Kornimate/medical-research-clean huggingface dataset:
evaluation of fondaparinux (also called arixtra) 2.5 mg subcutaneously once daily for the treatment of superficial thrombophlebitis (also known as superficial vein thrombosis)

Conditions: Thrombosis, Venous

Summary: to evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

comparison of arixtra™ in lower limb superficial thrombophlebitis with placebo (calisto). an international, multicentre, randomised, double-blind, placebo-controlled, two-parallel group, phase iii study to evaluate the efficacy and safety of arixtra (2.5 mg subcutaneously) for the treatment of patients with acute symptomatic isolated superficial thrombophlebitis of the lower limbs to prevent thromboembolic complications

Eligibility criteria:
inclusion criteria: * acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound. exclusion criteria: * superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction, * deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months, * anticoagulant medication for more than 48 hours prior to inclusion, * need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month, * major surgery within last 3 months, low platelet count (below 100×109/l), * kidney disease (calculated creatinine clearance \< 30 ml/min), woman of child-bearing potential not using reliable contraceptive method

Keywords: superficial vein thrombosis superficial thrombophlebitis fondaparinux deep vein thrombosis venous thromboembolism treatment thrombosis
the effect of eplerenone on ischemia reperfusion injury in human myocardium

Conditions: Ischemia-reperfusion Injury

Summary: in the laboratory, the researchers will investigate whether the drug eplerenone improves contractile function after ischemia and reperfusion in heart tissue.

in animal studies, the mineralocorticoid receptor antagonist eplerenone appears to limit myocardial infarct size. this cardioprotective effect might explain, at least in part, the beneficial effect on mortality of eplerenone in patients with heart failure. previous animal studies suggest that this cardioprotective effect is mediated by an increased formation of the endogenous nucleoside adenosine. our objective is to study for the first time in human myocardial tissue ex vivo wether eplerenone limits ischemia reperfusion injury and whether this is mediated by adenosine receptor stimulation. from patients undergoing open heart surgery, the right atrial appendage will be harvested by the cardiothoracic surgeon. in the laboratory, two trabeculae will be dissected and suspended in an organ bath. contraction will be induced by electrical field stimulation. recovery of contractile force after a period of simulated ischemia and reperfusion will be used as an endpoint of ischemia-reperfusion injury. the trabeculae of each patient will be randomized to pretreatment with a)ischemic preconditioning (ip) of no ip as a positive control experiment; b)eplerenone or vehicle; c)eplerenone with or without caffeine; and d)aldosterone with and without eplerenone.

Eligibility criteria:
inclusion criteria: * age\>18 years * willing to sign informed consent * planned elective surgery with extracorporal circulation exclusion criteria: * use of theophylline * use of sulfonylureas * use of oral antiarrhythmics (not beta blockers) * use of dipyridamole, use of mineralocorticoid receptor antagonists * atrial arrhythmias * right ventricular failure * known atrial enlargement

Keywords: ischemia-reperfusion injury
efficacy/safety of verteporfin photodynamic therapy and ranibizumab compared with ranibizumab in patients with subfoveal choroidal neovascularization

Conditions: Macular Degeneration; Choroidal Neovascularization

Summary: this study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * subjects of either gender age 50 years or older * subfoveal choroidal neovascularization (cnv) due to age-related macular degeneration (amd) exclusion criteria: * choroidal neovascularization due to causes other than amd * prior treatment for neovascular amd in the study eye other protocol-defined inclusion/exclusion criteria may apply

Keywords: age-related macular degeneration; amd choroidal neovascularization verteporfin ranibizumab
comparative efficacy of ovule vs tablet

Conditions: Clotrimazole; Ovulen; Vulvovaginal Candidiasis

Summary: the study is focused to prove that the efficacy of a new canesten formulation (ovule) is not inferior to the old canesten formulation (tablet)


Eligibility criteria:
inclusion criteria: * non-pregnant females aged at least 14 years in germany or at least 16 years in russia and not older than 50 years. * subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation). * subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. for adolescents the informed consent has to be provided to a legal representative in addition. * subjects of childbearing potential must use an acceptable method of contraception. hormonal or oral contraceptive drugs, intra-uterine devices (iud) and abstinence are considered acceptable methods of contraception. * negative saline smear for trichomonas vaginalis exclusion criteria: * subjects with known hypersensitivity to imidazoles or triazoles and their analogues. * subjects presenting a protozoan infection as confirmed by microscopic investigation. * pregnant, breast feeding or lactating subjects. * subjects with suspected bacterial vaginal infection. * subjects with abdominal pain, fever, or foul smelling vaginal discharge. * subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1. * subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial. * subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and otc vaginal products during treatment and 3 days thereafter (i.e. until day 4). * subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4). * subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2). * subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months. * subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections. * subjects who received another investigational drug within 30 days before visit 1. * unwillingness to refrain from sexual activity during 3 days thereafter. * actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.

