Kornimate/medical-research-clean huggingface dataset:
abdominal surgery study of gsk576428 (fondaparinux sodium)in japanese patients

Conditions: Venous Thromboembolism

Summary: this study is phase 3 study for prevention of vte in patients with abdominal surgery.


Eligibility criteria:
inclusion criteria: * patients aged \>=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes. * general or urologic surgery * cancer surgery * gynecologic surgery * radical surgery for pelvic malignancy exclusion criteria: * active, clinically significant bleeding thrombocytopenia body weight \<40kg

Keywords: fondaparinux abdominal surgery japanese vte
use of fact-gog/ntx questionnaire in peripheral neurotoxicity & validation of a french version of this questionnaire

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms

Summary: validation of a french version of fact-gog/ntx and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with epo.


Eligibility criteria:
inclusion criteria: * femal patient aged \> 18 years * histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneal * patients whose disease progresses or relapses * patients having received at least a line of platinum-based chemotherapy * patients whose treatment of relapse is envisaged to comprise paclitaxel * patients who will receive epo for treatment of their anaemia * ecog performans status \< 2 * life expectancy \> 16 weeks * patient who has clearly given her consent by signing on informed consent form prior to participation exclusion criteria: * peripheral neuropathy grade \> 2 * history of ischemic cardiopathy, congestive heart failure (nyha\>2), arrhythmia, hypertension or significant valvulopathy * abnormal biological values * a therapy or a serious disease which could involve a risk for the patient or interfere with the aims of the study * patient who is pregnant, breast feeding or using inadequate contraception * concomitant therapy by a potentially neurotoxic drug * concomitant inclusion in another therapeutic trial which could interfere with the aims of the study * patient who for familial, sociological, geographical or psychological condition could not be followed correctly

Keywords: peritoneal cancer relapse or progression
long term follow-up of post neck pain patients accompanying ossification of posterior longitudinal ligament treated with integrated complementary and alternative medicine: observational study

Conditions: OPLL; Medicine, Korean Traditional

Summary: the purpose of this study is to reveal the effectiveness and safety of integrative korean medicine for ossification of posterior longitudinal ligament(opll) by observation inpatients treated with integrative korean medicine. this study is a prospective observational study. the subjects for study are patients diagnosed with opll and who have been admitted to four jaseng hospital of korean medicine (gangnam, bucheon, daejeon, and haeundae) for 2016.04.01-2019.12.31. medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. the survey questions are numeric ratinc scale (nrs), vernon-mior neck disability index (ndi), quality of life, and patient global impression of change (pgic), etc.


Eligibility criteria:
inclusion criteria: * patients diagnosed with opll by c spine x-ray or mri or ct * paithents who was admitted to jaseng hospital of korean medicien. * patients have agreed to participate the study. exclusion criteria: * patient hospitalized under 3 days * patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on) * patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, fibromyalgia, rheumatoid arthritis, gout, and so on) * patients had cervical spinal surgery within 3 months * patients diagnosed with c spine fracture by c spine x-ray or mri or ct * patients deemed unable to participate in the clinical research by other researchers * patients haven't agreed to participate the study.

Keywords: acupuncture therapy herbal medicine
optimizing rural community health through dementia detection and care

Conditions: Alzheimer' Disease

Summary: the overall goal of this one-year study is to test a comprehensive protocol for alzheimer's disease and related dementias (adrd) diagnosis and care management that can be used as a model for rural communities, which experience low rates of dementia diagnosis and treatment.

the orchid study integrates 1) a one-group community educational intervention focused on increasing community awareness of brain-health promoting behaviors and dementia literacy and knowledge; and 2) a primary care provider dementia educational intervention designed to improve provider knowledge and confidence in detecting, diagnosing, and treating patients with cognitive impairment, with the goal of increasing adrd diagnosis and treatment rates, reducing dementia-related hospitalization rates, increasing utilization of available local support services, and improving caregiver-related outcomes. the community education intervention is a 6-week culturally-relevant educational program focused on brain health promotion. effects of the community intervention on dementia knowledge and literacy will be assessed with a pre-post analytic approach using paired t-tests to compare changes in mean ad knowledge and literacy. the provider dementia educational intervention uses a cluster-randomized trial design with participating primary care provider offices randomly assigned to either receive the intervention (arm a) or the control group (arm b). providers assigned to arm a receive an educational intervention that includes training in adrd detection, diagnosis, and care management. providers assigned to arm b do not receive educational intervention. both groups receive the following: detailed reports from neuropsychological testing performed by a study clinician, hands-on training of provider office staff on dementia screening tools, and support with referrals to local support services. the two study groups (arms a and b) will be compared on: 1) change in provider dementia knowledge and confidence, caregiver burden and self-efficacy; and 2) rates of dementia diagnosis and treatment, rates of dementia-related hospital admissions, and rates of referral to support service. a generalized linear mixed model analytic approach will be used to assess the effect of the provider intervention on study outcomes.

