Kornimate/medical-research-clean huggingface dataset:
rotating frame relaxation imaging in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Summary: the aim of this study is to develop novel magnetic resonance imaging (mri) protocols suitable for patients with multiple sclerosis using advanced mri such as rotating frame relaxation imaging. in addition, the investigators want to study the correlation between advanced mri parameters and clinical disease progression.


Eligibility criteria:
inclusion criteria: * the diagnosis of relapsing remitting ms made according to the poser, mcdonald's or revised mcdonald's criteria (group i) before participating in the study * initial ms diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (group ii). * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * any other autoimmune disease than ms requiring immunomodulatory or immunosuppressive medication * high-dose corticosteroid treatment within 30 days before participating in the study * prior medical history: patient must have no history of serious cardiovascular, liver or kidney disease * any psychiatric condition that compromises the subject's ability to participate in the study * infections: patient must not have an uncontrolled serious infection * no contraindications for mri (cardiac pacemaker, intracranial clips etc)

Keywords: multiple sclerosis, mri, rotating frame
post-exercise hypotension after water exercise

Conditions: Postexercise Hypotension

Summary: hypertension is the most prevalent cardiovascular disease risk factor among individuals 60 years of age and older. hypertension can be prevented and modified with lifestyle interventions that include regular exercise. water exercise is widely recommended for older adults for a variety of health benefits, but few studies have assessed the immediate ambulatory blood pressure (bp) response to water exercise, a response termed postexercise hypotension (peh). we will assess peh after a session of water aerobics in physically active, older women with hypertension. twenty-four women will be randomly assign to participate in a 45 min session of moderate intensity, water aerobics (water) and a 45 min land control session (control). all experimental sessions will start at 9 am sharply with 7 days between them. subjects will left the experiments wearing an ambulatory bp monitor for the next 21 hr.


Eligibility criteria:
inclusion criteria: * resting sbp ≤ 160 mmhg and dbp ≤ 100 mmhg documented by a physician; * 65 to 80 years of age; * physically active on land but not water (exercising 3 or more days per week as determined by the international physical activity questionnaire long-form). exclusion criteria: * any febrile condition and/or infectious diseases; * no other chronic diseases or conditions other than hypertension; * body mass index (bmi) \> 35 kg/m2; * active smoker; * physical or mental limitations that prevent exercising.
peri-operative prediction of prolonged stay in the cardiac intensive care unit for adult cardiac surgery

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Cytokine Release Syndrome

Summary: the purpose of this study is to create a model using intra-operative modified sofa score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (cicu) for adult cardiac surgery with heart-lung machine

cardiac surgery using cardiopulmonary bypass (cpb) is commonly associated with a systemic inflammatory response that exacerbates peri-operative life-threatening complications and multiple organ dysfunction syndromes. these features can prolong the stay in the cicu. many peri-operative clinical risk factors contribute to those adverse outcomes resulting in prolonged cicu stay. if the investigators can create a model to identify the effects of these intra-operative clinical risk factors to prolonged cicu stay

Eligibility criteria:
inclusion criteria: * adult patients who had undergone elective cardiac surgery with cpb exclusion criteria: * under 18 years of age * needing emergency surgery * needing intra-aortic balloon pump

Keywords: cardiac surgery cytokine clinical scoring system risk factor
association between 4-month isokinetic testing measures and second knee injuries after primary anterior cruciate ligament reconstruction

Conditions: ACL Injury; Knee Injuries; Muscle Weakness

Summary: anterior cruciate ligament (acl) is a frequent and disabling injury in athletes. most of the time, acl reconstruction (aclr) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. however, the risk of secondary severe knee injury is increased after aclr, especially in athletes returning to strenuous activities. if strength symmetry is considered as an important factor in the return-to-sport (rts) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after aclr. the main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after acl-r.


Eligibility criteria:
inclusion criteria: patients who have had an acl reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 3-4 months patient who received the information form patients with access to the internet exclusion criteria: patient who did not participate in all follow-up consultations and isokinetic muscular assessments patients who had a previous knee surgery before the aclr cognitive or sensory impairment making it impossible to understand the information form neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
clinical trial to evaluate the efficacy and safety of esoduo tab. 20/800mg

Conditions: Non-erosive Reflux Disease(NERD)

Summary: to evaluate the efficacy and safety of esoduo tab. 20/800mg

a multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of esoduo tab. 20/800mg in patients with non-erosive reflux disease(nerd)

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥ 19 years 2. episode of heartburn for 3 months or more during prior to randomization visit. 3. episode of heartburn for 2 days or more during the last 7 days prior to randomization visit. 4. grade n, m by egd test. exclusion criteria: 1. surgery history on stomach or esophagus 2. active medical history of stomach, esophagus area 3. other system disorder which can disturb this trial 4. patients taking the contraindication of concomitant medications 5. clinically significant abnormal lab test 6. pregnant woman, breastfeeding woman.
investıgatıon of the effect of the pandemıc process in indıvıduals wıth chronıc low back and neck paın

Conditions: Neck Pain; Low Back Pain; Cognitive Level; COVID-19 Pandemic

Summary: there are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. however, no study has been found that compares the effects of individuals actively carrying and not carrying the covid-19 virus. for this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.


