Kornimate/medical-research-clean huggingface dataset:
temporary peripheral nerve stimulation system for osteoarthritis of the knee

Conditions: Osteoarthritis, Knee; Osteoarthritis

Summary: the purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.


Eligibility criteria:
inclusion criteria: * age of 21 and older * will receive a temporary pns system for the management of chronic knee pain secondary to osteoarthritis * be capable of subjective evaluation, able to read and understand english-written questionnaires, and able to read, understand and sign the written informed consent in english * be willing and capable of giving informed consent * be willing and able to comply with study-related requirements, procedures, and scheduled visits exclusion criteria: * no knee pain at rest * same nerve targeted for both radiofrequency ablation (rfa) and peripheral nerve stimulation (pns) in less than 6 months post rfa, if applicable * pregnancy * history of repetitive skin infections * vulnerable populations (e.g., prisoners, minors, students, employees) * any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled diabetes) * confounding conditions such as lumbar radiculopathy * deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the sprint system. * be involved in an injury claim under current litigation * be a recipient of temporary social security disability insurance (ssdi) benefits due to chronic pain * have a pending or approved worker's compensation claim

Keywords: peripheral nerve stimulation pns
interest of the chair lift test in the prognostic evaluation of pulmonary embolism: a single-center open prospective study

Conditions: Non-severe Pulmonary Embolism

Summary: the objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current pulmonary embolism risk stratification score using the spesi score refined by the use of cardiac biomarkers and right ventricular dysfunction


Eligibility criteria:
inclusion criteria: * diagnosis of pulmonary embolism according to clinical algorithm, confirmed by thoracic angioscan or ventilation perfusion (v/p) scan, * non-serious pulmonary embolism, not requiring intensive care (thrombectomy or fibrinolysis not considered). * spesi score ≥ 1 \[or = 0 with elevated troponin or presence of markers of vd dysfunction, or = 0 with need for hospitalization due to comorbidities unrelated to pe (social isolation, comprehension disorders, intercurrent infection, chronic renal failure, advanced cancer...) * patients with no contraindications to chair lift testing (no o2 at the time of testing). * effective anticoagulation for at least 1 hour. exclusion criteria: * spesi score = 0 with outpatient referral. * diagnostic confirmation of pulmonia embolism by thoracic angioscan or scintigraphy more than 24h after suspicion of diagnosis. * hospitalization \> 24h after introduction of anticoagulation, with subsequent confirmation by scintigraphy. * any sign of serious pulmonia embolism, requiring hospitalization in an intensive care unit. * asymptomatic pulmonia embolism discovered by chance
retrospective data review of recap total hip resurfacing

Conditions: Osteoarthritis of the Hip

Summary: retrospective data review on clinical outcomes and survivorship of recap total hip resurfacing


Eligibility criteria:
inclusion: * patients received recap total hip resurfacing
transtympanic gentamicin vs. steroids in refractory meniere's disease

Conditions: Meniere's Disease

Summary: this trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral meniere's disease.

meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. in one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. for these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. major surgery of the balance organs or nerve, risking complete hearing loss, csf leak, meningeal infections, are rarely performed nowadays. gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. as hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. in fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. on the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. they are non toxic drugs without any known side effects during local treatment in ear. we will compare the two in this randomised, double blind trial.

Eligibility criteria:
inclusion criteria: * patients with unilateral ménière's disease (definite or probable, according to committee on hearing and equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. there should be normal, age appropriate hearing in the contralateral ear. exclusion criteria: * patients with ménière's disease in later stages (not having vertigo attacks). * age: patients older than 70 years at the start of the trial. * severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up. * active additional neuro-otological disorders that may mimic ménière's disease (e.g. vestibular migraine, vertebro-basilar tias, acoustic neuroma) and thus will make the objective follow up difficult. * concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease). * family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity). * history of known adverse/allergic reaction to steroids or gentamicin.

Keywords: meniere's disease transtympanic steroids randomised controlled trial
validation of self-administered questionnaire for assessing calcium intake in patients with multiple sclerosis or chronic inflammatory arthritis

Conditions: Multiple Sclerosis; Rheumatoid Arthritis

Summary: the main objective of this study is to measure, in patients with ms or chronic inflammatory arthritis (cia), the correlation between two calcium intake assessment methods: a self assessment questionnaire of calcium intake (qalcimum®) versus a food survey serving as a reference (gold standard) and based on data from ciqual \*. \* ciqual data: nutritional food composition table available on the website of the anses (national agency for sanitary security of food, environment and labour), published by the observatory of the nutritional quality of foods. this table includes 1500 sheets of 58 nutritional components. the data is integrated into the software (datameal) for calculating the ingesta parameters at the nîmes university hospital.

