Kornimate/medical-research-clean huggingface dataset:
quality of life and economic repercussions of combining proactive medication assessment and electronic monitoring of toxicities in subjects undergoing oral cancer therapy

Conditions: Cancer

Summary: therapies used to treat cancer are administered orally (ot) in 75% of cases, lending themselves to outpatient care. this care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital. drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. detection of drug interactions before treatment initiation is not always performed in routine practice. however, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (qol). they are classically documented by the physician at the time of the consultation using the common terminology criteria for adverse events (ctcae), which makes it possible to adapt management. nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient. studies have shown an improvement in the overall survival and qol of patients followed by electronic patient reported outcomes (epro) compared to patients followed conventionally. therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by epros on the qol of patients treated with oral therapies in oncology and to estimate the economic impact.


Eligibility criteria:
inclusion criteria: * patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer * patient able to use a connected electronic object * patient with a smartphone/tablet or computer with internet access and an email address. * patient with who status ≤2 * patients receiving other cancer therapy concurrently with oral therapy may be included * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan exclusion criteria: * the subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient pregnant, parturient or breast feeding * illiterate patient * patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.) * patient receiving hormone therapy alone for breast or prostate cancer
a safety and efficacy study of botulinum toxin type a (botox®) to treat urinary incontinence due to neurogenic detrusor overactivity or overactive bladder in korean patients

Conditions: Urinary Incontinence; Overactive Bladder

Summary: this is a safety and efficacy study of botox® (botulinum toxin type a) in the treatment of adult korean patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.


Eligibility criteria:
inclusion criteria: * urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder exclusion criteria: * myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis * use of botulinum toxin therapy of any serotype in the 3 months prior to screening * has acute urinary retention who do not routinely perform clean intermittent self-catheterization (cic)
study evaluating epidemiology of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in australia

Conditions: Ankylosing Spondylitis; Psoriatic Arthritis; Rheumatoid Arthritis

Summary: the study is a cross sectional, epidemiology study of disease severity for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in australia (illawarra, sutherland, hunter urban and hunter rural).


Eligibility criteria:
inclusion criteria include: adult patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who have visited a primary care centre within one of the specified catchment areas for their condition within the last 24 months.
pharmacokinetics of rifabutin combined with antiretroviral therapy in patients with tb/hiv co-infection in south africa

Conditions: HIV Infections; Tuberculosis

Summary: the overall aim of the project is to evaluate rifabutin (rbt) as a replacement for rifampicin (rmp), for the combined treatment of tuberculosis and hiv infection. rbt represents an alternative to rmp for hiv infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (art) drugs. this phase ii trial is to determine precisely the pharmacokinetics parameters of rbt in combination with different art regimens in vietnamese hiv infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase iii trial comparing safety, tolerability and efficacy of rbt and rmp regimens.

patients will be offered to participated in the study after the first 6 weeks of the nationally recommended tb treatment. all the enrolled patients will be switched to rifabutin and randomized, two weeks later, to one of the three study arv regimens. the rbt doses will be then adapted to the allocated arv regimen according to a cross over scheme. three full pharmacokinetics profile will be performed at different time point : before initiation of arv, after one month of the first rfb dosage and one month after the second rfb dosage.

Eligibility criteria:
inclusion criteria: * pulmonary tuberculosis (proven by afb positive sputum or culture) * having completed and adhered to 6 wks of intensive phase tb chemotherapy * positive hiv antibody and cd4 count \>50 /mm3 and \<=200 * weight \> 50 kg * no art in the preceding 3 months * no more than 2 weeks or art previously * no grade 3 or 4 clinical or laboratory findings * negative pregnancy test and appropriate contraceptive measures during the duration of the trial for female of childbearing age * having a firm home address that is readily accessible * karnofsky score\>=80% exclusion criteria: * history of tb within the 3 years preceding the presenting episode of tb * previous treatment for mdr tb * concomitant oi requiring additional anti-infectious treatment * formal contraindication to any drug used in the trial * diabetes mellitus requiring drug treatment * recreational drug or alcohol abuse * history of drug hypersensitivity to tb or related medications * interrupted tb therapy for more than 1 week * less than 90% adherent to first 6 weeks of intensive phase chemotherapy * mental illness that could impair ability to give informed consent or result in poor adherence to trial protocol and therapy * neutropenia \ grade 2 * requiring concomitant medications that may potentially interact with study drugs * pregnant or lactating women * karnofsky score \>80% * any condition rendering the patient unable to understand the nature, scope, and possible consequences of thes study and to provide consent

Keywords: hiv tuberculosis rifabutin pharmacokinetics south africa
behavioral counseling intervention trial to reduce alcohol-related sexual risk behavior among hiv-negative men in namibia

Conditions: Alcohol Consumption; Alcohol Abuse; HIV; Sexual Behavior

Summary: the overall purpose of this study is to evaluate an intervention that aims to reduce alcohol-related hiv sexual risk behaviors among hiv-negative men in namibia. the objectives of the study are to determine the effectiveness of an individual counseling intervention in reducing alcohol-related hiv sexual risk behaviors among men, and in reducing harmful and hazardous alcohol use among men.

