Kornimate/medical-research-clean huggingface dataset:
multidisciplinary education in lung cancer patients who receiving chemotherapy treatment

Conditions: Lung Cancer

Summary: the purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.

educate of self-care by oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. by using home exercise program, 30 minutes of physical education. teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.

Eligibility criteria:
inclusion criteria: 1. aged 45-65 years. 2. has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy. 3. performance status: ecog 0-1 4. no problem hearing it. 5. read and write thai. 6. be willing to cooperate in research. and signed a joint research exclusion criteria: 1. the complications include: high fever, severe nausea and vomiting. 2. injection drug use in diabetes treatment. 3. ischemic heart disease with heart arrhythmia and the drug continuously. 4. is unable to daily living. caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.

Keywords: lung cancer chemotherapy multidisciplinary self care programme fatigue
combination of rectal indomethacin and pancreatic duct stenting versus indomethacin alone in preventing pep

Conditions: Healthy

Summary: rectal indomethacin and pancreatic duct (pd) stenting (pds) are recommended for the prevention of post-ercp pancreatitis (pep). however, the effects of the combination of the two methods on preventing pep are controversial. we hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus pds (ip) compared with indomethacin alone (in).


Eligibility criteria:
inclusion criteria: 1. patients underwent diagnostic or therapeutic ercp 2. with native papilla 3. with difficult cannulation (cannulation time \>10min or cannulation attempts \>5 times or inadvertently pd cannulation ≥1) 4. receiving post-ercp rectal indomethacin exclusion criteria: 1. patients with indications of pd cannulation 2. no attempt of cannulation due to inaccessible papilla 3. non-difficult cannulation

Keywords: indomethacin double-guidewire technique adverse events pep pd stenting
a bayesian analysis of three randomised clinical trials of intraoperative ventilation

Conditions: Mechanical Ventilation Complication; Surgery; Pulmonary Complication; Postoperative Complications

Summary: the investigators designed a protocol for a bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. the primary endpoint will be a composite of postoperative pulmonary complications (ppc) within the first seven postoperative days, which reflects the primary endpoint of the original studies. the investigators will carry out a reanalysis of the harmonised database using bayesian statistics.

background: using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers. methods: the investigators designed a protocol for a bayesian analysis using the pooled dataset. the multilevel bayesian logistic model will use the individual patient data. prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. the primary endpoint will be a composite of postoperative pulmonary complications (ppc) within the first seven postoperative days, which reflects the primary endpoint of the original studies. the investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (or) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (hdi) falls between the region of practical equivalence.

Eligibility criteria:
inclusion criteria: * planned for major surgery * at risk for pulmonary complications exclusion criteria: * planned thoracic surgery . * unscheduled surgery (i.e., urgent, or emergent surgeries)

Keywords: mechanical ventilation, bayesian analysis peep recruitment maneuvers intraoperative mechanical ventilation postoperative complications perioperative medicine
bicarbonate given during dystocic labor

Conditions: Arrested Labor

Summary: dystocic deliveries and the use of bicarbonate

a randomized controlled trial of 200 primiparous women in active labour.if cervical dilation crossed the action line in the partogram or if labour progress was arrested for two hours or more the delivery was considered to be dystocic, and oxytocin was suggested for stimulation. inclusion criteria were: primiparity, singleton pregnancy, with an arrested labour progress with a need for oxytocin. gestational age was between 37-42 weeks, and no maternal /fetal chronic and/or pregnancy-related conditions. excluded were multiparous women, deliveries with non-cephalic presentation, multiples, deliveries with fetal chronic and/or pregnancy-related conditions, iufd (intra uterine fetal death) or premature \< 37 weeks of gestation. a randomization into two groups was performed. one group was treated with two bags of samarin® (=samarin® group, 5g bicarbonate) one hour before stimulation with oxytocin started. the other group (=nonsamarin® group) received no bicarbonate and started oxytocin immediately, according to local clinical guidelines. maternal and fetal data was collected from medical files after delivery and analysed according to group.

