Kornimate/medical-research-clean huggingface dataset:
bryostatin-1 in treating patients with recurrent non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: phase ii trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-hodgkin's lymphoma. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

objectives: i. determine the response to bryostatin 1 (bryo) administered weekly for 3 weeks in patients with relapsed non-hodgkin's lymphoma. ii. assess the toxic effects of this treatment. iii. establish the correlation between pkc isoenzyme activity and bryo function in lymphoma cells and normal lymphocytes. iv. determine the pharmacokinetic profile of bryo and its relationship to pharmacodynamics. outline: single-agent chemotherapy/differentiation therapy. bryostatin 1, bryo, nsc-339555.

Eligibility criteria:
disease characteristics: * histologically confirmed non-hodgkin's lymphoma * working formulation low-, intermediate-, and high-grade histologies eligible * mantle cell and marginal zone lymphoma eligible * relapse after at least 1 doxorubicin-containing regimen required * no more than 2 prior chemotherapy regimens * one prior biologic therapy in addition to the 2 prior chemotherapy regimens allowed * no prior bone marrow transplantation * ineligible for treatment on higher priority protocols * patients eligible for bone marrow transplantation may be treated to reduce tumor bulk * bidimensionally measurable disease required * no history of primary or metastatic cns disease patient characteristics: * age: any age * performance status: zubrod 0-2 * life expectancy: greater than 12 weeks * absolute neutrophil count at least 1,000/mm3 * platelet count at least 100,000/mm3 * bilirubin no greater than 1.8 mg/dl * transaminases no greater than 2.5 times normal * creatinine no greater than 1.5 mg/dl or creatinine clearance greater than 70 ml/min * no hiv antibody * no serious intercurrent illness * no pregnant or nursing women * effective contraception required of fertile patients throughout study and for 1 year thereafter prior concurrent therapy: -at least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered

Keywords: recurrent small lymphocytic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone b-cell lymphoma splenic marginal zone lymphoma
concurrent treatment of squamous cell carcinoma or adenocarcinoma of the cervix with cigb-300 for local application

Conditions: Squamous Cell Carcinoma of the Cervix; Adenocarcinoma of the Cervix

Summary: they include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy external radiation therapy + more qt based weekly cisplatin.


Eligibility criteria:
inclusion criteria: * stages iia and iib figo classification. * age between 21 to 70 years. * ecog performance status 0-1. * no history of another neoplastic disease. * value of hemoglobin ≥ 9 g / l. * total leukocyte count ≥ 3.0 x 109 / l. * absolute neutrophil count ≥ 1.5 x 109 / l. * platelets ≥ 100,000 x mm3. * total bilirubin ≤ 1.5 times uln, sgot and sgpt ≤ 2.5 times upper limit of normal. * creatinine ≤ 2 mg / dl and creatinine clearance calculated ≥ 60 ml / min(according to cockcroft-gault formula) * patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy. * life expectancy ≥ 12 months * measurable disease * informed consent signed by the patient exclusion criteria: * pregnancy and lactation period. * presence of lymph node metastases or hematogenous extrapelvic known. * uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient. * other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years. * hepatitis b or c active, positive serology for hiv. * atopy history of severe / severe asthma. * a history of autoimmune disease. * presence of significant abnormalities in ecg performed within 14 days prior to admission. * diseases that prevent the patient give informed consent or their ability to collaborate in the trial. * participating in another clinical trial "
nighttime dosing of antihypertensive drugs in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: the purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.

in recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. as a consequence there has been increasing focus on nighttime blood pressure and how to lower it. one way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm hg without negative effect on the 24 hour blood pressure. only recently a study was made on diabetic patients. this showed similar results as for non-diabetic patients.however this study was based on diabetic patients who did not receive any antihypertensive drugs before. this study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. the population is diabetic patients who are already in antihypertensive treatment.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * systolic nighttime blood pressure above 120 mm hg * systolic daytime blood pressure not exceeding 150 mm hg * antihypertensive treatment which must include * once-daily drugs * at least one drug must be a angiotensin-converting enzyme inhibitor, angiotensin ii receptor blocker or renin inhibitor. exclusion criteria: * mi or stroke within 6 months * heart failure (ef \< 45 %) * atrial fibrillation * egfr \< 30 ml/min
study comparing esomeprazole associated with sodium bicarbonate from eurofarma and esomeprazole in treatment of gastroesophageal reflux disease esobic

Conditions: Gastroesophageal Reflux Disease

Summary: a phase iii, randomized, open-label, superiority study comparing the incremental product esomeprazole associated with sodium bicarbonate made by eurofarma and nexium® in the treatment of gastroesophageal reflux disease. the study will enroll 94 patients in each arm (total of 188 patients).


