Kornimate/medical-research-clean huggingface dataset:
goelams sa4 study: the role of fludarabine in the treatment of acute myeloid leukemia in the elderly

Conditions: Acute Myeloid Leukemia

Summary: in this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction courses during maintenance.

eligibility for enrollment in the study was limited to patients aged 60 to 75 years old with previously untreated de novo aml as defined morphologically by the french-american-british (fab) classification with the exception of m3 and m7 subtypes.10,11 the bone marrow aspirate had to show at least 30 percent of nonerythroid blast cells. patients were not eligible if they had a performance status before diagnosis of 2 or more according to the world health organization (who) grading system, congestive heart failure or abnormal left ventricular ejection fraction, severe hepatic or renal disturbances if not related to leukemia (hepatic enzymes levels over four times the normal values, serum bilirubin over 35 micromol/l, creatinine over 150 micromol/l). patients with previous unexplained cytopenia were eligible for the study. conversely, patients with a history of documented myelodysplastic or myeloproliferative syndrome or previously treated with chemotherapy or radiation could not enter the study. the study received in june 1996 approval from the ethics' board of the nancy hospital and written informed consent was given by all eligible patients before entering the study, in accordance with the declaration of helsinki. the enrollment period was open from november 1996 to april 2000.

Eligibility criteria:
inclusion criteria: * patients aged 60 to 75 years old * untreated de novo aml * performance status less than 2 exclusion criteria: * performance status more than 2 * congestive heart failure or abnormal left ventricular ejection fraction * severe hepatic or renal disturbances * history of documented myelodysplastic or myeloproliferative syndrome * patients previously treated with chemotherapy or radiation

Keywords: fludarabine aml elderly patients
acute effects of natural and interesterified fats-margarine on lipemic and insulinemic response

Conditions: Healthy

Summary: interesterified (ie) fat blends will respond differently in terms of postprandial lipemia and insulinemic responses compare to a trans free palm margarine (tfpm).

the objective of this study was to investigate whether ie-fat blends behave differently on postprandial serum lipid, insulin, c-peptide and glucose concentration compare to tfpm. a randomised, double-blind crossover (3 × 3 arms) orthogonal latin-square design was used and conducted on 10 males and 10 females adults. during postprandial challenge day, each subject received an a test muffin incorporated with test margarine. blood samples were collected at half-hourly intervals until 4 hr by using cannulation technique.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 and 24.9 * \<130mmhg for systolic pressure and \<80 mmhg for diastolic pressure * blood glucose level in the range of 3.9 to 5.5 mmol/l * total cholesterol less than 5.17 mmol/l * no use of tobacco and no consumption of alcohol. exclusion criteria: * suffer from chronic disease * metabolic syndrome * consuming any medical prescriptions * people with blood clotting problem * women who are pregnant * hypertensive person
immune biomarkers related to bone pathology in patients with type 1 gaucher disease

Conditions: Gaucher Disease Type 1

Summary: bone-related problems represent the principal unmet medical need in gaucher disease (gd). 75% of gd type 1 patients develop skeletal complications, including bone remodeling defects, osteopenia, osteoporosis, marrow infiltration, avascular necrosis, and osteolysis. however, the underlying cellular/molecular basis of bone involvement and related complications in gd are not fully known. neither are there any bone-specific markers associated with individual bone pathology. early diagnosis of bone disease is the key issue for planning individual therapy to prevent and reverse bone disease in gd.

this clinical observational study is designed to identify specific biomarkers for bone involvement in patients with gd1 with decreased bone density and/or bone structural abnormalities aims: 1. identify novel immune cell surface and biochemical markers in peripheral blood correlating with bone involvement in gd. 2. assess the correlation between cytokine levels in peripheral blood and the severity of bone involvement in gd. 3. assess the relationship between glycosphingolipids accumulation and macrophage activation with specific bone markers and gd severity.

