Kornimate/medical-research-clean huggingface dataset:
phase iii double-blind comparative study of bay77-1931 (lanthanum carbonate) with calcium carbonate

Conditions: Hyperphosphatemia

Summary: to assess the effect on reduction of serum phosphate and the safety of bay77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with calcium carbonate.


Eligibility criteria:
inclusion criteria: * pre-dialysis serum phosphate levels: ≧5.6 mg/dl and \<11.0 mg/dl at 1 week after the initiation of the washout period. * out-patient * undergoing hemodialysis three times per week for at least previous 3 consecutive months exclusion criteria: * pre-dialysis serum phosphate levels of ≧10.0 mg/dl at the start of the washout period or ≧11.0 mg/dl at 1 week after * corrected serum calcium level of \<7.0 mg/dl or ≧11.0 mg/dl at the start of the washout period and/or 1 week after * serum intact pth (parathyroid) of ≧1000 pg/ml at the start of the washout period * pregnant woman, or lactating mother * significant gastrointestinal disorders including known acute peptic ulcer * liver dysfunction * history of cardiovascular or cerebrovascular diseases * requiring treatment for hypothyroidism

Keywords: hyperphosphatemia in esrd (end stage renal disease) patients on dialysis
the use of major depression inventory (mdi) in measuring preoperative depressive symptoms in breast cancer patients

Conditions: Depression; Depressive Symptoms

Summary: the purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with major depression inventory (mdi). the investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.

the major depression inventory is a self-rating depression scale with 12 questions. the questionnaire has previously been investigated in a danish population. the scale contains the 10 icd-10 (international classification of diseases)symptoms of depression and these symptoms are identical with the dsm-iv major depression symptoms with the exception of one symptom, low self-esteem, which in dsm-iv (diagnostic and statistical manual of mental disorders) is incorporated in the symptom of guilt. on a six-point likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. the mdi is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument. patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the mdi. patients therefore only complete the mdi once in the whole study. at the same time a mini mental state examination (mmse) and questions regarding previous illnesses and medication will be asked. patients will not be followed up in any way.

Eligibility criteria:
inclusion criteria: * women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy * asa i-iii exclusion criteria: * planned or ongoing preoperative chemotherapy * known and treated sleep apnea syndrome * insulin treated diabetes mellitus * known or previous treated depressive illness or bipolar disorder * known autoimmune disease * incompensated cirrhosis * other previous or ongoing cancer * known medically treated sleep disorder (insomnia, restless legs etc) * shift-work or night-work * daily alcohol intake of more than 5 units * preoperative treatment with psychopharmacological drugs, opioids or anxiolytics * predicted bad compliance * pregnant or breast feeding * preoperative mmse score less than 24
effects of low-dose theophylline during chronic obstructive pulmonary disease (copd) exacerbations

Conditions: COPD

Summary: molecular mechanisms of copd exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. nf-kappa b-dependent pathway and acetylation status of nuclear histones are to be studied.design: controlled, prospective and randomized study with or without theophylline, a potent hdac activator.objectives: 1) to determine nf-kb activation, histone deacetylase (hdac) and histone acetyl-transferase (hat) activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3 months later, once stability is achieved. to correlate these measurements with inflammatory and oxidative stress markers and with pulmonary function and clinical variables. 2) to assess the effect of theophylline on previous molecular, functional and clinical data. method: 25 patients with copd will be recruited during an episode of exacerbation requiring hospitalization. nf-kb activation, hdac and hat activity, markers of inflammation and oxidative stress will be determined with specific assays. these determinations will be repeated once the patient is stable and compared with smokers and non smoker controls with normal lung function


Eligibility criteria:
inclusion criteria: * severe copd according to gold guidelines * age between 40 and 75 * admission to hospital due to copd exacerbation exclusion criteria: * history of asthma * pulmonary embolism * pneumonia * other chronic inflammatory disease * patient on theophylline at the time of admission * patient on oral steroids at the time of admission

Keywords: copd exacerbation histone steroid resistance inflammation theophylline
captopril use on the degree of marrow fibrosis in bone marrow fibrosis/myeloproliferative neoplasms

Conditions: Bone Marrow Fibrosis; Myeloproliferative Neoplasm

Summary: the purpose of this study is to evaluate the safety and tolerability of captopril and evaluate the effectiveness captopril as measured by changes in the grade of bone marrow scar tissue. the change in spleen size by ultrasound will also be measured.

captopril is an investigational (experimental) drug that works by inhibiting the production of angiotensin ii by blocking angiotensin converting enzyme. reducing angiotensin ii may reduce the bone marrow scar tissue in myelofibrosis. it is not approved by the food and drug administration (fda) for this indication. participants in this study will be asked to have 2 bone marrow biopsies, a total of 3 blood samples, and fill out questionnaires asking about how you feel.

