Kornimate/medical-research-clean huggingface dataset:
donors after circulatory death heart trial

Conditions: Heart Transplant

Summary: to evaluate the effectiveness of the ocs heart system to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

a prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a dcd donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (standard of care 1 \[soc1\] and standard of care 2 \[soc2\] - from both randomized and concurrent control groups), adjusting for differences in risk factors.

Eligibility criteria:
donor inclusion * maastricht category iii dcd donor, defined as expected death after the withdrawal of life- supportive therapy (wlst) * donor age 18-49 years old inclusive * warm ischemic time (wit) ≤ 30 mins, with warm ischemic time defined as: time from when mean systolic blood pressure (sbp) is \< 50 mmhg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor. donor exclusion * previous cardiac surgery * known coronary artery disease * cardiogenic shock or myocardial infarction, or * sustained terminal ejection fraction (ef) of ≤ 50%, or * significant valve disease except for competent bicuspid aortic valve recipient inclusion * primary heart transplant candidates * age ≥ 18 years old * signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to transmedics' use of recipients' united network for organ sharing (unos)/organ procurement and transplantation network (optn) data and recipients' interagency registry for mechanically assisted circulatory support (intermacs) data. recipient exclusion * prior solid organ or bone marrow transplant * chronic use of hemodialysis or diagnosis of chronic renal insufficiency * multi-organ transplant * investigator unwilling to randomize to either arm.

Keywords: heart preservation beating heart transplant
evaluation of a new bi-condylar total knee prosthesis (tkp) with all-ceramic friction (the forgotten knee)

Conditions: Knee Osteoarthritis

Summary: the results of tkp (total knee prosthesis) are satisfactory but do not reach those of thp (total hip prosthesis) in terms of indolence and function. by using an all-ceramic friction torque, identical to that of the hip, the promotor of this clinical investigation expects to obtain an improvement in term of indolence, ability to perform heavy activities, knee stability and an improvement in the long-term survival of tkp, while at the same time, a decrease in the rate of re-intervention in young patients.

the aim of this study is to evaluate the all-ceramic knee prosthesis, according to clinical and radiological criteria of usual follow-up of a tkp for knee osteoarthritis, at 12 months. evaluation of clinical and radiographic endpoints at 12 months: - clinical: functional scores (oxford and international knee society iks), pain (from 0 to 6, better to worse outcome), knee mobility in flexion and extension (degrees), frontal and sagittal stability (in degrees and mm), joint sounds, forgotten joint score (fjs). the scores are mostly qualitative and all of them will be globally evaluated by the investigator regarding to the patient status. -radiographic: x-rays of the front and profile of the prosthesis, positioning of the implants (angle, axis), existence of borders (bone cement, prosthesis cement), presence of osteolysis or any notable element. mri will be performed to evaluate the creation of a specific fibrous tissue around the joint that is expected with a ceramic on ceramic bearing.

Eligibility criteria:
inclusion criteria: * previously active adult under 70 years of age with disabling knee osteoarthritis resistant to medical treatments (anti-inflammatories, infiltrations, analgesics), with a frontal deformity \< 10° for a primary implantation * written informed consent by the patient * patients affiliated to the french social security system exclusion criteria: * knee deformity \> 10 * obesity (bmi \> 30) * inflammatory rheumatism * history of infection * poor skin coverage at the knee joint * known allergy to the materials used and/or anesthetic used in the surgery * repeated falls, major neurological disorders, mental or neuromuscular disorders which can be a source of post-operative complications * significant functional deficit of the collateral ligaments * positive serum or urine pregnancy test for woman with child bearing potential. pregnancy or within 48 hours post-partum or breast feeding women * phobic patient refusing to have an mri * patient with a contraindication to have an mri (active medical devices, metal implants, etc.) * patient under legal protection * patient participating in another clinical investigation * post fracture osteoarthritis * osteoporosis * anatomical configuration not allowing the implant to be fixed (depending on size constraints) * disabling comorbidity upon any resumption of physical activity

Keywords: total knee prosthesis ceramic on ceramic bearing
confirm the safety and performance of avance solo npwt system

Conditions: Acute Wound; Traumatic Wound; Skin Graft; Skin Flap; Subacute Wound; Dehiscence

Summary: the primary objective of this post market clinical follow-up (pmcf) investigation is to confirm safety and performance of avance® solo npwt system in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the instructions for use, for up to 28 days.

