Kornimate/medical-research-clean huggingface dataset:
mycophenolate mofetil and rapamycin as secondary intervention vs. continuation of calcineurin inhibitors in patients at risk for chronic renal allograft failure

Conditions: Kidney Transplant

Summary: a study to determine the effect on renal function in renal transplant patients with biopsy proven chronic allograft nephropathy (can) nephropathy who are switched from a calcinerin inhibitor (ci) triple drug regimen to a rapamycin based triple drug regimen or maintained on their ci protocol


Eligibility criteria:
inclusion criteria: 1. patient is the recipient of a cadaveric or living donor renal transplant. 2. patient was \> 12 years of age at the time of transplant. 3. patient is at least 3 months post-transplant. 4. patient has been on a calcineurin inhibitor based immunosuppression since the transplant. 5. patient has one of the following risk factors for chronic renal allograft failure: i. serum creatinine \> 2.0 mg/dl 3 months or later post-transplant in males patients. ii. serum creatinine \> 1.7 mg/dl 3 months or later post-transplant in female patients. iii. serum \> 30% increased over post discharge nadir. 6. patients had a renal biopsy that shows chronic allograft nephropathy. 7. patient or legal guardian had signed and dated an institutional review board (irb) approved informed consent document and is willing and able to follow study procedures. 8. if female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (mmf), rapamycin and other immunosuppressants. - exclusion criteria: 1. patient is the recipient of a solid organ transplant other than the kidney. 2. patient is dialysis dependent. 3. patient has recurrence of primary renal disease, or de novo renal disease. 4. patient has an estimated creatinine clearance \<25ml/min calculated using the cockcroft/gault formula. 5. patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to mmf) within three months of randomization. 6. baseline biopsy shows acute rejection banff grade \> class 2 (iib). 7. patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy. 8. patient has received an investigational immunosuppressant within three months. 9. patient is pregnant or lactating. 10. patient is a known carrier of any of the hiv viruses. 11. patient has known hypersensitivity to rapamycin, or any of the excipients of the drug.
phase 1 study of quizartinib

Conditions: Relapsed AML; Refractory AML

Summary: this is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for japanese acute myeloid leukemia (aml) subjects.


Eligibility criteria:
inclusion criteria: * relapsed or refractory aml * aml for which no standard treatment is available * ecog performance status (ps) of 0 to 2 exclusion criteria: * acute promyelocytic leukemia * chronic myelogenous leukemia in blast phase (bcr-abl fusion gene positive) * history of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, aml, or mds.

Keywords: aml phase 1 oncology
study of karenitecin (bnp1350) in patients with brain tumors

Conditions: Brain Neoplasms; Malignant Neoplasms, Brain; Brain Tumors

Summary: the purpose of this study is to evaluate safety and efficacy ofkarenitecin (bnp1350) as a treatment of adults with brain tumors.


Eligibility criteria:
* confirmed diagnosis of a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma. * evidence of measurable recurrent or residual primary cns neoplasm. * an interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy. * hematocrit \> 29%, anc \> 1,500, platelets \> 125,000 * serum creatinine \< 1.5 mg/dl, bun \< 25 mg/dl, serum sgot and bilirubin \< 1.5 times upper limit of normal * negative pregnancy test for female patients
newborns in level iii services in alsace from mothers with covid-19

Conditions: COVID-19

Summary: very little is known about the impact on the newborn of late pre-partum maternal sars-cov-2 infection. care without separation of the mother and her newborn with continued breastfeeding has been advocated in france and by the who but is being debated in some countries. assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up. importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.


