Kornimate/medical-research-clean huggingface dataset:
demonstrate-tb study in ethiopia

Conditions: Reducing Tuberculosis Incidence

Summary: ending the tb epidemic by 2035 in ethiopia would be possible if tb notification declines by an annual factor of at least 15% from the current notification rate of 132 per 100,000 population. this requires highly effective strategies to reduce tb transmission and maximize tb prevention among populations at risk of developing tb, such as household contacts and people living with hiv. the investigators hypothesize that community wide administration of enhanced tpt will accelerate decline in tb incidence rates when combined with an optimized currently recommended comprehensive tb prevention and care packages described below. the investigators further hypothesize that such intervention packages will be acceptable to the community, providers and policy makers, and that they will be cost-effective. based on the study results, a tb elimination framework in high burden tb regions and woredas in ethiopia will be developed, and local evidence to enhance the shift toward tb elimination will be provided as input to the appropriate allocation of resources.


Eligibility criteria:
inclusion criteria: 1. adults: * greater than or equal to 18 years old * provides consent * living in study site area (woreda) 2. children * aged 12 to 17 years * living in the study site area (woreda) * assent to enrollment * guardian provides consent for enrollment 3. younger children: * less than 12 years old * living in the study site area (woreda) * consent for enrollment provided by the guardian exclusion criteria: 1. adults: * does not provide consent * declines to provide contact information * less than 18 years * living outside of the study site area * declines to allow study staff to contact them by phone and in person if they miss a study visit 2. children * does not provide assent * guardian does not provide consent * guardian declines to provide contact information * not within 12 to 17 years * living outside of the study site area * guardian declines to allow study staff to contact them by phone and in person if they miss a study visit 3. younger children * guardian does not provide consent * guardian declines to provide contact information * not less than 12 years * living outside of the study site area * guardian declines to allow study staff to contact them by phone and in person if they miss a study visit

Keywords: tuberculosis prevalence tuberculosis incidence tuberculosis elimination tuberculosis preventive therapy quasi experimental ethiopia
blood glucose levels in children during anesthesia

Conditions: Fasting

Summary: this cross-sectional study aims to investigate blood glucose levels in children during general anesthesia and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting. blood glucose will be measured following anesthesia induction and prior to discontinuing the administration of the anesthetic agent.

this cross-sectional study aims to investigate blood glucose levels in children \< 18 years during general anesthesia, and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting. the purpose is to evaluate whether guidelines for shortening the preoperative fasting period of children at our hospital have resulted in a shorter fasting duration and prevalence of low blood glucose levels during anesthesia induction. also to shed light on blood glucose levels during general anesthesia and its correlation with intravenous fluid management and administration of steroidal anti-emetics. blood glucose sampling will be obtained and measured following anesthesia induction and prior to discontinuing the anesthetic agent. if general anesthesia lasts longer than one hour, additional blood glucose analysis will be conducted one hour after the first measurement.

Eligibility criteria:
inclusion criteria: children under 18 years of age who undergo intervention under general anesthesia. the parent or guardian understands and speaks icelandic. exclusion criteria: coexisting disease or treatment that may affect fasting blood glucose level; preoperative intravenous fluid administration; beta-blockers; insulin and corticosteroids, endocrine disorders, acute pain, and emergency interventions.

Keywords: pediatrics children general anesthesia preoperative fasting fasting blood glucose hypoglycemia
evaluating trends in anaplastic thyroid cancer patients' clinical study experiences

Conditions: Anaplastic Thyroid Cancer

Summary: clinical trials can sometimes favor certain demographic groups. additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative. the goal is to identify the obstacles and challenges that prevent participation in anaplastic thyroid cancer clinical research, as well as the reasons for withdrawal or discontinuation. insights gained from this study will ultimately benefit those with anaplastic thyroid cancer who may be invited to participate in clinical research in the years to come.