Eligibility criteria:
inclusion criteria: * aged 50 years and older * lives in the glades area of florida * lives in the community/ be non-institutionalized * has no known diagnosis of alzheimer's disease and related dementias * speaks either english, spanish, or creole * has no known plans to move out of the glades area in the next 12 months exclusion criteria: * previous diagnosis of a dementia-related illness * aged under 50 years

Keywords: rural multicultural early detection multidisciplinary
study of treatment of antiretroviral-naive, hiv-1-infected patients comparing tenofovir disoproxil fumarate administered in combination with lamivudine and efavirenz vs. stavudine, lamivudine and efavirenz.

Conditions: HIV Infections

Summary: to compare tenofovir df plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of hiv-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/ml at week 48.

to compare the two treatment groups with the goal of achieving hiv-1 rna levels less than 50 copies/ml at week 48. to compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. to evaluate the long-term efficacy, safety and tolerability of tenofovir df in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.

Eligibility criteria:
inclusion criteria: * completed the original 96-weeks of open-label treatment. willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drugs completion. the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures related to the second 96-week open-label phase extension. exclusion criteria: * patients requiring therapy with any of the following: nephrotoxic agents (aminoglycoside antibiotics, iv amphotericin b, cidofovir, cisplatin, foscarnet, iv pentamidine, oral and iv vancomycin, oral and iv ganciclovir, other agents with significant nephrotoxic potential);probenecid; systemic chemotherapeutic agents; systemic corticosteroids; interleukin-2 (il-2); investigational agents (except on approval by gilead sciences); drugs that interact with efavirenz (astemizole, terfenadine, dihydroergotamine, ergotamine, midazolam, triazolam, cisapride, rifampin, ergonovine, methylergonovine, voriconazole). administration of any of the listed medications is not allowed throughout the duration of the study period. * pregnant or lactating patients. * evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication. * current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance. * malignancy other than cutaneous kaposi's sarcoma (ks) or basal cell carcinoma. patients with biopsy-confirmed cutaneous ks are eligible, if they are not anticipated to require systemic therapy during the study. * active, serious infections(other than hiv-1 infection) requiring parenteral antibiotic therapy. * any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.

Keywords: hiv antiretroviral treatment experienced hiv-1
bortezomib-melphalan conditioning regimen vs melphalan for frontline transplant eligible patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: phase iii multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.


Eligibility criteria:
inclusion criteria: * must have results from their initial diagnosis available at the time of screening to confirm all the following : 1. diagnosis of multiple myeloma according to the diagnostic 2. symptomatic de novo multiple myeloma * be eligible for high-dose therapy with autologous stem cell transplantation * autologous cell graft with a total number of cd 34 cells \> or = 5 x 106/kg before freezing exclusion criteria: * progressive disease * females participants pregnant or breast-feeding * a known infection by the human immunodeficiency virus * an active viral hepatitis b or c * unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure nyha class iii or iv angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker * uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment * a history of another malignancy. if cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator * a significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment
efficacy and safety of fosrenol in treating elevated serum phosphate levels in adults with end stage renal disease

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.


Eligibility criteria:
inclusion criteria: * patients with esrd who currently require treatment for hyperphosphatemia exclusion criteria: * female patient who is pregnant or lactating * patient has used any investigational product within 30 days of screening
stroke and pmsi (medicalisation information systems programm)

Conditions: Stroke

Summary: evaluation of the sensitivity and specificity of pmsi to identify the burden of stroke in france,from 2500 cases


Eligibility criteria:
inclusion criteria: * diagnosis of stroke in the hospital activity board exclusion criteria: * none
prospective randomized study of sils versus cls for rectal cancer

Conditions: Rectal Cancer; Adenocarcinoma

Summary: background: single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. however, the feasibility of this procedure in rectal surgery has not been determined yet. the aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery. design: randomized, prospective clinical study patients: 40 patients


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age. * asa i-iii. * tumor-location: maximum 15 cm from the anal verge. * no involvement of neighbouring organs. * no distant metastasis. exclusion criteria: * linguistic, physical or psychological barriers precluding oral and written consent. * history of intestinal surgery (excl. appendectomy).
new robotic assistance system for spinal fusion surgery

Conditions: Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Spondylosis

Summary: the main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the aqrate robotic assisted system during the spinal fusion surgery

based on the literature review of similar devices and on the pre-clinical tests performed with the aqrate system on bench and cadavers, the study is build around the following hypothesis: 1. the design and principle of operation of the aqrate system permits a correct integration in the surgical procedure flow thus enabling the surgeon to benefit from its advantages while not generating any additional operational difficulties 2. the stability and ease of use of the device will permit the surgeon to achieve any planned spinal fusion without requiring additional assistance from the medical staff compared to a conventional spinal fusion surgery. 3. a spinal fusion surgery procedure that is performed with the use of the aqrate system is similar to conventional spinal fusion surgery. if correctly used, no additional adverse event should be observed. 4. the exposure to x-ray should decrease as the need of intraoperative recheck of pedicle screws placed should be reduced 5. the precision of placement of pedicle screw should not be adversely affected by the use of the system compared to conventional spinal surgery.