this investigation is designed as a prospective, open, non-comparative, pmcf investigation to confirm safety and performance of avance solo npwt system in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). this is a multi-center study that will take place in approximately 5 european countries. the eligible subjects will be both in and out patients and all will be treated with avance solo npwt system, for up to 28 days. treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days). the primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. wound progression is determined by the investigator and will be assessed at each follow-up visit and measured by three outcomes: * deteriorated * no change * improved

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years. 2. signed written informed consent. 3. low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use npwt according to the investigator´s judgement and instructions for use exclusion criteria: 1. known malignancy in the wound or margins of the wound 2. untreated and previously confirmed osteomyelitis 3. non-enteric and unexplored fistulas 4. necrotic tissue with eschar present 5. exposed nerves, arteries, veins or organs 6. exposed anastomotic site 7. subjects with known allergies/hypersensitivity to product components. 8. known pregnancy or planning to become pregnant or lactation at the time of study participation. 9. subjects not suitable for the investigation according to the investigator's judgement and clinical investigation plan and ifu. 10. participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.

Keywords: negative pressure wound therapy post market clinical follow-up
retrospective cohort study of rebif® use in pediatric multiple sclerosis (ms) subjects (replay)

Conditions: Multiple Sclerosis

Summary: the aim of this retrospective study is to review and describe safety, tolerability and efficacy of rebif® (subcutaneous interferon \[ifn\]-beta-1a) in children and adolescents, using information already recorded in medical records. the study duration is 13 july 2010 (first data collected) to 13 july 2011 (last data collected). in this study, data of the subjects evaluated between 1997 and 2009 was observed.


Eligibility criteria:
inclusion criteria: * received one or more injections of rebif® for treatment of a demyelinating event * be younger than 18 years of age at time of rebif® treatment initiation * rebif® therapy must have been initiated before june 30, 2009 exclusion criteria: no exclusion criteria are applied

Keywords: interferon beta 1a autoimmune diseases demyelinating diseases immune system diseases immunologic factors nervous system diseases physiological effects of drugs demyelinating autoimmune diseases, cns autoimmune diseases of the nervous system retrospective cohort study
the prospective cohort study to evaluate the preventive efficacy of hpv vaccine in japanese women aged 27-45 years

Conditions: Cancer of Cervix; Vaccinia

Summary: a nonrandomized, non-double blinded prospective cohort study to evaluate the preventive efficacy of quadrivalent hpv6/11/16/18 vaccine for the persistent infection of hpv16 genotype or hpv18 genotype in japanese women aged 27-45 years.

a series of evidence for hpv vaccines has demonstrated the efficacy in young women (aged less than 26) across the globe. in contrast, limited evidence are available for the efficacy of the quadrivalent hpv6/11/16/18 vaccine in adult women (aged 27+). most importantly, evidence for japanese adult women is not available to date. nevertheless, , we hypothesize that the quadrivalent hpv6/11/16/18 vaccine demonstrate the efficacy also in japanese adult women. the outcome from this trial will be the first local evidence, which brings a considerable impact in ob/gy academia where local evidence is weighed heavily compared with global evidence - serves as a strong basis to support catch up program of hpv vaccines for young adults. as a consequence, we believe this study will develop a local supportive evidence for prevention of hpv infection by an hpv vaccine in young adults, which results in substantial public health improvement through prevention of hpv infection in japan where active recommendation is halted long time.

Eligibility criteria:
inclusion criteria: * women with normal cytology results confirmed in cervical cancer screening programs from may 2019 to march 2020 * 27-45 years-old * intact uterus * willing to undergo the hpv-dna test (cobas4800) within 12 months exclusion criteria: * pregnant women * undergo treatment or the follow-up evaluation for cin within the previous 12 months * previously administered hpv vaccine

Keywords: uterine cervical cancer hpv vaccine cancer screening
aerobic exercise, balance training, and ataxia

Conditions: Ataxia; Spino Cerebellar Degeneration; Spinocerebellar Ataxias

Summary: the first aim is to show aerobic training improves degenerative cerebellar patients functionally the second aim is to compare the effects of balance and aerobic training on degenerative cerebellar disease.

individuals with degenerative cerebellar disease (dcd) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. with no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. aerobic training, on the other hand, may modify dcd progression as evident from animal data. compared to sedentary controls, aerobically trained dcd rats have enhanced lifespan, motor function, and cerebellar purkinje cell survival. numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins. the effects of aerobic training in humans with dcd are relatively unknown, despite these encouraging animal data. a single study to date has evaluated the benefits of aerobic exercise on dcd in humans, and this was a secondary outcome of the study. although participants performed limited aerobic training during the study, modest functional benefits were still detected. the main objective of this project will be to compare the benefits of aerobic versus balance training in dcd. the investigators hypothesize that both aerobic and balance training will improve function in dcd subjects, but that the mechanisms in which these improvements occur differ.

