Kornimate/medical-research-clean huggingface dataset:
lidocaine versus esp - after bariatric surgery

Conditions: Anesthetics; Local Anesthetics

Summary: the erector spinal block (esp) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. the scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. the clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). the scope of the blockade, after its execution at the level of th5, most often includes the segments from th1 to l1. lidocaine used in intravenous infusion is one of the recommended components of multidirectional analgesia. its adjuvant properties make it possible to reduce the amount of opioid drugs used, and thus - to reduce the frequency of their side effects. the aim of the study is to test the effectiveness and safety of the use of lidocaine infusion or erector spinal block in multimodal analgesic management.

in bariatric surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Eligibility criteria:
inclusion criteria: patients requiring bariatric surgery obesity (bmi\>35) exclusion criteria: patient refusal contraindications to paravertebral blocks: infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation known allergy to local anesthetics inability to provide informed consent any patient on opioids for greater than or equal to 3 months duration prior to surgery patients with chronic pain syndromes

Keywords: acute pain pain ropivacaine anesthetics, local physiological effects of drugs
management of metastatic breast cancer in frail patients

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of gemcitabine in treating elderly women who have metastatic breast cancer.

objectives: i. determine the safety and efficacy of gemcitabine in the treatment of elderly women with metastatic breast cancer. ii. evaluate the quality of life in these patients. outline: patients receive gemcitabine iv over 1 hour weekly for 7 consecutive weeks in an 8 week course. treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed prior to treatment and then every 12 weeks. patients are followed every 3 months for 2 years, then every 6 months until year 5, and then annually thereafter. projected accrual: a total of 40 patients will be accrued for this study over 2 years.

Eligibility criteria:
disease characteristics: metastatic breast cancer measurable disease no progression after 3 or more different forms of chemotherapy hormone receptor positive breast cancer must be refractory to at least two forms of hormonal treatment (including antiestrogen, aromatase inhibitor, and/or progestin) unless there is life threatening metastases (e.g., lymphangitic metastases to the lung or liver metastases) must meet at least one of the following characteristics for frailty: ecog 2-4 dependence in at least one activity of daily living 85 and over history of three or more falls in the past 6 months mild dementia (must be oriented in time, space, and location) three or more comorbid conditions hormone receptor status: not specified patient characteristics: age: 65 and over sex: female menopausal status: not specified performance status: see disease characteristics life expectancy: greater than 12 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 neutropenia or thrombocytopenia secondary to myelophthisis from breast cancer allowed hepatic: increased bilirubin allowed renal: renal insufficiency allowed cardiovascular: congestive heart failure allowed other: no known allergy to gemcitabine prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics endocrine therapy: see disease characteristics radiotherapy: at least 4 weeks since prior radiotherapy to bony areas or cns metastases surgery: not specified other: concurrent bisphosphonates allowed no concurrent participation in other investigational studies

Keywords: stage iv breast cancer recurrent breast cancer
second line chemotherapy folfirinox in irresectable cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. chemotherapy is the most common treatment for advanced disease. on the basis of a phase iii clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy. since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (folfirinox) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase i study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of cholangiocarcinoma. * metastatic disease or irresectable locally advanced cholangiocarcinoma. * measurable disease according recist criteria version 1.1. * age from 18 to 75 year. * who/ecog performance status 0-2. * patients who received at least 3 cycles of gemcitabine/cisplatin in the first line. * adequate hematological function (wbc \> 3.0 x 109/l, platelets \> 100 x109/l) * adequate hepatic function (bilirubin ≤ 1.5 x upper normal limit (uln); alat or asat \<5x uln in case of liver metastases and \< 2.5 x uln in absence of liver metastases. * adequate renal function (creatinine clearance \> 60 ml/min; creatinine \<120 µmol/l) * absence of cardiac insufficiency, chest pain (not medically controlled) and myocardial infarction in the 12 months preceding study entry. * signed informed consent. exclusion criteria: * concurrent secondary malignancies or other malignancies within 3 years prior to enter this study with the exception of non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection * presence of cerebral or meningeal metastases * contraindication to any of the substances of the planned treatment. * history of chronic diarrhea or colorectal inflammatory conditions, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered * active infection or other serious underlying conditions which may prevent the patient from receiving the planned treatment. for example: prolonged unresolved bacterial cholangitis with destruction of bile duct branches (e.g. after endoprosthesis insertion) or two or more cholangitis in the last 6 months. patients with other active or uncontrolled severe infection, cirrhosis or chronic active hepatitis will be excluded. * presence of cardiac insufficiency, unstable angina pectoris, symptomatic congestive heart, failure myocardial infarction 6 months prior to randomization, serious uncontrolled cardiac arrhythmia. * inclusion in another investigational clinical trial * women who are pregnant, breast-feeding or not using adequate contraceptive * age younger than 18 or older than 76 years * individuals under correctional supervision or guardianship

Keywords: cholangiocarcinoma folfirinox phase ii study
catastrophizing and virtual reality's impact on pain in patients with fibromyalgia

Conditions: Fibromyalgia; Pain

Summary: this study evaluates the potential association between virtual reality, pain catastrophizing thoughts and pain measures in fibromyalgia.


