Kornimate/medical-research-clean huggingface dataset:
the establishment of total joint arthroplasty registry database

Conditions: Arthritis Knee; Arthritis Hip

Summary: the purpose of this study will establish total joint arthroplasty registry database in kaohsiung chang gung memorial hospital and collect patient-reported outcome.


Eligibility criteria:
inclusion criteria: * patients undergoing primary hip or knee arthroplasty * patients undergoing revision hip or knee arthroplasty * patients undergoing partial hip or knee arthroplasty exclusion criteria: * incomplete patients' data * follow up less than 1 year after surgery * unwillingness to sign the informed consent
mobile - bearing knee study

Conditions: Inflammatory Tissue Disorder; Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Secondary Arthritis

Summary: to evaluate the safety and efficacy of the encore mobile-bearing knee.


Eligibility criteria:
inclusion criteria: * skeletal maturity * less than 70 on preoperative knee society score (rating score) * sufficient bone stock, as judged by radiographs, to support primary knee implant * patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles * patient is not pregnant * primary total knee replacement * sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension) * varus deformity \<45 or valgus deformity \<45 or fixed flexion deformity \<90 * patient is likely to be available for evaluation for the duration of the study * able and willing to sign the informed consent and follow study procedures exclusion criteria: * skeletal immaturity * greater than or equal to 70 on preoperative knee society score (rating scale) * previous knee surgery that has adversely affected bone stock or prior total knee replacement * post patellectomy * patient is pregnant * insufficient collateral ligaments, as judged by the physician * neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as parkinson's disease, multiple sclerosis, previous stroke which affects lower extremity). * varus deformity \>45 or valgus deformity \>45 or fixed flexion deformity \>90. * mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and alzheimer's disease). * prisoners * conditions that place excessive demand on the implant (i.e. charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
nicorandil study to reduce cardiac death after percutaneous coronary intervention (pci) in hemodialysis patients

Conditions: Acute Myocardial Infarction; Congestive Heart Failure

Summary: survival after invasive coronary revascularization is worse in patients with chronic kidney disease than in those without it. the investigators aimed to examine whether oral administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive potassium channel opener, could improve the survival of end-stage renal disease patients with coronary artery disease by inhibiting cardiac death after coronary revascularization.


Eligibility criteria:
inclusion criteria: * hemodialysis patients with coronary artery disease who had undergone a successful first pci with bare-metal stents between july 1, 2001 and december 31, 2003. exclusion criteria: * subjects with moderate or worse cardiac valvular disease or old myocardial infarction at the point of first pci.

Keywords: sudden cardiac death
abbott esa chagas assay post-market study

Conditions: Chagas Disease

Summary: the study is conducted to meet an fda post market commitment to collect and report data on the performance of the esa chagas assay. a minimum of 50 donor specimens that are fda-licensed abbott prism chagas repeatedly reactive (rr)will be tested with the abbott esa chagas assay. in addition, minimum of 300 abbott prism chagas nonreactive (nr) unidentified donor specimens will be tested with abbott esa chagas assay.

abbott esa chagas testing will be performed at a minimum of two blood donor centers. testing will be performed using the fda-licensed esa chagas assay and will be performed in accordance with the esa chagas package insert. abbott prism chagas repeatedly reactive blood donor specimens identified by u.s. blood donor centers, as part of the routine blood donation process, will be tested with the fda-licensed esa chagas. specimens will also be tested with radioimmune precipitation assay (ripa) for antibody to t. cruzi, a laboratory developed test, and the fda-licensed ortho t. cruzi elisa. the donor centers will contact the donors and request the donor to return to complete a questionnaire and provide a follow-up specimen. in addition, a minimum of 300 blood donor specimens with abbott prism chagas nonreactive results will also be tested with esa chagas. these specimens will be unidentified, leftover specimens from routine donor testing and not individually identifiable. specimens that are positive or indeterminate with esa chagas will be further tested with ripa.