Eligibility criteria:
inclusion criteria: * diagnosed with anaplastic thyroid cancer * willing to comply with all study related procedures and assessments * capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (icf) and in the protocol exclusion criteria: * no documented diagnosis of anaplastic thyroid cancer * any serious and/or unstable pre-existing medical disorders * pregnant or lactating woman

Keywords: anaplastic thyroid cancer
developing strategies for effective debridement in patients for venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: the goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (vlus) and to test the efficacy of this approach.


Eligibility criteria:
inclusion criteria: 1. \>18 years of age 2. conformation of venous disease by non-invasive venous studies with either doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema) 3. have a venous ulcer between the knee and ankle, at or above the malleolus 4. wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone 5. wound duration of at least 6 months 6. vlu containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue 7. ability of subject to tolerate limb compression bandage exclusion criteria: 1. history of diabetes mellitus and a hba1c \> 12% (obtained within past 6 months) 2. ankle brachial index(abi) less than 0.80 3. any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years 4. suspicion of malignancy within vlu 5. life expectancy \<6 months 6. history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months) 7. history of liver disease and liver function test (alt, ast, alk phos, and bilirubin) \>2x upper limit of normal (obtained within past 6 months) 8. requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry 9. history of immunodeficiency 10. ulcers due to none venous etiology and leg ulcers associated with mixed etiology 11. untreated osteomyelitis 12. hepatitis 13. acute deep venous thrombosis 14. allergy to lidocaine and/or epinephrine 15. subject's inability to successfully tolerate compression therapy that is changed weekly 16. skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors) 17. if currently incarcerated 18. known pregnancy
reliability of duplex ultrasound for diagnosis of deep vein thrombosis performed by nurses

Conditions: Ultrasound

Summary: the purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients.

critically ill patients hospitalized in the intensive care unit are in increased risk of proximal deep vein thrombosis despite thromboprophylactic measures. diagnostic method of the first choice is point-of-care ultrasound examination. this method is usually performed by a trained intensive care physician. however, if this examination could be performed by trained nurses, its availability would be greatly increased. the results of the investigator's pilot study showed that general nurses are able to diagnose proximal deep vein thrombosis in critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a specificity of 99 %. before implementation of this examination into the optional competencies of general nurses, the results need to be confirmed in a larger group of patients. this is the goal of proposed clinical study. in this prospective observational study, the patients will be investigated by extended duplex ultrasound (compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region) by a trained nurse and on the same day, the examination will be repeated by a trained physician - intensivist. the results of the examinations of each patient will be blinded until both tests will be performed.

Eligibility criteria:
inclusion criteria: * inpatients * critically ill patients hospitalised in the intensive care unit for more than 72 hours exclusion criteria: * known deep vein thrombosis * contraindication of ultrasound examination * refusal of ultrasound examination by patient
raloxifene use for the heart

Conditions: Cardiovascular Diseases; Breast Neoplasms

Summary: the purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.


Eligibility criteria:
inclusion criteria: * postmenopausal women with established coronary heart disease or at risk for a major coronary event. exclusion criteria: * postmenopausal symptoms that required estrogen replacement therapy. * suspected or known history of breast or endometrial carcinoma. * known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis. * new york heart association classes iii or iv heart failure.
comparison of lopinavir/ritonavir or hydroxychloroquine in patients with mild coronavirus disease (covid-19)

Conditions: COVID-19

Summary: in vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against severe acute respiratory syndrome coronavirus 2 (sars-cov-2). however, there is no clinical studies on the reduction of viral load in patients with covid-19. this study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild covid-19.

this multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.