Eligibility criteria:
inclusion criteria: * participants must have histologically confirmed diagnosis of primary myelofibrosis (pmf), or post-polycythemia vera/essential thrombocythemia-mf (i.e. secondary mf) by 2016 who criteria * eastern cooperative oncology group (ecog) performance status 0 -2 * creatinine clearance \>30 ml/minute * women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment. all men and women of childbearing potential must use acceptable methods of birth control throughout the study. * participants should be able to give voluntary informed written consent to participate in the study. informed consent will be obtained prior to enrollment and before any study-related procedure is done that is not part of standard medical care, with the understanding that consent may be withdrawn by the participants any time without prejudice to future medical care. exclusion criteria: * completed hematopoietic cell transplant (hct) * presence of \>10% blasts in peripheral blood or on bone marrow examination * screening blood pressure(bp)parameters of systolic bp \< 100 and diastolic bp \< 60 * splenic irradiation within 3 months prior to the first dose of captopril * prior ace inhibitor, angiotensin ii receptor antagonist, or aliskiren use within 12 months prior to trial enrolment * known allergy/hypersensitivity to ace inhibitors * participants receiving any other investigational agents * pregnant or nursing participants - captopril is a risk category d and is excreted in breast milk * participants with creatinine clearance \<30 ml/minute or on dialysis * any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent

Keywords: primary myelofibrosis (pmf) post-polycythemia vera/essential thrombocythemia-mf (secondary mf)
expression analysis of urinary exosome in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value

Conditions: Diabetic Nephropathy

Summary: expression analysis of urinary exosome mir-142-3p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value

1. preliminary screening of mirnas: through geo database and reading related literature, mirnas differentially expressed in type 2 diabetes and diabetic nephropathy were selected as potential candidate biomarkers for follow-up verification. 2. collection and treatment of clinical samples: urine of diabetic patients was collected from the first affiliated hospital of shandong first medical university in strict accordance with the drainage standard, and the basic information of patients was registered. meanwhile, the collected samples were divided into type 2 diabetes group and diabetic nephropathy group according to whether the urine was accompanied by uacr≥30/g. subsequently, the collected samples were centrifuged and retained for supernatant. 3. isolation and identification of urinary exosomes: ultrafast centrifugation method was used to separate the treated urine samples of exosomes, and then identified by transmission electron microscopy, nanoparticle analysis and western blot respectively. 4. real-time pcr was used to detect the changes in urinary exosomal mirna expression levels of the two groups of patients, and statistical analysis and correlation analysis of clinical indicators of the differentially expressed mirnas were performed. target gene prediction and enrichment pathway analysis of differentially expressed mirnas were performed to screen out pathways that might be related to the occurrence and development of dkd, and then the relevant pathways were verified by immunofluorescence, immunocoprecipitate, western blot, real-time pcr and other methods.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. previously diagnosed with type 2 diabetes; 3. typical diabetic symptoms (polydipsia, polydipsia, polyuria and weight loss) plus random blood glucose ≥11.1mmol/l; 4. fasting blood glucose ≥7.0mmol/l, fasting is defined as at least 8 hours without intake of calories; 5. oral glucose tolerance test (ogtt) 2-hour blood glucose ≥11.1mmol/l, using a glucose load equivalent to 75 grams of anhydrous glucose dissolved in water (venous blood was drawn in all patients; 6. with or without uacr≥30mg/g. exclusion criteria: (1) refused to enroll patients; （2）type 1 diabetic nephropathy and other special types of diabetic nephropathy; （3）patients with kidney stones and urinary system infection; （4）patients with autoimmune system diseases, malignant tumors, and blood system diseases; （5）patients with severe chronic cardiopulmonary disease, chronic liver and kidney disease; （6）patients with severe infectious diseases; （7）use of glucocorticoids, immunosuppressants or cytotoxic drugs.
comparison of two endoscopic biopsic needles for pancreatic tumors