Eligibility criteria:
inclusion criteria: * primiparity, singleton pregnancy * with an arrested labour progress according to the partogram with a need for oxytocin * gestational age was between 37-42 weeks * and no maternal /fetal chronic and/or pregnancy-related conditions. exclusion criteria: * multiparous women * deliveries with non-cephalic presentation * multiples * deliveries with fetal chronic and/or pregnancy-related conditions * iufd (intra uterine fetal death) or premature \< 37 weeks of gestation

Keywords: labor dystocia
darbepoetin alfa treatment of anemia in hemodialysis subjects

Conditions: Anemia

Summary: the purpose of this study is to compare once a week and once every other week darbepoetin alfa on the change in hemoglobin levels between the screening/baseline period and the evaluation period (weeks 25-30). this study will also assess the change in mean hemoglobin over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing requirements and red blood cell transfusions.


Eligibility criteria:
inclusion criteria: - -receiving hemodialysis for at least 6 months before screening - -clinically stable as judged by the investigator - stable iv rhuepo therapy administered 1, 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than or equal to 25% change \[up or down\] in weekly dose and no change in frequency over 8 weeks) - adequate iron stores (serum ferritin greater than or equal to 100μg/l) during the screening period - available for follow up assessments - before any study specific procedure is carried out, the subject, or his/her legally acceptable representative must give informed consent for participation in the study exclusion criteria: - -treatment for grand mal epilepsy in the last 6 months - congestive heart failure (new york heart association \[nyha\] class iii or iv)- - uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement greater than or equal to 110mmhg during the screening period - clinical evidence of current uncontrolled hyperparathyroidism (e.g., serum parathyroid hormone greater than 1500pg/ml) within the past 12 months - major surgery within 3 months before screening (excludes vascular access surgery) - previously diagnosed hiv or chronic hepatitis b infection - clinical evidence of current malignancy excluding basal cell or squamous cell carcinoma of the skin - systemic hematological disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia - alanine transaminase (alt) and aspartate transaminase (ast) greater than 2 times the upper limit of the normal range - rbc transfusion(s) within 12 weeks before screening or during the screening/baseline period, or active bleeding - clinical evidence of current systemic infections - androgen therapy within 12 weeks before screening - no prior treatment with darbepoetin alfa - currently enrolled in, or has not yet completed a period of at least 30 days since ending, other investigational device or drug trial(s). subjects receiving other investigational agent(s) may only enter the study after discussion and agreement with amgen - pregnancy (women of child-bearing potential must be using adequate contraception) - breast feeding - psychiatric, addictive, or other disorder that compromises ability to give truly informed consent or is likely to alter compliance - anticipating or scheduled for a living-related kidney transplant

Keywords: hemodialysis darbepoetin alfa clinical trial amgen
patients with renal impairment undergoing ct

Conditions: Contrast Induced Nephropathy

Summary: the purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of isovue or visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated iv contrast-enhanced (multidetector computed tomography) mdct of the liver or mdct angiography of the lower extremities. serum creatinine (scr) will be measured before and up to 48-72 hours post dose.


Eligibility criteria:
inclusion criteria: * referred for mdct of liver or peripheral cta * stable baseline scr of 1.5 - 2.5 mg/dl and/or calculated crcl of 10-60 ml/min exclusion criteria: * unstable renal function * required prophylactic drugs to receive contrast (other than hydration) * uncontrolled diabetes * currently on dialysis
a study of kappa opioid receptor occupancy of pf-04455242, using pet (positron emission tomography)