Eligibility criteria:
inclusion criteria: * those between the ages of 18-60, * having low back or neck pain lasting longer than 3 months, * having a history of covid-19 (at least 6 weeks-post acute), * individuals with chronic low back and neck pain without a history of covid-19 will be included. exclusion criteria: * those with an active diagnosis of covid-19 * having a rheumatological disease, * broken etc. severe deformity that may lead to nerve injury, * having a history of spinal surgery, * having neurological disease in addition to spinal pathology, * having problems such as cancer, diabetes, dementia, organic brain dysfunction, * illiterate individuals will not be included.
effect of medium chain triglyceride intake on colonization of preterm infants with candida

Conditions: Candida Infection; Premature Infant

Summary: this study evaluates whether adding a dietary supplement similar to coconut oil (mct oil) to feedings in premature infants will reduce the amount of yeast (candida) detectable in their stool. infants who have candida in their stool are eligible to participate. half of the enrolled infants will have additional mct oil added to their feedings and half will not.


Eligibility criteria:
inclusion criteria: * premature infant admitted to the neonatal intensive care unit at women \& infants hospital * receiving full enteral feeds of either preterm or transitional formula or fortified breast milk * anticipated to have a minimum stay of two weeks exclusion criteria: * prior exposure to antifungal drugs
study on the fetal safety of new coronavirus vaccination for couples during the peri-pregnancy period

Conditions: Perinatal

Summary: all the pregnant women and newborns of both or one of the couples who gave birth in ditan hospital were collected as the observation group, and the pregnant women and newborns of both husband and wife who gave birth in our hospital without new crown vaccine during pregnancy were collected as the control group. the incidence of adverse events during pregnancy of the two groups and the incidence of intrauterine development and congenital malformations of the two groups were observed to observe the physical and intellectual development of children in the two groups at the age of 1 year, and to explore the safety of perinatal neocrown vaccination.

this study is a prospective observational cohort study. all the pregnant women and newborns of both or one of the couples who gave birth in ditan hospital were collected as the observation group, and the pregnant women and newborns of both husband and wife who gave birth in our hospital without new crown vaccine during pregnancy were collected as the control group. the incidence of adverse events during pregnancy of the two groups and the incidence of intrauterine development and congenital malformations of the two groups were observed to observe the physical and intellectual development of children in the two groups at the age of 1 year, and to explore the safety of perinatal neocrown vaccination.

Eligibility criteria:
inclusion criteria: * the pregnant women and newborns who were injected with the new crown vaccine during the perinatal period of both husband and wife or one of them were the observation group, and the pregnant women and newborns who were not vaccinated with the new crown vaccine during the perinatal period of both husband and wife were the control group. they were fully informed of the risk, voluntarily joined the study and signed the informed consent. exclusion criteria: * both husband and wife or family have previously delivered congenital abnormal fetus; * neither husband nor wife was willing to participate in this study.

Keywords: propofol tenofovir hbv dna mother-to-child block new crown vaccination perinatal period
assessment of clinical consistency of three production lots of gsk biologicals' hrv vaccine

Conditions: Infections, Rotavirus

Summary: the purpose of this study is to evaluate the lot-to-lot consistency of three production lots of gsk biologicals' hrv vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * child is unlikely to remain in the study area for the duration of the study. * previous confirmed occurrence of rotavirus gastroenteritis. * gastroenteritis within 7 days preceding the study vaccine administration. * household contact with an immunosuppressed individual or pregnant woman. * use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s). * planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * acute disease at time of enrollment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Keywords: gastroenteritis
follow-on study of pitavastatin versus atorvastatin in patients with type ii diabetes mellitus and combined dyslipidemia

Conditions: Type II Diabetes Mellitus; Dyslipidemia

Summary: this is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study nk-104-305.


Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus * combined dyslipidemia * completed nk-104-305 (nct00309751) exclusion criteria: * withdrawal from nk-104-305 (nct00309751)

Keywords: pitavastatin type ii diabetes mellitus combined dyslipidemia
study evaluating duvelisib in japanese subjects with relapsed or refractory lymphoma

Conditions: Lymphoma

Summary: this study seeks to evaluate the safety and pharmacokinetics of duvelisib in japanese participants with relapsed or refractory lymphoma.