this study involves a randomized controlled trial of 550 hiv-negative adult men recruited from a single voluntary counseling and testing (vct) center for hiv in windhoek, namibia who report harmful or hazardous alcohol consumption and more than one sex partner in the previous three months. after receiving standard counseling at the vct center, all men who test hiv-negative will be invited to be screened for eligibility for the study, and if eligible, to consent to enroll. personnel hired for the study will then administer a baseline survey via personal digital assistant to all enrolled men. enrolled participants will then be randomized to either an intervention arm, and receive an additional one-hour counseling session and take-home materials plus general alcohol information materials or to a control arm, and receive general alcohol information materials alone. all men enrolled in the study will receive the general alcohol information materials, consisting of a booklet with alcohol health information and a brochure detailing alcohol abuse support services in the local community. men in the intervention arm will also receive two cellphone text messages one month and four months following enrollment to boost the risk reduction counseling. follow-up surveys of all participants will be conducted three months and six months after enrollment outcomes measured include self-reported data at baseline, three months and six months post-enrollment regarding: 1) number, proportion of sex acts preceded by alcohol use; 2) number, proportion of sex acts protected by condoms; 3) number of sex partners; and 4) quantity and frequency of alcohol use; 5) condom use demonstration scores.

Eligibility criteria:
inclusion criteria: * self reported hiv negative status after testing at the council of churches namibia (ccn) newstart vct center * more than 1 sexual partner in the past 6 months * audit screen score 8 to 19 * able to provide informed consent * access to a cell phone to retrieve private text messages and calls * plans to stay in the local area for 6 months * able to verbally communicate in english, oshiwambo, or afrikaans exclusion criteria: * self reported hiv positive status after testing at the ccn newstart vct center * less than 1 sexual partner in the past 6 months * audit screen score less than 8 or greater than 20 * unable to provide informed consent to participate to enroll in the study * unable to retrieve private cell phone text messages and calls * unable to verbally communicate in english, oshiwambo, or afrikaans

Keywords: namibia alcohol hiv sexual risk
exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy

Conditions: Hematoma, Subdural, Chronic

Summary: a prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

chronic subdural hematomas (csdhs) are one of the most common neurosurgical conditions. the goal of surgery is to alleviate symptoms and minimize the risk of symptomatic recurrences. the standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. the drainage is removed after 48 hours, which can be described as fixed-time drainage strategy. according to literature, the recurrence rate is 5-33% with this strategy. in the investigators' retrospective study, postoperative hematoma volume (p=0.001, b=0.028, exp(b)=1.028, 95% ci 1.011-1.046) was found to significantly increase the risk of recurrence. based on these results, an exhaustive drainage strategy may minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes. this is a prospective, multicenter, randomized controlled trial designed to include 304 participants over the age of 18 years presenting with a symptomatic csdh verified on cranial computed tomography or magnetic resonance imaging. after informed consent is obtained, participants are randomly allocated to an exhaustive drainage or fixed-time drainage group. the primary endpoint is recurrence indicating a reoperation within 6 months. secondary outcomes include modified rankin scale, markwalder grading scale, european quality of life-5 dimensions-5 levels (eq-5d-5l), rate of complications, rate of adverse events and effect on comorbidity.

Eligibility criteria:
inclusion criteria: * patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma * chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging * written informed consent from patients or their next of kin according to the patient's cognitive status exclusion criteria: * no clinical symptoms correlating with chronic subdural hematoma * lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons * previous surgery for chronic subdural hematoma during the past 6 months * previous intracranial surgery for any neurological disorders but chronic subdural hematoma before * existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed * severe coagulopathy or high risk of life-threatening bleeding * postoperative cooperation is suspected to be insufficient for follow-up for 6 months * reproductive-age women without verified negative pregnancy testing * participating in other research

Keywords: chronic subdural hematoma fixed-time drainage exhaustive drainage drainage craniostomy urokinase
physical and psychological changes in crps patients undergoing multimodal rehabilitation

Conditions: Complex Regional Pain Syndromes

Summary: the goal of this clinical trial is to learn about cognitive changes during rehabilitation in crps patients. the main questions it aims to answer are: * what are the cognitive changes in crps? * do cognitive functions change during multimodal rehabilitation in crps? * what is the effect of multimodal rehabilitation on pain, functioning, mood, active range of motion, cognitive functions. participants will undergo a 4-week program of multimodal rehabilitation of physical therapy, education and graded motor imagery. assessment will be made at baseline and after 4 weeks. researchers will compare the interventional arm with healthy control to see if the observed psychological results are exclusive to crps group. there is no expanded access scheduled for this study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of crps (or equivalent); * mmse \>24 points; * has signed an informed consent to the study. exclusion criteria: * mmse ≤24 points; * inability to perform scheduled tasks (multimodal rehabilitation program).