Eligibility criteria:
inclusion criteria: * diagnosed with spinocerebellar ataxia * cerebellar atrophy on mri * prevalence of ataxia on clinical exam * ability to safely ride a stationary exercise bike exclusion criteria: * other neurologic conditions * heart disease * cognitive impairment * medical instability

Keywords: degenerative cerebellar disease ataxia aerobic exercise
sympathetic nerve activity during hypoglycemia and exercise

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity.

the body has defensive responses to correct low blood sugar (hypoglycemia). a vital component of this response is release of glucagon and activation of the sympathetic nervous system, which provides the means for raising blood glucose levels towards normal. we can measure circulating hormones indicating the level of these responses, but additionally, sympathetic nervous system responses can be measured directly. we can measure the sympathetic nerve activity that controls blood flow to muscles (msna) and blood flow and sweating to skin (ssna). the purpose of this study is to determine if either hypoglycemia or exercise cause differential responses in muscle and skin sympathetic nerve activity. we would also like to determine what the sympathetic response is to cycling exercise with insulin and normal blood sugar. therefore, we would like to test the sympathetic responses to insulin with normal blood glucose, hypoglycemia, and during exercise bouts and normal blood glucose, with or without insulin.

Eligibility criteria:
inclusion criteria: * 36 healthy male and female subjects (18 males and 18 females) aged 18-40 yr * all potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities * body mass index ≤30kg · m-2 * normal bedside autonomic function * female volunteers of childbearing potential will undergo hcg pregnancy test at screening and again on the study day. exclusion criteria: * pregnant women * subjects unable to give voluntary informed consent * subjects on anticoagulant drugs or anemic * subjects with a recent medical illness * subjects with a history of hypertension, heart disease or cerebrovascular disease * subjects with known liver or kidney disease * subjects with recent weight loss or consuming a low carbohydrate diet

Keywords: exercise hypoglycemia sympathetic nerve activity
use of guided imagery for functional abdominal pain in children:

Conditions: Functional Abdominal Pain

Summary: the purpose of the study is to evaluate the effectiveness of relaxation, with or without guided imagery, for treating children with functional abdominal pain. the study will evaluate a child's ability to decrease the amount of pain with these techniques to allow continuation of normal daily activities at home and at school. the hypothesis is that these relaxation techniques will help decrease reports of abdominal pain and improve levels of activity.


Eligibility criteria:
inclusion criteria: at least 3 episodes of abdominal pain over the previous 3 months normal complete blood count, sedimentation rate, urinalysis stable on current medications english speaking - exclusion criteria: unwillingness to participate chronic gastrointestinal disease cognitive-developmental delay major dissociative disorder -
effects of green light therapy on body contouring and cellulite

Conditions: Fat Reduction

Summary: a double-blind, placebo-controlled randomized evaluation of the effect of cellulize, a green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite.

this clinical trial will provide objective evidence showing effectiveness of the cellulize 532nm green light therapy for the non-invasive reduction in fat layer for body contouring, and for the non-invasive treatment for the appearance of cellulite.

Eligibility criteria:
inclusion criteria: * study participant between the ages of 18 and older. * female only * subject is willing and able to abstain from partaking in any treatment other than the study procedures (existing or new) to promote body contouring/circumference reduction/weight loss during the course of study participation. * subject is willing and able to maintain his or her regular (typical pre-study) diet and exercise regimen without effecting significant change in either direction during study participation. exclusion criteria: * no photo-therapy (red or green) within 3 weeks of treatment. * known cardiovascular disease such as cardiac arrhythmias, congestive heart failure. * cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers. * prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. * medical, physical, or other contraindications for body sculpting/weight loss. * current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent. * any medical condition known to affect weight levels and/or to cause bloating or swelling. * active infection, open wound (e.g. sores, cuts, ulcers, burns, etc.) or other external trauma to the areas to be treated with the laser/lymphatic drainage system devices. * photosensitive condition or medication. * active cancer within the past year. * pregnant, possibly pregnant or planning pregnancy prior to the end of study participation. * diminished ability to void waste (liver or kidneys). * developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
pazopanib in advanced gastrointestinal stromal tumors refractory to imatinib and sunitinib

