Kornimate/medical-research-clean huggingface dataset:
docetaxel and gemcitabine compared with docetaxel and cisplatin in treating patients with metastatic or locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. it is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer. purpose: randomized phase ii trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.

objectives: i. assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin in patients with metastatic or locoregionally advanced pancreatic cancer. ii. assess the toxicity, response rate, duration of response, time to progression, survival, performance status, and weight associated with these treatment regimens in these patients. outline: this is a randomized, open label, multicenter study. patents are randomized to one of two treatment arms. arm i: patients receive gemcitabine iv over 30 minutes on days 1 and 8 and docetaxel iv over 1 hour on day 8. arm ii: patients receive docetaxel iv over 1 hour followed by cisplatin iv over 1 hour on day 1. treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 6 weeks until disease progression, and then every 8 weeks until death. projected accrual: up to 82 patients (41 per arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed metastatic or locoregionally advanced (with metastatic lymph nodes) unresectable adenocarcinoma of the exocrine pancreas bidimensionally measurable disease outside previously irradiated fields no cns involvement or leptomeningeal disease patient characteristics: age: 18 and over performance status: who 0-1 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.5 times the upper limit of normal (uln) renal: creatinine no greater than uln other: no prior second malignancy in the past 10 years except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin no psychological, familial, sociological, or geographical condition that precludes study compliance not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: no prior immunotherapy chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: concurrent radiotherapy allowed if indicator lesions not included in irradiated field see disease characteristics surgery: not specified other: no concurrent investigational drugs

Keywords: stage iii pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer
advisatm ipg clinical evaluation study

Conditions: Bradycardia; Atrial Tachyarrhythmia

Summary: the purpose of the advisa ipg clinical study is to evaluate the overall system safety and clinical performance of the advisa dr implantable pulse generator (ipg).

the advisa ipg is an investigational dual chamber pacemaker that provides rate-responsive bradycardia pacing and diagnostics and atrial tachycardia detection and therapy. the study will be a prospective, non-randomized, multicenter clinical study, conducted. to allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the advisa device. data will be collected at baseline (enrollment), implant, 1-, 3- and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, system modifications, technical observations, study deviations, study exit, upon notification of new or updated adverse events and in case of death.

Eligibility criteria:
inclusion criteria: * patients who have an ipg indication for implantation of a dual chamber pacemaker. * patients who are geographically stable and available for follow-up at the study center for the duration of the study. * patients who have signed a medical ethics committee (mec) approved informed consent form. exclusion criteria: * patients with a life expectancy less than the duration of the study. * patients with a class iii indication for permanent pacing according to acc/aha/naspe 2002 guidelines. * patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
the efficacy of the caregiver psychoeducational consultation program

Conditions: Depression; Sleep

Summary: aim: to examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life. this is the 2-year study. the design adopts the randomized controlled trial (rct). the caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (cpcp). the usual care includes providing education materials only. measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.

to examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life. this is the 2-year study. the design adopts the randomized controlled trial (rct). the caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (cpcp). the usual care includes providing education materials only. measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.

Eligibility criteria:
inclusion criteria: * spouse caregivers of patients with resectable colorectal cancer, * those who are willing to participate in the research, * aged above 18. exclusion criteria: * who refuses to participate in this study.

Keywords: caregiver, psychoeducational, colon
new monitoring in differential diagnosis of hyperlactathemia in cardiopulmonary bypass surgery

Conditions: Etiology of Hyperlactathemia; Early Period After Cardiopulmonary Bypass Surgery; Washout Phenomenon

Summary: objective: the objective of the study was to investigate a reverse correlation between blood lactate levels and rso2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period.

the objective of the prospective study was to investigate a reverse correlation between blood lactate levels and rso2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period. sixty american society of anesthesiologists (asa) ii-iii patients were included in this study. perioperative data, including age, weight, body surface area, gender, body temperature, preoperative co-morbidities, intraoperative and postoperative hemodynamic parameters, arterial blood gas analysis (abg), cardiopulmonary bypass and aortic cross-clamp duration, flow rate, urine output, and blood product and inotropic agent usage, were recorded. postoperative plasma lactate levels were measured simultaneously with cerebral tissue oxygen saturation (rso2) in both cerebral hemispheres at 10 different time points.

Eligibility criteria:
inclusion criteria: * asa) ii-iii patients, aged 43-80 years, undergoing on-pump coronary artery bypass grafting exclusion criteria: * active congestive cardiac failure, intraoperative death, urgent cardiac surgery or reoperation, hemodynamic instability or need of inotropic support before the operation, the elevation of any parameters preoperatively suggestive of systemic hypoperfusion, coagulopathy, renal failure, hepatic dysfunction, local or systemic infection, and inflammation.

