Kornimate/medical-research-clean huggingface dataset:
individualized chiropractic and integrative care for low back pain

Conditions: Sub-Acute and Chronic Low Back Pain

Summary: this study proposes to compare two innovative treatment approaches for lbp, both of which focus on delivering individualized care through evidence-based, clinical care pathways. the primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute or chronic lbp, in both the short-term (after 12 weeks) and long-term (after 52 weeks). the primary outcome measure in this study is patient-rated back pain. chiropractic care will include therapies within the professional scope of practice. integrative, multidisciplinary care will include chiropractic, massage therapy, traditional chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education. secondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term. this innovative study is an exciting collaboration between an experienced and established team of chiropractic, conventional, and cam professionals dedicated to advancing the care of pervasive and costly lbp conditions. this trial will provide new and important information for all health care providers and lbp patients, informing decision making and improving care delivery systems.


Eligibility criteria:
inclusion criteria: * mechanical lbp classified as 1, 2, 3, or 4 using quebec task force (qtf) classification.70 (this includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs). * lbp localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds. * pain level \> 3 on 0 to 10 scale * current lbp episode \> 6 weeks duration * 18 years of age and older * stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month.) exclusion criteria: * ongoing treatment for lbp by other non-study providers * progressive neurological deficits or cauda equina syndrome * qtf classifications 5 (spinal instability or fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). these are serious conditions not amenable to the conservative treatments proposed. * qtf 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking). * uncontrolled hypertension or metabolic disease * blood clotting disorders * severe osteoporosis * inflammatory or destructive tissue changes of the spine * patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. this is a subgroup of lbp patients which generally have a poorer prognosis. * pregnant or nursing women
clinical research of adoptive bcma car-nk cells on relapse/refractory mm

Conditions: Multiple Myeloma

Summary: the purpose of this study is to infuse bcma car-nk 92 cells to the patients with relapsed and refractory multiple myeloma (mm), to assess the safety and feasibility of this strategy. the car enables the nk-92 cells to recognize and kill the mm cells by targeting of bcma, a protein expressed of the surface of the malignant plasma cells in mm patients.


Eligibility criteria:
inclusion criteria: 1. 18 years to 80 years, expected survival \> 3 months 2. confirmed diagnosis of active mm as defined by imwg. bcma expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry 3. bcma-expressing b cell malignancy must be assured and must be relapsed or refractory disease 4. ecog performance status of 0 - 1 5. cardiac function: 1 - 2 levels; liver: tbil ≤ 3uln，ast ≤ 2.5 uln，alt ≤ 2.5uln; kidney: cr ≤ 1.25uln 6. no serious allergic constitution 7. no other serous diseases that conflicts with the clinical program 8. no other cancer history 9. female participants of reproductive potential must have a negative serum pregnancy test 10. subjects must have signed written, informed consent exclusion criteria: 1. pregnant or lactating women 2. uncontrolled active infection, hiv infection, syphilis serology reaction positive 3. active hepatitis b or hepatitis c infection 4. recent or current use of glucocorticoid or other immunosuppressor 5. serious mental disorder 6. with severe cardiac, liver, renal insufficiency, diabetes and other diseases 7. participate in other clinical research in the past three months 8. previously treatment with any gene therapy products
psychiatric comorbidities in patients with painful peripheral neuropathy

