Kornimate/medical-research-clean huggingface dataset:
h-34 delta revision cup

Conditions: Hip, Osteoarthritis

Summary: this study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with delta revision acetabular cup.

this is an observational study designed to reflect real life clinical practice as closely as possible. thus, clinicians are free to choose the method to implant and total hip arthroplasty in accordance with the current local delta revision acetabular cup indication for use and current clinical practice.

Eligibility criteria:
inclusion criteria: * male or female in whom a decision has already been made to perform a total hip arthroplasty with delta revision acetabular cup as per indication for use. the decision to implant delta revision acetabular cup must be taken prior to, and independently from the decision to enroll the patient. this decision should be made in accorsance with routine clinical practice at the study site concerned. * age ≥ 18 years old * all patients mist give written informed consent approved by the study site's institutinal review board (irb)/ethical committee (ec) * patient is able to comply with the protocol exclusion criteria: * adult patients with any delta revision acetabular cup contraindication for use as reported in the current local instruction for use. * for female patiens, current pregnancy and/or lactation or planning a pregnancy

Keywords: revision
attention training for learning enhancement and resilience trial

Conditions: Age-related Cognitive Decline

Summary: healthy aging is associated with a decline in multiple cognitive domains, as well as motor control function. the long-term consequences of cognitive and functional impairment resulting from age-related cognitive decline are well documented in the scientific and clinical literature, with significant evidence of related problems with independent functional abilities. this study aims to understand how the experimental computer program can affect cognition and attention in participants with age-related cognitive decline.

following consent, participants will engage in an assessment process to determine eligibility. once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. this process consists of paper-pencil surveys and computerized tests. following the assessment process, participants will engage in an internet browser-delivered training sessions conducted on any internet-accessible computer. the computerized training sessions can be done up to 7 times a week (once a day) or at the participant's convenience (the recommended time commitment is 5 times a week). following the completion of training, the participant's cognitive function will be re-assessed. participation is voluntary and participants may withdraw from the study at any time.

Eligibility criteria:
inclusion criteria: * participants must be 65 years of age or older * participants must have a diagnosis of age-related cognitive decline as confirmed by interview and performance on screening assessments * participants must be fluent english speakers * participants must have adequate visual, auditory, and motor capacity to use computerized intervention exclusion criteria: * participants with diagnosis of ptsd, depression or other psychologically diagnosable emotional disorder * participants with a history of conditions that could affect thinking abilities, including brain injury, mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder), hiv/aids will be excluded * participants enrolled in another concurrent research study will be excluded * participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician, will be excluded * participants with a current or significant past history of substance abuse will be excluded * participants who show signs of suicidal ideations or behaviors will be excluded and referred for appropriate treatment

Keywords: healthy aging cognition age-related cognitive decline
prospective evaluation of interstitial lung disease progression with quantitative ct

Conditions: Interstitial Lung Disease

Summary: the interstitial lung diseases (ild) are a heterogenous group of conditions with varying degrees of inflammation and scarring (fibrosis) of the lungs. ild progression is unpredictable, making prognostication challenging. a proportion of patients will develop inexorably progressive disease termed progressive fibrosing ild (pf-ild). forced vital capacity (fvc), a lung function variable, is routinely used to monitor disease progression. however fvc can be a poor disease marker as it can be influenced by patient effort and can be difficult to perform. high resolution computed tomography (hrct) is a necessary investigation for suspected fibrotic-ild, making it a promising tool for research. a quantitative-ct (qct) approach uses computer software to analyse hrct scans and has advantage over visual radiologist assessments which are limited by inter/intra-observer variance. the investigators will undertake a feasibility study to determine whether baseline and longitudinal qct can predict and quantify disease progression in fibrotic-ild. the endothelial glycocalyx (eg) is a mesh-like layer that lines the small blood vessels. injury to this layer has been implicated in non-thoracic fibrotic diseases. telomeres are repetitive genetic sequences which cap chromosomes preventing their damage during cell replication. prematurely shortened leucocyte telomere lengths (ltl) have been demonstrated in a wide range of ilds. we will evaluate role of measuring eg health and ltl in disease prognostication. adult participants with fibrotic-ild from 3 centres in england will be recruited alongside healthy controls. case (disease) participants will undergo investigations at 0, 6 and 12 months from recruitment including: * hrct with quantitative analysis (qct) * lung function testing * eg and ltl measurement * health related quality of life assessments the primary outcome will assess the correlation of disease progression status measured by standard of care (fvc) with baseline qct and eg assessment. healthy controls will only undergo eg assessment at all time points. feasibility outcomes will be assessed including recruitment, consent and attrition rates. the results will inform a subsequent multi-centre study to assess the clinical benefit of disease monitoring with the measures assessed in this study.