Eligibility criteria:
inclusion criteria: * adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery, * primary spinal surgery (it is the first surgery on this patient's spine) * patient is capable of complying with study requirements, and * patient is willing to provide a signed informed consent. exclusion criteria: * pregnancy and lactation * simultaneous participation in other clinical studies * infection or malignancy * previous spondylodesis * previous spinal surgical procedures * neurologic diseases (e.g. charcot-marie tooth, guillain-barre syndrome, cerebral palsy, neurofibroma) * spinal cord abnormalities with any neurologic symptoms or signs * paraplegia * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study. * patient cannot follow study protocol, for any reason * patient cannot or will not sign informed consent * patients in emergency situation, are not legally competent, cannot understand the situation, * pediatric patients

Keywords: robotic spinal fusion surgery
development and evaluation of a therapeutic education intervention in prostate cancer patients treated with radical prostatectomy to improve their sexuality

Conditions: Prostate Cancer

Summary: prostate cancer is the most common cancer in france (54,000 cases in 2011). about 20,000 radical prostatectomies (pr) per year are performed. despite the progress of pr over the past 20 years, the rate of erectile dysfunction post pr varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections. there is currently no validated post-prostatectomy rehabilitation protocol. the associations of patients, including the national association of prostate cancer patients have a very strong demand for treatment of sexual problems after treatment.


Eligibility criteria:
inclusion criteria: patients treated in urology consultation at the university hospital of lyon sud or edouard herriot: * aged over 18 * presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips. * affiliated to a social security scheme. * and having been informed and given informed consent to participation in the program. exclusion criteria: * refusal of participation, signature of consent, * protected major patients, under guardianship or curators. * patients unable to understand the course of the study * patient with a documented history of cognitive or psychiatric disorders.

Keywords: prostatectomy
an evaluation of leo 138559 in adults with moderate to severe atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: this is a clinical study in adult participants with moderate to severe atopic dermatitis (ad). the purpose of the study is to test a new medicine (leo 138559) given by injection to see if it works to treat ad and what the side effects are when compared with a placebo injection with no medical ingredient. the study will last up to 36 weeks for each participant. the study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. the participants will regularly visit the clinic for tests and the study doctor will evaluate their ad. the participants will also be asked to answer questions about their ad symptoms and quality of life.


Eligibility criteria:
inclusion criteria: * 18-64 years old (both included) at screening. * diagnosis of atopic dermatitis (ad) (as defined by the american academy of dermatology consensus criteria) that has been present for ≥1 year prior to screening. * subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable. * eczema area and severity index (easi) score ≥12 at screening and ≥16 at baseline. * validated investigator global assessment scale for atopic dermatitis (viga-ad) score ≥3 at screening and baseline. * body surface area (bsa) of ad involvement ≥10% at screening and baseline. * worst daily pruritus numeric rating scale (nrs, weekly average) of ≥3 points at baseline. exclusion criteria: * treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomization, whichever is longer. * treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomization, whichever is longer. * treatment with topical corticosteroid(s) (tcs), topical calcineurin inhibitor(s) (tci), topical phosphodiesterase-4 (pde-4) inhibitor, or other topical prescription treatments within 1 week prior to randomization. * treatment with a live (attenuated) vaccine within 12 weeks prior to randomization. * clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomization that may compromise the safety of the subject. * skin infection within 1 week prior to the baseline visit. * presence of hepatitis b or c infection at screening. * history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening. * participant has a positive or indeterminate test for tuberculosis at screening. * participant is pregnant or lactating.
effects of lycra suits in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: lycra garments have recently been used for children with cerebral palsy, with favorable effects on alignment, biomechanics and neuromuscular activity. the aim of the present study is to determine the efficacy of a lycra suit in improving motor function and static balance in children with cerebral palsy. the children included in this study will be part of a prospective project on children with cerebral palsy, older than 4 years of age, and their families regularly followed at the child neurology unit of the catholic university of rome.

a total of 10 children with cerebral palsy will be recruited and included in the study. five of them will be considered as study group and will wear a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. the other 5 will be considered as control group, matched for age and sex to the study group, and will not wear the lycra suit. the evaluation of static balance and the gross motor function measure will be used as outcome measure. the children of both groups will be assessed twice, at baseline and 6 months after, each child acting as his/her own control. the motor function assessments will be performed without the lycra suit, whereas the static balance assessments were performed with and without the suit.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cerebral palsy based on the predominant type of motor impairment and classified according to the criteria proposed by himmelmann. exclusion criteria: * presence of major congenital malformations or metabolic or haematological complications. * the investigators will also exclude children who had previously worn a lycra garment and who received botulinum toxin injections or orthopaedic surgery in the year before the study.

Keywords: cerebral palsy lycra motor function static balance