Kornimate/medical-research-clean huggingface dataset:
moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine in the treatment of abdominal obesity: a study protocol for a randomized controlled trial

Conditions: Obesity

Summary: this study will investigate whether the combination of moxibustion and characteristic lifestyle intervention of tcm can alleviate the clinical symptoms and improve quality of life and mental health in patients with abdominal obesity. the results are expected to provide clinical evidence for the application of the combination of moxibustion and characteristic lifestyle intervention of tcm in patients with abdominal obesity.

this study will be a randomized controlled trial conducted from january, 2020 to january, 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria. the participants will be randomly divided into 3 groups in a 2:2:1 allocation ratio.the intervention group will receive moxibustion combined with characteristic lifestyle intervention of tcm;the other group will receive moxibustion combined with lifestyle intervention;the control group will receive lifestyle intervention only.each treatment will last 12 weeks including 8 weeks of intervention period and 4 weeks of follow-up period. the primary outcome is the waist circumference(wc),the secondary outcomes include obesity-related indicators,serum biochemical indexs,blood pressure, conversion score of constitution characteristics, and measurement of the scale.adverse events will be recorded during the intervention and follow-up period.

Eligibility criteria:
inclusion criteria: patients recruited for this study should meet the following inclusion criteria: 1.satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.being able to fully understand and voluntarily sign informed consent. exclusion criteria: patients with any of the following criteria will be excluded from the study: 1. presence of endocrine disorders such as: polycystic ovary syndrome; cushing's syndrome; uncorrected thyroid disease. 2. presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases. 3. pregnant or lactating state, women who plan to become pregnant within 12 weeks. 4. history of bulimia, anorexia, or any other eating disorders. 5. use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite. 6. history of surgical weight loss, postoperative adhesions. 7. history of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months. 8. presence of local skin rupture, allergy and scar constitution. 9. unable to cooperate with the research caused by other diseases or reasons.

Keywords: abdominal obesity moxibustion characteristic lifestyle intervention
chronic kidney disease antidepressant sertraline trial

Conditions: Chronic Kidney Disease; Depression

Summary: this is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. the investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. the study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.

this is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 chronic kidney disease and major depressive episode. subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. the primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the quick inventory of depressive symptomatology clinician rated (qids-c-16) score. secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.

Eligibility criteria:
inclusion criteria: * male or female adults aged greater than 21 years. * predialysis stages 3, 4 or 5 ckd. * current major depressive episode. * qid-c-16 score of 11. * able to understand and sign informed consent. exclusion criteria: * no healthcare power of attorney to sign informed consent. * unwilling or unable to participate. * kidney transplant recipient. * initiated on maintenance dialysis * significant hepatic dysfunction or liver enzyme abnormalities 3 times the upper limits of normal. * terminal chronic obstructive pulmonary disease or cancer. * recent history of active bleeding, such as gastrointestinal bleeding requiring hospitalization 3 months prior * current use of class i anti-arrhythmic medications. * use of pimozide, mao inhibitors, reserpine, guanethidine, cimetidine or methyldopa; tri-cyclic anti-depressants, neuroleptics or anti-convulsants, excluding gabapentin * use of other serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and st. john's wort. * ongoing use of anti-depressants * past treatment failure on sertraline * initiation of psychotherapy for depression in the 3 months prior to study entry * alcohol or substance abuse or dependence that requires acute detoxification at study entry * present or past psychosis or bipolar i or ii disorder * dementia or a mini-mental state examination score of \<23 * suicidal ideation * pregnancy, lactation and women of childbearing potential not using adequate contraception

Keywords: chronic kidney disease depression antidepressants randomized controlled trial treatment sertraline
on site sensors monitoring impacts of cognitive decline on adls

Conditions: Dementia; Dementia Alzheimers

Summary: the purpose of this research is to compare the effectiveness of a continuous monitoring system to assess activities of daily living (adls) over time compared to the traditional assessments used by medical professionals as alzheimer's disease and alzheimer's disease related dementias (ad/adrd) progresses.