Eligibility criteria:
inclusion criteria: * to be enrolled in this study the subject must meet the following criteria 1. subject is greater than 16 years old but not older than 90 years 2. signed informed consent/assent 3. subject is able and willing to sign informed consent or assent 4. if the subject has gd1, the must have a confirmed diagnosis of gaucher disease by * gcase enzyme activity * dna analysis demonstrating pathogenic variants in the gba gene exclusion criteria: * a) have evidence of hepatitis b, hepatitis c infection or any other chronic infectious disease b) be pregnant or breastfeeding

Keywords: gaucher disease osteoporosis
a study to determine the antitumor activity and evaluate the safety of mkc-1

Conditions: Breast Cancer

Summary: this phase 2 study will determine the antitumor activity, based on the objective rate, of oral mkc-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. the study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following mkc-1 therapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the breast * 18 years or older * karnofsky performance status greater than or equal to 70% * radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the response evaluation criteria in solid tumors (recist) criteria * must have failed both a taxane and an anthracycline, given sequentially or in combination, either in an adjuvant or metastatic setting * all acute toxicity of any prior chemotherapy, surgery or radiotherapy must have resolved to national cancer institute common toxicity criteria (nci ctc) grade less than or equal to 1 * lab results, within 10 days of mkc-1 administration: * hemoglobin less than or equal to 9 g/dl * absolute neutrophil count greater than or equal to 1.5 x 10\^9/l * platelet count greater than or equal to 75 x 10\^9/l * serum creatinine less than or equal to 1.5 x uln (upper limit of normal) * ast less than or equal to 2.5 x uln * serum albumin greater than or equal to lln (lower limit of normal) * total bilirubin less than or equal to uln * alkaline phosphatase less than or equal to 2.5 x uln * signed informed consent exclusion criteria: * pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below the costal margin, secondary to malignancy * administration of cancer specific therapy within the following periods prior to study drug initiation: * chemotherapy less than 3 weeks prior * hormonal therapy less than one week prior * radiation therapy less than 2 weeks prior * be pregnant or lactating; not employing effective birth control * known central nervous system (cns) metastases unless treated, clinically stable and not requiring steroids * clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy * administration of any investigational agent (therapeutic or diagnostic) within 4 weeks prior to receipt of study medication * uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dl) * serious cardiac condition * any medical conditions that, in the investigator's opinion would impose excessive risk to the patient * patients with previous malignancies unless free of recurrence for at least 5 years except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix * treatment with antiretroviral therapy metabolized through cyp3a4

Keywords: advanced and metastatic breast cancer
prediction of unfavourable outcome in newly covid-19 hospitalized patient

Conditions: to Predict an Unfavorable Evolution of Covid-19 at the Hospital Admission of Patients

Summary: the project is a part of the "protocol for a multicentre study of nosocomial sars-cov2 transmission: the noso-cor project" registered in clinicaltrials (nct04290780). in the current pandemic context, medical resources have often been exceeded. developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following sars-cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of covid-19 at the hospital admission of patients


Eligibility criteria:
inclusion criteria: * participant must be 18 years or older at the time of signing the informed consent * volunteer patients, care givers and healthcare professionals in france and hospitals affiliated with the gabriel network. demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project. * a nasopharyngeal swab will be collected and tested for sars-cov2 by rt-pcr. * admission to hospital exclusion criteria: * age lower than 18 years old * patients protected by the law
infection rates of myeloablative allo sct recipients receiving neutropenic diets versus non-neutropenic diets

Conditions: Hematologic Malignancies

Summary: in the transplant community, there is debate regarding the most appropriate food services for stem cell transplant patients. recommendations regarding the use of low bacterial diets have been based on theoretical concepts of reducing the risk of contracting infections from pathogens found in food sources rather than clinical trials. the evidence for the use of a neutropenic diet is weak. to date, there have been little to no randomized controlled studies addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is necessary as infection prevention in myeloablative stem cell transplant patients. for this reason, our research is aimed at providing data to substantiate the use of neutropenic diets in preventing infections in recipients of myeloablative stem cell transplants.

in the proposed pilot study, a randomized design will be used to address the primary and secondary aims. subjects will be randomized to either the experimental group receiving a non-neutropenic diet without restriction, or to the control group receiving the standard neutropenic diet. while randomization will occur prior to, or on the day of their inpatient admission and the subjects will begin study procedures upon admission to the adult stem cell transplant inpatient unit at duke university medical center. the diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged from the inpatient unit to continue their care in the adult stem cell transplant outpatient clinic. by limiting the study to the time of care on the inpatient unit, we will minimize the opportunity for deviation from the assigned diet. absence of neutropenia will be defined as an absolute neutrophil count of greater than 500/ul (manual differential) and a total white blood cell count of 1000/ul for three consecutive days. all subjects enrolled will follow the standard prophylactic antibiotic regimen. other supportive care will also be consistent in the two groups.

