Kornimate/medical-research-clean huggingface dataset:
post epidural steroid injection follow-up

Conditions: Lumbago; Lumbar Spinal Stenosis; Lumbar Disc Herniation

Summary: to determine the expected pain response timeline for patients receiving epidural steroid injections, our team plans to assess patient pain severity and degree of pain relief every 3 days for 23 days.

patients who are already planning to receive an epidural steroid injection from their physiatrist will be approached by study members on the day of their injection. if enrolled, the patients will be contacted every 3 days for 23 days to determine the severity of pain and degree of pain relief from the injection.

Eligibility criteria:
inclusion criteria: * any patient schedule for an epidural steroid injection (esi) at stallworth rehabilitation hospital through the department of physical medicine \& rehabilitation. * the epidural steroid injection will be performed as part of standard clinical care, this study only aims to describe the clinical response to the procedure. exclusion criteria: * esi has been performed within the last 6 months * steroid injection elsewhere in body within last 8 weeks * oral or intramuscular steroids within last 8 weeks * unwilling or unable to provide informed consent * unable to comply with required follow up * please note that it is assumed that a patient scheduled for an epidural steroid injection clinically is assumed to not have any contraindications to the injection itself such as active systemic infection or pregnancy.

Keywords: epidural steroid lumbar back pain pharmacokinetics timeline natural history
decreasing nightmares in adults with narcolepsy

Conditions: Narcolepsy; Narcolepsy Type 1; Narcolepsy with Cataplexy; Narcolepsy Without Cataplexy; Nightmare; Nightmare Disorder with Associated Other Sleep Disorder

Summary: the purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. all participants will receive the treatment and will complete three assessments. half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment.


Eligibility criteria:
inclusion criteria: * diagnosis of narcolepsy type 1 or narcolepsy type 2 * nightmare frequency of ≥1 times per week * age 18 or older * able to speak, read, and write in english * live in the united states * sleep and medications stable for ≥ 1 month and willing to keep medications stable for the duration of the study exclusion criteria: * currently engaged in trauma- or sleep-related psychotherapy * previous behavioral treatment for nightmares * medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment * untreated moderate-severe sleep apnea

Keywords: imagery rehearsal therapy cognitive behavioral therapy for nightmares
investigating mechanisms underlying spinal cord stimulation efficacy using virtual reality and full body illusion

Conditions: Neuropathy;Peripheral

Summary: the study hypothesis is that spinal cord stimulation (scs) combined with virtual leg illumination (provided through a wearable headset (oculusrift, oculusvr, irvine, ca) and a custom-designed virtual reality leg scenario) will lead to controlled analgesia induction, boosting analgesic effects obtained with standard scs treatments and will further be associated with changes in the perception of the affected body part.

epidural spinal cord stimulation (scs) is an approved treatment for truncal and extremity neuropathic pain. the mechanisms underlying the efficacy of scs are unknown. recent advances in cognitive neuroprosthetics using virtual reality allow for modulation of body perception and bodily experience, which has also been shown to modulate pain perception. the present research proposal plans to merge expertise in cognitive neuroprosthetics with neuromodulation techniques in order to test the analgesic properties of the combination of epidural spinal cord stimulation with a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation). the investigators propose to study this hypothesis prospectively in 25 patients with implanted scs systems for the treatment of chronic neuropathic pain. primary outcomes will be pain reduction (based on subjective, functional and physiological measures) and changes in body perception (based on subjective and objective measures). the present study will generate a proof-of-concept for the application of neuro-visual stimulation for the treatment of chronic pain and will form the basis for future nih funding application.

