Kornimate/medical-research-clean huggingface dataset:
integrating spoz technology to support and enhance the vitality acupunch (va) exercise program for older adults with dementia

Conditions: Disease and Dysfunction; Functional Fitness Deterioration; Activities of Daily Living; Instrumental Activities of Daily Living; Sleep Quality

Summary: this project aims to examine the effects of a six-month va exercise program incorporate the spoz technology in improving the disease dysfunction and functional fitness deterioration of older adults with dementia in adult daycare centers.

a cluster-randomized controlled trial will be conducted to examine the effects of a six-month va exercise program incorporate the spoz technology in improving the disease dysfunction, functional fitness deterioration (balance, lower muscle endurance, gait speed, handgrip strength, cardiorespiratory endurance, muscle endurance, agility, body flexibility), activities of daily living, instrumental activities of daily living, and sleep quality of older adults with dementia in adult daycare centers. using convenience sampling, 10 adult daycare centers with 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. the experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. the two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Eligibility criteria:
inclusion criteria: * diagnosed as dementia by a physician, or * screened by the spmsq as dementia * age 65 and older exclusion criteria: * have severe cardiopulmonary disease * have physical mobility impairment * have spinal cord injury
evaluation of the incidence of cerebral lesions post pulmonary vein ablation catheter (pvac)

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to determine the rate of diffusion weighted (dw)-mri cerebral lesions following a pulmonary vein ablation catheter (pvac) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * subject has been diagnosed with atrial fibrillation (af) * subject is indicated for a pulmonary vein ablation using pvac * subject (or subject's legally authorized representative) is able and and willing to give informed consent. exclusion criteria: * subject has permanent af * subject has a left atrial thrombus detected on tee * subject has had a prior left atrial ablation * subject has a intracardiac thrombus * subject is contraindicated for warfarin (coumadin) * subject has a cardiac valve prosthesis * subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor pfo) * subject has presence of any pulmonary vein stents * subject has presence of any pre-existing pulmonary vein stenosis * subject has had a cerebral ischemic event (strokes or transient ischemic attacks \[tia\]) which occurred during the 6 month interval preceding the consent date * subject is a woman known to be pregnant * subject is unwilling or unable to comply fully with study procedures and follow-up
bio|master.csp study

Conditions: Cardiac Pacing, Artificial; Cardiac Pacemaker, Artificial; Cardiac Resynchronization Therapy Devices; Bradycardia; Conduction Disorder; Conduction Defect, Cardiac; Heart Failure

Summary: the goal of this clinical study is to test the clinical safety and performance of the amvia pacemakers and the solia csp s lead when used for left bundle branch area pacing (lbbap). the patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. additional annual follow-up(s) may apply until study termination after regulatory approval of solia csp s. the total duration of the clinical investigation is expected to be until september 2027, with last patient out (lpo). during the visits the regular pacemaker and lead measurement are performed. a 12-lead ecg is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. programming of the pacemakers will be done according to the participant´s therapeutical needs. the study will be conducted in approximately 18 sites in europe, australia and new zealand where more than one physician per site are expected to participate.


Eligibility criteria:
inclusion criteria: for patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment: * standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (crt) * patient is intended for implantation of a pacemaker or crt-p system with left bundle branch area stimulation * ability to understand the nature of the study * ability and willingness to perform all follow-up visits at the study site * ability and willingness to use the cardiomessenger and acceptance of the biotronik home monitoring concept exclusion criteria: enrollment of a patient is not permitted if at least one of the following criteria is fulfilled: * planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * expected to receive heart transplantation or ventricular assist device within 12 months * life-expectancy less than 12 months * pregnant or breast feeding * age less than 18 years * participation in another interventional clinical investigation (according to the definition given in the cip)

Keywords: conduction system pacing (csp) left bundle branch area pacing (lbbap)
stabilization exercises alone vs stabilization exercises plus neuromuscular electrical stimulation in people with chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.