Eligibility criteria:
inclusion criteria: * able to understand, read and speak danish * able to independently answer a questionnaire * able to give informed consent fibromyalgia group: * confirmed diagnosed with fibromyalgia controls: * healthy participants exclusion criteria: applies for both groups: * signs of anxiety, depression and post-traumatic stress syndrome that require treatment * neurologic, musculoskeletal or mental illnesses that could influence the results. * parallel participating in other studies, that can influence this study * pregnancy fibromyalgia group: * regulation in medication * anticonvulsivant use the last week * serotonin-norepinephrine reuptake inhibitor (snri) the last two weeks * tricykliske antidepressants (tca) the last four weeks controls: * no regular use of pain medication * no current or previous history of subacute or ongoing pain
nacer ii: reducing prenatal exposures to household air pollution in rural guatemala through a gas stove/behavior intervention to improve neonatal health

Conditions: Premature Birth; Fetal Growth Retardation; Infections, Respiratory; Exposure to Environmental Pollution, Non-occupational; Infant, Small for Gestational Age

Summary: greater efforts are needed to bring affordable, clean stoves and adaptive behavioral strategies to the millions of households worldwide that continue to burn solid cooking fuels using inefficient stoves. two of the leading causes of infant mortality, preterm birth and pneumonia, are associated with high exposures to household air pollution during pregnancy and early infancy. the proposed study will assess the feasibility and acceptability of an introduced liquid petroleum gas stove, complemented by two alternative approaches to delivering tailored behavioral change interventions, among pregnant women and their neonates.


Eligibility criteria:
inclusion criteria: * pregnant woman less than 20 weeks gestation * does not smoke cigarettes * uses an open fire or deteriorated woodstove for cooking * purchases wood * intends to stay in the study area for at least one year * uses ministry of health clinics for routine prenatal care * has a mobile phone * primary person responsible for cooking in the household * able to give informed consent exclusion criteria: * multiple pregnancy (eg twins) * identified as a high-risk pregnancy by physician * regularly taking prescription medication * smokes cigarettes * routinely carries a child less than 2 years old on their back
radial versus femoral investigation in st elevation acute coronary syndrome

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; ST Elevation Acute Myocardial Infarction

Summary: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (nace) of transfemoral vs. transradial approach for the treatment of patients with st-elevation acute coronary syndrome (steacs) undergoing primary angioplasty

prospective, randomized, double arm study. the study population will include all consecutive patients presenting with a st-elevation acute coronary syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study. before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion. in the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Eligibility criteria:
inclusion criteria: 1. subject is \>18 years old with recent acute st-elevation acute coronary syndrome (steacs) requiring emergent coronary angiography. 2. patient has no contraindication to percutaneous arterial access by both and transfemoral route. 3. subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board/ethics committee of the respective clinical site. 4. patient and the treating physician agree that the subject will comply with all follow-up evaluations. exclusion criteria: 1. subject's age is \<18 years and he has no acute st-elevation myocardial infarction (st elevation of a least 0.1 mv in ≥2 extremity leads or at least 0.2 mv in ≥2 precordial leads). 2. subject has had a recent stroke or tia (\<4 weeks), irrespective of age. 3. patient has an international normalized ratio (inr) \> 2.0, or other severe bleeding diathesis 4. the patient is pregnant or breastfeeding. 5. known allergies to: aspirin, clopidogrel and ticlopidine, heparin, iib/iiia inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated). 7.subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 8.prior participation in this study.

Keywords: radial access primary angioplasty trial randomization outcome
yoga intervention in supporting children with cancer and their parents during chemotherapy infusion

Conditions: Malignant Neoplasm

Summary: this trial studies how well yoga works in supporting children with cancer and their parents during chemotherapy infusion. pediatric cancer and its treatment is one of life's most stressful events for children and their parents. yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit. participating in yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.

primary objectives: * to determine the feasibility of yoga for children with cancer and their parents, specifically * identify possible required modifications for safe and feasible practice during infusions. * obtain recruitment estimates and determine barriers. * assess satisfaction. secondary objectives: * to determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of yoga for the following outcomes: * child psychological distress (stress, anxiety). * parent psychological distress (stress, anxiety, anger, depression). * child and parent physiological stress (heart rate, respiratory rate, and blood pressure). * parent-child communication. * child physical symptoms. outline: patients and parents participate in up to 8 yoga sessions consisting of check in, awareness, breathing practices, gentle movement, and relaxation over 30 minutes each.