Keywords: crps cognitive functions physical therapy pain graded motor imagery mirror therapy rehabilitation
gemcitabine in treating patients with recurrent or refractory bladder cancer

Conditions: Bladder Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving the drugs in different ways may kill more tumor cells. purpose: phase i trial to study the effectiveness of gemcitabine given directly into the bladder in treating patients who have recurrent or refractory bladder cancer.

objectives: i. determine the maximum tolerated dose of intravesical gemcitabine in patients with recurrent or refractory superficial bladder cancer. ii. determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. iii. assess any responses in patients treated with this regimen. outline: this is a dose-escalation, multicenter study. patients receive intravesical gemcitabine that is left in the bladder for 2 hours and then removed on day 1. treatment continues every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 3-36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed stage tis, ta, or t1 bladder carcinoma no stage b1 disease or greater no locally invasive or metastatic disease by ct or mri no upper urinary tract disease measurable persistent or recurrent superficial disease after standard treatment with intravesical bcg stage tis disease must fail second course of bcg if complete response achieved with first course of bcg prior maximal transurethral resection high-grade t1 or tis disease must be ineligible for cystectomy patient characteristics: age: 18 and over performance status: ecog 0-1 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl ast no greater than 2 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl other: not pregnant negative pregnancy test fertile patients must use effective contraception for 1 week prior to, during, and for at least 2 weeks after study no active bacterial infection requiring treatment with antibiotics prior concurrent therapy: biologic therapy: see disease characteristics at least 4 weeks since prior immunotherapy chemotherapy: prior intravesical chemotherapy allowed at least 4 weeks since prior chemotherapy endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy no prior radiotherapy to bladder surgery: see disease characteristics at least 2 weeks since prior transurethral resection of the bladder/bladder biopsy

Keywords: stage 0 bladder cancer stage i bladder cancer recurrent bladder cancer
the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting disease.

Conditions: Length of Stay; Postoperative Complications; Morality

Summary: to assess the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting diseases, the investigators designed a prospective cohort study. the investigators will recruit 250 patients preparing to undergo a selective epigastrium surgery with coexisting medical diseases which need an anesthetic consultation. the patients will be randomly assigned into two groups. the intervention group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. no additional interventions will be given during and after surgery. the length of stay, hospitalization expense, postoperative complication rate and mortality rate of the two groups will be compared. the investigator assume that consultation in preoperative assessment clinic will improve the prognosis and decrease the hospitalization expenses.


Eligibility criteria:
inclusion criteria: * patients preparing to undergo a selective epigastrium surgery * patients with coexisting medical diseases needing an anesthetic consultation * over 60 years old * asa ii-iii * patients with good compliance exclusion criteria: * patients ubdergoing emergency operation * asa i, iv * patients under 60 years old * patients with bad compliance
study of impact of not measuring residual gastric volume on nosocomial pneumonia rates

Conditions: Ventilation-Associated Pneumonia

Summary: early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. however, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (vap). many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and vap. routine monitoring of residual gastric volume (rgv) to minimize the risk of aspiration is standard practice. rgv is assumed to reflect gastric content, with high rgvs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.however, rgv measurement is neither standardized nor validated. the cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. no data are available to support a correlation between rgv and the rates of adverse events. in experimental studies, rgv failed to correlate with vomiting, aspiration, or vap. the investigators hypothesize that rgv monitoring fails to decrease the risk of vap and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. to assess the effects of not measuring rgv on vap and enteral feeding delivery, the investigators designed a prospective randomized controlled study.


Eligibility criteria:
inclusion criteria: * treatment with invasive mechanical ventilation * feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation. * age over 18 years * informed consent exclusion criteria: * mechanical ventilation started more than 36 hours before institution of enteral feeding * patients turned in the prone position at inclusion * abdominal surgery within 1 month before inclusion * history of esophageal or gastric surgery * en via a gastrostomy or a jejunostomy * bleeding from esophagus, stomach or bowel * moribund patient * age less than 18 years * pregnancy. * no informed consent.

Keywords: mechanical ventilation enteral nutrition ventilation-associated pneumonia residual gastric volume measurement vomiting gastro-oesophageal reflux early enteral nutrition intensive care unit enteral feeding
propionic acid in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (ms).

this is a single-center, double-blinded, randomized trial. one hundred multiple sclerosis (ms) patients will be randomly assigned in a 2:1 ratio to receive either 100 mg of propionic acid or a placebo over a period of 90 days. outcome measures will encompass nfl and gfap levels, fatigue scores, quality of life assessments, and physical examinations. additionally, subgroup analysis will involve the evaluation of mri and meg data.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis (ms) * clinically and radiologically stable ms in the previous 3 months * age between 18 and 60 years * positive finding for oligoclonal bands (ocbs) * written consent * blood collection at the beginning and end of the study for routine parameter examination as well as sample preservation (especially for measuring propionic acid levels) * negative pregnancy test for female participants of childbearing age exclusion criteria: * existing propionic acid supplementation * change in disease-modifying therapy (dmt) in the previous 4 weeks * existing severe systemic diseases * presence of other concomitant structural nerve diseases (e.g., polyneuropathy, brain tumor, strokes) * high jcv titer under natalizumab

Keywords: multiple sclerosis propionic acid progression disability fatigue