Eligibility criteria:
inclusion criteria: * between 18 years of age and 60. * body mass index (bmi) of less than 34. * low back pain duration of 3 months or greater (chronic). * minimum pain level on numeric pain rating scale (nprs) is 3 or greater. * minimum score of modified oswestry disability questionnaire (modq) is 20 or greater. * understands english exclusion criteria: * positive nerve root tension signs * progressive neurological deficit * positive babinski sign. * sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves. * history of spinal surgery * history of inflammatory joint disease * contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise. * contraindications to nmes including cardiac pacemaker or skin allergy to adhesives * history of metastatic cancer in previous 5 years or present treatment for cancer * women who indicate that they are pregnant or plan to become pregnant

Keywords: low back pain stabilization exercises neuromuscular electrical stimulation
adding lomustine to chemotherapy in older patients with acute myelogenous leukemia (aml), and allogeneic transplantation for patients from 60 to 65 years old

Conditions: Acute Myeloid Leukemia

Summary: a multicenter randomized trial comparing induction therapy (ic: idarubicin and cytarabine, 5 + 7) to icl (the same drugs plus lomustine (ccnu), 200 mg/m2 orally at day 1). patients in complete remission (cr) will then receive a post-remission schedule with or without lomustine according to randomization. patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

* principal objective: the primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy. * secondary objectives: * to assess the ability of lomustine to increase the cr rate. * to assess the ability of lomustine to increase the event-free survival. * to evaluate the toxicity and side-effects of lomustine. * to evaluate the feasibility of reduced conditioning allogeneic transplantation \*between 60 and 65 years old. * to evaluate prognostic factors. * to evaluate qol in elderly. * study design: parallel * study plan: * induction therapy: patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1. * consolidation therapy: after completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine. * maintenance therapy: in all patients with persisting cr one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months. * allogeneic transplantation: patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in cr) an allobmt with a reduced conditioning regimen of fludarabine (3d) and tbi (2gy). * number of subjects: 460

Eligibility criteria:
inclusion criteria: * patients aged 60 years and older with de novo aml and non-poor cytogenetic features. * patients with no unfavourable cytogenetic (based on goelams-bgmt criteria) * performance status and sorror score \< 3 . * signed and dated informed consent. exclusion criteria: * acute promyelocytic leukemia. * patients with myeloproliferative syndromes prior to diagnosis of aml. * patients who previously had myelodysplastic syndrome. * positive serology for hiv. * patients with unfavourable cytogenetic * patients with an isolated medullary extra localization of their disease

Keywords: aml chemotherapy older de novo aml
hpv self-test intervention in ohio appalachia

Conditions: Cervical Carcinoma; Human Papillomavirus Infection

Summary: this study will pilot test a culturally appropriate human papillomavirus (hpv) self-test intervention among women from ohio appalachia in order to determine the feasibility of hpv self-testing as a potential cervical cancer screening strategy. the intervention group will receive culturally appropriate materials and the control group will receive standard materials with their hpv self-test device.

primary objectives: i. to determine the feasibility of hpv self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use. outline: participants are randomized to 1 of 2 arms. arm i: participants receive a study kit that includes culturally appropriate instructions for using and returning the hpv self-test device and a photo story information sheet about hpv and hpv self-testing. participants are asked to complete the hpv self-test and return the test for hpv testing. arm ii: participants receive a study kit that includes standard instructions for using and returning the hpv self-test device and a standard information sheet about hpv and cervical cancer. participants are asked to complete the hpv self-test and return the test for hpv testing. participants are followed up at 4 weeks for return of their hpv self-test device and then for 2 months after notification letters are sent.