Eligibility criteria:
inclusion criteria: * newborns born between march 1 and june 30, 2020 to covid 19 * from positive mothers in strasbourg university hospital or mulhouse hospital. * parents' non-opposition to the analysis of hospitalization data for children contained in the medical file exclusion criteria: - parents' opposition to the analysis of hospitalization data for children contained in the medical file

Keywords: covid-19 sars-cov-2 newborns of covid-19 mothers covid-19 pandemic covid-19 virus disease
comparison of daily home hemodialysis (hd) with conventional in center hd in terms of patients quality of life and clinical outcomes

Conditions: End Stage Renal Disease

Summary: the objective of this study is to describe the characteristics of patients on daily home hemodialysis and to confirm in real practice in france the effectiveness shown in studies, mainly american, both in terms of clinical outcomes and quality of life. due to the few studies available in this population, the focus will be particularly on physical activity.

primary objective : the main objective of this study is to evaluate the physical activity in the daily life of patients in daily hemodialysis in comparison with patients treated 3 times a week (conventional hemodialysis) others objectives are also: 1. to describe the characteristics of daily hemodialysis patients; 2. to describe the prescription procedures of the home daily hd; 3. to compare the evolution of the blood pressure between the 2 modalities of hemodialysis; 4. to compare the frequency of hospitalizations, duration and hospitalization reasons between the 2 hemodialysis modalities; 5. to compare the quality of life of the patients between the 2 modalities ; 6. to evaluate the quality of the sleep of the patients between the 2 modalities ; 7. compare the percentage of patients with restless leg syndrome (rls) and the severity of rls between the two modalities; 8. compare the evolution of drug intake between the two modalities; 9. evaluate the number of abandoning subjects and causes of discontinuation of hqd;

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or over 2. patient who dated and signed the consent form 3. patient (s) affiliated to a social security scheme 4. interventional arm: patient who begins or will begin daily hemodialysis training (5, 6 or 7 times per week) at home. 5. comparator arm: prevalent or incident patient treated by conventional hemodialysis (3 times per week) and fitting with the matching criteria of an interventional patient included in the center exclusion criteria: 1. patient with needs any help to walk (wheelchair, crutch, walker, cane ...) 2. patient with active neoplasia; 3. patient with predicted life expectancy of less than one year; 4. patient with significant reading or writing difficulties; 5. patient participating in a clinical trial or other interventional study; 6. patient with history of mental instability, major cognitive impairment in the previous 5 years, or major psychiatric condition not adequately controlled or stable under pharmacological treatment

Keywords: home hemodialysis daily hemodialysis frequent hemodialysis
a research study to look at how insulin 287 and semaglutide work in the body of people with type 2 diabetes when taken alone or together

Conditions: Diabetes Mellitus, Type 2

Summary: the study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. this study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. the order in which participants get them is decided by chance. participants will get all medicines as an injection under the skin in the thigh. the injections will be done by study staff. the time between injections is 6 to 9 weeks. the study will last for about 19 to 32 weeks in total.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening * body weight between 80.0 to 120.0 kg (both inclusive) * glycosylated haemoglobin (hba1c) 6.0 to 8.5% (both inclusive) * no current and no regular previous intake of insulin. previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records) * stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) any metformin formulation (dose as documented in the subject medical record), b) one other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (dpp-4) inhibitor and sodium glucose co-transporter 2 (sglt2) inhibitor exclusion criteria: * known or suspected hypersensitivity to trial products or related products * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening * receipt of any investigational medicinal product within 90 days before screening * history of severe allergies to drugs or foods or a history of severe anaphylactic reaction
a novel approach to posterior mesh fixation in laparoscopic sacral colpopexy

Conditions: Pelvic Organ Prolapse

Summary: this randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.


Eligibility criteria:
inclusion criteria: -patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence exclusion criteria: * age \> 75 years * severe cardiovascular or respiratory disease * pregnancy
efficacy, safety & utilisation of nuwiq, octanate and wilate in previously untreated & minimally treated haemophilia a patients

Conditions: Haemophilia A

Summary: international, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of octapharma's fviii concentrates nuwiq, octanate, and wilate in previously untreated and minimally treated severe haemophilia a patients in routine clinical practice.