Conditions: Bipolar Disorder; Depression

Summary: this is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. up to 15 healthy subjects will be included in the study. in the first part of the study the test retest reliability of the radiotracer \[11c\] pf 04767135 binding in man will be assessed. in the second part of this study, using \[11c\] pf 04767135, kappa opioid receptor occupancy (ro) will be assessed in up to three cohorts of subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests.) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen at screening or day 0. * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men. * use of tobacco- or nicotine-containing products within 3 months of screening. * treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication (excluding \[11c\]pf 04767135). * 12 lead ecg demonstrating qtc \>450 msec at screening. * pregnant or nursing females; females of childbearing potential.
pertussis infection in adolescents and adults with prolonged cough

Conditions: Pertussis

Summary: this study aims to determine the burden of pertussis infection among adolescents and adults with prolonged cough in four asian countries, namely malaysia, philippines, taiwan and thailand. this study also aims to assess the health economic (he) impact of pertussis.

data from this cross-sectional study will be useful in reviewing the need for introduction of booster doses of pertussis vaccines in adolescent and adult population in malaysia, philippines, taiwan and thailand. this study will enrol patients with prolonged cough of 2 weeks or more and detect pertussis with serological tests in order to estimate the prevalence of pertussis infection among such patients. no vaccine will be administered during this study.

Eligibility criteria:
inclusion criteria: * adolescents aged 13-18 years or adults aged \>18years. * presenting with prolonged cough of 2 weeks (14 days) or more. * subjects who the investigator believes that they/ their parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * written informed consent obtained from the subject/ from the parent(s)/lar of the subject. if the subject below the age of consent is legally eligible, his/her signature on the informed assent form should be obtained. exclusion criteria: * child in care. * subjects with known chronic cough-causing disease and immunodeficiency. * subjects treated with angiotensin-converting enzyme inhibitors (acei), within the past 4 weeks (28 days).

Keywords: pertussis infection prevalence health economic burden prolonged cough
safety and clinical activity of lapatinib in patients with her2-positive refractory advanced cancer

Conditions: HER2-positive Refractory Advanced Cancer

Summary: although anti-her2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the her2 protein or amplified for the her2 gene, her2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. indeed, about 1-37% of tumors of the following types harbor her2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct. lapatinib is an orally active, reversible, small molecule tki that potently inhibits both erbb1 and erbb2 tyrosine kinase activity. data suggest that a dual erbb1 and erbb2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor. therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with her2-positive refractory cancer.


Eligibility criteria:
inclusion criteria: * age \> 19 * written informed consent * ecog 0-2, * histologically confirmed her2-positive refractory solid tumor(ihc 3+ alone, or ihc 2+ with fish amplification) and/or specific sensitivity to lapatinib by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. * the presence of measurable disease as defined by the response (evaluation criteria in solid tumors (recist) version 1.1) * adequate organ function exclusion criteria: * uncontrolled symptomatic brain metastasis,uncontrolled active infection * uncontrolled systemic illness (dm, chf, unstable angina, hypertension or arrhythmia) * prolonged qt interval in ecg (qtc \>450 msec) * pregnant, lactating women * prior treatment with lapatinib,malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication * prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Keywords: lapatinib
celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Conditions: Colon Cancer Stage

Summary: the study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

the primary aim of the study is to evaluate the anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Eligibility criteria:
inclusion criteria: * advanced colorectal cancer exclusion criteria: * cerebral metastases * other malignancy * h pylori infection * thromboembolism
open label study of oto-104 in subjects with meniere's disease

Conditions: Meniere's Disease

Summary: this is a 1-year, multicenter, phase 2, open-label safety study in subjects with unilateral meniere's disease. subjects will receive 1 intratympanic (it) injection of 12 mg oto-104 at 3-month intervals for a total of 4 injections total.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject has a diagnosis of definite unilateral meniere's disease. * subject agrees to maintain their current standard of care treatments for meniere's disease while on-study. exclusion criteria includes, but is not limited to: * subject has an infection in the ear, sinuses, or upper respiratory system. * subject is pregnant or lactating. * subject has a history of immunodeficiency disease. * subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma. * subject has experienced an adverse reaction to intratympanic injection of steroids.
using mscs for chronic active antibody mediated rejection

