Kornimate/medical-research-clean huggingface dataset:
diagnostic of d-lactate in cerebrospinal fluid level in patients with suspected ventriculostomy-related meningitis

Conditions: Nosocomial Infection

Summary: the totem study is a single-center study designed to evaluate the performance of the d-lactate assay in cerebrospinal fluid (csf) for the diagnosis of ventriculostomy-related nosocomial meningitis. the study will be conducted in the neurosurgical intensive care unit of the toulouse university hospital, in patients with a suspected diagnosis of ventriculostomy-related nosocomial meningitis.

for each study participant, an additional csf sample will be taken from the ventriculostomy during the routine sampling performed for the diagnosis of nosocomial meningitis. this sample will be stored at -80°c. assays of d-lactate, procalcitonin (pct), and pro-inflammatory cytokines (il-1, il-6, il-8, tnfa) will be performed serially on these csf samples. if the csf sample taken at inclusion does not meet the criteria for nosocomial meningitis, a second sample will be taken 48 to 96 hours later to reassess the cellularity of the csf. finally, the end-of-participation visit takes place after 4 weeks. two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.

Eligibility criteria:
inclusion criteria: * age ⩾ 18 years. * patient with an external ventriculostomy implanted at the toulouse university hospital. * patient suspected of nosocomial meningitis due to a febrile syndrome (in the absence of any other identified infectious site), headache, nausea, lethargy, change in neurological status, meningeal syndrome, epileptic event and cutaneous or subcutaneous inflammation at the ventriculostomy site of insertion. * patient having expressed oral consent, after free and informed information. * patient affiliated to a social security scheme. exclusion criteria: * diagnosis of community meningitis. * proven or suspected meningitis and/or ventriculitis during the previous month. * diagnosis of nosocomial meningitis made in another medical centre prior to admission. * short bowel syndrome. * acute mesenteric ischaemia. * end-stage renal failure (gfr \< 15 ml/min/m2). * peritoneal dialysis. * patient participating in another research protocol with an exclusion period still in progress. * pregnant or breastfeeding woman. * patient under guardianship or trusteeship, persons placed under the protection of justice

Keywords: external ventriculostomy nosocomial meningitis bacterial meningitis
the mechanism of action of unite biomatrix in venous leg ulcers

Conditions: Venous Leg Ulcers

Summary: the purpose of this study is to assess the mechanism of action of the unite biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.


Eligibility criteria:
inclusion criteria: * venous ulcer confirmed w/ duplex ultrasound * ulcer greater than 6 months duration * post-debridement, the ulcer size must be \>5cm2 * at least 18 years old * abi is between 0.7 to 1.2 and/or one of the following: * tcpo2 \> 30mmhg at the ankle * doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) * able and willing to provide a voluntary written informed consent * three or fewer ulcers separated by \>3.0 cm distance * able and willing to attend scheduled follow-up visits and study related exams exclusion criteria: * greater than 20% reduction in wound size during the first 2 weeks of observation with the investigator * ulcer with exposed bone or tendon * clinical infection at the studied ulcer site including cellulitis and osteomyelitis * ulcer of a non-venous insufficiency etiology * phlebitis or deep leg vein thrombosis in past 30 days * arterial bypass in previous 30 days * severe anemia (hgb\<8) * serum albumin \<3.0 * uncompensated congestive heart failure * renal failure with creatinine \>2.5mg/dl * rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, hiv * severe liver disease as defined by treating physician * uncontrolled diabetes mellitus determined by treating physician * malignancy at or near the ulcer site * any condition judged by the pi that would cause the study to be detrimental to the patient * known allergy to equine derived tissue * received another investigational device or drug within 30 days of day 0 * radiation therapy at the wound site * chemotherapy or immunosuppressive therapy within 30 days of enrollment * received another allograft, autograft, xenograft within 30 days of the study * pregnant or nursing women

Keywords: venous leg ulcers
comparison of lasik and sbk

Conditions: Myopia

Summary: the objective of the study is to compare clinical outcomes from lasik and sbk using fda-approved laser technology on the same patient

patients undergoing bilateral refractive surgery on the same day will have one eye randomized to lasik and the fellow eye assigned to sbk treatment.