Eligibility criteria:
inclusion criteria: * confirmed mild covid-19 (news scoring system 0-4) exclusion criteria: * unable to take oral medication * pregnancy or breast feeding * immunocompromised patients * creatinine clearance (ccl) \< 30 ml/min * aspartate transaminase (ast) or alanine transaminase (alt) \> 5 times upper limit of normal (uln)
novel mhealth platform to ensure quality of community-based malaria diagnosis

Conditions: Quality Assurance of Malaria Diagnosis

Summary: the investigators propose to implement a new mobile interface that automatically reads and troubleshoots malaria rapid diagnostic test (rdt) cassettes. this device, called a deki reader (dr), will allow the investigators to establish an extensive quality assurance program of malaria diagnosis performed by trained community health volunteers (chvs). the study will lease 10 drs and rotate them amongst 200 chvs performing community-based malaria diagnosis through rapid diagnostic testing. the study setting is bungoma east subcounty and kiminini subcounty in kenya. the overall goal is to measure and improve the quality of malaria diagnosis by chvs using malaria rdts. the investigators aim for every chw to exceed 90% sensitivity and specificity and zero operator errors within six months. there are no appreciable risks to the chv associated with evaluation by the dr device. the investigators' analysis will focus on descriptive statistics of rdt use and accuracy amongst all participating chvs.


Eligibility criteria:
inclusion criteria: * all community health volunteers in 10 community units in bungoma east and 6 community units in kiminini that have been trained to provide community-based malaria diagnosis through rapid diagnostic testing are eligible. exclusion criteria: * any person not meeting the inclusion criteria.

Keywords: quality assurance monitoring & evaluation malaria rapid diagnostic test (rdt) community-based malaria diagnosis community health workers
the effects of eplerenone on markers of myocardial fibrosis in adult congenital heart disease

Conditions: Tetralogy of Fallot; Transposition of the Great Vessels With an Arterial Switch; Single Ventricle With a Fontan Palliation

Summary: hypothesis: by blocking aldosterone signaling in patients with tetralogy of fallot, transposition of the great vessels with a prior atrial switch, and single ventricle "fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis. half of enrolled patients will complete an sf-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.


Eligibility criteria:
inclusion criteria: * established diagnosis of tetralogy of fallot, transposition of the great vessels with a systemic right ventricle, or fontan type palliation * patient followed regularly at washington university-affiliated institution * if female, willing to use 2 forms of contraception including one barrier method during protocol exclusion criteria: * gfr \<30 ml/min * potassium \>5.0 mmol/l * unable or unwilling to comply with study protocol * use of potassium sparing diuretics * use of an aldosterone blocker currently or previously * known intolerance of eplerenone or aldosterone blockade * pregnant, breastfeeding, or actively trying to get pregnant
the effect of zumba dance on primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the objective of this study is to investigate the effect of practising zumba exercise in decreasing menstrual pain in young women with primary dysmenorrhea.

primary dysmenorrhea or painful menstruation without pelvic pathology is one of the most common complaints in women's medicine. the pain begins with the onset of menstrual bleeding and lasts for 72-12 h. pain is usually in the middle line of the highest severity. dysmenorrhea pain is often described as cramped and intermittent. zumba is a dance-based fitness class that originated in colombia in the 1990s and is now extremely popular worldwide. the aim of this study is to investigate the effect of 8 weeks of regular zumba exercise on the severity of primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: * having regular menstrual cycles (30-35 days) and bleeding time of 3-10 days. * history of primary dysmenorrhea(pd) which had affected daily activities in at least 50% of their cycles through the past 6 months; and pain intensity over 4 cm, based on the 10-cm visual analog scale score. * having a pain score for pd on the visual analog scale (vas) of 4-7 cm * age: 18-25 years. exclusion criteria: * pregnancy * known diseases of the genitourinary system (e.g., pelvic inflammatory disease and urinary tract infections) or secondary dysmenorrhea and chronic diseases (heart disease, respiratory, kidney, blood pressure, asthma, diabetes, epilepsy, migraine, thyroid, anemia, nervous disorders). * previous zumba fitness practice. * irregular menstrual cycles; the use of intra-uterine devices and oral contraceptive pills. * musculoskeletal injuries and metabolic/cardiorespiratory contraindications to physical exercise
study of betaferon adherence in patients with multiple sclerosis treated with interferon beta-1b

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (cis), relapsing-remitting multiple sclerosis (rrms), or secondary progressive multiple sclerosis (spms) who had more than 6 months in treatment.