Keywords: early hyperlactatemia cerebral oxygen saturation, cardiovascular surgery
ph2 gem/nov/rituxan rel/ref mantlecell

Conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Summary: to determine the efficacy (response rate) produced by the combination of gemzar, novantrone, and rituxan in relapsed or refractory mcl


Eligibility criteria:
inclusion criteria: * stage iii or iv, histologically confirmed relapsed or refractory mcl as reviewed by the si * is cd20 positive (by immunohistochemistry or facs) * is cyclin d positive (by immunohistochemistry or facs) * has received prior chemotherapy (required minimum of 1 prior therapies) * has received prior treatment with rituxan * has an ecog performance status (ps) 0-2 * is greater than or equal to 18 years of age * has appropriate laboratory values (please refer to protocol for specific laboratory values) * if a history of cardiac disease is indicated, patient has an lvef greater than or equal to 50% (muga) * has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential) * if fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter * has signed a patient informed consent form * has signed a patient authorization form exclusion criteria: * has other lymphomas not classified as mcl * has had prior treatment with gemzar and/or novantrone * a history of known hypersensitivity to gemzar, novantrone, rituxan, or any component of these drugs * has a history of hypersensitivity to murine-cell derived therapeutics * has a lvef indicative of a cardiac condition (lvef \< 50%) * is receiving concurrent immunotherapy * has evidence of cns involvement * has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection * has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs * is a pregnant or nursing woman * is unable to comply with requirements of study
phase ii cont. iv of on 01910.na in mds w/ trisomy 8/intermed-1, 2/high risk

Conditions: Myelodysplastic Syndromes

Summary: this study is under molecular and cellular characterization of myelodysplastic syndromes (mds) (eprotocol 15369). the purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent on 01910.na (eprotocol 16214). this study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in on01910.na-treated mds patients. this study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in on01910.na-treated mds patients.


Eligibility criteria:
inclusion criteria: * diagnosis of ipss intermediate or high risk mds by bone marrow biopsy, marrow cytogenetics and blood counts, using fab morphologic criteria * eastern cooperative oncology (ecog) performance status of 0-2 * adequate liver function, as evidenced by a serum bilirubin less or equal to 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of gilberts disease) or an alt and ast 3 times the laboratory normal range * a serum creatinine concentration less or equal to 2mg/dl * subjects must be equal or greater than 18 years of age at the time of obtaining informed consent * written informed consent exclusion criteria: * prior history of leukemia or aplastic anemia * prior history of bone marrow transplantation * platelet count \<100,000/mm\^3 \*prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization * active or uncontrolled infections * unstable angina, congestive heart failure \[nyha\>classii\], uncontrolled hypertension \[diastolic \>100mmhg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction * less than 4 weeks since receipt of any investigational product or device * pregnant or breast feeding * subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator * previously enrolled in this study * will not be available for follow-up assessments * any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
an evaluation of a novel glucose sensing technology in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: to evaluate the impact of the abbott sensor based glucose monitoring system on glycaemic control (hba1c) compared to self monitoring blood glucose (smbg) testing using a randomised controlled study design in adults with type 2 diabetes using insulin.


Eligibility criteria:
inclusion criteria: 1. has type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry. 2. their insulin management must be one of the following; 1. an injection regimen of prandial insulin at least once daily, 2. or, prandial insulin at least once daily plus basal insulin at least once daily, 3. or, continuous subcutaneous insulin infusion (csii) with no plans to change during the study. 3. hba1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study. 4. reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to study entry. 5. in the investigator's opinion the subject is considered technically capable of using the abbott sensor based glucose monitoring system. 6. in the investigator's opinion the subject is proactive and therefore willing to modify their diabetes management 7. aged 18 years or over. exclusion criteria: 1. insulin regimen consists entirely of basal or includes bi-phasic insulin. 2. subject is currently prescribed animal insulin. 3. subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study. 4. has known allergy to medical grade adhesives. 5. currently participating in another device or drug study that could affect glucose measurements or glucose management. 6. currently using a continuous glucose monitoring (cgm) device or has used one within the previous 4 months. 7. is planning to use a cgm device at any time during the study. 8. total daily dose of insulin (tdd) is \>1.75iu/kg at entry to the study. 9. a female subject who is pregnant or planning to become pregnant within the study duration. 10. currently receiving dialysis treatment or planning to receive dialysis during the study. 11. has experienced an acute myocardial infarction within previous 6 months. 12. has a concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition. 13. has a pacemaker or any other neuro stimulators. 14. has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months. 15. has experienced any episode of diabetic ketoacidosis (dka) or hyperosmolar hyperglycaemic state (hhs) in the previous 6 months. 16. in the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.

