Kornimate/medical-research-clean huggingface dataset:
prediction of outcomes following total knee replacement

Conditions: Osteoarthritis

Summary: this is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. the study includes 5 visits, 1 before surgery and 4 after surgery. you may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. the study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

this is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. the study includes 5 visits, 1 before surgery and 4 after surgery. the last visit will be about 1 year after surgery. you may be eligible if you are 50 or older, will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. the study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Eligibility criteria:
inclusion criteria: * age 50 or older * meet the american college of rheumatology criteria for knee osteoarthritis * scheduled to undergo total knee arthroplasty * facility with the english language that is adequate to complete study procedures exclusion criteria: * cognitive impairment preventing completion of study assessment procedures * myocardial infarction within the past 12 months * severe raynaud's or severe neuropathy * active vasculitis or severe peripheral vascular disease * current infection * use of oral steroids * recent history of substance abuse or dependence * confirmed diagnosis of periodic limb movement disorder or restless legs syndrome * systemic inflammatory or autoimmune disorders such as rheumatoid arthritis, lupus, etc. * known anemia
comparison of methods for prevention of urinary tract infection following botox injection

Conditions: Overactive Bladder; Urinary Tract Infections

Summary: injection of onabotulinumtoxina (btx-a) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. while antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. the investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.

intravesical injection of onabotulinumtoxina (btx-a) is a widely practiced third line therapy for non-neurogenic overactive bladder (oab). however, a paucity of data exists regarding urinary tract infections (uti), the most common adverse event following injection. the investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural utis and their affect on treatment efficacy. the investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. enrollment is planned to achieve a total of 68 participants. participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. inter-injection time will be measured and used a surrogate for efficacy over multiple injections. these results, in addition to filling a void in current literature regarding the increasingly utilized treatment with btx-a, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. the means to stratify patients based on their specific risk of uti may be used to facilitate antibiotic stewardship and improve patient outcomes.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * medication refractory oab, identified per american urological association guidelines exclusion criteria: * post void residual urine \>150ml on two occasions * untreated, symptomatic uti * comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke) * prior pelvic irradiation * current or prior bladder malignancy * hematuria lacking a clinically appropriate evaluation * chronic indwelling or intermittent catheterization

Keywords: onabotulinumtoxin
metformin as add-on to the standard therapy in patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis b.

this is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis b. patients with chronic hepatitis b who met eligibility criteria were randomly assigned (1:1) to receive either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) for 24 weeks in addition to their ongoing entecavir therapy. patients and investigators were both blinded to group allocation. the primary outcome, serum hbsag level (log iu/ml) at weeks 24 and 36, was analysed using a linear mixed-effect model. the intention-to-treat populations were included in primary and safety analyses.

Eligibility criteria:
inclusion criteria: * hbeag-negative chronic hepatitis b * ongoing treatment with entecavir for more than 12 months * hbv dna \< 500 iu/ml * quantitative hbsag \< 3 log iu/ml * alt and ast \< 2 × upper limit of normal (uln) * agree to take contraceptive measures during participation for women of a fertile age * agree not to engage in other clinical trials during participation * understand and sign the informed consent form before taking any steps related to this study exclusion criteria: * diabetes mellitus * alcoholic liver disease * drug-induced liver damage * autoimmune liver disease * decompensated cirrhosis * liver cancer * liver transplantation * pregnant or lactating women * other conditions unsuitable for participation

Keywords: metformin entecavir chronic hepatitis b hepatitis b virus
remimazolam and endovascular procedures of cerebrovascular diseases

Conditions: Cerebrovascular Disorders; Anesthesia

Summary: remimazolam, a novel ultra-short acting benzodiazepine that combined the advantages of midazolam and remifentanil, has been developed for procedural sedation, induction and maintenance of general anesthesia, and sedation in the icu. previous studies have suggested that efficacy and safety of remimazolam are not inferior to propofol or midazolam in patients undergoing colonoscopy,bronchoscopy and some other treatments. however, the efficacy and potential adverse effects of remimazolam on patients undergoing endovascular procedures of cerebrovascular disorders is still unclear. in this study, we tend to conduct a single-center, randomized, single-blind ,non-inferiority trial to compare the efficacy and safety of remimazolam and propofol in endovascular procedures of cerebrovascular disorders.