Eligibility criteria:
inclusion criteria: * patients with relapsing-remitting ms (rrms), secondary progressive ms (spms) or patients with a first outbreak or clinically isolated syndrome (cis) that carry more than 6 months in treatment with interferon beta-1b exclusion criteria: -

Keywords: interferon beta-1b (infb-1b) multiple sclerosis (ms) relapsing-remitting ms (rrms) secondary progressive ms (spms) clinically isolated syndrome (cis)
acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis

Conditions: Hemodialysis; Uremic Pruritus

Summary: the research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. the research method adopts the experimental research method using randomization. the patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group.

there are about 60-90% of hemodialysis patients complain of itchy skin, which can cause the sleep quality decline. the important issue of non-invasive acupressure methods to relieve skin itching symptoms and to improve sleep quality are worth explored. therefore, the research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. the research method adopts the experimental research method using randomization. the patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group. the experimental group will receive the acupressure at the hemodialysis center for a total of 12 weeks, three times a week. the patients will receive 4 acupuncture points, including quchi acupoint, xuehai acupoint, sanyinjiao acupoint, and zusanli acupoint. each acupoint will be pressed for 3 minutes, and totally 4 acupuncture points are 12 minutes. the effectiveness will be evaluated at the fourth week, eighth week and twelfth week. the effectiveness assessment in the study will use the "visual analog scale (vas)", "5d pruritus scale", and "pittsburgh sleep quality scale". this study uses the pre-test before the implementation of acupuncture, and uses the post-test at week 4, 8, and 12 end of acupuncture. hopefully, this study may develop a beneficial non-drug care measures to improve the itching symptoms and sleep quality of hemodialysis patients, and to improve their quality of life. if this research result proves that the application of acupressure can be effective, it can not only improve the symptoms of itchy skin and sleep problems in hemodialysis patients, but also hope that can be extended to patients with end-stage renal disease.

Eligibility criteria:
inclusion criteria: 1. at least 3 months hemodialysis 2. at least 1 month have itching 3. at least mild itching on the 5d tickling scale (9-11 points) 4. can answer questions correctly exclusion criteria: 1. skin-related disease 2. liver disease 3. psychiatric disorder 4. cancer undergoing chemotherapy or radiation therapy 5. nerve or vascular or soft tissue diseases of the extremitie 6. infections or surgeries on the extremitie

Keywords: hemodialysis acupressure uremic pruritus sleep quality effect
a study to assess preference for subcutaneous trastuzumab treatment in participants with human epidermal growth factor receptor (her)2-positive metastatic breast cancer responding to first-line intravenous trastuzumab for at least 3 years

Conditions: Breast Cancer

Summary: this open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (sc) versus intravenous (iv) trastuzumab (herceptin) in participants with her2-positive metastatic breast cancer responding to first-line treatment with iv trastuzumab for at least 3 years. participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab sc followed by 3 cycles of trastuzumab iv or 3 cycles of trastuzumab iv followed by 3 cycles of trastuzumab sc. all participants will receive trastuzumab sc for cycles 7 to 18. anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed her2-positive metastatic breast cancer * on treatment with first-line trastuzumab iv and free of disease progression for at least 3 years * left ventricular ejection fraction (lvef) of greater than or equal to (\>/=) 50 percent (%) * hormonal therapy will be allowed * prior use of anti-her2 therapy will be allowed exclusion criteria: * history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years; participants with previous ductal carcinoma in situ of the breast are also eligible * participants with severe dyspnea at rest or requiring supplementary oxygen therapy * serious cardiac illness or medical conditions that would preclude the use of trastuzumab * hepatitis b, hepatitis c or human immunodeficiency virus infection * pregnant or lactating women * concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment * known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma * central nervous system metastases, unless they have been treated and have been stable for at least 3 years * inadequate organ function