Conditions: Painful Peripheral Neuropathy

Summary: psychiatric comorbidities in patient with painful peripheral neuropathy

neuropathic pain has been redefined by the international association for the study of pain, as'' pain caused by a lesion or disease of somatosensory system''.diabetic peripheral neuropathy is the result of nerve damage in the toes, feet, and hands . approximately 50% of those diabetic peripheral neuropathy have neuropathic pain . patients with persistent neuropathic pain experience work disability and activity limitation, with a substantial impact on their social functioning. as any chronic pain state comorbid depression, anxiety and sleep disturbance are common occurring in up to one half of those with painful neuropathy. the relationship between chronic pain and cognitive function has not been adequately studied and little is known about cognitive functioning in neuropathic conditions. this may be because the clinicians pay more attention to psychiatric comorbidities, such as depression and anxiety.although chronic pain associated with cognitive deficits may impact on everyday behaviour and interfere with emotional decision-making tasks. in a cross-sectional survey at the mayo clinic, the prevalence of clinician-diagnosed symptomatic or painful diabetic peripheral neuropathy was 13-15% out of 78% of those with any type of diabetic peripheral neuropathy . many patients with diabetic peripheral neuropathy experience neuropathic pain, typically characterized as burning, electric, sharp and shooting which initially starts in both feet and may progress to involve calves, fingers, and hands (stocking and glove pattern) . recently it has been demonstrated an association between diabetes , diabetes complication and impairment of mental health and particular emphasis has been placed on the association between painful diabetic sensory neuropathy with depression .

Eligibility criteria:
inclusion criteria: 1. any female or male diabetic patient is aged 18 years or above had diabetic peripheral neuropathy. 2. patients must be able to swallow tables exclusion criteria: 1. patients have other comorbid psychiatric disorders or psychological troubles that is not secondary to diabetic neuropathy according to clinical and psychiatric evaluation, 2. patients have any other causes of pain condition, or had skin conditions that are likely to confound the assessment of diabetic peripheral neuropathic pain.
adenoma detection by polypectomy during both insertion and withdrawal

Conditions: Adenoma of Large Intestine

Summary: standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. however, small polyps (e.g. \<1cm) seen during insertion phase are difficult to find during withdrawal phase. also, colon is in different conformation during insertion and withdrawal phases. we think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.


Eligibility criteria:
inclusion criteria: * patient undergoing screening or surveillance colonoscopy exclusion criteria: * previous colorectal resection, polyposis syndrome, inflammatory bowel disease
cryptogenic stroke study

Conditions: Cryptogenic Stroke

Summary: the purpose of this study is to determine whether the sleuth implantable loop recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.


Eligibility criteria:
inclusion criteria: * recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours. * negative brain image for hemorrhagic stroke * in sinus rhythm at time of enrollment exclusion criteria: * know history of atrial fibrillation * previous implanted cardiac device (ppm or icd) * serious illness making it unlikely to survive one year * known secondary cause of stroke

Keywords: cardiac monitor loop recorder stroke ecg implantable loop recorder cryptogenic ilr
a study of roactemra/actemra (tocilizumab) plus dmards in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label study will evaluate the long-term safety and efficacy of roactemra/actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (dmards) in patients with moderate to severe rheumatoid arthritis. patients who successfully completed studies wa17823 and wa18696 in south africa are eligible to participate in this study. patients will be allowed dmards according to the treatment they received in the previous studies. patients will receive 8 mg/kg roactemra/actemra intravenously every 4 weeks. the anticipated time on study treatment is 104 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study * patients successfully completed studies wa17823 and wa18696 in south africa * body weight \<150 kg exclusion criteria: * patients who have withdrawn from studies wa17823 and wa18696 are not eligible to participate in this study treatment with any investigational agent since last administration of study drug in studies wa17823 and wa18696 * previous treatment with any cell depleting therapies * treatment with intravenous gamma globulin, plasmapheresis or prosorba(tm) column since the last administration of study drug in studies wa17823 and wa18696
optimal tailored treatment for h. pylori infection

Conditions: Helicobacter Pylori Infection; Antibiotic Resistant Infection

Summary: the efficacy of the current standard triple therapy is at an unacceptably low level. resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. point mutations in the 23s rrna gene are known to be the primary mechanism of clarithromycin resistance against h pylori. recently, a point mutation detection kit using a dual-priming oligonucleotide (dpo)-based multiplex polymerase chain reaction (pcr) assay was introduced and made commercially available. the primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of dpo-pcr for detecting h. pylori resistance.

patients are randomly assigned to the empirical therapy group and tailored therapy group. the empirical therapy group recieves triple therapy of 7 or 14 days. the tailored therapy group receives treatment based on their dpo-pcr results. patients who are sensitive to clarithromycin based on dpo-pcr receives triple therapy for 7 or 14 days. patients who are resistant to clarithromycin based on dpo-pcr recieves bismuth quadruple therapy for 7 or 14 days.