Eligibility criteria:
inclusion criteria: 1. scheduled to undergo a myeloablative allogeneic stem cell transplant for any cancer or non-cancer illness from any related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood 2. age 20-70 years of age 3. karnofsky performance scale kps\> 80 4. ability to read and write english exclusion criteria: 1. autologous stem cell transplant recipients 2. non-myeloablative or reduced intensity stem cell transplant recipients 3. pregnant women 4. patients with a documented active infection prior to starting their preparative regimen. this includes grade 3 or higher viral, bacterial, or fungal infection.

Keywords: neutropenic diet, non-neutropenic diet, allogeneic sct
a long term extension study evaluating acc-001 with qs-21 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the long term safety, tolerability, and immunogenicity of acc-001, an investigational vaccine, plus qs-21 in subjects with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: subjects randomized under previous 3134k1-2201 study (nct00498602) and met all inclusion/and none of the exclusion criteria. screening brain mri scan is consistent with the diagnosis of ad. mini-mental state examination (mmse) score greater than or equal to 10. other criteria apply. exclusion criteria: significant neurological disease other than alzheimer's disease. current clinically significant systemic illness. other exclusion criteria apply.
risk factors for long-term opioid use

Conditions: Pain Syndrome

Summary: surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. we examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making. using the ibm marketscan® research database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (january 2007-september 2015). multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year.


Eligibility criteria:
inclusion criteria: * 18-64 years old * at least one encounter for anorectal, foot/ankle, or tmj pain * marketscan continuous enrollment for 1 year prior and 1 year after the index pain encounter
study of nimotuzumab combined with concurrent chemoradiotherapy for locally advanced cervical cancer

Conditions: Neoplasms; Cervical Adenosquamous Cell Carcinoma; Cervical Squamous Cell Carcinoma in Situ; Stage IB Cervical Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer

Summary: the purpose of this phase ii trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

this phase ii trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (egfr) monoclonal antibody that is approved in many countries for the treatment of egfr-positive cancers. some block the ability of tumor cells to grow and spread. others find tumor cells and help kill them or carry tumor-killing substances to them. nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. radiation therapy uses high-energy x-rays to kill tumor cells. drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.

Eligibility criteria:
inclusion criteria: * all volunteers will sign the informed consent. * histologically confirmed squamous cell of the uterine cervix, egfr(+). * the figo stage (iib-iva) and was not available for surgical treatment. * there is at least one tumor lesion that is measurable by recist. * during the study, contraception should be ensured. * karnofsky performance status \>60. * wbc \>= 3,000/mm\^3 * absolute granulocyte count \>= 1,500/mm\^3 * platelet count \>= 100,000/mm\^3 * inr \< 1.5 * total bilirubin =\< 1.5 mg/dl * serum creatinine =\< 1.5 mg/dl * ast and alt =\< 2.5 times upper limit of normal (uln) * serum calcium =\< 1.3 times uln * hemoglobin \>= 9g/dl (transfusion allowed) exclusion criteria: * positive para-aortic lymph nodes or positive lymph nodes beyond pelvic * prior invasive malignancy (except nonmelanomatous skin cancer) * contraindication of chemotherapy; * rare pathological subtype; * cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.

Keywords: cervical cancer radiation therapy chemotherapy nimotuzumab cisplatin
a 3-fold crossover bioequivalence study between glucobay odt (orally disintegrating tablet) 100 mg and glucobay standard tablet 100 mg

Conditions: Diabetes Mellitus, Type 2

Summary: to establish the bioequivalence between glucobay odt (orally disintegrating tablet) 100 mg taken without or with water and the glucobay standard tablet 100 mg taken with water.