the secondary objectives of this study are: a. to estimate the average calcium intake and variability in a population of ms patients and the proportion of patients at risk for osteoporosis. b. to estimate the average calcium intake and variability in a population of cia patients and the proportion of patients at risk for osteoporosis. c. to describe the dietary changes observed in ms or cia patients . d. to estimate the administration time of the qalcimum® self-questionnaire. e. estimate calcium intake means and variability in a population of patients with ms or cia and the proportion of patients at risk of osteoporotic fracture f. to assess the quality of life of patients with ms or cia g. to evaluate endogenous mean vitamin d production in a population of patients with ms or cia

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * patient with confirmed diagnosis of multiple sclerosis or chronic inflammatory arthritis (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) exclusion criteria: * the patient is participating in another biomedical research study * the patient has participated in another biomedical research study in the past 3 months * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, or under guardianship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the subject is not able to complete a self-administered questionnaire
assessment of the anesthetic effect on the activity of immune cell in patient with breast cancer

Conditions: Breast Cancer

Summary: anesthetics agents has variety inflammation during the cancer surgery. this perioperative inflammation can influence to cancer metastasis or recurrence. the purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

the patients were allocated randomly to receive propofol or sevoflurane. also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order. 1. immediate before anesthesia induction 2. postoperative 1 hours 3. postoperative 24 hours serum in blood will be obtained and activity of helper t cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Eligibility criteria:
inclusion criteria: * patient who was planned to undergo colon cancer surgery. exclusion criteria: * age \< 20 years old * history of hypersensitivity reaction in propofol or sevoflurane * history of previous cancer * patient with ongoing inflammation
stn-dbs and the risk of sialorrhea

Conditions: Parkinson Disease

Summary: objective: the aims of this study were to assess the incidence rate and risk factors for sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced parkinson's disease \[84 with deep brain stimulation (dbs) and 86 on medical treatment\]. design, setting, and participants: this study was a multi-center prospective non-randomized concurrent clinical trial. a total of198 persons with parkinson disease were referred for dbs between june 2019 and july 2021 and analyzed between june 2023 and july 2023.the primary outcome follow-up visit was conducted 36 months after dbs.

importance: sialorrhea is a frequent and disabling symptom in patients with pd. no prospective study has been specifically designed to test the effects of dbs on sialorrhea development. objective: the aims of this study were to assess the incidence rate and risk factors for sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced parkinson's disease \[84 with deep brain stimulation (dbs) and 86 on medical treatment\]. design, setting, and participants: this study was a multi-center prospective non-randomized concurrent clinical trial. a total of198 persons with parkinson disease were referred for dbs between june 2019 and july 2021 and analyzed between june 2023 and july 2023.the primary outcome follow-up visit was conducted 36 months after dbs. interventions: bilateral subthalamic nucleus dbs was performed in one study arm and not performed in the other. both arms of the study completed the drooling rating scale (drs), the drooling severity and frequency scale (dsfs) and examination of salivary secretion rate. main outcomes and measures: the primary outcome was the drs scores of the patients with pd, with or without stn-dbs 36 months postoperatively. the secondary outcomes included the dsfs scores, saliva secreting rate, ratio of botox injection in different group.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease * age between 20 and 80 years * without drooling * swallowing function \<5 on the drooling rate scale (drs). * medications affecting drooling had to have stopped medications at least 4 weeks before study entry. exclusion criteria: * not he typical pd * subjects on warfarin, * with significant medical illnesses or neuromuscular transmission disorders * past use of bont * -cognitive impairment (\<23/30 on mini mental status exam) were excluded.

Keywords: deep brain stimulation sialorrhea
drug interactions between morphine and orally or iv administered acetaminophen

Conditions: Pain

Summary: morphine is the opioid used to treat pain after surgery. acetaminophen (called apap) can reduce the amount of opioids needed for this. the problem is that morphine slows down digestion. that can delay pain relief from apap pills. it can even change what the body does to the drug \[pharmacokinetics (pk)\]. some doctors have started using intravenous (iv) apap with morphine, instead of the pills. this study will measure the pk of apap pills and iv when used with morphine in healthy volunteers. iv apap will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.

acetaminophen can significantly reduce the use of opioid analgesics when both are used concomitantly for treating moderate to severe pain. the use of iv acetaminophen used concomitantly with opioids has increased in practice for postsurgical pain relief over orally administered acetaminophen because it provides an immediate peak plasma concentration and is believed to provide a faster analgesic effect. opioids used to treat pain inhibit gastrointestinal motility, including delaying gastric emptying. in patients receiving opioids the absorption of orally administered acetaminophen may be delayed and could result in gastric accumulation of acetaminophen thereby markedly changing the pharmacokinetic profile. the opioid-induced inhibition of gastrointestinal motility would not be expected to affect iv acetaminophen pharmacokinetics. thus coadministered iv acetaminophen with opioid would yield better outcome in efficacy and reduced risk of side effects comparing with coadministration of oral acetaminophen and opioids.