Eligibility criteria:
inclusion criteria: * diagnosis of lymphoma (excluding lymphoblastic lymphoma) * progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy * eastern cooperative oncology group (ecog) performance status lower than or equal to 2 * life expectancy of at least 3 months exclusion criteria: * any prior treatment with a pi3k inhibitor or bruton's tyrosine kinase (btk) inhibitor * ongoing treatment with chronic immune-suppressants * overt cns lymphoma * inadequate hepatic, bone marrow, or renal function * history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months * venous thromboembolic event requiring anticoagulation * presence of active systemic infection within 72 hours of treatment * human immunodeficiency virus (hiv) infection * pregnant or lactating women

Keywords: relapsed lymphoma phosphoinositide 3-kinase (pi3k) inhibitor duvelisib japanese refractory lymphoma
natural history study for dna repair disorders

Conditions: DNA Repair Disorder; Cockayne Syndrome; Xeroderma Pigmentosum; Trichothiodystrophy

Summary: this will be a single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with dna repair disorders, including cockayne syndrome (cs), xeroderma pigmentosum (xp), and trichothiodystrophy (ttd).

this will be a single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with dna repair disorders, including cockayne syndrome (cs), xeroderma pigmentosum (xp), and trichothiodystrophy (ttd). our hypothesis is that a reliable and reproducible baseline natural history course can be established for dna repair disorders using the early childhood assessment of balance (ecab) as a primary endpoint and other measures as secondary and exploratory endpoints that may be used in future therapeutic clinical trials.

Eligibility criteria:
inclusion criteria: * diagnosis of cockayne syndrome (cs), xeroderma pigmentosum (xp), or trichothiodystrophy (ttd), based on genetic testing and/or key clinical characteristics l characteristics * has one or more of the following neurodevelopmental or neurological complications * gross motor delay (non-ambulatory or started walking after age 18 months) * language delay (non-verbal or started talking after 18 months) * altered muscle tone (hypertonia, dystonia, hypotonia) * gait difficulties, including stiff gait, short stride, frequent falls, use of orthotics, use of walker * tremors * microcephaly * is a family member of an individual with the above condition * no restrictions regarding current ambulatory status * minimum age for enrollment eligibility will be 6 months due to fragility of neonates with severe forms of dna repair disorders and limitations of motor assessment scales in infants younger than 6 months. there will be no maximum age for enrollment eligibility. * no restrictions regarding gender, race, or ethnicity. * voluntary written consent from the participant if adult capable of consenting or parent/guardian if minor or not capable of consenting * written consent of legally authorized representative if enrolling adult lacks capacity to consent exclusion criteria: * any prior history of systemic gene or cell-based therapy * current participation in an interventional clinical trial
a global phase 3 study to evaluate the safety and efficacy of elagolix in subjects with moderate to severe endometriosis-associated pain

Conditions: Endometriosis

Summary: a randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

the study consists of 4 periods: 1) washout period (if applicable); 2) a screening period of up to 100 days prior to first dose; 3) a 6 month treatment period; and 4) a post treatment follow-up period of up to 12 months (if applicable). an electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. pregnancy testing will be performed monthly throughout the study. subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Eligibility criteria:
inclusion criteria: 1. premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent. 2. clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the washout period. 3. agrees to use required birth control methods during the entire length of participation in the study. 4. subject has a composite pelvic signs and symptoms score total score of 6 or greater at screening with a score of at least 2 for dysmenorrhea and at least 2 for non-menstrual pelvic pain. 5. subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the screening period, prior to day 1. exclusion criteria: 1. subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the screening period. 2. subject has a history of previous non-response to gonadotropin-releasing hormone (gnrh) agonists, gnrh antagonists, depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain. 3. subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain. 4. clinically significant gynecologic condition identified on screening transvaginal ultrasound or endometrial biopsy. 5. subject has a history of osteoporosis or other metabolic bone disease. 6. subject has a current history of undiagnosed abnormal uterine bleeding.

Keywords: non-menstrual pelvic pain (nmpp) dysmenorrhea (dys) elagolix endometriosis associated pain gonadotropin-releasing hormone antagonist
protein supplementation for chronic stroke treatment

Conditions: Chronic Stroke

Summary: stroke patients usually have difficulties with moving and are venerable to secondary problems such as sarcopenia and strength loss. these problems may accelerate the disability process during aging. it is well known that exercise helps to maintain or promote human fitness. this study is conducted to explore the beneficial effects of exercise and protein supplement on fitness and body composition among patients with chronic stroke.

this is a multicenter randomized control trial. participants will be recruited from 4 teaching hospitals in taipei. participants are randomly assigned to 2 groups: 1. protein supplementation + exercise (pro group); 2. carbohydrate supplementation + exercise (cho group); the 1-hour exercise intervention includes aerobic cycling exercise followed by progressive resisted exercise with theraband. pro group receives ps immediately before and after the exercise while the cho group receive sham product (the same calories with no protein). the interventions are arranged 3 sessions a week for 10 weeks. the outcome measurements are performed at 0-week, 10-week, and 20-week.

Eligibility criteria:
inclusion criteria: 1. chronic stroke\>6months 2. age : 20-75 y 3. able to walk independently over 10 mins (with or without orthosis) 4. able to use stationary bike exclusion criteria: 1. physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments. 2. not able to exercise due to severe cardiopulmonary dysfunction 3. malnutrition (mna\<11) 4. severe obesity (bmi\>35) 5. renal insufficiency 6. unable to tolerate our cardiopulmonary exercise test (cpet) (eg, too short stature to fit the machine, leg spasticity is too strong to peddle the cycling, unable to maintain 50 rpm at the beginning of cpet, indications for early termination of cpet based on the american college of sport medicine suggestions)