Eligibility criteria:
prism chagas repeatedly reactive donor specimens inclusion criteria: * blood donor specimen documented as prism chagas repeatedly reactive exclusion criteria: * none

Keywords: chagas disease trypanosoma cruzi american trypanosomiasis south american trypanosomiasis kissing bugs reduviid bugs
prospective study of safety and efficacy of inqu® bone graft extender in lumbar interbody fusion surgery

Conditions: Intervertebral Disc Degeneration

Summary: the purpose of this study is to collect on-label safety and efficacy data where inqu bone graft extender is applied to transforaminal lumbar interbody fusion (tlif) and posterior lumbar interbody fusion (plif). it is expected that this study will contribute to the compilation of clinical data required to demonstrate the ability of inqu to promote safe, effective and timely spine fusion in patients who undergo plif or tlif surgery. the results of this study will lead to further analysis (i.e. comparison to historical data of other marketed bone graft products, as well as, to local bone alone).

the purpose of this study is to collect on-label safety and efficacy data where inqu bone graft extender is applied to transforaminal lumbar interbody fusion (tlif) and posterior lumbar interbody fusion (plif) at multiple clinical sites. adverse events, time to fusion and patient reported outcomes(pros) will be recorded through 12 months follow-up.

Eligibility criteria:
inclusion criteria: * a subject may be included if s/he meets the following criteria: 1. ≥18 years of age; 2. able to give appropriate informed consent; 3. willing and able to meet the proposed follow-up schedule; 4. has documented diagnosis of up to, and including, grade 1 spondylolisthesis and/or degenerative disc disease; 5. has given appropriate consent for, and undergoes, standard-of-care transforminal or posterior lumber interbody fusion; 6. use of inqu bone graft extender on-label. exclusion criteria: 1. any prior lumbar fusion surgery; 2. requires fusion surgery of more than two adjacent levels; 3. has fusion surgery requiring titanium cages; 4. has a systemic infection or has infection at the site of surgery; 5. has a medical condition or requires post-operative medication that, in the opinion of the investigator, may interfere with bony/soft tissue healing; 6. has any physical, social, psychological or economic condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.
study of tesomet with open-label extension in subjects with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: this study will evaluate the safety and efficacy of tesomet (tesofensine + metoprolol) in subjects with pws.

for the double-blind portion of the study, dosing will be initiated in a subgroup of adults who are 18-65 years of age. following independent data monitoring board review of subgroup safety data, and review and confirmation to proceed by fda, enrollment of subjects \<18 years of age will commence.

Eligibility criteria:
key inclusion criteria: * subject and their legally authorized representative must be willing to provide informed consent * confirmed genetic diagnosis of pws * body mass index (bmi) within the following range at screening: 1. female and male subjects 18 to 65 years of age: 27 to 60 kg/m2; or 2. female and male subjects 13 to 17 years of age with bmi that is at least 85th percentile for age and sex; * female subjects must be of non-child-bearing potential * documented stable body weight * moderate hyperphagia at screening and at baseline * participants must have a reliable and stable caregiver who should be able to spend an adequate amount of time with the participants to be able to address behaviors, activities and symptoms * male subjects who are sexually active must be surgically sterile key exclusion criteria: * females who are pregnant, breastfeeding, or actively intending to become pregnant during the study * sitting bp that meets the following criteria after 5 minutes of rest at screening: 1. adult subjects with systolic bp \>/=145 mmhg or \<100 mmhg; or 2. adult subjects with diastolic bp \>/=95 mmhg or \<70 mmhg; or 3. adolescent subjects with a systolic or diastolic bp that is 95th percentile or greater for age and sex * type 1 diabetes mellitus * history of dementia (eg, alzheimer's disease, parkinson's disease) * history of bulimia or anorexia nervosa * history of major depressive disorder within 2 years prior to screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder), or symptoms of delusions, hallucinations, or mania/hypomania within 90 days prior to screening, as described by the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) * uncontrolled endocrine disorders (eg, cushing syndrome, addison's, hypothyroidism, hyperthyroidism) * medical condition or recent systemic infection that, in the opinion of the investigator, could impact the safety of the subject * use of prohibited medications, including current use of ssris/snris

Keywords: hyperphagia
phase i/ii clinical study of pralatrexate in japanese patients with relapsed or refractory peripheral t-cell lymphoma

Conditions: Peripheral T-cell Lymphoma

Summary: phase i portion: to evaluate the safety and tolerability of pralatrexate with concurrent vitamin b12 and folic acid supplementation in japanese patients with relapsed or refractory ptcl and to determine the recommended dosage. also, to evaluate pharmacokinetics. phase ii portion: to evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase i portion. the primary efficacy endpoint shall be objective response rate (orr).