octapharma's fviii concentrates have been tested in clinical trials and registered for treatment of haemophilia a; however, as haemophilia a is a rare disease, the numbers of patients treated in studies so far are limited. for previously untreated patients (pups), who are typically young children, and for minimally treated patients (mtps), who have been exposed to only minimal fviii dosages, there is a general interest to increase the body of data on treatment effectiveness and safety, particularly related to inhibitor development. also, specifically for pups, treatment algorithms are not standardized, e.g. with respect to utilisation, dosage, frequency or optimal start age of fviii prophylaxis. real world evidence derived from a non-interventional study (nis) can describe product utilisation and demonstrate value over a product's life cycle and facilitate benefit-risk assessments. the purpose of this study is thus to evaluate product utilisation, effectiveness and safety, including inhibitor development information, in severe haemophilia a pups and mtps, who have been prescribed octapharma's fviii concentrates.

Eligibility criteria:
inclusion criteria: * male and female patients of any age and ethnicity * severe haemophilia a (fviii:c\<1%) * decision to prescribe octapharma's fviii concentrate before enrollment into the study * either * no previous treatment with fviii concentrates or other blood products containing fviii (pups) or * less than 5 exposure days (eds) to fviii concentrates or other blood products containing fviii (mtps), if * data are available on all previous treatment, and * they did not develop an inhibitor at any time point, or * they developed an inhibitor during treatment with an octapharma fviii concentrate and continue treatment with this octapharma fviii concentrate (in the presence or absence of emicizumab). * voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian) exclusion criteria: * diagnosis with a coagulation disorder other than haemophilia a * concomitant treatment with any systemic immunosuppressive drug * participation in an interventional clinical trial during the time period evaluated * participation in another non-interventional study of octapharma
enteral nutrition and glycemic variability neurological intensive care unit study

Conditions: Subarachnoid Hemorrhage; Intracranial Hemorrhage; Ischemic Strokes; Subdural Hematoma

Summary: primary objective: to determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological icu. blood glucose will be recorded every minute using a continuous blood glucose monitor. the primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the icu and receiving tube feeds and for up to a maximum of 14 days. secondary objectives: to determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients icu stay.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 89 years old * patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage * patients who are expected to stay in the icu for at least 5 days * hyperglycemia is not an inclusion criteria exclusion criteria: * patients who have received or will be treated with systemic corticosteroids. * patients who will be receiving high doses of propofol (\>40 cc/hr) * patients with type 1 diabetes * patients with sepsis or acute trauma * patients with an expected stay in the icu of less than 4 days * patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components * pregnant and lactating patients * patients with prior history of gastroparesis * patients with acute kidney failure (creatinine \> 2.5mg/dl) * patients with acute liver failure (bilirubin \> 2.0 mg/dl)

Keywords: glycemic control glycemic variability mean blood glucose level
effectiveness in dental plaque reduction of mouthwashes containing fatty acids compounds (f.a.g.) or stannous fluoride

Conditions: Gingivitis; Gingival Diseases

Summary: comparative study on the efficacy of two mouthwashes containing fatty acids compounds (f.a.g.) or stannous fluoride in the reduction of plaque score in individuals with spontaneous gengivitis


Eligibility criteria:
inclusion criteria: * healthy individuals exclusion criteria: * smoking * drugs prior month * dental hygiene \<6 months * pregnancy
levocarnitine and vitamin b complex in treating peg-asparaginase or inotuzumab ozogamicin-induced hyperbilirubinemia in patients with acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia; Hyperbilirubinemia

Summary: this phase ii trial studies how well levocarnitine and vitamin b complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with peg-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. amino acids, such as levocarnitine, may work in normalizing liver enzyme levels due to treatment. vitamin b complex is a dietary supplement that may be used for patients with nutritional deficiencies. giving levocarnitine and vitamin b complex may work better in treating hyperbilirubinemia in patients with acute lymphoblastic leukemia.