Eligibility criteria:
inclusion criteria: * ages 30-65 * no pap test in the last 3 years * resident of an ohio appalachia county * not currently pregnant or was not pregnant in the last 3 months * no history of invasive cervical cancer * no history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (rct) if they participated in the focus groups that helped develop this study (focus groups were institutional review board \[irb\] approved as protocol 2014c0086) or the preliminary device test; we will also require women to read and understand english and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and health insurance portability and accountability act (hipaa) forms

Keywords: hpv
a study of xeloda (capecitabine) compared with 5-fluorouracil in combination with low-dose leucovorin in patients who have undergone surgery for colon cancer

Conditions: Colorectal Cancer

Summary: this 2 arm study will compare the safety and efficacy of oral xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. patients will be randomized to receive either xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-75 years of age; * histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation. exclusion criteria: * previous chemotherapy
fertility supportive behavior education based on watson's theory of human care

Conditions: Infertility, Female; IVF

Summary: infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in watson's human care theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (ivf) in women with primary infertility


Eligibility criteria:
inclusion criteria: * women have a diagnosis of primary infertility. * women over the age of 18 and under the age of 32. * women able to read and write in arabic. * the cause of infertility must be a male factor. * women who are undergoing assisted reproductive techniques, specifically i̇n vitro fertilization-intracytoplasmatic sperm injection. * women using the same drugs and protocols for ivf treatment. * only women who receive a fresh embryo transfer during their ivf treatment included in the study. exclusion criteria: * women who have problems with understanding or perception * the presence of tubal, uterine or other infertility factors in women * women undergoing a frozen embryo transfer as part of their ivf treatment * women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.

Keywords: fertility watson's human caring theory lifestyle nursing care
treatment of childhood social phobia

Conditions: Social Phobia

Summary: this 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (prozac®), and placebo for treatment of social phobia in children and adolescents.

social phobia affects 3-5 percent of children, and prevalence rises with age. youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. recent findings indicate a new psychosocial treatment called social effectiveness therapy for children (set-c) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. treatment effects have been maintained for up to 6 months. this study will examine set-c in children ages 8-15. because available data suggest that the drug fluoxetine is a promising treatment, set-c will be compared to fluoxetine in this trial. durability of treatment will be monitored over a 1-year follow-up period.

Eligibility criteria:
inclusion criteria: * diagnosis of social phobia exclusion criteria: * pervasive developmental disorders (pdd) * schizophrenia * major depression * iq of less than 80 * medical conditions contraindicating use of fluoxetine

Keywords: phobic disorders mutism
mentors offering maternal support (m-o-m-s™): a prenatal program for decreasing maternal anxiety and depression

Conditions: Anxiety Fear; Prenatal Depression; Infant, Low Birth Weight; Preterm Birth; Maternal

Summary: the m-o-m-s project evaluates the effectiveness of the m-o-m-s program for improving birth outcomes and maternal-infant attachment and role satisfaction in a large military sample.

the m-o-m-s project is a longitudinal, multi-site, randomized controlled trial to test program effectiveness for decreasing prenatal maternal anxiety and depression and increasing self-esteem and resilience and assess the relationship to pregnancy complications, birth outcomes, postpartum maternal-infant attachment, role satisfaction and parental stress.

Eligibility criteria:
inclusion criteria: * prima or multigravida, first trimester of pregnancy at consent, greater than or equal to 18 years old, active duty, a wife of an active duty service member, or a retiree exclusion criteria: * anticipated permanent change of station during the study (unless going to another one of the study sites or able to complete all treatment components prior to move), dependent daughter of active duty or retired military, greater than 12 weeks gestation at consent, less than 18 years of age and inability to understand english.

Keywords: prenatal anxiety pregnancy depression military intervention
study in healthy adults evaluating pf-07202954

Conditions: Non-Alcoholic Fatty Liver Disease; Liver Fibrosis

Summary: the study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in part 1 and part 2; and a randomized, open label design, in part 3 (if conducted).


Eligibility criteria:
inclusion criteria:- healthy subjects (all 3 parts) * evidence of steatosis on fibroscan (part 2 only) * bmi 17.5 to 30.5 kg/m2 (part 1, part 3) * bmi 17.5 to 35.4 kg/m2 (part 2) exclusion criteria:- evidence of clinically significant disease * subjects on chronic medications * clinically significant, abnormal laboratory results, vital signs, or cardiac conduction abnormalities * contraindication to mri (part 2, only)
active drug comparative trial to evaluate the antiviral activity and safety in chronic hepatitis b patients

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to evaluate the antiviral activity and safety of entecabell odt. in chronic hepatitis b patients.


