Kornimate/medical-research-clean huggingface dataset:
a study to assess the effectiveness and safety of irinotecan liposome injection, 5-fluorouracil/leucovorin plus oxaliplatin in patients not previously treated for metastatic pancreatic cancer, compared to nab-paclitaxel+gemcitabine treatment

Conditions: Metastatic Adenocarcinoma of the Pancreas

Summary: the purpose of this study is to look at the efficacy and safety of irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5fu/lv) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting. * initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening. * subject has one or more metastatic lesions measurable by computed tomography (ct) scan (or magnetic resonance imaging (mri), if the subject is allergic to ct contrast media) according to recist version 1.1 criteria. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * subject has adequate biological parameters as demonstrated by the following blood counts:(a) absolute neutrophil count (anc) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) platelet count ≥100,000/mm3 (c) haemoglobin (hgb) ≥9 g/dl obtained ≤14 days prior to randomisation. * adequate hepatic function as evidenced by: (a) serum total bilirubin ≤1.5x uln (biliary drainage is allowed for biliary obstruction), and (b) aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5x upper limit of normal (uln) (≤5x uln is acceptable if liver metastases are present). * adequate renal function as evidenced by creatinine clearance ≥30 ml/min. * adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xuln ). exclusion criteria: * prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy * prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present. * subject has only localised advanced disease. * documented serum albumin \<3 g/dl * known history of central nervous system (cns) metastases. * clinically significant gastrointestinal disorder * history of any second malignancy in the last 2 years * concurrent illnesses that would be a relative contraindication to trial participation * use of strong inhibitors or inducers of cyp3a, cyp2c8 and ugt1a1 * neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma * known low or absent dihydropyrimidine dehydrogenase (dpd) activity
a resilience-based approach to improve long-term quality of life in post-treatment lymphoma survivorship

Conditions: Lymphoma

Summary: the goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.

the stress management and relaxation response resiliency program for lymphoma survivors (smart3rp-lymphoma) was adapted by researchers at the mgh. this group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools. the main questions it aims to answer are: * will survivors randomized to smart3rp-lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a health education program? * will improvements in resiliency lead to improvements in quality of life? to answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (smart3rp-lymphoma) to a health education program to see how they affect quality of life of lymphoma survivors. participants will: * fill out 4 surveys across 12 months * participate in 8 weekly, virtual group sessions * submit hair cortisol samples

Eligibility criteria:
inclusion criteria: * english or spanish speaking adults (18+ at time of enrollment) * within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other) exclusion criteria: * active psychiatric or cognitive comorbidity as determined by the site pi or treating clinician

Keywords: quality of life psychosocial intervention supportive care cancer survivorship resilience
the effect of stress ball application on anxiety and fetal heart rate before cesarean section

Conditions: Nursing; Pregnant; Anxiety; Caesarean Section; Fetal Conditions

Summary: this study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in turkey will be included in the study. pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. during the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. it will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. pregnant women in the control group will not receive any intervention other than routine general care. data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the research, * be over 18 years of age, * having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, threat of preterm labor, pre-eclampsia, etc.), * compliance with at least one of the criteria in the "ministry of health risk assessment form for pregnancy" in the evaluation of current pregnancy, * planning a cesarean delivery, * being in the last trimester of pregnancy (28 weeks and above) * having a single live fetus, * to be able to read and write turkish. exclusion criteria: * a diagnosed psychiatric illness, * visual, hearing, speech, physical or mental disability, * any communication barriers, * cardiovascular disease in the pregnant woman and fetus, * fetal distress, * fetal anomaly, * any physical or medical condition that prevents the use of a stress ball, * need for urgent intervention before caesarean section according to the physician.

Keywords: anxiety risky pregnant nurse stress ball fetal heart rate
does goal elicitation improve patient perceived involvement

Conditions: Orthopedic Disorder

Summary: the purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.

this is a rct with 2 intervention arms. in the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. the second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.

Eligibility criteria:
inclusion criteria: * new patients visiting the orthopaedic service * english fluency and literacy exclusion criteria: * returning patients * children * non-english speaking patients
pain & expert: global pain-assessment: a prospective registry

Conditions: Chronic Pain

Summary: full assessment of chronic pain patients based on the icf-model.