Keywords: clotrimazole ovule tablet vulvovaginal candidiasis non-inferiority
a european registry and sample sharing network to promote the diagnosis and management of light chain amyloidosis (eureka)

Conditions: AL Amyloidosis

Summary: a prospective patients' registry collecting all new cases of al amyloidosis evaluated at referral centers from across europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.

in the frame of the eureka consortium, a patients' registry collecting all new cases of al amyloidosis evaluated at referral centers across europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. a dedicated site will support the consortium with big data analysis and artificial intelligence applied to health. the aims are: 1) defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of al patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, mrd).

Eligibility criteria:
inclusion criteria: * diagnosis of systemic al amyloidosis; * treatment-naïve; * age ≥18 years; * ability to understand and willingness to sign an informed consent; * planned follow-up at participating center. exclusion criteria: * non-al amyloidosis; * previous treatment for al amyloidosis.
application of ectoin allergy nasal spray in comparison to beclomethasone nasal spray

Conditions: Allergic Rhinitis

Summary: this is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of ectoin® allergy nasal spray. in addition the effectiveness and safety shall be compared to a beclomethasone nasal spray. the patient applies ectoin® rhinitis nasal spray or beclomethasone nasal spray according to the instructions for use. the observation takes place over a period of 14 days. response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.


Eligibility criteria:
inclusion criteria: * diagnosed allergic rhinitis during the observational period exclusion criteria: * contra indications according to the label

Keywords: allergic rhinitis ectoine bitop ectoin
study of pharmacokinetics, efficacy and safety of a recombinant and protein-free factor viii (rahf-pfm) in hemophilia a patients - a continuation of clinical study 069901

Conditions: Hemophilia A

Summary: the purpose of this study is to evaluate whether rahf-pfm is safe and effective in the treatment of hemophilia a subjects. the study consists of 2 parts: part 1 is a pharmacokinetic and safety study, and part 2 is an evaluation of efficacy and safety. the study is open to patients who completed baxter study 069901.


Eligibility criteria:
inclusion criteria: * subject has completed baxter protocol 069901 * subject is hiv-1 seronegative or, if hiv-1 seropositive, has a cd4+ lymphocyte count \>= 400/mm3 documented within three months of the screening visit * subject (and his legally acceptable representative, in the case of study participants \>= 10 and \< 18 years of age) has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate irb/iec and baxter exclusion criteria: * the subject received factor viii products other than rahf-pfm upon completion of baxter protocol 069901 * the subject developed an inhibitor to factor viii, measured in the central laboratory, during baxter protocol 069901. an inhibitor is defined as a bethesda titer \> 1.0 or, if bethesda titer \ 0.6 * the subject is scheduled to receive an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids) during the course of the study * the subject is identified by the investigator as being unable or unwilling to cooperate with study procedures

Keywords: factor viii deficiency
retro comparison of subsidence following interbody devices in lumbar spine

Conditions: Degenerative Disc Disease (DDD)

Summary: the objective of this retrospective study is an investigational clinical follow-up, of patients treated with interbody fusion devices (ibfd), both expandable (exp) and static (stc), according to their intended use and cleared labeling to understand ibfd design and technique characteristics that affect occurrence rates of subsidence. patients treated with ibfd's (both exp and stc) according to their intended use and cleared labeling 1. exp ibfd's that expand in width and height demonstrate reduced occurrence of subsidence post-operatively when compared to exp ibfd's that expand in height only and stc ibfd's. 2. exp ibfd's that are comprised of multi-material composition with polyetheretherketone (peek) endplate contacting surfaces demonstrate reduced occurrence of subsidence on post-operative radiographs when compared to exp and stc ibfd's that are primarily comprised of ti with ti endplate contacting surfaces. 3. achieve radiographic fusion at a rate consistent with the state-of-the-art 4. achieve significant improvements in pain and function compared to baseline 5. experience adverse events at a frequency comparable to reported rates for tlif or plif surgery 6. not demonstrate any intraoperative complications during the implant process 7. operative approach does not correlate with increased rates of subsidence


Eligibility criteria:
inclusion criteria: 1. the patient was treated with tlif or plif surgery using the ibfd according to the cleared labeling, based on the surgeon's clinical judgment and patient-specific decision making. based on the product labeling, the patient must: 1. was at least 18 years of age and skeletally mature at the time of surgery 2. had clinical and radiological evidence of ddd of the lumbar spine 3. undergone treatment with the ibfd with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone at 1 or 2 contiguous levels from l2 to s1 exclusion criteria: 1. history of fusion surgery or large laminectomy at l2 to s1 prior to treatment with the ibfd(s) spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure 2. surgery with the ibfd(s) at more than 2 contiguous levels 3. surgery with the ibfd(s) at levels outside the range of l2 to s1 4. treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space 5. any contraindications listed in the cleared product labeling 6. osteoporosis, other systemic bone d.o. t score ≤ -1.5 7. bmi \> 40 8. systemic infection 9. h/o iv drug use 10. cancer
pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 and biphasic human insulin 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a treatment with biphasic insulin aspart 30 (biasp 30) administered once, twice or thrice daily and biphasic human insulin 30 administered once daily in type 2 diabetic subjects