Eligibility criteria:
inclusion criteria: * multidisciplinary team diagnosis of ipf or non-ipf fibrotic-ild * treatment naivety to anti-fibrotic therapy at entry to study * adult ≥18 years \<85 * informed consent exclusion criteria: * forced expiratory volume in 1s/fvc \<0.7, * significant other respiratory pathology including emphysema \>15% on ct (radiologist determined) * evidence of ild exacerbation at the time of ct
dynamic changes of the human microbiome predict the risk of poor prognosis in patients with acute ischemic stroke: a multi-center study

Conditions: Acute Ischemic Stroke

Summary: recent studies have found a close relationship between acute ischemic stroke(ais) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study

this study was designed as a prospective, observational, multicenter cohort study. 2000 patients with ais will be enrolled continuously through multiple centers. oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. after the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.

Eligibility criteria:
inclusion criteria: * meet the ais diagnostic criteria; * age 18-80; * within 7 days of the onset; * signing the informed consent, providing relevant medical history and biological specimens. exclusion criteria: * mrs \> score 2 before onset; * serious systemic diseases including malignant tumors; * hematological diseases and autoimmune diseases; * alt or ast \> 2 times the upper limit of normal value or severe liver disease; * serum creatinine \> 1.5 times the upper normal limit or severe nephropathy; * history of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning); * history of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; * antibiotic use within 1 month before admission; * fece cannot be obtained within 4 days after admission.

Keywords: acute ischemic stroke, microbiome, prognosis
meditation for older adults with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: this pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. this study aims to test the preliminary effect of a mindfulness-based meditation (mbm) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the mbm intervention on the host gut-brain axis (gba).

aim 1: to test the preliminary effect of a mindfulness-based meditation (mbm) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain. hypothesis: we hypothesize that our active mindfulness-based meditation intervention will be feasible and acceptable to community-dwelling older adults with chronic low back pain and improve pain and symptoms to a greater extent than older adults randomized to a sham mindfulness-based meditation group. aim 2: to test the effect of the mindfulness-based meditation intervention on the host gut-brain axis (gba). hypothesis: we hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly improved compositional patterns and functional profiles of gut microbiota and increased pain-related cortical response measured by functional near-infrared spectroscopy (fnirs) to a greater extent than older adults randomized to the sham mindfulness-based meditation group at 2-weeks post-intervention, and 8-weeks follow up.

Eligibility criteria:
inclusion criteria: 1. aged 50 years older 2. intact cognition (examined by the mini-mental state exam, ≥ 24) 3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[nrs\]) 4. able to speak and read english 5. not intent to change medication regimens for pain throughout the trial exclusion criteria: 1. serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy) 2. other concurrent chronic pain conditions (e.g., arthritis, headache, irritable bowel syndrome) 3. psychosis 4. inflammatory or malabsorptive intestinal diseases 5. function limitation precluded the meditation practice 6. participated meditation program before 7. no access to the internet

Keywords: mindfulness older adults
effects of exercise on young adult women with aces: an integrative pilot study