primary objectives: i. to evaluate the efficacy of levocarnitine in combination with vitamin b complex in treating peg-asparaginase (peg) or inotuzumab ozogamicin (ino) induced hyperbilirubinemia (total bilirubin \[tbili\] \> 3 x upper limit of normal \[uln\]) in patients (pts) with acute lymphoblastic leukemia (all). secondary objectives: i. to evaluate chemotherapy dose intensity in patients treated with peg-asparaginase or inotuzumab ozogamicin. ii. to characterize the safety, tolerability, and adverse event profile of levocarnitine and vitamin b for the treatment of hyperbilirubinemia. outline: patients are assigned to 1 of 2 cohorts. patients receive levocarnitine intravenously (iv) over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or orally (po) three times a day (tid) (outpatient). patients also receive vitamin b complex po twice daily (bid). treatment continues for up to 30 days after the last dose of either peg-asparaginase or inotuzumab, or until tbili of ≤ 1.5 x uln or at least a 50% reduction in peak tbili is achieved. after completion of study treatment, patients are followed up at 30 days.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age. * non-english speakers may be enrolled. * patients with a diagnosis of all who are receiving treatment with peg-asparaginase or inotuzumab ozogamicin with tbili \> 3 x uln * signed informed consent exclusion criteria: * pregnant or nursing women * known hypersensitivity to levocarnitine or vitamin b complex
a study of radiation therapy after surgery in people with oral tongue squamous cell carcinoma

Conditions: Oral Tongue Squamous Cell Carcinoma

Summary: this study will test whether limiting standard photon intensity modulated radiation therapy (imrt) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. the researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * surgical resection of all gross disease without evidence of residual loco-regional disease on simulation pet/ct. * pt1-2,pn0-2b squamous cell carcinoma of the oral tongue confirmed on final surgical pathology. patients must have: * at least two of the following pathologic risk features * lvi * doi ≥ 4mm or * 1 or 2 pathologically positive nodes n1 to low volume n2b. * primary specimen surgical margins ≥3 mm * signed informed consent form by the participant or their legally authorized representative (lar) exclusion criteria: * n2c/n3 nodal disease * \>2 pathologically positive nodes * primary specimen surgical margin \< 3 mm * extensive perineural invasion (pni); non-extensive pni is permitted. * extra-capsular extension in any pathologically positive lymph node * surgery at outside institution (pi can give approval for patients operating on outside) * prior or simultaneous invasive malignancy that, in the opinion of the pi, represents a competing risk of death equivalent to the patient's oral tongue squamous cell carcinoma. * auto-immune conditions that would otherwise preclude radiation in the opinion of the pi (e.g. scleroderma). * lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.

Keywords: pt1-2,pn0-2b intensity modulated radiation therapy (imrt) 24-167
a study to evaluate the effectiveness of medi-563 in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to evaluate the effect of the drug in moderate to severe chronic obstructive pulmonary disease (copd) in adults.

to evaluate the effect of multiple subcutaneous (sc) doses of benralizumab (medi 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (aecopd) in adult subjects with moderate-to-severe copd who exhibit eosinophilia (greater than or equal to \[\>=\] 3.0 percent \[%\] sputum eosinophilia in the previous 12 months or at screening) in sputum compared to placebo.

Eligibility criteria:
inclusion criteria: * subjects aged 40-85 years at the time of screening * written informed consent obtained from the subject prior to performing any protocol related procedures * documented history of 1 or more annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (aecopd) * current smoker or ex-smoker with a tobacco history of greater than or equal to (\>=) 10 pack-years * adequate contraception from screening through end of trial * able to read and write. exclusion criteria: * any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * pregnant, breastfeeding, or lactating women * known history of allergy or reaction to any component of the investigational product formulation * history of anaphylaxis to any other biologic therapy * donation or transfusion of blood, plasma or platelets within the past 3 months prior to screening * other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study * fever greater than (\>) 37.0 degree centigrade (98.6 degree fahrenheit) at screening * receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study * seropositive for hepatitis a, hepatitis b surface antigen, hepatitis c, or human immunodeficiency virus 1or 2 (hiv-1 or hiv 2) * history of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation * past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to screening * subjects participating in, or scheduled for, an intensive copd rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part) * current diagnosis of asthma according to global initiative for asthma guidelines * previous treatment with medi-563.

Keywords: benralizumab medi-563 pulmonary disease, chronic obstructive