Eligibility criteria:
inclusion criteria: 1. age 18-and older at the time of enrollment 2. patients carrying a diagnosis of cprs type 125 or chronic refractory neuropathic leg pain following fbs4 3. patients who have implanted epidural scs 4. the scs implantation for at least three months prior to enrollment 5. patients with efficacious scs as defined by ≥ 50% pain improvement after switching scs from an off state to an on state ('optimal' stimulation efficacy) 6. patients willing and able to provide informed consent exclusion criteria: 1. patients who are unable to effectively or efficiently communicate for example patients suffering from speech deficits (dysarthria, aphasia) or are non-english speaking. 2. patients with history of prior cranial surgery, significant brain lesions for example intracranial tumors, strokes etc. 3. non efficacious response to scs \<50% pain improvement with optimal stimulation parameters 4. evidence of untreated psychiatric disorders or drugs/alcohol abuse. 5. history of seizures

Keywords: spinal cord stimulation virtual reality full body illusion
an observational study to assess respiratory syncytial virus (rsv) respiratory events among premature infants

Conditions: Healthy

Summary: the primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wga) infants in the usa who did not receive rsv prophylaxis during the infants' first rsv season.

the primary objective is to determine the burden of rsv disease in outpatient settings among 32 to 35 wga infants in the usa who did not receive rsv prophylaxis, as measured by rate of rsv-associated outpatient lower respiratory tract illness (lri) during the infants' first rsv season.

Eligibility criteria:
inclusion criteria: * premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days ga) * age 6 months or less at the time of screening, and born in may 2009 through january 2010 for season 1, or may 2010 through february 2011 for season 2 * written informed consent and any locally required authorization (eg, hipaa), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures. exclusion criteria: * receipt of any rsv prophylactic agent: at any time prior to study participation * participation in studies of investigational rsv prophylaxis or rsv therapeutic agents * presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects * any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months
effect of reminders on adherence

Conditions: Diabetes; Hypertension

Summary: the investigators seek to increase medication adherence of subjects. the investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. the investigators will measure whether this increases medication adherence.

the investigators seek to increase medication adherence of subjects. the investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. the investigators will measure whether this increases medication adherence. the investigators will send mailings to subjects once per month, and elicit responses via mail, phone, and web surveys.

Eligibility criteria:
inclusion criteria: * customers of the investigators' insurance company partner exclusion criteria: * none
high vs standard energy children's drink study

Conditions: Growth Failure

Summary: this study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.

a four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. the primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.

Eligibility criteria:
inclusion criteria: * male or female * aged 1-12yrs * faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements * expected to receive at least one bottle of the study product per day * able to take study products orally during the study period * written informed consent from parent/carer exclusion criteria: * requirement for 100% of their nutrition via enteral tube and/or parenteral feeding. * children with major hepatic or renal dysfunction * children with galactosaemia or severe lactose intolerance * requirement for elemental or semi-elemental feeds * investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements * participation in other studies within 2 weeks of study
steroids in the maintenance of remission of proliferative lupus nephritis

Conditions: Lupus Nephritis

Summary: there is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (sle) in patients who are in remission from their lupus nephritis. if low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. this pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of sle in patients with previous lupus nephritis.


Eligibility criteria:
inclusion criteria: * age at least 18 years * diagnosis of sle by acr criteria * diagnosis of proliferative lupus nephritis (isn/rps class iii or iv) * currently on prednisolone (5 to 20 mg/day) * in partial or complete remission for at least 3 months exclusion criteria: * currently pregnant * in end-stage renal failure * receiving corticosteroids for an indication other than lupus nephritis

Keywords: systemic lupus erythematosus lupus nephritis
effects of long biliopancreatic limb vs. long alimentary limb in superobesity, a randomized study

Conditions: Morbid Obesity; Weight Loss

Summary: super obesity, i.e. a bmi above 50, is difficult to treat. normal gastric bypass surgery is not always enough for proper weight control. bypassing a longer segment of the gut may be more beneficial. which part to bypass is not clear. the investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice. endpoints are quality of life, gastrointestinal function, and weight development.

two variations of gastric bypass are compared: method 1 (test method):a 200 cm bp-limb (distance treitz to ea) + 150 cm common channel (ea to ileocecal valve) + roux-y-limb variable method 2 (standard method): a 60 cm bp limb + 150 cm roux-y-limb + common channel variable. patients are evaluated according to the principles of the scandinavian obesity surgery registry (soreg) with the addition of two additional questionnaires. fu time is set at 5 years.