Eligibility criteria:
inclusion criteria: * children: 8-17 years of age, within 4 weeks of: 1) any new cancer diagnosis or newly diagnosed relapsed cancer, and 2) medical clearance who anticipate 3-weeks of continous contact with monroe carell jr. children's hospital. * parents: 18 years of age and older, child's primary caregiver (planning to attend appointments, infusions visits, or be in hospital rooms/clinics) or secondary caregiver (an as needed back-up to primary). children and parents: able to speak and understand english, absence of cognitive impairment, and willing to engage in yoga as part of a dyad. exclusion criteria: * children: medical conditions that would prohibit the safe implementation of a yoga practice * parents: practices yoga weekly * parents: pregnant or plans to become pregnant during next 3 months * children and parents: unwilling to work as a dyad.
vitamin e and infection in the elderly

Conditions: Respiratory Infection; Elderly

Summary: aging is associated with a variety of changes in the immune system. these changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. respiratory infections cause a great number of morbidity and mortality in the elderly population. vitamin e has been known to improve the immune response of the elderly and has been suggested for use in preventative strategies for this population. the purpose of this study is to examine the effect of one year vitamin supplementation on respiratory infection in the elderly population residing in nursing homes. this study was conducted using a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities in the greater boston area. a total of 617 subjects over the age of 65 were enrolled in the study, with 451 completers. the participants were supplemented wit either 200 iu of vitamin e per day or placebo. the primary outcomes consisted of respiratory tract infection, number of sick days, and antibiotic use. the study involved use of questionnaires, standard anthropometrics measurements, non-invasive body composition, blood and urine sample collection, and delayed type test (dth) using the mantoux method. this study has been closed since august 2000 and is in the stage of data analysis only.


Eligibility criteria:
inclusion criteria: * aged 65 years or older; * life expectancy greater than 6 months; * no anticipated discharge within 3 months; * not room-bound for the past 3 months; * absence of active neoplastic disease; * no tube feeding, no kidney dialysis; * no intravenous or urethral catheters for the last 30 days; * no tracheostomy or chronic ventilator; * antibiotic-free for more than 2 weeks; * no long-term steroid treatment greater than 10 mg/d, no use of immunosuppressive drugs, or greater than the recommended daily allowance (rda) level of supplements of vitamins e, c, or b6, selenium, zinc, beta-carotene, or fish oil; * body mass index of at least 18; * serum albumin at least 3.0 g/dl; able to swallow pills; * willing to receive influenza vaccine; * willing to provide informed consent (for patients with dementia, family members provided informed consent) exclusion criteria:

Keywords: vitamin e
a retrospective study of surgical treatment of congenital pseudarthrosis of tibia in china

Conditions: Congenital Pseudarthrosis of Tibia

Summary: the study aims to evaluate the current methods of surgical treatment for congenital pseudarthrosis of tibia(cpt) in children and their results respectively.

the study aims to evaluate the current surgical treatment and its result for congenital pseudarthrosis of tibia (cpt)in children in china. a retrospective study will be conducted with around 150 patients at 11 centers in china. this study will use available registry data from a defined time period of jan 2006-dec 2014. the treatment method will be recorded. the bone union rate and the refracture rate were calculated to evaluate the final result of several surgical treatment.

Eligibility criteria:
inclusion criteria: the inclusion criteria consists of patients with congenital pseudarthrosis of tibia who were surgical treated to obtain bone union. exclusion criteria: * patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth. * patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc * children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ecg abnormalities.
pecto-intercostal fascial block (pifb) for postop analgesia following sternotomy in cardiac surgery patients

Conditions: Analgesia; Sternotomy

Summary: the purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by pecto-intercostal fascial block (pifb) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. the study team hypothesizes that the patients receiving pifb with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving pifb with just bupivacaine and epinephrine.

this will be a randomized, triple-blinded, prospective, feasibility trial. written informed consent will be obtained from all study participants prior to randomization. patients scheduled to undergo cardiac surgery involving sternotomy at atrium health wake forest baptist will be screened for eligibility. these patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. subjects chosen to participate will be randomized into one or other arm and pifb will be performed after skin closure and before transport from the operating room to the icu. for patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.

Eligibility criteria:
inclusion criteria: * adults between undergoing cardiac surgery involving sternotomy exclusion criteria: * patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants * existing neurologic deficit in the chest wall; * remaining intubated at the six hour point after block placement * weight under 50kg * undergoing emergency surgical procedures or urgent return to the operating room * active endocarditis or mediastinitis * moderate to severe right ventricular function before or after cardiopulmonary bypass * reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or impella * reliance on extracorporeal membrane oxygenation * localized or systemic infection * chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (omme) for over one month prior to surgery) * those who are pregnant

Keywords: pecto-intercostal fascial block postoperative pain cardiac surgery