Conditions: Pancreatic Tumor; Puncture

Summary: this observational study compared quality of histological sampling of pancreatic eus-fnb with the 20-gauge procore® and 22-gauge acquire® needles. in total, 68 patients were recruited. histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge procore® group and 97% of patients (33/34) in the 22-gauge acquire® group (p=0.1). core biopsy specimens obtained were significantly longer with the 22-gauge acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge procore® (p\<0,01). reproducibility of this simple histological criterion was validated in intra and inter-observer.

between march and december 2017, 68 eus-fnb were consecutively performed in our unit for a pancreatic or peripancreatic mass. the choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge procore®, and 34 with a 22-gauge acquire®. histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. intra and inter-observer variability of this criterion was then evaluated.

Eligibility criteria:
inclusion criteria: * all consecutive patients ≥18 who were referred for eus-fnb for solid pancreatic or peripancreatic mass were included exclusion criteria: * non-accessible pancreatic mass because of history of billroth ii or roux-en-y reconstruction * coagulation disorders (such as partial thromboplastin time \>42 seconds, prothrombin time \[quick value\] \<50%, platelet count \<50 000/mm³), treatment with clopidogrel, pregnancy. * patients \<18 years of age

Keywords: eus-fnb comparative study
long-term follow-up of subjects treated with otl-300 for transfusion dependent beta-thalassemia study (tiget-bthal)

Conditions: Beta Thalassaemia

Summary: otl-300 is a gene therapy drug product consisting of autologous hematopoietic stem/progenitor cluster of differentiation (cd) 34+ cells genetically modified with a lentiviral vector (globe) encoding the human beta globin gene. the tiget-bthal is a phase i/ii study evaluating safety and efficacy of otl-300 in subjects with transfusion dependent beta-thalassemia for two years post gene-therapy. subjects with rare disease who have undergone gene therapy are followed for efficacy and possible delayed adverse events. thus, this study is designed to follow patients who have received gene therapy on tiget-bthal for an additional six years (for a total of eight years).


Eligibility criteria:
inclusion criteria: * subjects who have completed study tiget-bthal i.e. who have received treatment and been followed for two years post treatment with otl-300. * for adults; capable of giving signed informed consent. for children; informed assent and/or consent in writing signed by the subject and/or parent(s) / legal representative (according to local regulations and age of the subject). exclusion criteria: * none

Keywords: beta thalassaemia previously gsk2696277 lentiviral vector tiget-bthal gene therapy
dose-finding study comparing efficacy and safety of a parp inhibitor against doxil in brca+ve advanced ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of the study is to compare the efficacy and safety of 2 doses of drug azd2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable brca1- or brca2-positive advanced ovarian cancer and who have failed previous platinum therapy.


Eligibility criteria:
inclusion criteria: * advanced ovarian cancer with positive brca1 or brca2 status * progressive or recurrent disease after platinum-based chemotherapy * measurable disease by recist exclusion criteria: * previous anthracycline treatment * brain metastases * less than 28 days since last treatment used to treat the disease * considered a poor medical risk due to a serious uncontrolled disorder

Keywords: advanced ovarian cancer brca1 protein brca2 protein poly(adp ribose) polymerases
fenofibrate in primary biliary cholangitis: a real world study

Conditions: Primary Biliary Cholangitis (PBC)

Summary: an open label long-term study to evaluate the safety and tolerability of fenofibrate in combination with ursodeoxycholic acid in subjects with primary biliary cholangitis (pbc)


Eligibility criteria:
inclusion criteria: 1. must have given written informed consent (signed and dated) 2. completed in a pbc study with fenofibrate(nct05749822,nct06174402) 3. alp\> 1\*uln 4. females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose exclusion criteria: 1. treatment-related adverse event (ae) leading to study drug discontinuation in a previous pbc study with seladelpar 2. a medical condition, other than pbc, that in the investigator's opinion would preclude full participation in the study or confound its results
stress-induced scratching in healthy and ad

