -2.5 or less at mean lumbar spine(l1-l4), femoral neck or total. or evidence of at least one vertebral fracture * definition of menopause(can be one of three condition) * for 12months spontaneous amenorrhea * for 6months spontaneous amenorrhea with serum fsh(follicle stimulating hormone) is 40mlu/ml and over * 6weeks after bilateral ovariectomy whether hysterectomy or not. exclusion criteria: 1. patients with esophagus disorder (i.e:esophagostenosis) 2. patients administered with osteoporosis therapy(except calcium, vit.d medication)within the previous 3 months 3. patients with serum calcium concentrations 8.0mg under 4. patients with severe nephropathy (ccr 30ml/min less) 5. patients with unable to sit upright or stand for 30minutes

Keywords: risedronate, cholecalciferol, bmd
exploring the preventive effect of mitochondrial protective agent idebenone on post-stroke epilepsy

Conditions: Post Stroke Epilepsy

Summary: according to the random number table, all patients were divided into short-term treatment group, long-term treatment group and non-intervention stroke control group according to the proportion of (1:1:1) epilepsy disease modifier idebenone. patients in the short-term treatment group will take idebenone for a total course of 14 days (acute period) after stroke, and patients in the long-term treatment group will take idebenone for a total course of 3 months after stroke.


Eligibility criteria:
inclusion criteria: * patients admitted to hospital within 24 hours of stroke symptoms and diagnosed with stroke (including cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous sinus thrombosis, etc.) after relevant examinations; * able to cooperate with the inspection; * sign the informed consent form. exclusion criteria: * history of epilepsy before stroke; * a history of serious comorbidities that may lead to seizures (including malignant tumors, specific autoimmune diseases, severe electrolyte abnormalities, end-stage renal disease, and severe head trauma); * secondary stroke caused by head trauma or surgery; * other patients that the researchers think need to be excluded.

Keywords: post-stroke epilepsy idebenone
evaluating the role of the microbiome in antidepressant treatment in adolescents.

Conditions: Depression in Adolescence

Summary: the goal of this observational study is to learn about the role of the human gut microbiome in antidepressant treatment response in adolescents with major depressive disorder (mdd). specifically, the study aims to collect microbiota samples of adolescents treated with fluoxetine, over the span of 8-weeks, to: * determine the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression. * test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine * investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine. depression symptom severity will be evaluated upon enrollment and 6-weeks into antidepressant treatment.

for this project the investigators are interested in changes in the gut microbiome associated with adolescent depression and the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression. it is hypothesized that the composition of the human gut microbiome alters the response to fluoxetine of adolescents with depression. this study aims to collect gut microbiota of adolescents being treated with antidepressants at several timepoints to (1) determine the efficacy of fluoxetine to treat depression, (2) test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine, and (3) investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine. adolescent patients with clinically significant depressive symptoms who are prescribed fluoxetine, from rady children's hospital san diego (rchsd) inpatient child and adolescent psychiatry services (caps), will be recruited for this study. up to twelve stool samples are planned to be collected, including prior to start of antidepressant treatment for a baseline measure of gut microbiome composition, daily samples over during the first week of fluoxetine treatment, and then biweekly collections until the end of the 8-week study duration.

Eligibility criteria:
inclusion criteria: * subjects from all ethnic backgrounds will be eligible to participate. * having clinically significant depressive symptoms based on a score \>40 on the children's depression rating scale-revised * prescribed more than 5mg of fluoxetine (prozac) * has an identifiable legal guardian. exclusion criteria: * has been taking a standing psychotropic medication in the past 6 months * has been taking antibiotics or metformin during the past 6 months (known strong effects on gut microbiome) * admitted to rchsd caps post-overdose (potential strong effects on gut microbiome) * currently using nicotine-containing substances (known strong effects on gut microbiome)
measuring erythrocyte iron incorporation from different dosing regimens in anemic women

Conditions: Iron Deficiency Anemia

Summary: iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. the investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.


Eligibility criteria:
inclusion criteria: * ferritin \<15 µg/l * hb 8-11.9 g/dl * bmi 18.5-24.9 kg/m2 * body weight \<70 kg exclusion criteria: * severe anemia (hb \<8 g/dl) * elevated crp \>5.0 mg/l * chronic disease * long-term medication, except contraception * consumption of mineral and vitamin supplements within the study period * therapeutic iron infusion over the past 6 months * pregnancy or breastfeeding * smoking