Eligibility criteria:
inclusion criteria: * japanese patients at least 20 years of age. * patients histologically diagnosed with peripheral t-cell lymphoma by pathological diagnosis of biopsied lesion. * relapsed or refractory patients with a treatment history of at least one regimen. * patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed. * patients expected to survive for at least 3 months. * ecog ps 0-2. * patients with adequate hemopoietic efficacy, liver and kidney function. * patients from whom written consent has been obtained prior to study initiation. exclusion criteria: * patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug. * patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug. * patients who received another study drug within 28 days prior to initial administration of the study drug. * patients who received antibody therapy within 100 days prior to initial administration of the study drug. * patients with a history of allogeneic hematopoietic stem cell transplantation. or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug. * patients with cerebral metastasis or central nervous system lesion or a past history. * patients with active multiple primary cancer. or patients with a history of a malignant neoplasm other than peripheral t-cell lymphoma within the past 5 years. * patients with severe cardiovascular disease. * patients positive for hbs antigen, hcv antibody or hiv antibody on immunological investigation. or patients positive for either hbc antibody or hbs antibody, and showing dna more than sensitivity in hbv-dna assay. * patients positive for cmv antigen on immunological investigation. * patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug. * patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.
using real-time fmri neurofeedback and motor imagery to enhance motor timing and precision in cerebellar ataxia

Conditions: Cerebellar Ataxia; Spinocerebellar Ataxias; Cerebellar Degeneration

Summary: the aim of the research is to improve motor function in people with cerebellar ataxia by using neuroimaging methods and mental imagery to "exercise" motor networks in the brain. the relevance of this research to public health is that results have the potential to reduce motor deficits associated with cerebellar atrophy, thereby enhancing the quality of life and promoting independence.


Eligibility criteria:
inclusion criteria: * 18-100 years of age * at least 8th-grade education * right-handedness * clinical diagnosis of progressive, degenerative cerebellar ataxia by a movement disorder specialist (cerebellar ataxia of unknown etiology, and spinocerebellar ataxias with and without genetic confirmation) exclusion criteria: * history of axis i psychiatric disorders (including alcohol and drug dependence) * severe or unstable medical disorder, neurological disorders, such as stroke or epilepsy * history of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae * any condition that is contraindicated for the mri environment (e.g., metal in the body, pacemaker, claustrophobia) * currently pregnant * clinical diagnosis of multiple system atrophy (msa) or friedrich's ataxia (fa) * eligible subjects may be asked to refrain from medications that affect the central nervous system that would also make data difficult to interpret (e.g., sedatives) for an appropriate period of time prior to scanning * participants will be excluded if the participants do not have a home computer with internet available to complete the 3-week at-home component of the study protocol

Keywords: cerebellar ataxia spinocerebellar ataxias cerebellar diseases neurodegenerative diseases cerebellum gait balance movement disorders
remote and intensive program for physical activity promotion for people with type 2 diabetes (the practice trial)

Conditions: Type 2 Diabetes

Summary: the purpose of this trial is to evaluate the effects of a remote and intensive physical activity promotion program for people with type 2 diabetes (t2d), in comparison to a usual model of pa counseling, in glycemic levels, level of physical activity and quality of life in adults in elderly with t2d.

the practice trial aims to assess the effectiveness of a remote and intensive physical activity promotion program in contrast to the usual advice for physical activity on the management of hba1c in people with t2dm. the duration of the trial will be 24 weeks. participants will be allocated to the intervention group or control group. the data collection will include variables related to (a) physical activity levels; (b) quality of life; (c) self-care in t2d; (d) functional capacity levels; and (e) adverse events related or not to the study.