Eligibility criteria:
inclusion criteria: * patients with chronic pain for at least 3 months * age =\> 18 years * patient has been informed of the study procedures and has given written informed consent exclusion criteria: * healthy patients or patients with acute pain. * addiction to drugs, alcohol (\>5 units per day) * evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator * pregnancy
natriuretic effect of amiloride in relation to the alpha adducin gene (add-ami) rs4961 variant

Conditions: Hypertension Essential; Salt Excess; Genetic Hypertension

Summary: the study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.

the study is carried out to evaluate primarily the difference in the activity of the renal transporter enac (through dosage of sodium) through its inhibition with a single dose of amiloride in hypertensive patients characterized by the polymorphism of alpha adducin rs496. it's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration

Eligibility criteria:
inclusion criteria: * male patients aged 18-60 years; * naïve hypertensive patients: newly diagnosed, never previously treated for hypertension; * bmi\<30 kg/m2, * documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic bp measurements must be \>=140 mmhg or diastolic bp \>=90 mmhg; * signature of the informed consent for participation in the study * patient who has already undergone genomic dna sampling (accompanied by relative consent) and genotyped for the add1 rs4961 variant (gg, gt or tt). exclusion criteria: known causes of secondary hypertension; * severe or malignant hypertension; history of renal artery disease; * significant renal disease (creatinine clearance less than 60 ml/min); * hyperkalemia (kpl \> 6meq/l) at enrollment visit; * hypercalcaemia (ca pl \> 2.6 mmol/l) at enrollment visit; * symptomatic hyperuricemia (\> 7.5 mg/dl); * liver disease (transaminases greater than 3 times the normal value); * cardiac pathologies (myocardial infarction, atrial fibrillation, etc.); * diabetes (fasting blood sugar \>125mg/dl); * in therapy with statins, nsaids, systemic steroids; * known hypersensitivity to amiloride or to any of the excipients; * patients unable to express a valid consent -

Keywords: hypertension salt
comparative pharmacokinetics (pk) study of efavirenz or lopinavir/ritonavir between older and younger hiv-infected adults

Conditions: HIV Infections

Summary: hiv infected patients, aged \ /= 55 years, who are regularly taking either efavirenz (efv) or lopinavir/ritonavir (lop/r) as part of their antiretroviral regimen are being asked to spend 12 hours at the researchers' clinic (the acs clinic at jacobi medical center, bronx, new york) for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period. patients taking efv will return for one additional blood draw the following day.

hiv infected patients, aged \ /= 55 years, who are regularly taking either efavirenz or lopinavir/ritonavir as part of their antiretroviral regimen are being asked to spend 12 hours at our clinic (the acs clinic at jacobi medical center, bronx, ny) for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period. patients taking efv will return for one additional blood draw the following day. patients will be asked to come to the clinic at 7 am and bring their medication to the clinic. blood will be drawn to obtain a trough level of either efv or lop/r after which the patient will be instructed to take their efv or lop/r. then blood will be drawn 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours later. patients on efv will be asked to return the next morning for a 24 hour blood level. the blood will be spun and the plasma frozen at - 70 c. the plasma samples, labelled with the patients' initials and the draw date, will be shipped to university of alabama, department of pharmacology, where the drug levels will be measured. patients will be recruited from the acs outpatient clinic. they will be identified by their providers.

Eligibility criteria:
inclusion criteria: * hiv+ * taking lopinavir/ritonavir or efavirenz * age \ /= 55 years exclusion criteria: * concurrent therapy with drugs that alter lopinavir/ritonavir levels. * other renal or kidney disease. * chronic hepatitis b or c

Keywords: regular lopinavir/ritonavir or efavirenz use age >/= 55 y or </= 35 y hiv+
the use of indocyanine green as a diagnostic adjunct for pediatric solid malignancies

Conditions: Metastatic Disease; Primary Tumor; Solid Malignancies

Summary: use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable we will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. these patients will receive a targeted dye to aid in the resection of these metastases. we plan to assess icg as it relates to: 1. diagnostic accuracy using pathologic correlation as gold standard measure 2. short and long term event free and overall survival

patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their oncologist. the oncologist will inform the subject/family about the study and ask if they may be interested in participating. if the subject/family demonstrates potential interest in the study, the pediatric surgery research team will discuss the risks and benefits of pre-operative icg administration with the patients and enrollment. study subjects: all patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. diagnosis will be made: 1. in a multimodal fashion including physical exam, radiologic evaluation (ultrasound, mri, ct scan, etc), and sometimes biopsy. 2. prior to definitive surgical resection of the newly diagnosed malignancy

Eligibility criteria:
inclusion criteria: all patients with newly diagnosed solid, primary malignancies or their related metastatic lesions. diagnosis of primary or metastatic malignancy will be made by combination of: 1. clinical evaluation and physical exam 2. radiologic study including ultrasound, ct scan, and/or mri 3. pathologic diagnosis after biopsy exclusion criteria: 1. those patients and parents/guardians unwilling to provide consent/assent. 2. pregnant and/or women who are breast feeding. 3. patients with iodine allergies
neonatal intensive care unit virtual family-centered rounds

Conditions: Pediatric Disorder; Neonatal Disease

Summary: the aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.