Eligibility criteria:
inclusion criteria: * patients deemed to be suitable candidates for bilateral lasik surgery exclusion criteria: * patients who desire monovision correction rather than bilateral distance correction
cannabidiol and older adult cannabis users

Conditions: Sleep; Anxiety; Depression; Pain

Summary: cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. the overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived cbd+thc, hemp-derived cbd-thc, or placebo. this work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.


Eligibility criteria:
inclusion criteria: * at least 60 years of age * able to provide informed consent * must have used a cannabis product at least once with no negative effects * must not have been regularly using any cannabis products (\<3x/month) in the last 6 months * female participants must be postmenopausal * liver function tests (alanine transaminase (alt) and * aspartate transaminase (ast)) must show levels no greater than 2x the upper normal limits for age * must be currently taking medication/s for pain, sleep, and/or mood exclusion criteria: * blood alcohol level \> 0 at screening (to sign consent form) * report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs * past or current diagnosis, or family history of diagnosis of psychosis * current use of anti-epileptic medications (e.g. clobazam, sodium valproate) * current use of medications known to have major interactions with epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide). * current use of antipsychotic medications * currently undergoing chemotherapy (to prevent drug interactions)
lottery incentive nudges to increase influenza vaccinations

Conditions: Influenza; Vaccination; Health Promotion; Health Behavior

Summary: in the current study, the study team will explore whether small incentives are effective at promoting flu vaccine uptake. the study is designed to compare the relative efficacy of incentives of equal perceived expected value (ev) or equal implementation costs, to assess whether people are more likely to get vaccinated in response to lotteries with very high payoffs than to small certain cash payout or slightly higher-probability, more moderate payoffs. in particular, given the potential appeal of official state lottery tickets, one study arm will receive a pennsylvania scratch-off lottery ticket for getting a flu vaccine. a primary hypothesis is that lotteries will outperform simple reminders (encouraging respondents to get the flu shot at their upcoming appointment) and the standard of care, representing the ambient healthcare system and public health campaigns to increase vaccination.

during the 2021-22 flu season, the study team will contact geisinger patients who have a primary care or specialist appointment scheduled during flu season and encourage them to get a flu shot. patients will be randomized into 4 to 9 study arms, depending on a sample size projection completed in august 2021. arms will test the relative efficacy of a variety of small monetary incentives on flu shot uptake. incentives may include (a) a $1 pennsylvania scratch-off lottery ticket (with top prize of $5,000), (b) $1 in cash, (c) entry into a raffle for $5,000 absent upfront odds, (d) entry into a raffle for $5,000, with 1-in-5,000 odds of winning, (d) entry into a raffle for $50, with 1-in-50 odds of winning, and (e) entry into a raffle for $500, with 1-in-500 odds of winning. there will be one no-contact control arm and at least 1 reminder control arm (with additional control arms added given sufficient sample size and additional message versions to be tested). included in the study will be current geisinger patients 18+ years of age with no contraindications for flu vaccine who have an appointment scheduled during the study period with a provider who can administer the vaccine. the primary study outcomes will be the rates of flu vaccination and flu diagnosis during the 2021-22 season by targeted patients.

Eligibility criteria:
inclusion criteria: * aged 18+ * pennsylvania mailing address listed * geisinger primary care provider (pcp) assigned * upcoming appointment with pcp or select specialist who stocks and can administer the vaccine during the study period exclusion criteria: * has opted out of receiving messages from geisinger on all modalities being tested

Keywords: lottery financial incentives
reduced intensity double umbilical cord blood transplantation

Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia

Summary: this trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (atg), as used in prior cord blood transplants. subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the atg. the number of patients with virus infections in this study will be compared to our prior experience using the atg.