Eligibility criteria:
inclusion criteria: * fluent in english to understand and sign the consent or assent documents. * adult over 65 years of age with no children under 18 years old living in residence. * adult anticipates they will be living primarily at designated residence over next 18 months. * must receive caregiver interaction at least 6 hours/week. * must undergo a mini-mental state exam (mmse) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study. * must be willing to have home or facility equipped with sensors to obtain activity and location data. exclusion criteria: -
a study to evaluate quality of life in patients switched to solifenacin from other antimuscarinics

Conditions: Urinary Bladder, Overactive

Summary: this is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (qol) of patients previously treated with antimuscarinics (males and females with overactive bladder (oab) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by perception of treatment satisfaction (ts-vas) and to evaluate the effect of solifenacin on quality of life measured by over active bladder-q short form (oab-q sf), euroqol group scoring system (eq-5d-5l).


Eligibility criteria:
inclusion criteria: * patient willing and able to complete the questionnaires * diagnosis of oab * previous unsuccessful oab medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by: * number of micturitions \> 8/24 h or * decrease in urgency urinary incontinence (uui) or incontinence episodes / 24 h less than 50% or * decrease in urgency episodes / 24 h less than 50% or * decrease in number of micturitions / 24 h less than 20% or * not acceptable tolerability * eligible to start vesicare™ 5 or 10 mg according to summary of product characteristics (smpc) exclusion criteria: * history of stress incontinence * active urinary tract infection (confirmed by positive urine analysis) * symptoms suggestive of severe bladder outlet obstruction (boo) defined as peak urinary flow rate (qmax) \ 150 ml * uncontrolled diabetes mellitus * history of drug and/or alcohol abuse at the time of enrolment * history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk for these conditions. * undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent cyp3a4 inhibitor * previous treatment with solifenacin * likely to participate in another study during study period of 12 months from study entry

Keywords: overactive bladder solifenacin quality of life
wavelight® refractive myopic study

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the wavelight® refractive suite (excimer ex500 and femtosecond fs200 lasers).


Eligibility criteria:
inclusion criteria: * willing and able to understand and sign an informed consent form. * have refractive error (in both eyes) that requires refractive surgery. * willing to undergo lasik surgery using the wavelight® refractive suite. * myopia between 0.00 to -12.0 diopters pre-operatively. * astigmatism between 0.00 to +6.00 diopters pre-operatively. * willing and able to attend post-operative examinations per protocol schedule. * other protocol-defined inclusion criteria may apply. exclusion criteria: * participation in a clinical study within the last 30 days. * history of previous corneal surgery in either eye. * multifocal ablations in either eye. * prk or ptk surgery in either eye. * suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc. * any ocular disease and/or condition that, in the investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study. * unable to discontinue contact lens wear as specified in protocol. * history of herpes simplex or herpes zoster keratitis. * active ocular rosacea. * lyme disease. * history of dry eye that is unresponsive to treatment. * severe ocular allergies. * other medical conditions and use of medications as specified in protocol. * pregnant or planning to become pregnant during the study. * other protocol-specified exclusion criteria may apply.

Keywords: nearsighted farsighted astigmatism lasik refractive surgery wavelight
assessment of hypoxia inducible factor and autophagy related genes in patients with non-segmental vitiligo

Conditions: Vitiligo

Summary: the present study will aim to evaluate: 1. the presence of hypoxia inducible factor in vitiligo patient 2. defect of autophagy related genes in vitiligo patient 3. the cross relation between autophagy related genes and hypoxia inducible factor in the pathogenesis of vitiligo among egyptian patients in sohag governorate


Eligibility criteria:
inclusion criteria: * adult \>18 years * with non segmental vitiligo * a group of participants will be included as a control group exclusion criteria: * pregnancy * patient with chronic inflammatory skin disorders * patient on anti-oxidant or anti-inflammatory drugs * patient on topical or systemic treatment for vitiligo in last 4 weeks * patients with other autoimmune diseases * patients with diabetes mellitus
effect of chorioamnionitis on platelet activation and placental vessel among preterm infants by wnt-flt1 signal pathway