Eligibility criteria:
inclusion criteria: icf signing; * age ≥ 18 years; * gastroesophageal reflux disease diagnosis; * grade 0 to grade iii reflux esophagitis, assessed by means of upper gastrointestinal endoscopy; * ability to have the endoscopy, ph-metry and esophageal manometry examinations performed; * washout period of 1 week without using ppi, h2 antagonists and prokinetic agents and of at least 1 day without using antacids. exclusion criteria: * presence of esophagitis requiring intervention (grade iv), esophageal varices, barrett's esophagus, systemic sclerosis or ulcers (gastric or duodenal ulcers); * previous gastric or esophageal surgery; * dietary sodium restriction, metabolic alkalosis, hypokalemia, barter syndrome; pregnancy or breastfeeding; * concomitant diseases, such as kidney, liver and heart failure; * suspected or confirmed cancer of any type; * abusive drug or alcohol use; * abnormal values for white blood cells, platelets or hemoglobin; * significant changes in serum sodium, potassium, calcium or creatinine concentrations; * treatment with ppi, h2 antagonists or prokinetic agents that may not be withheld during the washout period of 1 week or during the study; * intolerance or allergy to any of the components in the drug products assessed in the study; * use of nonsteroidal anti-inflammatory drugs (nsaids), antiemetic agents, macrolide antibiotics and systemic corticoids for a period equal to or greater than 2 weeks before the study or that is expected to require prolonged use during study treatment; * concomitant use or requirement of a gastric ph-dependent medication for optimal absorption; * scheduled use of other medications metabolized by cytochrome cyp during the study; * history of active peptic ulcer; * rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency; * recent participation (within the last 12 months) in another clinical study.
effects of continuous esp catheters on recovery, pain and opioid consumption after multilevel spine surgery

Conditions: Post Operative Pain; Spine Surgery

Summary: single-shot erector spinae plane (esp) blocks (espb) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. continuous esp catheter techniques may solve these problems but are associated with challenges of their own. this trial will investigate the role of adding surgeon-placed, continuous esp catheters to single-shot espbs for patients undergoing multilevel spine surgery. it will assess whether adding esp catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to esp catheters with saline/placebo infusion for 48 hours.


Eligibility criteria:
inclusion criteria: * age 18-80 * presenting for elective multilevel (\>2 spinal levels) spinal fusion * lumbar, thoracic, and thoracolumbar procedures included * posterior surgical approach * willing and able to follow the study protocol * able to provide informed consent exclusion criteria: * opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months) * daily gabapentin/pregabalin use for longer than 3 months * prior spine surgery at the index level * allergy or contraindication (including renal, liver disease) to included study medications * patient refusal
the role of massage in increasing total motile sperm count of iui

Conditions: Infertility

Summary: the purpose of this prospective, randomized study, was to determine if neck and shoulder massage performed within 15 minutes of semen sample collection will increase the semen volume, and therefore increase the total motile sperm available for insemination as a result of decreased stress.