subjects will receive their transplants as in-patients. * iv-catheter * one or two iv catheters will be placed on the day of hospital admission * conditioning * fludarabine iv six days before transplant (days -7, -6, -5. -4, -3, -2) * melphalan iv (day -1) * total body radiation on day 0 (same day as transplant) * immunosuppressive therapy * tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. given iv as in-patient, orally as out-patient * infusion of cord blood units * 2 cord blood units iv on day 0 routine post-transplant supportive care will be provided

Eligibility criteria:
inclusion criteria: * hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate * appropriate candidate for reduced intensity regimen, according to the treating physician * lack of 6/6/ or 5/6 hla-matched related, 8/8/ hla-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant * able to comply with the requirements for care after allogeneic stem cell transplantation exclusion criteria: * cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction * pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease * renal disease * hepatic disease * neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation * hiv-positive * uncontrolled infection * pregnant or breast-feeding

Keywords: nhl lymphoma leukemia myelodysplastic disorder aplastic anemia
efficacy and safety of statin on the course of progressive smoldering multiple myeloma

Conditions: Smoldering Multiple Myeloma

Summary: the aim of the study is to evaluate the effect of statin administration on the course of progressive smoldering multiple myeloma.

in vitro data indicate that statins affect myeloma cells, mainly by inducing cell death and growth suppression. this is a national, multicenter, phase iia, single arm (not controlled), open label clinical trial of simvastatin 80mg p.o. /day in a population of patients with progressive smm. patients will be treated with simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months. all further treatment decisions after completion of the study are at the discretion of the investigator.approximately 15 patients will be enrolled.

Eligibility criteria:
inclusion criteria: 1. patients fulfilling the criteria of smm. (see appendix i) 2. patients with progressive smoldering myeloma. (see appendix ii) 3. age 18-80 years. 4. signed informed consent prior to patient recruitment. exclusion criteria: 1. patients fulfilling diagnostic criteria of active mm .(see appendix i) 2. patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma. 3. patients on statin treatment on the day of recruitment. 4. patients on chemotherapy or receiving steroids. 5. patients with any contraindication to statin treatment: * known intolerance or hypersensitivity to statin. * sgot or sgpt above 1.5 times of upper normal level (unl). * cpk above unl * concomitant treatment with macrolides and or antifungal agents (ketoconazole) * creatinine level above 1.5 mg% * any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). 6. patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years. 7. patients who have a history of alcohol or drug abuse. 8. patients who are mentally or physically unable to comply with all aspects of the study. 9. participation to an investigational drug trial

Keywords: smoldering multiple myeloma simvastatin paraprotein
supporting effect of dronabinol on behavioral therapy in fibromyalgia and chronic back pain

Conditions: Fibromyalgia; Back Pain

Summary: it is known, that a so called "pain memory" usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception. thus, the principal object of pain therapy is to "delete" this dysfunctional pain memory. the combination of medication, physiotherapy and psychological therapy seems to be the most effective treatment. this study investigates the effect of a concomitant dronabinol medication (cannabinoid) on the effectiveness of behavioral therapy. it is hypothesized that the combination of behavioral therapy and dronabinol will be most effective in deleting the pain memory.

this study investigates the combination of operant behavioral treatment and cannabinoid medication in patients with fibromyalgia and patients with back pain. it is well known that cannabinoids (thc) accelerate learning processes. it is assumed that the combination of both treatments may exert an synergetic effect. a low dose of thc is used, which ist not expected to have direct analgetic effects. the study also investigates genetic determinants of both disorders and the response to treatment, respectively. the patients will be randomly assigned to one of four groups: behavioral therapy and dronabinol, behavioral therapy and placebo, behavioral therapy only, standard medical therapy. patients will attend 12 weekly group-sessions (6-8 patients) of behavioral therapy. behavioral therapy sessions will include training in reducing pain behaviour and establishing active and "healthy" behaviour instead. there will be weekly medical safety visits, in which the patients receive medication and undergo a physical examination (blood and urine samples). patients will be evaluated before and after behavioral therapy and will be followed for an additional 6- and 12-months phase. the outcome variables will be recorded by the use of interviews and questionnaires.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia meeting acr-criteria * diagnosis of chronic back pain * pain duration exceeding 3 months * age between 18 and 70 years * the patient has been informed about the study, understood the information and signed the informed consent form exclusion criteria: * tumors, fractures and heavy osteoporosis * secondary back pain at arthrosis or degenerative scoliosis * radicular back pain * other pain syndrome is main problem * opiate medication \> 60mg morphine per diem * addiction (drugs, alcohol, medicaments) * cardiac insufficiency \> nyha ii * exercise induced dyspnea, angina pectoris a detailed version of exclusion criteria: see study protocol