Conditions: Gastrointestinal Stromal Tumors

Summary: patients with metastatic or locally advanced gastrointestinal stromal tumors (gist) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (tkis) imatinib and sunitinib, have a poor prognosis. sometimes a further response may be achieved by other drugs, mainly other tkis, which have been explored in different studies but not yet have been approved for clinical use. pazopanib is a tki inhibiting the tyrosin kinases kit, pdgfra, and vegf 1-3, all of which have important roles in the pathogenesis of gist. theoretically, it may function in gist, and it deserves investigational trials. the drug is approved for metastatic renal cancer and is relatively well tolerated. in this trial (ssg xxi), the disease control rate (dcr) = (cr+pr+sd) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. secondary endpoints include orr, pfs, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). the goal is to include 72 patients in the trial, which is open and single arm.


Eligibility criteria:
eligibility criteria: * metastatic and/or locally advanced gist, with diagnosis based on histology with positive c-kit and/or dog-1, or with a gist-typical mutation in kit or pdgfr * measurable disease on ct (computed tomography) as defined by recist criteria; at least one measurable lesion not given radiotherapy * history of progressive disease on ct according to recist criteria after both imatinib and sunitinib treatment, and also after nilotinib if this drug has been given * no other tkis given than imatinib, sunitinib and nilotinib * age at least 18 years at the time of diagnosis of gist * who performance status 0-2 * resolution of all toxic side effects from earlier tki treatment and any other potential non-tki treatment to grade 1 or below * sufficient organ functions as defined in the protocol * absence of earlier or present certain other conditions as defined in the protocol * no pregnancy or lactation * women with childbearing potential must accept the use of adequate contraception throughout the study period * written informed consent

Keywords: clinical trial investigational drugs gastrointestinal stromal tumors pazopanib
effects of hmg-coa reductase inhibitor on rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is: 1. to evaluate the prevalence of preclinical atherosclerosis in chinese patients with ra compared to healthy controls. 2. to determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness. 3. to ascertain the efficacy and safety of rosuvastatin in the prevention of atherosclerosis in patients with ra measured by carotid intima-media thickness (imt) and pulse wave velocity (pwv).

150 consecutive ra patients followed at the rheumatology clinic of the prince of wales hospital will be recruited for this double-blind, randomized, placebo-control trial. patients were matched to 150 controls on the basis of age (within 5 years), sex, body mass index (+/-5kg) and ethnicity for the cross sectional study on the prevalence of subclinical atherosclerosis. controls were healthy individuals recruited from the same community who underwent similar imaging protocols of the imt and pwv assessments. primary outcome is the improvement of atherosclerosis by rosuvastatin therapy, evaluated by imt and pwv. secondary outcomes: * prevalence of premature atherosclerosis in ra patients compared to healthy controls in terms of the presence of plague and pwv. * correlation between clinical parameters, inflammatory markers (crp/hscrp, tnf-alpha and il-6) and atherosclerosis (evaluated by imt, the presence of plaque and pwv). * relation among pwv, abi and ai in ra patients, and clinical significance of their combination. * determine which segment's pwv has a better relation with ra disease activity.

Eligibility criteria:
inclusion criteria: * men or women, 18 years of age or older * clinical diagnosis of ra with a duration of at least 6 month * prednisolone \< =10 mg/day * nsaid or dmard * informed consent exclusion criteria: * little or no ability for self-care * type 1 diabetes mellitus * uncontrolled hypertension(\> 160/95 mmhg) * total cholesterol \> 240 mg/dl, current or recent (within the past 3 months) * history of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction \< 40%), significant valvular heart disease * current treatment with ace inhibitor, angiotensin ii receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins * current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study * current treatment with antioxidant therapy (vitamin c or multivitamin) * received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening * clinically significant renal disease(serum creatinine level ≥ 270 µmol/l) or aspartate aminotransferase(ast), alanine aminotransferase alt), or creatine kinase (ck)≥ 2 x uln * female of childbearing potential, unwilling to use adequate contraception during the study * current or recent (within the past 3 months) pregnancy and cancer

Keywords: hmg-coa reductase inhibitors crestor rosuvastatin