Eligibility criteria:
inclusion criteria: * consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of h pylori infection exclusion criteria: * subjects younger than 18 years old * subjects with a history of h pylori eradication * subjects who had previous gastric surgery * subjects who were pregnant or lactating * subjects with serious concurrent illness * subjects who were administered antibiotics, bismuth, or ppis in the 8 weeks preceding the study * subjects with a history of allergy to any one of the compounds in this study
efficacy and tolerability of atomoxetine (strattera) in adult patients with generalized social anxiety disorder

Conditions: Generalized Social Phobia

Summary: the purpose of this study is to determine the effectiveness and tolerability of atomoxetine (strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder characterized by a fear of interpersonal interactions).

controlled studies show that approximately 50% of patients with generalized social anxiety disorder(gsad)will respond to treatment with available pharmacotherapeutic agents such as ssri's. this still leaves 50% that respond partially or not at all. those who do respond, often experience adverse events (e.g., sexual dysfunction), which leads them to discontinue treatment. thus, there is a strong rational for identifying alternatives to ssri's that are effective with fewer side effects (or with a different side-effect profile, that features less sexual dysfunction)for the treatment of gsad. available data demonstrate that sustained-release venlafaxine, a dual reuptake inhibitor, is also effective for gsad.(stein et al., 2005). it is unclear from these studies whether serotonin reuptake is integral to efficacy for social anxiety disorder, or whether norepinephrine reuptake will convey similar efficacy. atomoxetine (strattera)an inhibitor of the presynaptic norepinephrine transporter, is an ideal candidate to address both these issues.

Eligibility criteria:
inclusion criteria: * men and women, ages 18-65, in good general health * meet dsm-iv criteria for social anxiety disorder exclusion criteria: * pregnant or breastfeeding * narrow angle glaucoma * any uncontrolled medical condition or any medical condition which would represent a contraindication to atomoxetine (strattera) pharmacotherapy (e.g., hepatic insufficiency, untreated hypertension, untreated cardiovascular or cerebrovascular disease) * any concomitant non-psychotropic medications that the physician determines are a contraindication to atomoxetine (strattera) pharmacotherapy (e.g., albuterol, various pressor agents) * bipolar disorder, or any psychotic or organic mental disorder or dementia * current substance abuse or dependency * current active suicidal ideation * current use of herbal psychoactive treatments such as st. john's wort * concurrent psychotropic medication is not permitted for 2 weeks prior to randomization (4 weeks in the case of fluoxetine) or at any point thereafter. * receipt of formal psychotherapy concurrently * inability, in the investigator's opinion, to comply with study procedures or assessments
remise study: remnant biospecimen investigation in sepsis

Conditions: Sepsis

Summary: in the remise is study, we will compare blood proteins, biomarkers, and other -omics prospectively collected from patients with sepsis from two sources, i.) remnant (discarded) samples from the clinical laboratory, and ii.) prospectively collected in upmc presbyterian hospital research coordinator specimen collected biospecimens. analyses will include traditional biomarkers, quantitative proteomics, metabolomics, lipidomics, transcriptomics, and pathogen genomic sequencing in both sets of samples. this data will allow the assessment of the feasibility, integrity, and scientific value of remnant samples compared to research coordinator samples collected at the bedside for mechanistic sepsis research.


Eligibility criteria:
inclusion criteria: * adult patient, at least 18 years of age * meeting sepsis-3 criteria within 6 hours of admission * biospecimens obtained for routine clinical care and measurement * peripheral intravenous access exclusion criteria: * patients who do not have sepsis-3 * traumatic injury, * inability to consent or contact legal representative, * cardiac arrest, * stroke, * comfort measures only, * unable to obtain intravenous access, and/or * subject declines to participate. * no residual blood left in clinical sample
efficacy of telerehabilitation in the patients with aphasia

Conditions: Aphasia

Summary: the study will invite 30 patients to join, and they will be arranged in the face to face group and telerehabilitation group randomly. in the telerehabilitation group, the investigators use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform. concise chinese aphasia test (ccat) and asha facs conceptual framework test will be used as the assessment tool for evaluation speech ability and functional ability. the investigators expect that patients can improve their speech ability, functional ability, and quality of life via telerehabilitation speech therapy. and the investigators can establish the standard telerehabilitation speech therapy protocol for aphasia therapy.