Keywords: fibromyalgia back pain behavior therapy operant learning tetrahydrocannabinol
post-operative radiotherapy in poor responders ewing's sarcoma patients

Conditions: Ewing's Sarcoma

Summary: local recurrence after surgical resection is a complex phenomenon. an important predictive factor is the response to chemotherapy. central site of disease may be a second independent predictive factor (lin et al. 2007). patients with more than 10% viable tumour cells at surgery following neo-adjuvant chemotherapy had a less favourable outcome with an event-free survival \[efs\] of 47% after 10 years. patients with good histological response (\< 10% viable tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years. however, further studies are necessary to determine the merit of adjuvant radiation for high-risk patients (poor responders). taking into consideration that the toxicity and morbidity of combined surgery and radiation is greater than either alone and must be closely monitored.


Eligibility criteria:
inclusion criteria: * age \< 18 years old. * non-metastatic ewing sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy. * negative surgical margins. * patients show good safety profile and acceptable performance status. exclusion criteria: * patients who show progressive disease and undergo surgery before the time of local control. * patients who undergo amputation or rotationplasty will be excluded. * post-surgical complications that may hinder the administration of radiotherapy
acupressure in preventing nausea and vomiting in young cancer patients receiving chemotherapy

Conditions: Nausea and Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: using acupressure wrist bands to press and stimulate nerves at an acupressure point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy. purpose: this randomized clinical trial is studying how well acupressure works in preventing nausea and vomiting in young cancer patients receiving chemotherapy.

objectives: * determine the feasibility of implementing an acupressure therapy for the prevention of chemotherapy-associated nausea in children with cancer. * test the hypothesis that acupressure bands will prevent chemotherapy-associated nausea and vomiting in children, when compared to placebo acupressure (wrist bands without acupressure). * develop a competitive grant application for a large, multi-institutional randomized controlled trial of the efficacy of acupressure in preventing chemotherapy-associated nausea in children. outline: this is a prospective, randomized, placebo-controlled, crossover, pilot study. patients are randomized to 1 of 2 treatment arms. * arm i: patients wear sea-band elastic acupressure wristbands on each wrist beginning approximately 1 hour before beginning their first inpatient chemotherapy session and continuing for at least 24 hours after completing chemotherapy. patients do not wear wristbands for their second chemotherapy session. patients wear placebo wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy. * arm ii: patients wear placebo wristbands on each wrist beginning approximately 1 hour before their first chemotherapy session and continuing for at least 24 hours after completing chemotherapy. patients do not wear wristbands for their second chemotherapy session. patients wear sea-band acupressure wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy. all patients also receive standard antiemetic therapy. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * patients must receive in-patient primary oncology care at least monthly at brenner children's hospital * patients may have any type of cancer * must be receiving at least 1 of the following chemotherapy agents as an inpatient: * an alkylating agent (e.g., cisplatin, cyclophosphamide, or ifosfamide) * an antitumor antibiotic (e.g., doxorubicin, daunomycin, dactinomycin, or mitoxantrone) * high-dose cytarabine patient characteristics: * patient's primary caregiver must speak english prior concurrent therapy: * see disease characteristics

Keywords: nausea and vomiting unspecified childhood solid tumor, protocol specific