Eligibility criteria:
inclusion criteria: 1. over the age of 20 years old 2. patients with chronic hepatitis b diagnosed 3. patients who show positive hbsag 4. patients who show positive hbeag or negative hbeag 5. patients who showed hbv dna undetected(less than 300 copies/ml) 6. patients who have administered baraclude tab. 0.5mg for 1\~4 years 7. patients who showed alt less than 5 times of the upper limit in the normal range 8. patient who decided to participate and signed on an informed consent form willingly exclusion criteria: 1. patients who have hepatitis c (hcv), hepatitis d (hdv), or human immunodeficiency virus (hiv) 2. patients with a uncompensated liver disease who have at least one of the following values or signs * total bilirubin \> 2.5mg/dl * prothrombin time delayed more than three seconds of upper limit in the normal range * serum albumin \< 3 g/dl * a medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss 3. patients who are estimated to have hepatocellular carcinoma (hcc) through imaging examination or showed alpha-fetoprotein(afp) more than 100 ng/ml 4. patients who showed creatinine clearance \< 50 ml/min by calculating cockcroft-gault equation 5. patients who were not administered any anti-viral agents except baraclude tab.(entecavir) 6. administration of other investigational product within 30 days 7. history of malignant tumor within 5 years (including leukemia and lymphoma) 8. patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial 9. patients who have other hepatic diseases except hepatitis b 10. administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks 11. patients who have to administer immunosuppressants or nephrotoxic drugs, hepatotoxic drugs for period of clinical trial 12. pregnant, breast-feeding and childbearing age who don't use adequate contraception 13. patients who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial 14. patients who received an organ transplant or are going to received an organ transplant 15. severe hypersensitivity to entecavir 16. another clinical condition in investigator's judgement

Keywords: entecavir, entecabell odt., hepatitis b
effect of eggplant extract on lipid profile during fasting and postprandial period

Conditions: Dyslipidemia

Summary: the purpose of this study was to assess the effect of eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test in a randomized, double-blind, placebo-controlled clinical trial.

dry eggplant extract(solanum melongena) has been used by the population as an alternative treatment for dyslipidemia. it is a vegetable rich in flavonoids, which are polyphenol anti-oxidants found in foods. studies suggest an inverse relationship between the ingestion of foods rich in flavonoids and mortality from coronary artery disease. the aim of this study was to assess the effect of administering eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test. participants underwent a baseline clinical evaluation conducted by a doctor, who assessed whether the volunteer was apt to participate in the study. diabetics, smokers and users of hypolipidemic medication were excluded. after signing an informed consent form, 59 healthy volunteers of both genders were randomized to take either capsules containing 450 mg of dry eggplant extract or placebo. both interventions were administered in quantities of two capsules, twice a day, for 14 days, and both patient and doctor were unaware of the drug in use. the main outcome measure was lipid profile, which was checked during fasting on days 0 and 14, and also during postprandial period on the 14th day, when participants underwent a lipid overload test immediately after ingesting 900 mg of eggplant extract or placebo, as per prior randomization. the nutritional analysis of the meal contained 361 kcal and 22.5g of total fat, 14.5 g of which was saturated and 251mg of cholesterol. laboratory exams were taken (total cholesterol, triglycerides, hdl-c). ldl-c was calculated according to the friedewald formula: ldl-c = ct - hdl-c - tg/5. the nutritional value of food records was conducted with the help of diet win for windows nutritional evaluation software. anthropometric evaluation was also performed, including body weight, height and abdominal circumference, at baseline and on day 14, by the same investigator, blinded to the intervention.

Eligibility criteria:
inclusion criteria: * baseline clinical evaluation conducted by a doctor * informed consent form exclusion criteria: * diabetes mellitus * smoking * use of hypolipidemic medication

Keywords: eggplant dyslipidemia postprandial lipemia