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject) * type 2 diabetes mellitus diagnosed for at least 12 months prior to screening * hba1c value between 7% and 10.5% (both inclusive) at screening * any insulin treatment for at least 3 months prior to screening * body mass index (bmi): 25 - 40 kg/m2 exclusion criteria: * use of any oral antidiabetic agent within the past 6 months * active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening * cardiac disease: nyha class iii or iv chronic heart failure (chf), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening * hepatic insufficiency (alt or ast greater than or equal to 2 times the central laboratory's upper reference limit) * renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dl for males; greater than or equal to * recurrent hypoglycaemia or hypoglycaemic unawareness * anaemia (haemoglobin less than 13.0 mg/dl in males and less than 12.0 mg/dl in females) (who criteria) * use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers * history of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, one glass of wine, or 20 ml spirits) * smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period * known hepatitis or positive serological tests for the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or hiv antibodies * uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmhg and/or diastolic blood pressure greater than or equal to 95 mmhg)
robotic-assisted pedicule screw placement

Conditions: Lumbar Degenerative Spinal Disease

Summary: the main objective of the study is to evaluate the feasibility of using the robotic assisted device rosa™ for pedicle screws placement. this device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. in the future, the use of rosa™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.

the medical device subject of this research is the surgical robot rosa™ designed for cranial surgery, and used here in another application, spinal surgery - more specifically for the placement of pedicle screws. it is intended for spine surgeons to treat diseases requiring the placement of pedicle screws through posterior open surgery approach or minimally invasive surgery. the system allows the precise guidance of instruments as defined by the surgeon on patient radiological images. the expected performance is a good rate of pedicle screws placement, increasing the performance observed with the conventional method. this system can be transported from one operating room to another, and stored in a storage room. it interfaces with the most common intra -operative surgical imaging systems (mobile c-arms available at montpellier university hospital). further versions of the device will enable the use of 3d intra-operative imaging systems such as the o-arm from medtronic. the main objective of the study is to evaluate the feasibility of using the robot rosa™ for pedicle screws placement. in this study, the robot will be used with an open surgery approach, which is a first step in demonstrating the potential of the robot.

Eligibility criteria:
inclusion criteria: * patients suffering from lumbar back pain for more than 3 months * consent signed exclusion criteria: * pregnant patient * patient nursing

Keywords: spine accurancy robotic screw placement degenerative
insulin glulisine, diabetes mellitus type 1

Conditions: Diabetes Mellitus, Type 1

Summary: to provide local data on efficacy and safety of insulin glulisine in patients with type 1 diabetes mellitus receiving insulin glargine as basic insulin therapy


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 1 * hba1c 6.5-11.0% * bmi \<35 kg/m² exclusion criteria: * diabetes mellitus, type 2 the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a chemoprevention study of an investigational drug in men with high grade prostate intraepithelial neoplasia (pin)

Conditions: Prostatic Intraepithelial Neoplasia

Summary: if you are a male 30 years of age or older and have a positive diagnosis of high grade (ii or iii) prostate intraepithelial neoplasia (pin) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. this is a study of an investigational medication that may reduce high grade pin and prevent the occurrence of prostate cancer. this study is currently enrolling up to 500 men at approximately 60 locations in the united states.

high grade pin is the development of precancerous, abnormal tissue of the prostate gland that puts men at high risk of developing prostate cancer. this study will take one year of participation with clinic visits every three months. there will be two prostate biopsies during the study, at six and twelve months. if qualified to participate, you will be randomly assigned to one of four treatment groups. three out of four groups are varying doses of the study medication and the other is the placebo group (like a sugar pill).

Eligibility criteria:
* must have confirmed high grade pin on prostate biopsy within past 6 months. * must have a serum psa \<12 ng/ml. * can not have prostate cancer. * have significant ocular opacities. * can not take finasteride or other testosterone like supplement.

Keywords: pin high grade prostate intraepithelial neoplasia (pin)
vinorelbine for recurrent aclc

Conditions: Anaplastic Large Cell Lymphoma; Vinorelbine

Summary: the purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced alcl in children and adolescents.

anaplastic large cell lymphoma (alcl) is a rare non-hodgkin's lymphoma, around 30% patients would get relapse. vinorelbine(navelbine) is a third-line treatment option for hodgkin's disease(hd) after transplantation failed, while both hd and alcl express cd30. when alcl recurred, vinblastine monotherapy was used and the 5-year efs up to 30%, 5-year os up to 60%. in china vinblastine is unavailable. vinorelbine is very similar to vinblastine in molecular formula, and is available in china. from november 2016 to march 2017, two patients with recurrent alcl were recruited in the department of hematology and oncology, shanghai children's medical center. they received vinorelbine monotherapy and achieved clinical remission (pet cr) at 8 weeks. one patient with bone marrow recurrence showed negative alk / npm by pcr . based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with alcl.

Eligibility criteria:
inclusion criteria: children and adolescents with a clear diagnosis of recurrent / progressive alcl at shanghai children's medical center or other centers since september 2017 include: * diagnosed as alcl, already received first-line treatment, but get disease progression; * after receiving alcl treatment has got cr then diagnosed relapse, need for pathological diagnosis. exclusion criteria: * patients with other systemic diseases, severe infections or critically illness.

Keywords: anaplastic large cell lymphoma childhood adolescent recurrent treatment