Eligibility criteria:
inclusion criteria: * eighteen years of age or older; * glycated hemoglobin ≥ 8.0%; * being a resident in porto alegre or metropolitan areas (viamão, alvorada, cachoeirinha, or canoas); * eligibility to perform physical activity after cardiovascular risk assessment; * have some means of access to the internet (direct access or via a family member who can receive the research material and share the information/material sent with the participant). exclusion criteria: * physically active, that is, performing at least 150 minutes of moderate to vigorous pa per week; * not having their own cell phone capable of receiving calls and text messages; * progressive neurological disorder (e.g., parkinsonism, alzheimer's disease); * psychiatric disorder that makes the intervention unfeasible; * physical, language, hearing, vision or cognition disorder that makes it impossible to attend the evaluations and carry out the intervention; * severe cardiovascular disease (class iii and iv heart failure, unstable angina), history of macrovascular event in the last 12 months (acute myocardial infarction, revascularization procedures, deep vein thrombosis, stroke or pulmonary embolism); * joint, muscle or bone injury that makes the intervention unfeasible; * planning to move to cities outside the geographic area where the study is carried out; * inadequate control of comorbidities. resting systolic blood pressure \>180 mmhg and/or resting diastolic blood pressure \>100 mmhg; * physical limitation that makes it impossible or brings risk to the participant's practice (e.g. lower limb amputation that makes locomotion difficult, use of crutches, cane).

Keywords: type 2 diabetes mellitus randomized controlled trial physical activity aging pragmatic clinical trial
the effect of probiotics on the frequency and intensity of migraine attacks and intestinal permeability

Conditions: Migraine

Summary: rationale: the prevalence of migraine is higher in patients with various intestinal diseases. an explanation could be that migraine is caused by a 'leaky gut': an increased intestinal permeability that allows food particles to pass the gastrointestinal wall. probiotics may be able to improve intestinal barrier function. objective: to test whether probiotics, as adjuvant therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability. study design: 12-week placebo-controlled randomized double-blind intervention with selected probiotics. study population: adults who experience at least 4 migraine attacks per month. intervention: subjects will receive either one daily dose of 2 g of ecologic® barrier or 2 grams of the placebo, containing only the carrier material (both provided by winclove probiotics). main study parameters/endpoints: incidence and severity of migraine attacks, measured by diaries and validated headache questionnaires will be measured at baseline and after 4, 8, and 12 weeks of probiotic/placebo administration. secondary, intestinal permeability will be measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). inflammation will be assessed from blood c-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks). fecal samples will also be used for microbial analysis.


Eligibility criteria:
inclusion criteria: * subjects confirm to have migraine characterized by : * recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity * sensitivity for light or sounds is possible but not exclusive. * attacks last for 4 to 72 hours. * self-reported frequency of migraine attacks (or days) at least 4 per month * fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity) * age ≥ 18 years * good overall health (self-reported in medical questionnaire) exclusion criteria: * migraine patients who suffer from chronic daily migraine/headaches * migraine patients who suffer from medication-dependent headaches * subjects who suffer from cluster headache or tension-type headaches * subjects who used antibiotics up to two months before the start of the study * subjects who are unwilling to stop taking probiotics other than study products * patients with a chronic use of non steroid anti inflammatory drugs (because of increased gut permeability) * patients with inflammatory bowel diseases (because of increased gut permeability) * pregnancy or lactation (because of their possible effect on migraine incidence)
feasibility and clinical utility of the dexcom g6 continuous glucose monitoring device for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (cgm, dexcom g6) for the care of patients with type 2 diabetes who are on non-insulin therapies.

the investigational device used in this study is the dexcom g6 pro/personal continuous blood glucose monitoring system. this investigation is a 2-phase sequential study with patients serving as their own controls. the demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. during phase 1 (10 days), the patient wears the dexcom g6 pro cgm in blinded mode and is unaware and unable to access the data. the patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. during this phase, the medical providers are also blinded to the cgm data and continue standard care without any specific intervention. during phase 2 (3 months), the patient wears the dexcom g6 personal cgm in un-blinded mode and the medical providers have access to the data via clarity and/or direct download via the transmitter. cgm data are collected continuously in each phase and at the end of each phase. anthropometric and laboratory data (including hb a1c) are collected. medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on cgm data, as appropriate. all patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, m.d. visits, medication interventions, referrals to support programs outside the scope of cinema program and nursing support

Eligibility criteria:
inclusion criteria: * type 2 diabetes of any duration * hb a1c ≥ 7% (no upper limit) * bmi ≥ 30 kg/m2 * ability to wear cgm (e.g. no dermatological issue precluding device insertion) * access to a smartphone device exclusion criteria: * any insulin use in the past 3 months * planned use of insulin in the next 6 months * presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate * current use of a weight loss medication * unable or uncomfortable with wearing a cgm device