Conditions: Chorioamnionitis; Placenta Diseases; Thrombocytopenia; Preterm Infant

Summary: objective:the purpose of this study was to explore the effect and mechanism of maternal chorioamnionitis on placental microvasculature and platelet activation among preterm infants by activating wnt-flt1 signal pathway . methods:with clinical randomized controlled trial (rct), the cases were matched with 1:1 according to gestational age and divided into 2 groups according to the placental pathology result: chorioamnionitis group and control group. (1) to observe the platelet parameter, birth weight, thrombrocytopenia and hemorrhage complication, such as intracranial hemorrhage, retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage. (2) to observe the miscrovascular density (mvd) in placenta, platelet activating factor (cd62p,cd63) and thrombopotetin (tpo) in preterrn infants.the placental mvd was assessed by immunohistochemical method. the platelet activating factors were detected by flow cytometry. tpo was detected by elisa. (3) to observe wnt5a, flt1 and vegf in placenta and fetal circulation.the measurement data were analyzed by pair t test and conditional logistic regression. pearson correlation analysis was used for relationship.

the exclusive criteria included :(1) born to mother with no any other maternal complications; (2) no congenital abnormalities and neonatal asphyxia; (3) died or discharged within 72 hours.

Eligibility criteria:
inclusion criteria: 1. gestational age\<37weeks 2. admitted to the nicu at guangdong women and children hospital, with a date of birth from june 2016 to december 2016 3. whose mothers were diagnosed chorioamnionitis by placental histopathology exclusion criteria: 1. born to mother with no any other maternal complications 2. no congenital abnormalities and neonatal asphyxia; 3. died or discharged within 72 hours.
long-term follow-up findings of inpatients for covid-19 pneumonia

Conditions: Covid19

Summary: coronavirus disease 2019 (covid-19) is a respiratory tract infection caused by a newly emergent coronavirus (sars-cov-2) that can progress to severe multiorgan disease requiring hospitalization. the medium and long-term impact in survivors of covid-19 on lung function, imaging by thoracic ct, exercise capacity, and health-related quality of life and the relation of these parameters remains to be determined.

aim: to evaluate medium to late (visit 1: 6-12 months after hospital discharge) effects of covid-19 on lung function, exercise capacity, thoracic ct findings, symptoms and hrqol in patients with confirmed diagnosis of sars-cov-2 infection and the relation between these parameters. material and methods: prospective cohort of subjects with laboratory and/or thoracic ct confirmed covid-19 who were treated as inpatients. participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6mwt) and cardiopulmonary exercise testing (cpet) after 6-12 months (visit 1) of covid-19. clinical, laboratory and chest image data during the covid-19 hospitalization will be obtained from medical records. the minimum sample size was estimated as 37 participants.

Eligibility criteria:
inclusion criteria: * adult patients with covid 19 diagnosis * ability to read and speak * signed informed consent. * able to perform exercise testing and walking exclusion criteria: - subjects with limited exercise capacity

Keywords: covid19 lung functions cardiopulmonary exercise testing thoracic ct 6 minute walking test short form 36 questionnaire
randomized study of train the colonoscopy leaders course versus audit and feedback on colonoscopy quality indicators

Conditions: Colorectal Cancer

Summary: professional societies recommend that endoscopists measure their ceacal intubation rate, adenoma detection rate as indicators of the screening colonoscopy quality. however, it is uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in the detection of adenomas. the investigators hypothesize that a hands-on-training intervention tailored to the results of environmental assessment and audit on colonoscopy quality indicators results in higher adenoma detection rate improvement than simple audit and feedback. the investigators further hypothesize that by training the leaders of the screening centres, the effect of the intervention will be further disseminated among other endoscopists from the participating centers, and will thus result in additional increase in individual adenoma detection rate. the primary aim is to compare the impact on adenoma detection rate of two screening colonoscopy improvement programs: 1. tailored training intervention. 2. audit feedback on colonoscopy quality indicators.