Eligibility criteria:
inclusion criteria: * infertility, * initiating clomiphene + iui therapy * signed study consent exclusion criteria: * severe male infertility (baseline semen concentration \< 10 million total motile sperm) * female bilateral tubal occlusion * failure to ovulate with clomiphene * failed clomiphene + iui therapy (three prior cycles with no conception) * unable to tolerate clomiphene * unable or unwilling to follow study protocol

Keywords: infertility intrauterine insemination male factor infertility massage total motile sperm count
genetic investigation of solid tumors cohort

Conditions: Prostate Cancer; Colon Cancer

Summary: the objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia samples to learn more about genetic differences that are linked to the formation of solid tumors.

recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop solid tumors. even though it has been firmly established that if an individual carries these dna variants they have an increased chance of developing a solid tumor the underlying biological mechanisms for most of these associations are largely unknown. in addition to inherited dna variants that are associated with the development of solid tumors it is well established that during the development and growth of solid tumors the dna in these cancer cells undergo somatic changes (mutations). these somatic dna changes have been studied over the past decade and frequently are specific chromosomal translocations and amplifications associated with the development of particular solid tumors. in some instances, examining the chromosomal translocation and amplification has lead to the discovery of proteins contributing to solid tumor pathology. the human 8q24 interval that has strong genetic associations with solid tumor development has also been noted as frequently amplified in solid tumors and serves as a predictor of poor survival in prostate cancers.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. eligible to have their blood drawn 3. be reliable, cooperative and willing to comply with all protocol-specified procedures 4. able to understand and grant informed consent 5. diagnosis of a solid tumor exclusion criteria: 1. has a significant chronic medical condition which would potentially confound interpretation of the individual's phenotype. 2. treatment with any investigational agents or devices within thirty days preceding enrollment in the study. 3. been administered or taken any cns sedatives or depressants in the 12 hours prior to informed consent process

Keywords: solid tumor prostate cancer colon cancer
effect and associated factors of the clinical pharmacy model in the incidence of medical errors

Conditions: Pharmaceutical Services; Medication Errors; Drug-Related Side Effects and Adverse Reactions; Outcome Assessment (Health Care)

Summary: medication errors are considered by who to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication. these strategies are aimed at the patient's safety policy. in colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care. the hospital pablo tobón uribe, it is a highly complex institution in medellin (colombia), certified by join comission international (jci), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. in this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (drps) or a negative outcome related to medicine. the objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the who initiative to reduce these errors of medication.

a randomized controlled clinical trial of stepped wedge will be performed. patients will be admitted according to the inclusion criteria. randomization will be done at the cluster level (group) and the result measured in the participants within the cluster.

Eligibility criteria:
inclusion criteria: * to be hospitalized in the hospital pablo tobón uribe a minimum of 24 hours. * patient with at least 5 drugs in their pharmacological therapy exclusion criteria: * patients with only surgical procedures.
mindful moms: mechanisms of mindfulness-based cognitive therapy during pregnancy and postpartum

Conditions: Psychological Distress; Pregnancy Related; Postpartum Blues; Postpartum Depression; Postpartum Anxiety; Postpartum Sadness

Summary: the proposed study seeks to elucidate the mechanisms underlying mindfulness-based cognitive therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.

pregnancy and postpartum is a period of vulnerability for new or worsening psychiatric symptoms. mindfulness based cognitive therapy (mbct) is an effective approach to mitigate pregnancy-related worsening of psychological distress. however, prior research has focused predominantly on symptoms of depression and anxiety, and is it not clear how or why mbct improves psychological health during the perinatal period. thus, the goals of this project are to (1) examine whether mbct improves psychological functioning among pregnant women and whether these improvements persist at three-months postpartum, (2) examine whether improved ability to regulate emotions and behavior accounts for the beneficial effects of mbct, and (3) determine what demographic, socioeconomic, and psychosocial factors impact treatment engagement and effectiveness.

Eligibility criteria:
inclusion criteria: * pregnancy between 12 and 30 weeks gestation * reporting at least mild psychological distress (based on self-report) * access to high-speed internet or cellular network access * located in the u.s. exclusion criteria: * current suicidal or homicidal ideation as assessed verbally during screening * symptom severity necessitating a higher level of clinical care * current psychosis * untreated mania * active substance abuse * lack of high-speed internet connection or cellular network access * planning to be traveling without access to internet for more than two weeks in the next 12 months
safety and efficacy of remote ischemic conditioning for patients taking off-pump coronary artery bypass grafting

Conditions: Coronary Artery Bypass Grafting; Remote Ischemic Conditioning; Ischemia-Reperfusion Injury