Eligibility criteria:
inclusion criteria: * patients diagnosed as aphasia exclusion criteria: * poor auditory comprehension

Keywords: telerehabilitation aphasia speech therapy rehabilitation device visual action therapy naming drills
serologic assay validation and proficiency testing of hil-214 in adults

Conditions: Gastroenteritis

Summary: the purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of hil-214.

this single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to hil-214 in peripheral-blood samples. given the large volume of blood required, the pediatric dose will be tested in healthy adults. the main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (cmi) specific to norovirus strains not represented in the hil-214 vaccine (i.e. cross-reactivity).

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 49 years, inclusive. * individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. * the individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements. * individuals willing and able to comply with trial procedures and are available for the duration of follow-up. exclusion criteria: * females who are pregnant or breastfeeding. * gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration). * known hypersensitivity or allergy to any of the hil-214 components (including excipients). * known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease. * any serious chronic or progressive disease (including hepatitis b or c). * previous exposure to an experimental norovirus vaccine. * subject or subject's first-degree relatives are involved in the trial conduct.
a phase 1b/2 safety and tolerability study of medi6469 in combination with therapeutic immune agents or monoclonal antibodies

Conditions: Advanced Solid Tumors; Aggressive B-cell Lymphomas

Summary: the main purpose of this study is to determine the best dose of medi6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, medi4736 (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large b-cell lymphoma (dlbcl). tremelimumab and medi4736 (durvalumab) will be tested with medi6469 in a set of participants with advanced solid tumors while rituximab will be tested with medi6469 in participants with dlbcl. medi6469 will be tested as monotherapy in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * adults \>/= 18 years old * histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exists (monotherapy and in cohorts a and b) * at least one lesion measurable by recist not previously irradiated (monotherapy and in cohorts a and b) * histologically confirmed dlbcl(cohort c) * adequate organ and marrow function * ecog performance status of 0 or 1 * willingness to provide consent for biopsy samples exclusion criteria: * prior exposure to immunotherapy (either as a single agent or in combination) including but not limited to cd137 or ox40 agonists, anti-ctla-4, anti-pd-1, or anti-pd-l1, anti-pd-l2 antibody or pathway-targeting agents * history of organ transplant that requires use of immunosuppressives * history of primary immunodeficiency or tuberculosis * active or prior documented autoimmune disease within the past 3 years * active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months * major surgical procedure within 30 days prior to the first dose of investigational product or still recovering from prior surgery * women who are pregnant or lactating

Keywords: advanced solid tumors diffuse large b-cell lymphoma programmed death 1 programmed dealth ligand 1 cytotoxic t-lymphocyte-associated antigen-4 ox40 ligand
pain education and patient-led goal setting in adults with chronic low back pain: a randomised controlled trial

Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)

Summary: the goal of this clinical trial is to investigate the effectiveness of two treatments for adults with chronic low back pain. the main question this study seeks to answer is "in adults with chronic low back pain, what is the effectiveness of pain education and patient-led goal setting compared to guideline-based written advice on reducing pain intensity and disability?". a total of 392 participants will be randomised into two groups: 1) pain education and patient-led goal setting or 2) guideline-based written advice. participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks delivered online via telehealth. participants randomised to written advice group will receive information developed for people with chronic low back pain. outcomes will be assessed at baseline and week 8, 26 and 52.


Eligibility criteria:
inclusion criteria: * low back pain of at least 3 months duration * physically inactive (less than or equal to 150min/week moderate intensity physical activity; 75 min/week vigorous activity, or some combination of the two) * no known contraindication(s) to performing physical activity * english language proficiency * access to internet exclusion criteria: * physically active (more than 150min/week moderate intensity physical activity, 75 min/week vigorous activity, or some combination of the two) * known contraindication(s) to performing physical activity * known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder) * scheduled for major surgery during the treatment or follow-up period

Keywords: pain education patient-led goal setting chronic low back pain