Conditions: Kidney Transplant Rejection

Summary: mesenchymal stem cell (mscs) therapy has already been studied in kidney transplant recipients (ktrs), and the available data showed that it is safe and well tolerated. the aim of this study was to evaluate the safety and efficacy of autologous mscs in combination with standard therapy in ktrs with biopsy-proven chronic active antibody-mediated rejection (amr). patients with biopsy-proven chronic active amr received treatment with autologous bone marrow-derived mscs (3 × 106 cells/kg iv) after completion of standard therapy and were followed for up to 12 months. the primary endpoints were safety by assessment of adverse events. secondary endpoints included assessment of kidney graft function, immunological and histological changes related to amr activity and chronicity assessed by conventional microscopy and molecular transcripts. a total of 3 patients were enrolled in the study before it was terminated prematurely because of adverse events. we found that amr did not improve in any of the patients after treatment with mscs. in addition, serious adverse events were observed in one case when autologous mscs therapy was administered in the late phase after kidney transplantation, which requires further elucidation.

the aim of this study was to evaluate the safety and efficacy of autologous mscs in combination with standard therapy in ktrs with biopsy-proven chronic active antibody-mediated rejection (amr). patients with biopsy-proven chronic active amr will receive treatment with autologous bone marrow-derived mscs (3 × 106 cells/kg iv) after completion of standard therapy and will be followed for up to 12 months. the primary endpoints are safety by adverse events. secondary endpoints include assessment of kidney graft function, immunological and histological changes related to amr activity and chronicity assessed by conventional microscopy and molecular transcripts.

Eligibility criteria:
inclusion criteria: * chronic active antibody mediated rejection in kidney transplanted recipients exclusion criteria: -
an innovative trial assessing donor sex on recipient mortality

Conditions: Red Blood Cell Transfusion

Summary: the itads trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood. the trial will help determine how the investigators can tailor the selection of blood donors based on donor characteristics (e.g. sex) to further improve the safety and optimize the clinical benefit of blood products in canada.

the investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions. primary objective: to confirm that a transfusion strategy of receiving male donor rbc (red blood cell) units only will improve survival compared to a transfusion strategy of female donor rbc units in all hospital patients requiring a transfusion. secondary objectives: 1. to assess effects of male rbc units on major morbidities (cancer, infection, end-organ damage) 2. to assess effects across major patient subgroups (major surgery, intensive care, oncology) 3. to assess the effect of female donor pregnancy history on recipient transfusion outcome 4. to build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.

Eligibility criteria:
inclusion criteria: * all patients (excluding neonates) requiring one or more allogeneic rbc transfusions for the treatment of anemia will be included. exclusion criteria: * patients that do not have a valid ontario health insurance plan (ohip) number at time of first transfusion * patients that require emergent release of a rbc transfusion and in whom emergency randomization could not be completed * patients with complex antibody profile in which it is impossible to match rbc units

Keywords: anemia donor sex prospective blinded pragmatic randomized
specific molecular signatures predict neoadjuvant chemotherapy response in cervical cancer

Conditions: Uterine Cervical Neoplasms; Cervical Cancer; Uterine Cervical Cancer

Summary: cervical cancer is one of the major health problems for chinese women. besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. however, not all patients respond well to neoadjuvant chemotherapy. knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments. this study is undertaken to build specific molecular signatures to predict the effects of neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * untreated cervical cancer with figo stage ib-iib * measurable lesions * possible to radical hysterectomy * age: 18 and older * karnofsky performance status≥ 70. * wbc \> 3,000/mm³, hb \> 9.0g/dl, platelet \> 100,000 /mm³, sgot/sgpt \ 80 torr, normal ecg * written informed consent exclusion criteria: * previous history of cancer * patients with previous treatment * patients without information of clinical risk factors * patients who have active infection