Conditions: Life Experiences

Summary: the process by which the body responds to stressors to maintain homeostasis is called allostasis and is dependent on the integrated function of the nervous, endocrine, and immune systems. aces adversely affect these system, cause allostatic load, and can modify development of allostatic systems. however, the central hypothesis is that exercise can reduce allostatic load by positively augmenting function of each of these three systems. no previous studies have examined the effects of structured exercise interventions in individuals with aces. the investigators are studying the effects of 8-weeks of structured resistance and aerobic exercise on biomarkers related to nervous, endocrine, immune, and metabolic function and several clinical outcomes in young adult women with aces. the specific aims will test several hypotheses, and are as follows: specific aim 1: conduct a feasibility study to explore whether progressive, structured exercise can help mitigate the adverse physiological effects of stress and trauma early in life. specific aim 2: determine whether progressive, structured exercise can help improve health-related quality of life, anxiety, and traits like hope, self-efficacy, or self-control, resilience. specific aim 3: determine whether the type and timing of exposure to aces has a significant influence on the severity of psychopathology and long-term physiological response to aces.


Eligibility criteria:
inclusion criteria: 1. provide written and dated informed consent to participate in the study; 2. be willing and able to comply with the protocol; 3. be between the ages of 18 and 29, inclusive; 4. be free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire; 5. not currently prescribed or taking anti-inflammatory or lipid-lowering medications; 6. have either an ace score of 0 or 4 or higher; 7. have a bmi between 18.5 and 40.0, inclusive; 8. not enrolled in another clinical trial within thirty days prior to enrollment; and 9. answer no to all questions on the par-q for people aged 15 to 69, which assesses a person's eligibility to engage in exercise without contraindications.

Keywords: adverse childhood experiences exercise intervention inflammation resilience health
a clinical study on the efficacy and safety of abcd in the treatment of patients with invasive fungal disease

Conditions: Invasive Fungal Disease

Summary: this study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin b cholesterol-sulfate complex (abcd) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with abcd antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.


Eligibility criteria:
inclusion criteria: 1. age≥ 18 years old, gender is not limited; 2. patients with hematologic malignancies such as leukemia and lymphoma who have undergone chemotherapy or hematopoietic stem cell transplantation; 3. peripheral blood absolute neutrophil count (anc) \< 0.5×109/l, or expected anc \< 0.5×109/l after 48 h; 4. within 48 hours before the screening, at least 2 oral temperature measurements (with an interval of more than 30 minutes) ≥ 38.3°c (axillary temperature≥38.0°c), or ≥ 38°c (axillary temperature≥37.7°c) for more than 1h; 5. received broad-spectrum antimicrobial therapy for at least 96 hours before screening but still had recurrent or persistent fever and suspected fungal infection; 6. the patient or his/her legal representative signs the informed consent form. exclusion criteria: 1. those who are allergic to amphotericin class b drugs or any component of the cholesterol-sulfate complex; 2. patients with clinical suspicion of invasive fungal disease who have received antifungal therapy; 3. patients with clinically diagnosed or confirmed invasive fungal disease (ifd) during the screening period; 4. patients with abnormal liver function, aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≥ 5 times the upper limit of normal (uln), or alt or ast \> 3 times uln and total bilirubin \> 1.5 times uln; 5. patients with reduced renal function, who need or are currently undergoing hemodialysis or peritoneal dialysis; 6. clinically significant hypokalemia (defined as serum potassium \< 3.2 mmol/l, or blood potassium lower than the lower limit of normal while receiving digitalis therapy), and hypokalemia cannot be corrected before starting trial treatment; 7. expected survival time\< 3 months; 8. pregnant women, lactating women, or women of childbearing age who have not taken contraceptive measures and are planning to become pregnant; 9. other investigators believe that it is not appropriate to participate in clinical trials.
simplified severe sepsis protocol-2 (sssp-2) in zambia

Conditions: Sepsis; Severe Sepsis; Tuberculosis

Summary: this study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis with hypotension in zambia. this is a follow-up study to the simplified severe sepsis protocol (sssp) study. the intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. it is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis and hypotension.

in recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. in sub-saharan africa, simple therapies such as iv fluids and early antibiotics are frequently under-utilized. studies of fluid interventions in the region, however, have demonstrated conflicting results. outcomes in septic patients may be further affected by delays in the diagnosis of tuberculosis-associated severe sepsis. the aims of this study are (1) to assess the impact on survival of a simple evidence-based protocol for severe sepsis with hypotensionor septic shock, (2) to evaluate the cost of implementation for a simplified severe sepsis protocol, (3) to develop a clinical diagnostic score for identifying tuberculosis in hiv positive patients with severe sepsis, and (4) to assess the performance of the xpert tb/rif rapid pcr system and urine lipoarabinomannan assay for diagnosing tuberculosis in hiv positive patients with severe sepsis.