Eligibility criteria:
inclusion criteria: * screening center leading colonoscopist * at least 30 screening colonoscopies in the 2011 edition of the screening program * adenoma detection rate lower than 25% exclusion criteria: * lack of participation in the 2012 edition of the screening program
study of the efficacy and safety of apricitabine, a new nrti, to treat drug-resistant hiv infection

Conditions: HIV Infections

Summary: apricitabine is a new nrti which is active against drug-resistant hiv. nrtis are often included as part of patients' treatment, but many hiv-infected patients develop resistance to commonly used nrtis such as lamivudine (3tc) and emtricitabine (ftc). this study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.

atc has potent antiviral activity both in vitro (against wild-type hiv-1 and hiv-1 with mutations in reverse transcriptase that confer resistance to nrtis), and in clinical studies in both treatment-naïve and treatment-experienced patients with m184v, including in the presence of additional nrti mutations in reverse transcriptase. the m184v mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. whilst lamivudine therapy is often maintained in patients harboring the m184v mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of hiv-1 containing the m184v/i mutation, particularly in the presence of other additional nrti mutations. the purpose of this study is to extend the efficacy and safety established in study avx-201 of atc in patients who are hiv-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed m184v/i mutation. patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining nrti treatment options. this study will investigate whether it is possible to improve control of hiv-1 viral replication by including atc within a treatment experienced patient's new optimized background regimen following art treatment failure.

Eligibility criteria:
inclusion criteria: * hiv-1 positive with m184v/i mutation in reverse transcriptase; * 18 years of age or older; * currently taking lamivudine (3tc) or emtricitabine (ftc) exclusion criteria: * female patients who are pregnant or breastfeeding; * current hepatitis b virus (hbv) infection; * current treatment for hepatitis c virus infection; * renal function not adequate

Keywords: hiv infection drug resistance reverse transcriptase inhibitor nucleoside analogue treatment experienced
a study to compare pk characteristics and safety profiles between ad-228b and ad-2284

Conditions: Primary Hypercholesterolaemia

Summary: primary endpoint of this study is to evaluate the pharmacokinetic characteristics of ad-228b in healthy subjects.


Eligibility criteria:
inclusion criteria: * body weight equal to or greater than 50kg (female 45kg) and body mass index (bmi) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy volunteers at the time of screening visit exclusion criteria: * participation in other clinical study with an investigational drug within the 6 months from scheduled first administration * other exclusions applied
frequency of orthostatic hypotension in patients who underwent colonoscopy

Conditions: Orthostatic Hypotension

Summary: patients who will undergo colonoscopy accompanied by sedoanalgesia will be admitted at aksaray training and research hospital gastroenterology clinic between may and july 2024. orthostatic hypotension will be evaluated after patients meet the discharge criteria in the postoperative recovery unit.

patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. patients who will be excluded from the study; patients with cognitive dysfunction for whom consent could not be obtained patients who cannot walk routine asa (american society of anesthesiologist) monitoring will be applied when patients are taken to the procedure room. patients will be monitored for oxygen saturation with an oxygen saturation probe, non-invasive blood pressure monitoring, and heart rate and rhythm monitoring with an electrocardiogram. patients will be given oxygen support via nasal cannula or mask. patients will be given maintenance intravenous fluids. patients will receive moderate to deep sedation/analgesia. at the end of the procedure, patients will be taken to the postoperative recovery unit and monitored. patients will be evaluated according to the aldrete score and a discharge decision will be made. when the decision to discharge the patients is made, they will first be seated and vital signs will be monitored when they are first placed in a sitting position and at the 3rd minute in the sitting position. then, the patients will be stood up and vital signs will be monitored when they first stand up and at the 3rd minute. it will be noted whether patients develop additional symptoms. patients who do not have symptoms and are decided to be discharged will be taken to a second waiting room and will be monitored under observation for a while.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who apply to the endoscopy unit for colonoscopy will be included. exclusion criteria: * patients with cognitive dysfunction for whom consent could not be obtained patients who cannot walk

Keywords: orthostatic hypotension colonoscopy