Eligibility criteria:
inclusion criteria: 1. subject must have a health status of "healthy" assessed by the investigator and defined as no clinically significant deviation from normal medical history, physical examination, vital signs, and clinical laboratory determinations. 2. subject must have a body mass index ≥ 19.0 and ≤ 32.0 kg/m² with a minimum weight of 110 pounds (50 kg) at screening. exclusion criteria: 1. subject has a positive test result for human immunodeficiency virus (hiv), hepatitis b (surface antigen), or hepatitis c virus antibody at screening. 2. subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine/opioids or to any of the excipients in the iv or oral formulations used. 3. subject has an oxygen saturation of less than 95% while awake at screening and check-in. 4. subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine) or alcohol at the screening and check-in. 5. subject has donated or had significant loss of whole blood (480 ml or more) within 30 days, or plasma within 14 days prior to dosing. 6. subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Keywords: post-surgical pain pharmacokinetics
subconjunctival bevacizumab effect on bleb vascularity

Conditions: Bleb Vascularity; Bleb Fibrosis; Trabeculectomy Failure

Summary: trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out. a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.

trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out. a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure. during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.

Eligibility criteria:
inclusion criteria: * post uneventful trabeculectomy with mitomycin c application during surgery * adult exclusion criteria: * usage of 5-fluorouracil in trabeculectomy * post-operative complications * ischemic heart disease * s/p cerebrovascular accident * allergy to bevacizumab

Keywords: bevacizumab subconjunctival injection trabeculectomy bleb mitomycin c
a phase i study of three doses of opc-8212 (vesnarinone) in hiv-infected persons with cd4+ cell number > 300 cells/mm3

Conditions: HIV Infections

Summary: to examine the safety and tolerance of three doses of oral vesnarinone in hiv-infected patients with cd4 count \> 300 cells/mm3.

twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. at least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * chemoprophylaxis for pneumocystis carinii, candida, mycobacteria, and herpes simplex. patients must have: * asymptomatic hiv infection. * cd4 count \> 300 cells/mm3. * no prior aids-defining illness or current constitutional symptoms of hiv disease. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * current history of cardiac disease, including patients who exhibit long qt syndrome on ekg screening. * active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix. concurrent medication: excluded: * antiretroviral agents, including ddi, ddc, and azt. * immunosuppressive agents. * investigational hiv drugs/therapies including vaccines. * interferon. * steroids (other than topical). * hematopoietins. * megestrol acetate. * trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. * cytotoxic chemotherapy. concurrent treatment: excluded: * radiation therapy. patients with the following prior conditions are excluded: * prior history of cardiac disease. * history of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function. prior medication: excluded: * azt, ddi, and ddc within 14 days prior to study entry. * prior cytotoxic chemotherapy. prior treatment: excluded: * radiation therapy (including electron beam irradiation) within 30 days prior to study entry. active illicit drug abuse.

Keywords: vesnarinone
study of breakthrough cancer pain: assessment of fentanyl buccal tablets titration and treatment in opioid-tolerant patients

Conditions: Cancer Pain; Breakthrough Pain

Summary: breakthrough cancer pain (btcp) is a common problem in patients with cancer. fentanyl buccal tablet (fbt) is used for the treatment of btp in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. fbt treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. to reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. the aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective fbt dose after titration starting with either a 100 mcg dose or a 200 mcg dose.


Eligibility criteria:
inclusion criteria: * the patient is willing to provide written informed consent to participate in this study. * the patient can be either an out-patient or an in-patient. * the patient has a histologically documented diagnosis of cancer. * the patient has stable background pain due to cancer. * the patient experiences up to 4 btcp episodes per 24 hours. * as maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug. * women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study. * the patient must be willing and able to successfully self-administer the study drug and to fill in study documents. exclusion criteria: * the patient is without maintenance opioid therapy. * the patient has uncontrolled or rapidly escalating pain as determined by the investigator. * the patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug. * the patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression. * the patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. * the patient is expected to have surgery during the study. * the patient is pregnant or lactating. * the patient has participated in a study involving an investigational drug in the prior 30 days. * the patient has received a monoamine oxidase inhibitor (maoi) within 14 days before the first treatment with study drug. * the patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.

Keywords: breakthrough cancer pain