Conditions: Healthy; Atopic Dermatitis

Summary: the purpose of this study is to examine scratching behavior and identify brain areas responsible for stress-induced spontaneous scratching in patients with atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: 1. healthy subjects and ad patients between 18 and 59 years of age. 2. healthy subjects: in general, good health without history of neurological and psychiatric diseases. 3. ad patients: an average itch rating of 3 out of 10 or greater in the past two weeks using a numerical rating scale (nrs). 4. all patients will be required to cease use of oral antihistamines from the night before each study visit until the end of the experiment. the purpose is to avoid that participants fall asleep during mri measurement due to side effect oral antihistamine (i.e., sedation). 5. women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant. 6. mri compatibility, criteria include having no major contraindication for mri (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by mri technologist using site approved screening form. 7. participants have to be able to speak and read english fluently. 8. participants must have signed a written informed consent before being enrolled in the study exclusion criteria: 1. individuals under 18 or over 59 years of age. 2. inability to complete the required measures. 3. suffering from any disease state or physical condition, which would increase their health risk by study participation. 4. currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy. 5. recent initiation (within last 3 months) of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications. 6. patients who use centrally acting agents only when they need. the purpose is to avoid a risk of acute effect of these agents on brain activity and perceived stress due to the stress task. 7. current treatment with opioid analgesics. 8. uncontrolled thyroid disease. 9. use of illicit drugs or history of opiate addiction. 10. diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active right now. 11. any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., hiv, hepatitis c, etc). 12. inability to speak and read english. 13. being pregnant. 14. incarcerated.
photodynamic therapy for prevention of nonmelanoma skin cancer in organ transplant recipients

Conditions: Nonmelanoma Skin Cancers

Summary: the study will draw patients from the transplant dermatology specialty clinic, where the investigators see organ transplant recipients (otr) for regular screening and serve as a regional referral center for this population. enrollment will be limited to 20 patients. inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one nmsc.

patients will receive levulan kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation: 2.5 hours and blue light photodynamic therapy utilizing the dusa blu-u device; illumination: 1000 seconds (16 min, 40 secs); administered quarterly for 3 years. patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. the patients will be evaluated by the principal investigator every 3 months, prior to photodynamic therapy (pdt) administration. primary endpoints include: 1. development of non melanoma skin cancers (nmsc) lesions and 2. assessment of actinic damage score. the primary endpoint will be development of new skin cancers at 3 years, based on comparison to rate at baseline from previous (x) year(s) using absolute slope value for number prior to treatment vs. number after treatment. the patients will serve as their own controls and the investigators will analyze the delta in development of non melanoma skin cancers and actinic damage score pre- and post- treatment. additionally, an actinic damage score will be assigned based on the number of actinic keratosis on initial evaluation. at each 3 month follow up visit, the actinic damage score will be reassessed. the investigators will be able to secondarily analyze the delta in the actinic damage score on treatment.

Eligibility criteria:
inclusion criteria: 1. the patient has been the recipient of any solid organ transplant. 2. active immunosuppression for at least 5 years 3. history of at least one nmsc 4. subject is willing to sign an informed consent to participate in this study. exclusion criteria: 1. patient is not appropriate candidate for treatment or research trial per treating physician 2. patient has a mental health condition that makes them unable to participate in this research trial, per pi judgment. 3. patient is on additional immunosuppression for diagnosis unrelated to organ transplant -
efficacy of erythropoietin to prevent acute kidney injury in chronic kidney disease patients undergoing cardiac surgery

Conditions: Acute Renal Failure

Summary: the purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in ckd patients undergoing cardiac surgery.

acute kidney injury (aki)occur 7.7-42% after cardiac surgery. the incidence of aki requiring renal replacement therapy following coronary artery bypass grafting (cabg) surgery was 0.7-3.5% and increase mortality rate. erythropoietin (epo) is now considered a novel anti-apoptotic and anti-inflammatory action. the present study was designed to evaluate the administration of epo as a means of preventing aki in these patients.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * serum creatinine levels \> 1.2 mg/dl and baseline creatinine clearance levels \< 60 ml/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study) * patients who need cardiac surgery exclusion criteria: * patients with acute kidney injury * end stage renal disease (requiring dialysis) * unstable renal function (as evidenced by a change in serum creatinine of \> 0.5 mg/dl, or \> 25%, within 14 days prior to the study) * allergy to any of erythropoietin * suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery. * receiving erythropoietin within 14 days before the study

Keywords: acute kidney injury erythropoietin cardiac surgery