Eligibility criteria:
enrolling family units (which consists of infants and parents \[surveys\]): infant inclusion * infants aged less than 365 days who are admitted to the nicu * have at least one adult parent or guardian with english proficiency infant exclusion * have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information * infants with a previous nicu admission (and enrollment) during the trial period parents \[surveys\] inclusion * parents/guardians of the eligible infants (described above) * age 18 years and older parents \[surveys\] exclusion * age less than 18 years * non-english speaking

Keywords: pediatrics neonatal intensive care units neonate clinical trial telemedicine patient-centered care patient reported outcome measures
community based obesity prevention among black women

Conditions: Obesity

Summary: this study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) black women (aged 25-44), compared to usual care.

obesity prevention among black women is a major public health priority; presently, nearly 54% of the adult black female population is obese. to date, most intervention attention has been focused on weight reduction among the overweight and obese. however, both conditions are notoriously recalcitrant to treatment, particularly among blacks. we posit that obesity prevention might represent a particularly effective intervention strategy for overweight black women. most studies have shown that black women have a greater social acceptance of overweight, less body weight dissatisfaction, and higher ideal body weights, compared to whites. furthermore, numerous studies have shown that obesity is less lethal and causes fewer co-morbidities among black vs. white women, suggesting that maintaining overweight may be an appropriate public health goal for black women. we posit that an intervention approach that emphasizes maintaining overweight, while preventing the transition to obesity will resonate among the target population. very few obesity prevention rcts appear in the published literature and, to our knowledge, none have been conducted solely among black women. we propose to randomize overweight, black women (n=184) to either usual care (uc) or an obesity prevention (op) intervention condition. the op condition is comprised of several intervention components that will be delivered over 12 months; each participant will receive a tailored action plan, tailored print materials, monthly coaching calls, and weekly self-monitoring via an interactive voice response system. assessments will be taken at baseline, 6, 12, and 18 months post baseline.

Eligibility criteria:
inclusion criteria: * african-american * female * ages 25-44 * bmi between 25-34.9 kg/m2 * patients with at least 1 visit in the previous 24 months to a participating community health center exclusion criteria: * not currently pregnant * not given birth within the past 12 months * no history of myocardial infarction or stroke in last 2 years

Keywords: obesity women's health minority health obesity prevention
negative pressure therapy for groin wounds

Conditions: Wound Infection

Summary: the purpose of this study is to compare wound infection rates between negative pressure therapy (prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

this is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or prevena. patients with the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon. the patients with prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. the primary objective of this study is to see if using negative pressure therapy decreases the rate of infection. the secondary objectives will include multivariate analysis to understand which patients may have a compounded benefit from prevena (e.g. smokers, diabetics, and obese patients). the prevena system is an fda approved bandage and will be used in this study for on-label purposes.

Eligibility criteria:
inclusion criteria: * patients undergoing vascular surgery with a groin incision. exclusion criteria: * allergy to silver.
surgery as needed for oesophageal cancer - 2

Conditions: Cancer of Esophagus

Summary: a prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: sano-2 study.

an active surveillance approach after completion of neoadjuvant chemoradiotherapy for locally advanced oesophageal cancer is being investigated in the sano (surgery as needed for oesophageal cancer) trial, that completed patient inclusion in december 2020. first long term results are expected end 2023. based on current retrospective studies and short term results of the sano, to date there is no evidence that active surveillance is unsafe. within the follow-up of the sano trial, the safety of active surveillance is continuously monitored. based on a high participation rate (\>90%) in the sano trial and on the view of the dutch patient federation for cancer of the digestive tract (spks) to offer active surveillance as an alternative treatment option in a controlled setting, there is a demand for a tailored surgery approach after neoadjuvant chemoradiotherapy until results of the sano trial are available. when patients request active surveillance outside the sano trial, it is of the utmost importance to set up a prospective cohort study (extension study) in order to monitor safety, implementation and effectiveness of active surveillance outside the sano trial before the final results of the sano trail are available.

Eligibility criteria:
inclusion criteria: * operable patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to cross followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction * age ≥18 * written, voluntary, informed consent. exclusion criteria: * non-fdg-avid tumour at baseline pet-ct scan * initial treatment with endoscopic resection * patients who underwent of who are planned to undergo definitive chemoradiotherapy * language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent.