Kornimate/medical-research-clean huggingface dataset:
nitrates and bone turnover; nitrates and bone turnover bisphosphonate sub-study

Conditions: Osteoporosis

Summary: purpose: nabt: to compare five widely available nitrate formulations: (1) 15 of nitroglycerin (ntg) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual ntg, (4) 20 mg of isosorbide mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their efficacy on markers of bone formation and resorption and for the incidence and severity of headache they cause. hypothesis: there is one ideal nitrate preparation which balances the clinical efficacy in bone remodeling against the common side effect of headache. nabt-b: to determine if nitrates affect markers of bone formation (serum balp and p1np) and resorption (serum ctx and urine ntx) in women who have recently discontinued treatment with alendronate, risedronate or zoledronate.


Eligibility criteria:
inclusion criteria: nabt: * women aged 50 years and older whose last menstrual period occurred at least 3 years ago * women without a uterus will be eligible after age 55 nabt-b: * women aged 50 years and older whose last menstrual period occurred at least 3 years ago * women without a uterus will be eligible after age 55 * previously treated with alendronate but stopped within 2 years of study commencement; or previously treated with risedronate but stopped within 1 year of study commencement; or previously treated with zoledronate. exclusion criteria: nabt: * a previous fracture of the hip, wrist, spine or ankle within the last 3 months; or a diagnosis of osteoporosis; * a history of bone disorders such as hyperparathyroidism or paget's disease; * treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater); * treatment with any antiresorptive agent, including alendronate, risedronate, etidronate or denosumab use for at least four weeks within the last three years; * previous treatment with intravenous zoledronate or parathyroid hormone; * current treatment with nitrates; * a history of migraine headaches; * a history of angina or cardiovascular disease; * inability to give informed consent; * hypersensitivity to nitroglycerin. nabt-b: * a previous fracture of the hip, wrist, spine or ankle; or a self-reported diagnosis of osteoporosis; * a history of bone disorders such as hyperparathyroidism or paget's disease; * treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater); * treatment with etidronate or denosumab use for at least four weeks within the last three years and any previous treatment with parathyroid hormone; * current treatment with nitrates; * a history of migraine headaches; * a history of angina or cardiovascular disease; * inability to give informed consent; * hypersensitivity to nitroglycerin.

Keywords: postmenopausal osteoporosis bone turnover nitrate headache
home-based in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: pulmonary rehabilitation consists of a multidisciplinary program of care for patients with chronic respiratory disease, which currently encompasses numerous features and physical training methods aimed at maintaining stability clinic for people with chronic obstructive pulmonary disease (copd), especially in patients who, even with optimized clinical treatment, continue their decline and symptomatic physical functions and 8 so that these social. goals are achieved the patient with copd should integrate into a program of rp assiduous and with accompanying several times per week, for several months, which for a number of factors is not always possible. for this reason, it is the research of methodology of rp that hold their effectiveness, but with greater flexibility and viability to people with copd. on this basis, this study aims to investigate the effectiveness of a program of rp semi-domiciliar in which the patient suffering from copd can receive guidance and training in person, to develop it partially in own domicile.

the protocol of the experimental procedure will begin with the explanation of the purpose, risks and benefits of the study volunteers to patients with copd. subsequently, based on an evaluation form, will collect data on the past history and current disease and performed a general physical examination. then the patients will respond to two questionnaires. the first will research the medical council (mrc) 13, which is a dyspnea scale to categorize in terms of disability, patients with copd. the second questionnaire will be the airway questionnaire 20 (aq20) 14 specific for obstructive pulmonary disease, which is validated for the local language and highly reliable for the evaluation of patients with copd, containing 20 questions related to respiratory health to evaluate the quality of life. subsequently, the same day, the patients carry out the following tests: spirometry, respiratory muscle strength, respiratory muscle endurance, assessment of training load of the upper and shuttle test and bioimpedance

Eligibility criteria:
inclusion criteria: * will be included patients of both sexes, * over 40 years and diagnosis of copd according to criteria of ats, gold and ii brazilian consensus of copd. * must be medically stable, * without having presented the framework of exacerbation of disease over the past 30 days and, * must have agreed to participate in this study which, after being presented and explained to patients, this accepted should be confirmed by subscription term of free and informed consent, pursuant to resolution 96 of 1996 of ms. exclusion criteria: * will be excluded from the study patients with serious comorbidity, * orthopedic diseases such as heart defects in upper and lower limbs, * sequelae of motor neurological disorders or impaired that may interfere with the ability to carry out physical exercise, * uncontrolled hypertension, * lung diseases and * those who do not grant support to participation in this study.

Keywords: home-based pulmonary rehabilitation copd
the effect of using walking aid on tug test

Conditions: Stroke; Locomotion Disorder, Neurologic

Summary: the timed up and go test is a measurement tool that allows the participant to use assistive devices and walking aids during the test that evaluates functional mobility. this study was conducted to determine the effect of using walking aids on the timed up and go test and it's correlation with balance in stroke patients.

cross-sectional, observational study

Eligibility criteria:
inclusion criteria: * mini mental state test \>24 * stroke patients who can walk 10 meters with or without walking aid exclusion criteria: * individuals dependent on bed or wheelchair * individuals with musculoskeletal disease that may adversely affect mobility and balance. * individuals who have had any operation in the last 6 months

Keywords: stroke timed up and go test balance locomotion
a client-based outcome system for individuals with lower limb amputation

Conditions: Amputation

Summary: standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (o\&p) services. though numerous instruments have been developed, existing measures of o\&p outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes. the investigators are developing the prosthetic limb users survey-mobility (plus-m) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (lla). the investigators propose the following objectives to achieve this goal. key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss key objective 2: study health profiles of lower limb prosthetic users key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs key objective 4: study longitudinal health patterns of persons with lower limb amputation


Eligibility criteria:
inclusion criteria: (1) be 18 years of age or older; (2) have a unilateral or bilateral amputation of the lower limb between the hip and knee or between the knee and ankle; (3) own and use a lower limb prostheses; (4) and be able to read, write, and understand spoken english. exclusion criteria: (1) do not currently use or do not intend to be fitted for a lower limb prosthesis; or (2) appear to have moderate to severe cognitive impairment, as evidenced by inconsistent responding to the study instruments.

Keywords: artificial limbs questionnaires mobility limitation
phase iii trial of dp followed by folfiri or the reverse sequence in unresectable gastric cancer

Conditions: Gastric Cancer; Metastases

Summary: to assess the optimal sequence of the palliative chemotherapy regimen (dp --\> folfiri vs folfiri --\> dp) in metastatic gastric cancer patients.

gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in korea. metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. a recent phase iii trial comparing docetaxel-cisplatin-5-fu (dcf) to the reference arm of cisplatin-5-fu (cf) showed a significant superiority of dcf in terms of survival, time-to-progression, and response rate. however, because dcf regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed metastatic adenocarcinoma of the stomach 2. age ≥ 18 3. eastern cooperative oncology group (ecog) performance status less than or equal to 2 4. life expectancy of at least 3 months 5. adequate renal, liver, bone marrow functions 6. adjuvant chemotherapy more than 12 months from the date of study entry 7. written informed consent exclusion criteria: 1. active infection requiring antibiotics 2. pregnant, lactating women 3. brain metastasis 4. systemic illness not appropriate for chemotherapy 5. radiotherapy within 2 weeks before the study entry 6. allergy to drugs used in the trial

Keywords: gastric cancer chemotherapy irinotecan docetaxel
the progression from dysmenorrhoea to chronic pelvic pain

Conditions: Dysmenorrhoea; Pelvic Pain; Chronic Pain

Summary: this is a cross-sectional observational study. for participants resident in adelaide, south australia. the study consists of 3 visits to the pain and anaesthesia research clinic (parc), within the royal adelaide hospital (rah). a total of 56 participants will be recruited for this study.

the study will involve a screening visit followed by two visits to parc for blood sampling and questionnaires. at the baseline visit, blood samples to assess biomarkers and confirm hormonal status will be taken. from screening until the final study visit a total of approximately 120 ml in blood samples will be taken from each participant. the study aims to further knowledge in the presence of severe pelvic pain in young women which is an area that has been under-researched with regard to it's impact on society. the study proposes to enroll 7 groups of 8 healthy nulliparous women aged 18-35 with the following characteristics: mild or absent dysmenorrhoea (pain scale 0-3) and no other pelvic pain symptoms. (3 groups) * group 1, without contraceptive pill use * group 2a , contraceptive pill user and with a history of mild or absent dysmenorrhoea prior to pill use * group 2b, contraceptive pill user and with a history of severe dysmenorrhoea (pain scale 7-10) prior to pill use severe dysmenorrhoea (pain scale 7-10), but without chronic pelvic pain. (2 groups) * group 3, without contraceptive pill use * group 4, contraceptive pill user chronic pelvic pain and severe dysmenorrhoea (2 groups) * group 5, without contraceptive pill use * group 6,contraceptive pill user

Eligibility criteria:
inclusion criteria: * age between 16 to 35 years old exclusion criteria: * irregular menstrual cycles * use of any reproductive hormonal preparations (other than the combined oral contraceptive pill), thyroxine, insulin or corticosteroids * presence of an inflammatory process, or clinically significant infection in the 4 weeks * clinically significant renal, hepatic, cardiac, auto-immune disease * current use of immunosuppressant medication such as hydroxychloroquine, methotrexate or azathioprine * inability to read or comprehend the written information provided * current use of medications known to affect tlr responsiveness including amitriptyline or minocycline * current use of any analgesics, including non-steroidal anti-inflammatory medications and opioids for 5 drug half-lives prior to the day of testing * current or previous pregnancy * body mass index less than 18 or more than 30

Keywords: tlr2 tlr4 biomarker tlr responsiveness peripheral blood responsiveness inflammatory pain
evaluation of oncoxin-viusid® in head and neck cancer

Conditions: Head Cancer Neck

Summary: nutritional supplements containing antioxidants seem to decrease toxicity associated with radiotherapy (rt) and chemotherapy (ct) in patients with malignant head and neck tumors. oncoxin-viusid® (ov) is a nutritional supplement with antioxidant, immunomodulator and antitumor effects.

objective to assess the efficacy and safety of ov in patients with head and neck tumors during treatment with radio-chemotherapy. materials and methods patients diagnosed with head and neck carcinoma, and indicated to follow a radiotherapy treatment concurrent with radiosensitizing chemotherapy, were included in a phase ii, randomized, prospective, controlled and double-blind study in two treatment arms: rt + ct + placebo (n = 30) and rt + ct + ov (n = 30) during one year in a tertiary center (inor), with the aim of evaluating the reduction of toxicities of rt-ct and improve the quality of life of patients during these oncospecific treatments.

Eligibility criteria:
inclusion criteria: * patients of both sexes * over 18 years of age * with histological diagnosis of carcinoma of the head and neck * regardless of the variety or degree of histological differentiation and clinical stage * tributaries of concomitant treatment with ionizing radiation and radiosensitizing chemotherapy with intercurrent diseases compensated and index of karnofsky \> 59 * acceptable hematological parameters * women not pregnant or lactating * who authorized their inclusion in the investigation, through their informed consent. exclusion criteria: * patients with a second concomitant primary tumor and / or contraindication to platinum chemotherapy * patients who are under another research protocol or who have decompensated psychiatric disorders.

Keywords: head carcinoma neck carcinoma chemotherapy radiotherapy oncoxin viusid nutritional supplement
evaluation of the relationship between zinc vitamin d and b12 levels in the covid-19 positive pregnant women

Conditions: COVID; Zinc Deficiency; Vitamin D Deficiency

Summary: zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.

serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.

Eligibility criteria:
inclusion criteria: * covid-19 positive pregnant women * under 18 or more than 45 years old exclusion criteria: * vitamin d , vitamin b12 or zinc supplement use * multivitamine use * have taken vitamin supplements in the past 3 months * use of medicines for vitamin deficiency * having metabolic disease covid-19 negative pregnant women
improving post-acute stroke follow-up care by adopting telecare consultations in a nurse-led clinic

Conditions: Stroke

Summary: since 2017, hong kong has provided post-acute stroke services in clinics operated by stroke advanced practice nurses (apns). currently, the applicability of the clinics has been further limited by the emergence of the coronavirus (covid-19) pandemic due to restrictions on visits to the clinics and tightened social distancing requirements. telecare consultations may be a viable option for contributing more flexible, interactive, and cost-efficient care models to support stroke survivors over the longer run. the present study takes advantage of this opportunity by utilizing implementation science to simultaneously implement and evaluate a telecare model of care in a nurse-led post-acute stroke clinic.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stroke within 1 month before enrolment, will be discharged home within a week, aged 18 or above, cognitively competent with a score equal to or greater than 22 in the montreal cognitive assessment hong kong version, own a smartphone exclusion criteria: * have unaccompanied hearing or vision loss, cannot be reached by phone, bedbound, have no internet connection at home, participating in other clinical trials at the same time, require physical contact, i.e. wound dressing

Keywords: stroke telecare consultation
tranexamic acid vs. quixil - reducing blood loss in joint replacement

Conditions: Hemorrhage; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Summary: we will compare the effectiveness of quixil and tranexamic acid in reducing bleeding during hip and knee joint replacements.

this is a prospective randomised controlled trial to compare the benefits of quixil vs. tranexamic acid in reducing blood loss. both medicines are used for the reduction of blood loss in major joint surgery; previous studies have shown each one to be effective and safe, but they have not been directly compared in this setting. we will compare the blood loss in each of 3 groups: tranexamic acid used, quixil used, and control group (neither drug used). blood loss is to be calculated from height, body weight and difference between pre and post-operation haematocrit.

Eligibility criteria:
inclusion criteria: * patients who are to undergo elective hip or knee joint replacement * must be cemented arthroplasty * must be primary arthroplasty exclusion criteria: * uncemented arthroplasty. * revision arthroplasty. * patients on anticoagulant (warfarin, low molecular weight heparin) or other medication known to affect clotting (except aspirin, which is to be given as part of standard dvt prophylaxis in all cases). * other drugs that may affect the activity of the drugs under investigation. * allergy to asprin (all patients to receive 150mg aspirin as standard dvt prophylaxis for 6 weeks). * patients with known coagulopathy (aptt or pt outside normal range pre-operatively). * previous reaction or ethical/religious objection to receiving blood products (quixil contains a derivative of human blood). * pregnancy or breastfeeding. * patients who have a past medical history of thrombo-embolism at any time. * patients who need intravenous fluid administration for greater than 24 hours following operation. * patients who need allogenic blood transfusion within study period. * jehovah's witnesses, or any other group of patients with ethical objections to receiving blood products.
effect of beta blockade on left ventricular remodeling and function in moderate to severe asymptomatic aortic regurgitation

Conditions: Aortic Valve Insufficiency

Summary: the primary objective of this study is to evaluate the effect of beta-blocker on left ventricular (lv) remodeling in asymptomatic patients with moderate to severe aortic regurgitation.

the left ventricle responds to the volume load of chronic aortic regurgitation (ar) with a series of compensatory mechanisms, including an increase in end-diastolic volume, an increase in chamber compliance that accommodates the increased volume without an increase in filling pressures, and a combination of eccentric and concentric hypertrophy. the greater diastolic volume permits the ventricle to eject a large total stroke volume to maintain forward stroke volume in the normal range. this is accomplished through rearrangement of myocardial fibers with the addition of new sarcomeres and development of eccentric lv hypertrophy. as a consequence left ventricular ejection fraction will remain in the normal range. the clinical course of chronic aortic regurgitation is characterized by a prolonged phase of stability during which the left ventricle adapts to the volume overload. eventually myocardial failure ensues through a series of complex events that include changes in myocyte phenotype due to re-expression of fetal genes, cellular apoptosis alteration in the expression and function of contractile proteins and changes in the extracellular matrix. the role of long-term vasodilator therapy in the care of asymptomatic patients with severe aortic regurgitation is controversial. vasodilator therapy has been used to reduce the regurgitant volume, afterload, left ventricular volumes, and wall stress in an effort to preserve left ventricular function and reduce left ventricular mass. thus time to surgical intervention has been found to be delayed by calcium antagonists, ace-inhibitors and hydralazine, while a more recent study did not find any effect of nifedipine or enalapril on time to surgery or left ventricular volume and function. the decision to recommend operative intervention to the asymptomatic patient with chronic, severe aortic regurgitation (ar) is very difficult because aortic valve replacement (avr) continues to entail immediate risk, and biologic and mechanical valves still have problems resulting in significant morbidity and mortality. on the other hand, the mortality rate in asymptomatic patients with ar is very low, and surgery does not improve the quality of life. thus, the indication in asymptomatic patients must be delayed until changes occur that will predict an increased risk of operative or long-term death after avr. at present indication for aortic valve replacement is development of symptoms, an increase in left ventricular volume or a decline in left ventricular function.

Eligibility criteria:
inclusion criteria: * moderate to severe aortic valve insufficiency * asymptomatic exclusion criteria: * arrhythmia * other severe valve disease

Keywords: aortic valve insufficiency beta-blocker
natural history study in patients with lgmdr5/2c

Conditions: Gamma-sarcoglycanopathy

Summary: prospective, longitudinal, interventional, multicenter natural history study to better understand the lgmdr5/2c disease physiopathology. the duration of participation for each patient will be up to 24 months.

study duration duration from first visit of first patient (fpfv) to last visit of last patient (lplv) : 3 years. each patient will have a visit every 6 months over 2 years (5 visits in total). study primary objective is to characterize the disease course in gamma-sarcoglycanopathy (lgmdr5/2c) patients using standardized and disease appropriate evaluations. secondary objectives are to identify clinical, imaging and/or laboratory parameters that are indicators of the disease course in lgmd2c and to identify the best outcome measure for further therapeutics approaches

Eligibility criteria:
inclusion criteria: * male and female patients 6 to less than 35 years of age * ambulant patients should be less than 12 years of age and able to walk/run 10 meters (item 29 of nsad) in less than 15 sec * confirmed diagnosis of lgmdr5 (genotyping) * fvc \> 40% exclusion criteria: * subjects with co-morbidity which may interfere with lgmdr5 natural evolution and/or evaluation of outcome measures * need of non-invasive ventilation \> 16h per 24h or any invasive ventilation * left ventricular ejection fraction (lvef) \< 30% or prior heart failure decompensation requiring hospitalization * past participation in a gene therapy or cell therapy trial