Keywords: sensing technology type 2 diabetes,
behavioral pharmacology of thc and beta-myrcene

Conditions: Cannabis Use

Summary: this study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and thc administered via inhalation.

the proposed study will be conducted at the johns hopkins behavioral pharmacology research unit (bpru). participants will complete 9 acute drug administration periods in which they will administer thc alone, myrcene alone, thc and myrcene together, or placebo. subjective drug effects and vital signs will be assessed following drug administration. each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. the study will help us understand the individual and interactive effects of thc and b-myrcene, two common constituents found in cannabis.

Eligibility criteria:
inclusion criteria: 1. have provided written informed consent 2. be between the ages of 18 and 55 3. be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests 4. test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission 5. not be pregnant or nursing (if female). all females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission. 6. have a body mass index (bmi) in the range of 18 to 36 kg/m2 7. blood pressure at screening visit does not exceed a systolic blood pressure (sbp) of 150 mmhg or a diastolic blood pressure (dbp) of 90 mmhg 8. have no allergies to any of the ingredients used to prepare vapor (delta 9-thc, myrcene). 9. demonstrate competency on cognitive performance measures at screening visit (e.g., pasat score over 75). exclusion criteria: 1. non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the screening visit; 2. history of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures. 3. use of an otc, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. 4. use of a prescription medication (with the exception of birth control prescriptions) within 5 half-lives for that specific drug; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. 5. cannabis use that is inconsistent with protocol requirements. 6. clinically significant cardiac arrhythmias or vasospastic disease (e.g., prinzmetal's angina). 7. individuals with anemia or who have donated blood in the prior 30 days
prevalence and clinical characterization of hepatitis d virus (hdv) infection among sudanese patients with hepatitis b virus

Conditions: Hepatitis B; Hepatitis D; Viral Hepatitis

Summary: background: sudan has a high prevalence of hepatitis b surface antigen (hbsag), exceeding 8%. the prevalence of hepatitis b varies across different regions of sudan, ranging from 6.8% in central sudan to as high as 26% in southern sudan. hepatitis b virus (hbv) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (hcc). hepatitis d virus (hdv) relies on hbv for replication and can accelerate the progression of hbv-related liver diseases, leading to more severe outcomes. this study aims to determine the prevalence of hdv infection among sudanese patients with hbv-related liver diseases and to investigate the clinical characteristics of patients with hbv/hdv co-infection. design/method: this descriptive cross-sectional hospital-based study was conducted at ibn sina specialized hospital in sudan between june and september 2022. ninety hbv patients aged 16 years and above were included. patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. investigations included liver function tests, abdominal ultrasounds, and elisa for ant-hdv-igg


Eligibility criteria:
inclusion criteria: * patients aged 16 years and above * with hepatitis b virus infection exclusion criteria: * patients with hiv or hcv co-infection
phase ii study of bexarotene in patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with acute myeloid leukemia (aml) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. retinoic acids are a class of drugs related to vitamin a, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * confirmed diagnosis of aml as proven by bone marrow biopsy * must have received prior induction therapy with conventional chemotherapy and/or mylotarg or otherwise not eligible for conventional chemotherapy * ecog performance status of 0-2 * recovered from toxicities of prior chemotherapy exclusion criteria: * history of pancreatitis * active alcohol abuse * taken bexarotene in the past * wbc \> 10,000/ul at time of enrollment * cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose mylotarg * significant organ disfunction: total bilirubin \> 3x uln, ast or alt \>3 x uln, creatinine \> 3 mg/dl, on blood pressure supporting medications or mechanical ventilation * active participant in any other investigational treatment study for aml * life expectancy of less than 1 month * use of blood growth factors (g-csf, gm-csf, aranesp, erythropoietin, or neumega) within 1 week prior to treatment initiation * uncontrolled hyperlipidemia * known history of hiv * known active cns involvement with aml * women of childbearing potential or active breast feeding

Keywords: acute myeloid leukemia aml bexarotene
platelet function in patients with an acute coronary syndrome

Conditions: Acute Coronary Syndrome (ACS)

Summary: the aims of the study are to: * explore whether platelet reactivity in patients treated wih novel platelet inhibitors is associated with clinical outcome * investigate whether a therapeutic window exist for novel platelet inhibitors * investigate the incidence of adverse events under treatment with novel platelet inhibitors in the real life clinical scenario * investigate the association between genetic polymorphisms, inflammation, platelet reactivity and clinical outcome * investigate synergistic effects between aspirin and novel platelet inhibitors


Eligibility criteria:
inclusion criteria: * signed informed consent * acute coronary syndrome at admission * planned treatment with novel platelet inhibitors * age \>18 exclusion criteria: \* participation in interventional trials

Keywords: platelets, acute coronary syndrome (acs), prasugrel, ticagrelor, aspirin