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 45 years (inclusive) at the first screening examination / visit * ethnicity: white * body mass index (bmi): above/equal 18 and below/equal 28 kg / m² exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor * known hypersensitivity to the study drugs (active substances or excipients of the preparations) * known severe allergies, non-allergic drug reactions, or multiple drug allergies * chronic intestinal disorders associated with distinct disturbances of digestion and absorption * states which may deteriorate as a result of increased gas formation in the intestine (e.g. roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, crohn´s disease, ulcerative colitis, malabsorptions) * fasting blood glucose level outside normal range * impaired glucose tolerance in glucose tolerance test

Keywords: bioequivalence acarbose odt
the randomised study of preoperative radiotherapy with consolidating chemotherapy for unresectable rectal cancer

Conditions: Rectal Cancer

Summary: the addition of oxaliplatin to conventionally fractionated chemoradiation (fulv or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. the investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of folfox4 may increase the rate of r0 resection in patients with unresectable rectal cancer.

patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. the preoperative treatment in the control arm is conventionally fractionated chemoradiation with 50.4 gy total dose in 28 fractions of 1.8 gy over 5.5 weeks simultaneously with 5-fu, leucovorin and oxaliplatin. experimental group receive 25 gy in 5 fractions of 5 gy over 5 days and after one week interval - consolidating chemotherapy of 3 courses of folfox4. surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil or radiation. the study hypothesis is that the short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10% increase of the rate of r0 resection compared to preoperative chemoradiation.

Eligibility criteria:
inclusion criteria: * patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases. * who performance status ≤ 2. * lower border of tumour ≤ 15 cm from anal verge. exclusion criteria: * cardiac coronary arterial disease, * arrhythmias, * stroke even if they have occurred in the past and are controlled with medication

Keywords: rectal cancer preoperative radiotherapy and consolidating chemotherapy
delphi study to identify crucial steps and errors in the placement of chest tubes

Conditions: Thoracic Injury

Summary: the goal of this delphi study is to identify the crucial steps and the errors in chest tube insertion (cti). these steps and errors will be used for the development of a new assessment tool based on international consensus.


Eligibility criteria:
inclusion criteria: * must be experts in their respective fields. * must hold a degree of master in medicine * must have finished the residency training specific to their field (be an attending physician) * must have 5 years post-residency experience * must have performed at least 50 ctis independently in their career * must have an interest in educating and guiding junior residents in their training. exclusion criteria: * insufficient experience in cti * insufficient experience as an attending physician

Keywords: assessment chest tube insertion rating scale
a trial of hrs-8427 in the treatment of adults with bacterial pneumonia

Conditions: Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP)

Summary: the purpose of this study is to evaluate the efficacy and safety of hrs -8427 in patients with habp/vabp.


Eligibility criteria:
inclusion criteria: 1. be able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol. 2. male and female, ≥18 years. 3. judged by the investigator, clinical diagnosis with habp/vabp, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics. 4. all subjects must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia. 5. women of childbearing potential must have a negative serum pregnancy test before the first dose and must be non-lactating. fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth and sperm/ovum donation from the time of signing the informed consent form (icf) till 14 days after the end of treatment. exclusion criteria: 1. subjects who have known or suspected community-acquired bacterial pneumonia (cabp), atypical pneumonia, or chemical pneumonia. 2. subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites. 3. habp or vabp caused by obstruction. 4. subjects who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization. 5. impairment of renal function with estimated glomerular filtration rate \< 15 ml/min, or receiving peritoneal dialysis/hemodialysis. 6. subjects with significant laboratory abnormalities. 7. other pulmonary diseases that may confound the assessment of efficacy or safety. 8. known history of immune deficiency disease or receive immunocompromising treatment. 9. severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition. 10. known or suspected central nervous system infections. 11. patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period. 12. drug abuse within 1 year prior to randomization. 13. judged by the investigator, other reasons unsuitable for this study.