Eligibility criteria:
inclusion criteria: * infection suspected by the treating physician * 2 or more of the following sirs criteria: * - heart rate \>90/min * respiratory rate \>20/min * - temperature ≥ 38° c or \< 36° c * white blood count \> 12,000 or \< 4,000/µl * 1 of the following: * systolic blood pressure (sbp) ≤ 90 mm hg * mean arterial blood pressure (map) ≤ 65 mm hg exclusion criteria: * gastrointestinal bleed in the absence of fever * need for immediate surgery * respiratory rate greater than 40/min with oxygen saturation less than 90% * suspected congestive heart failure exacerbation * end-stage renal disease * raised jugular venous pressure (jvp) at baseline * currently incarcerated

Keywords: sepsis severe sepsis tuberculosis bundle zambia
ultrasound evaluation of hands in patients with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate ultrasound hands in patients with systemic lupus erythematosus.

introduction: the systemic lupus erythematosus (sle) is a disease with a common articular involvement. approximately 1-2% of patients with sle have joint inflammation similar to rheumatoid arthritis (ra). there are no well-designed studies of lupus arthropathy. primary objectives: to evaluate the ultrasonographic examination of the hands in patients with systemic lupus erythematosus and make its correlation with examination of patients with rheumatoid arthritis (ra) established and with clinical, serological, radiological and functional. material and methods: a transversal study will be carried out on patients diagnosed with with sle and ra. clinical instruments: count of swollen and tender joints, visual analogue scale (vas) for pain (0-10 cm), edema and for disease activity; disease activity (das 28 and sledai), hand grip strength and pinch (jamar dynamometer and preston pinch gauge); functional questionnaires (haq and dash). it will be observed the presence of "puffy hands", raynaud's phenomenon and presence of autoantibodies. radiographic instruments: evaluation of radiographs of hands and wrists according to the sharp score modified by van der heijde. ultrasonographic instruments (quantitative and semi-quantitative measures): synovial hyperplasia, synovial blood flow (power doppler), bone erosions and cartilage. the joints that will be evaluated: radiocarpal, distal radioulnar, first to fifth metacarpophalangeal and proximal interphalangeal. ultrasonographic interobserver reproducibility will be carried out in 10% of the patients. all the examinators will be blind for each other findings. rheumatoid factor and anti-ccp will be investigated in ra patients. statistical significance will be set at 5%.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years; * female and male; * patients with sle, according to the revised classification criteria of the acr (arthritis rheum, 1997) with current or previous joint activity (arthritis or arthralgia; * patients with established ra according to acr classification criteria (arthritis rheum, 1988) exclusion criteria: * changing the dose or drug-based immunosuppression in the last 3 months. * corticosteroid pulse therapy in the last 30 days; * infiltration with corticosteroids at hand in the last 3 months; * previous surgery in the joints studied; * irreducible deformity of the joints studied; * overlap with other joint diseases or collagen; * chiropractic diabetic; * hypothyroidism

Keywords: systemic lupus erythematosus rheumatoid arthritis
a study to characterize the abuse liability of alo-02 in healthy, non-dependent, recreational opioid abusers

Conditions: Healthy

Summary: the main purpose of this study is to determine if oxycodone and naltrexone combination capsules (alo-02) have the potential to be abused.

abuse liability study

Eligibility criteria:
inclusion criteria: * healthy subjects. * non-dependent, recreational opioid users. (must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before screening visit, and at least once in 8 weeks before the screening visit. exclusion criteria: * diagnosis of substance and/or alcohol dependence. * subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder. * history of sleep apnea. * positive urine drug screen (uds) for other that marijuana. * positive for hepatitis b or c and hiv on screening.

Keywords: relative abuse potential study; oxycodone; nalteone; opioid-related disorders; drug abusers chronic pain