Summary: remote ischemic conditioning (ric) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing iri in vital organs. this improve trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump cabg in five centers in china, to access whether ric can and improve short-term prognosis.

remote ischemic conditioning (ric) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing iri in vital organs. however, the effect of ric in patients undergoing off-pump cabg is still unclear. this improve trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump cabg in five centers in china, to access whether ric can and improve short-term prognosis. patients will be randomly assigned into ric group and control group. the primary outcome is the occurrence of the major adverse cardiovascular and cerebrovascular events (macce) within the 3-month follow-up. the macce is defined as all-cause of death, myocardial infarction, stroke and coronary revascularization surgery.

Eligibility criteria:
inclusion criteria: * diagnosed with coronary artery disease and require off-pump cabg surgery. * between 18 and 75 years old; * normal left ventricular systolic function (ejection fraction \>40%) and left ventricular end-diastolic internal diameter (\<60 mm) in the cardiac ultrasound tests; * no or mild heart valve and great vessel abnormalities which do not require surgical intervention; * participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent. exclusion criteria: * severe tissue injuries. * myalgia, fractures and other peripheral vascular lesions. * bypass graft being the radial artery. * stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins. * previous vagus nerve trunk dissection or vagus nerve block surgery. * other surgical operations at the same time. * patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock. * severe coagulation abnormality or severe anemia. * severe mental disorder. * malignant tumors. * pregnant or lactating. * increased risk of treatment for patients, according to investigators. * refuse to sign the informed consent form.
study to measure and enhance the health related quality of life in cancer patients

Conditions: Cancer

Summary: the me-q study aims to validate a patient reported outcome tool called fact-icm, which measures health related quality of life (hrqol) in patients receiving immune checkpoint modulator (icm) therapy. in addition, this trial seeks to answer if hrqol can be improved by monitoring and managing patient symptoms whilst they are treated with icms.

immunotherapy has revolutionized cancer care by extending survival, but with a unique set of toxicities known as immune-related adverse events (iraes), less is known about impact of icms on hrqol. the me-q trial will produce two major innovations: 1) the first validated tool to measure hrqol in patients on icms that can be used in clinical trials and routine clinical care; and 2) a system to monitor and manage patient symptoms on icms which can enhance health care delivery for these cancer patients. me-q will randomize patients who are treated with standard of care icms to either a monitoring arm developed specifically for this trial or the usual care arm, which is currently how they are managed. all participants will respond to hrqol questionnaires of which fact-icm is a core component. a study nurse will review and manage responses which indicate new or worsening symptoms for those in the monitoring arm. the nurse will contact the patient via telephone or video teleconferencing to conduct a clinical assessment and develop a management plan following iraes management guidelines. we hypothesize that patients on the monitoring arm will have better hrqol, longer overall survival, fewer presentations to the emergency department and less hospital admissions than the usual care arm.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * diagnosed with advanced, incurable solid tumors * eligible for immunotherapy (monotherapy or combination icm) * life expectancy ≥ 6 months * ecog ps 0-3 * fluent in english * able to provide informed consent * able to complete questionnaires using digital device or web based application exclusion criteria: * participation in a therapeutic clinical trial testing anticancer therapies * receiving adjuvant immunotherapy

Keywords: icms immune checkpoint modulators
a study of bms-663513 administered in combination with chemotherapy to subjects with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: the purpose of this study is to assess the safety and tolerability of multiple escalating doses of bms-663513 when given in combination with paclitaxel and carboplatin.


Eligibility criteria:
inclusion criteria: * good activity level * life expectancy of ≥ 6 months * solid tumor malignancy for which paclitaxel and carboplatin are appropriate exclusion criteria: * major surgery within 4 weeks * any concurrent cancer * history of autoimmune diseases * symptomatic bowel obstruction * continued use of steroids * symptomatic brain metastases * current nerve damage in fingers/toes * positive for hiv, hepatitis b/c * white blood cells \< 3,000 * hemoglobin \< 9 * platelets \< 100,000 * alt/ast and/or alkaline phosphatase \>= 2.5 x uln * creatine \> 1.5 * prior bms-663513