Eligibility criteria:
inclusion criteria: 1. aged 18 years or older 2. scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia exclusion criteria: 1. american society of anesthesiologists class ⅲ or higher 2. hunt-hess class ⅲ or higher 3. body mass index (bmi) \ 30kg/㎡ 4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm 5. posterior circulation infarction 6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping 7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure 8. be allergic or likely to be allergic to the study drugs 9. participate in other clinical researchers within 3 months 10. history of neurological or psychiatric diseases 11. existed or suspected abuse of drug or alcohol 12. use of sedative or analgesics before surgery 13. patients with difficulty in communication

Keywords: propofol remimazolam endovascular procedures
retrospective study of immediate hypersensitivity (ihs) reactions to platinum salts in the university hospital of nancy

Conditions: Drug Allergy

Summary: to assess the efficacy of skin tests with platinum salts in patients suspects with immediate hypersensitivity reactions. all patients adressed in consultation to the allergy department of university hospital of nancy for an immediate hypersensitivity reaction to platinum salts between 2015 and 2021 were retrospectively recruited.


Eligibility criteria:
inclusion criteria: * adult * suspected immediate hypersensitivity reaction to platinum salts exclusion criteria: * skin tests not achievable

Keywords: immediate hypersensitivity platinum salts skin tests tolerance induction
influence of pain sensitivity on lumbar surgery outcomes

Conditions: Lumbar Spinal Stenosis

Summary: pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.


Eligibility criteria:
inclusion criteria: 1. patients aged 40-80 years 2. lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between june 2012 and april 2013 exclusion criteria: * a history of major psychiatric disorders (schizophrenia, major depression) or peripheral vascular disease * any concurrent serious medical condition that would cause disability or decreased general health status such as sepsis or cancer.
determinants of intensity of care of lung cancer patients with organ failure

Conditions: Lung Cancer

Summary: investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. the place of patient or family on care's decision will be noticed. investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

two hundred patients have to be enrolled in 2 years in the grenoble teaching hospital and in the saint louis hospital in paris between november 2010 and november 2012. each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in icu will be included. the objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Eligibility criteria:
inclusion criteria: * lung cancer * organ failure exclusion criteria: -

Keywords: organ failure intensive care palliative care patient's wishes
lovastatin as a potential modulator of apoptosis in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will test whether lovastatin helps to modify lung inflammation in patients with copd (chronic obstructive pulmonary disease).

the impact of lovastatin, 40mg by mouth once daily on biological and clinical outcomes will be evaluated in an exploratory 16-week comparative treatment efficacy trial in 44 adult former smokers with established copd of moderate severity. this trial employs a longitudinal randomized, parallel-arm, double-blind, placebo-controlled design using biomarkers of airway inflammation as the primary outcomes of interest.

Eligibility criteria:
inclusion criteria: 1. adult (≥45 years) former smokers with ≥ 10 pack-years of cigarette smoking 2. fev1/fvc ratio \< 70% 3. post-bronchodilator fev1 between 50% and 80% of predicted if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only 4. dlco/va \< 80% predicted 5. ability to perform and adhere to study protocol 6. ability to provide informed consent. exclusion criteria: 1. asthma or other comorbid lung disease, 2. hypoxemia (pao2 \< 55 mmhg or spo2 \< 88% on room air), if undergoing bronchoscopy 3. exacerbation of copd within the last 6 weeks 4. upper or lower respiratory tract infection within the last 6 weeks 5. current smoking 6. significant coronary artery disease as reflected by unstable angina, myocardial infarction or angioplasty/stenting/bypass surgery within 6 months 7. current use of hmg-coa-reductase inhibitors 8. current use of inhaled corticosteroid 9. concurrent use of other cyp3a4 (isoform of cytochrome p450) inhibitors 10. history of adverse reaction to hmg-coa-reductase inhibitors (rhabdomyolysis, hepatitis) 11. for patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.
predictors of constipation in healthy children

Conditions: Constipation

Summary: the purpose of this research is to see if a questionnaire on bowel habits can help identify children who will have constipation 12 months later.

constipation in children is a common complaint, accounting for an estimated 3% of all pediatric office visits and 20% of visits to a pediatric gastroenterologist. unfortunately, constipation can become chronic in many children even before the problem has been recognized by a parent or primary care physician. we have previously characterized the bowel habits of more than 3300 primarily middle class caucasian children 1 to 8 years of age presenting to their primary care practitioner for a health maintenance visit. however, the validity of information concerning bowel habits of children obtained by recall is not well established. the potential benefit of this study to society will be the demonstration that a bowel habit questionnaire can predict the outcome of clinically important constipation.

Eligibility criteria:
inclusion criteria: * presenting for a health maintenance visit

Keywords: constipation bowel habits
post operative pain management through adductor canal block with bupivacaine for acl reconstruction

Conditions: Pain, Postoperative; ACL

Summary: liposomal bupivacaine injectable suspension (exparel), manufactured by pacira pharmaceuticals, is an fda-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. exparel's extended bioavailability allows for 48 hours of pain control. periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to fnbs, avoiding transient quadriceps weakness and potential in-hospital falls. recently exparel has been fda approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. it is not yet approved for peripheral nerve blocks of the lower extremity. no study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with exparel compared to femoral nerve catheter with bupivacaine. we pose that exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias. the purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing acl reconstruction.