Eligibility criteria:
inclusion criteria: * bmi 50-65 * age 18-55 * conservative attempts at weight reduction failed exclusion criteria: * inability to speak and understand the swedish language * residence outside the county of skåne * psychotic disease * inflammatory bowel disease

Keywords: gastric bypass morbid obesity gut function weight loss
probiotics for prevention of antibiotic-associated diarrhea

Conditions: Antibiotic-Associated Diarrhea

Summary: the purpose of this study is to evaluate if ingestion of a probiotic formula (jarrow-dophilus eps)reduces incidence of diarrhea and improves the quality of life of patients receiving antibiotic therapy.

a common complication of antibiotic use is antibiotic-induced diarrhea (aad). aad is the result of disrupted microflora, occurring two to eight weeks after antibiotic use. probiotic supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea, improving quality of life and reducing symptoms associated with antibiotic administration. the proposed study will be a prospective, randomized, double blind, placebo-controlled trial that will assess the efficacy of the jarro-dophilus eps probiotics formula for the prevention of aad. in addition,a subgroup of participants will be requested to provide one fecal sample at the initiation of the study and one sample in the last three days of probiotic (or placebo) treatment. the samples will undergo microbial analysis for routine c \& s(salmonella, shigella, campylobacter, ecoli 0157, yersinia), vre, yeast, fungus culture (moulds) and c. difficile toxin.

Eligibility criteria:
inclusion criteria: * 18-75 years of age * prescribed oral or iv antibiotics by physicians in saskatoon health region's community medical clinics exclusion criteria: * treatment with an antibiotic two weeks prior to study entry * underlying long term gastrointestinal disease (i.e., ulcerative colitis, crohn's disease, irritable bowel syndrome, ileostomy, colostomy) * pregnant or lactating * immunocompromised state * chronic illness such as hepatitis b, hepatitis c, renal failure * inability to provide informed consent, inability to speak or write in english * receiving tube feeds * insufficiently functional (physically and cognitively) to complete the study diary and questionnaires.

Keywords: antibiotic-associated diarrhea probiotic quality of life antibiotics
single ascending dose study to investigate the safety and pharmacokinetics of xc101-d13h in healthy adult subjects

Conditions: Migraine

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (sad) study. there are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. one of the planned dose levels will cross over after a washout period to receive the same single dose of xc101-d13h or placebo under fed conditions.

this is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (sad) study. there are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. one of the planned dose levels will cross over after a washout period to receive the same single dose of xc101-d13h or placebo under fed conditions. dose escalation will be supervised by a safety monitoring board (smb). dose escalation to the next dose level will not take place until the smb has determined that adequate safety, tolerability, pk, and core-lab analyzed ecgs from the previous cohort and all previous cohorts have been demonstrated to permit proceeding to the next cohort. pk data from all available cohorts will be used to guide the dose-escalation decisions.

Eligibility criteria:
major inclusion criteria: * healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening. * body mass index (bmi) ≥ 18 and ≤ 30.0 kg/m2 at screening. * medically healthy with no clinically significant finding in medical history, physical examination, laboratory profiles, vital signs, or ecgs, as judged by the pi or designee. creatinine must be within the upper limit of normal at screening. * understands the study procedures in the informed consent form (icf), and is willing and able to comply with the protocol. major exclusion criteria: * is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * history or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease. * history of any illness that, in the opinion of the pi or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. * history of clinically significant hypotension. * history of lightheadedness, dizziness or syncope in the 12 months prior to screening.
phase i open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide (revlimid®, cc-5013) with pemetrexed in subjects with advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: study will deteremine the mtd and evaluate the safety profile of oral lenalidomide on days 1-14 when combined with pemetrexed on day 1 of a 21 days cycle. subjects will continue on study until documention of disease progression.