Eligibility criteria:
inclusion criteria: 1. patients undergoing primary anterior cruciate ligament reconstruction with autograft 2. has not used narcotic pain medication in 3 months 3. ages of 18+ 4. proficient in the english language 5. willing and able to follow study protocol exclusion criteria: 1. acl repair, revision surgery, or allograft 2. multi-ligamentous knee injuries 3. cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol 4. patients taking baseline opioid for other injury 5. dementia or other psychiatric illness that would preclude accurate evaluation 6. pregnant or lactating patients 7. non-english speakers as questionnaires are only available in english
vitamin d supplementation in overweight/obese african american adults and youth (d-sunny)

Conditions: Vitamin D Deficiency

Summary: primary specific aim 1: to compare the dose-responsive effects of vitamin d3 supplementations on 25(oh) d, parathyroid hormone (pth), and serum/urine calcium. primary specific aim 2: to compare the dose-responsive effects of vitamin d3 supplementations on non-invasive vascular measures including pulse wave velocity (pwv), flow-mediated dilation (fmd), carotid arterial compliance (cac), carotid intima-media thickness (cimt), and 24-hours ambulatory blood pressure (abp) monitoring as well as casual bp.


Eligibility criteria:
inclusion criteria: 1. african-americans (blacks) 2. age 13-45 3. overweight/obese (bmi ≥ 85th percentile for their age and gender for age 13-17 and bmi ≥ 25 kg/m2 for age 18-45) 4. relatively healthy (no medical history of any heart, lung, endocrine or malignant disorder) 5. non pregnant 6. not on any medication or vitamin supplements that can influence the study outcomes 7. serum 25 hydroxy vitamin d (25\[oh\] d) levels ≤ 20 ng/ml (50 nmol/l) at the time of screening exclusion criteria: 1. not meeting any one or more of the above criteria 2. females who become pregnant/test positive on urine pregnancy test during the screening or any of the testing visits 3. anyone who is taking any multivitamin supplements that contains vitamin d
high dose-rate brachytherapy and/or intensity modulated external beam radiation therapy for prostate cancer

Conditions: Adenocarcinoma of the Prostate

Summary: the principal objective of this study is to demonstrate that patients can safely receive combined high dose rate brachytherapy and intensity-modulated radiation therapy without experiencing a treatment limiting toxicity.

patients will receive a single high dose rate brachytherapy dose of 6 gy to the prostate, followed by 61 gy delivered to the prostate and nearby tissues using intensity-modulated radiation therapy in 28 treatments.

Eligibility criteria:
inclusion criteria: * trus biopsy proven adenocarcinoma of the prostate pretreatment psa \ 80 acceptable anesthesia risk as determined through routine pre-operative screening in the vcuhs diagnostic testing clinic exclusion criteria: * pubic-arch interference or regional disease ( no evidence of metastatic disease for patients whose psa is greater than 10 ng/ml, gleason's sum is greater than 6, or t-stage is greater than t2a. patients at high risk for distant disease (psa \> 30 ng/ml, gleason's sum \> 8 or clinical stage \> t2c), clinically involved seminal vesicles or extension beyond the prostate capsule history of inflammatory bowel disease require steroid or cytotoxic therapy for collagen vascular disease uncontrolled or poorly controlled hypertension uncontrolled or poorly controlled diabetes mellitus history of cancer other than skin cancer within five years of the initiation of protocol treatment history of pelvic irradiation require the routine use of warfarin

Keywords: brachytherapy intensity-modulated radiation therapy prostate specific antigen
risk assessment of febrile neutropenia and grade 3-4 neutropenia in patients with non-hematological cancer treated with conventional chemotherapy

Conditions: Non-hematologic Cancer

Summary: the purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.


Eligibility criteria:
inclusion criteria: * male or female \> 18 years * histologically confirmed solid tumor. * subjects who have not received chemotherapy and / or radiotherapy in the last 3 months. * subject to initiate a chemotherapy (ie, cycle 1, day 1) * the chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%. * planning a minimum of 3 cycles chemotherapy. * adequate bone marrow reserve defined by: leukocytes ≥ 3,000 / mm3, platelets ≥ 100.000/mm3; neutrophils ≥ 1,500 / mm3. * adequate hepatic and renal function, defined by: bilirubin \<1.5 times the normal value, alt and ast \<3 times the normal range (both can be elevated up to 5 times the normal value in patients with known liver metastases); creatinine \<1.5 times upper normal value * ecog ≤ 2. * informed consent exclusion criteria: * patients under treatment with an investigational treatment. * active infection in the last 72 h before starting chemotherapy. * indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia \ 20%. * patients with concomitant chemoradiotherapy. * patients being treated with biological drugs in monotherapy. * any other condition causing neutropenia. * history of bone marrow transplant or stem cells.