Eligibility criteria:
inclusion criteria: 1. subjects must understand and voluntarily sign an informed consent document. 2. age \>or= 18 years at the time of signing informed consent form. 3. subjects must be able to adhere to the study visit schedule and other protocol requirements. 4. histological or cytologic documentation of advanced nsclc. 5. radiographic or clinical evidence of measurable advanced nsclc. subjects must have measurable disease at least 2 cm in diameter. 6. subjects must have been treated and progressed following chemotherapy. 7. ecog performance status of 0 or 1 (appendix i: ecog performance status scale). 8. women of childbearing potential (wcbp) must have a negative serum or urine pregnancy test within 7 days of starting study drug. in addition, sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. exclusion criteria: 1. any of the following laboratory abnormalities: 1. absolute neutrophil count (anc) \<1,500 cells/mm3 (1.5 x 109/l) 2. platelet count \<100,000 cells/mm3 (100 x 109/l) 3. serum creatinine \>1.5 mg/dl (133 mmol/l) 4. serum sgot/ast or sgpt/alt \>3.0 x upper limit of normal (uln) 5. serum total bilirubin \>or = 1.5 mg/dl (26 mmol/l) 2. any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent. 3. prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> 1 year. 4. known brain or leptomeningeal disease (ct scan or mri of the brain required only in case of clinical suspicion of central nervous system involvement). 5. more than one prior chemotherapy for advanced nsclc. 6. concurrent use of any other anti-cancer agents. 7. any prior use of lenalidomide. 8. pregnant or lactating females. 9. prior \> or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide. 10. prior \> or = to grade 3 allergic reaction/hypersensitivity to thalidomide. 11. use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy. 12. known hepatitis c.

Keywords: cc-5013 non small cell lung cancer revlimid celgene cc5013
gcf mirna-223 , -214 levels in smokers and nonsmokers periodontitis patients

Conditions: Periodontitis, Adult

Summary: objective: periodontitis is a multifactorial disease that affects a wide range of populations. however, its pathogenesis remains unclear. mirnas are now considered potential diagnostic markers for many inflammatory diseases. thus, the aim of this study was to assess the expression of microrna-223(mirna-223) and microrna-214 (mirna-214) in gingival crevicular fluid (gcf) of smoker and nonsmoker with periodontitis. materials and methods: we conducted a prospective study among 42 participants: 14 healthy controls, 14 nonsmoker periodontitis participants, and 14 smoker with periodontitis. eligibility criteria for inclusion were consecutive adults, aged 20-60 years, with stage iii periodontitis grade b/c and no systemic diseases. all consenting participants had gingival crevicular fluid samples collected after diagnosis to assess mirna-214 and -223 by quantitative real-time polymerase chain reaction assay.


Eligibility criteria:
inclusion criteria: * both genders * age from 20 to 60 years * no more than 4 teeth lost due to periodontitis * systemically free participants exclusion criteria: * pregnant or lactating female * participants with a history of an inflammatory or immunological disease * history of any current medication

Keywords: periodontitis microrna smoking gcf biofluids
biopoly rs knee registry study for cartilage defect replacement

Conditions: Cartilage Injury; Defect of Articular Cartilage; Cartilage Damage

Summary: information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the biopoly rs partial resurfacing knee implant, a permanent orthopaedic implant. the overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.

information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the biopoly rs partial resurfacing knee implant, a permanent orthopaedic implant. the overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device. patients will be followed for 5 years after surgery.

Eligibility criteria:
inclusion criteria: * cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical) * lesion classified as icrs grade 2, 3, or 4 exclusion criteria: * body mass index (bmi) of 30 or more * osteoarthritis or rheumatoid arthritis * gout * uncorrected mal-alignment, ligamentous instability, or meniscal tear * total meniscectomy * kissing lesion on tibia

Keywords: focal defect focal lesion chondral lesion osteochondral lesion