Kornimate/medical-research-clean huggingface dataset:
endoscopic nasogallbladder drainage versus gallbladder stenting before cholecystecomy

Conditions: Cholecystitis, Acute; Common Bile Duct Calculi

Summary: early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (gb) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. also preoperative endoscopic retrograde cholangiopancreatography (ercp) is often needed because common bile duct (cbd) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%. two-steps approach of percutaneous transhepatic gb drainage (ptgbd) followed by ercp or vice versa has been performed for the treatment of acute cholecystitis with concomitant cbd stone who are not suitable for urgent cholecystectomy. however single-step drainage of cbd and gb through ercp and endoscopic transpapillary gb drainage (etgd) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for ptgbd. in clinical practice, many endoscopists have hesitated to perform etgd because of its relatively low technical success rate and specific concern about post-ercp adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route. currently there are scarce data on if etgd using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.


Eligibility criteria:
inclusion criteria: * grade ii or iii acute cholecystitis met tokyo 13 diagnostic criteria * a high suspicion of cbd stone based on laboratory and imaging study * informed consent given. exclusion criteria: * bilo-pancreatic malignancy or surgically altered enteric anatomy * subsequent elective surgery is expected to be impossible even after gb decompression based on american society of anesthesiologist class
vagal nerve stimulation for post covid fatigue

Conditions: Post COVID Syndrome; Fatigue; Headache

Summary: the purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post covid syndrome who have fatigue and headache.

patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo pet/ct scans of the brain. patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. for those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.

Eligibility criteria:
inclusion criteria: * presence of fatigue and post exertional malaise. * presence of headache * clinical diagnosis of post covid syndrome. * they have consented to participate in the study * they have the ability to participate in all aspects of the study. exclusion criteria: * pregnant. * prior adverse reaction to 14fdg. * active implantable medical device e.g. pacemaker, hearing aid implant * metallic device e.g. stent, orthopedic hardware in neck * using another electronic device at the same time e.g. tens, mobile phone. * any other condition deemed exclusionary by the study principal investigator
a study of avastin (bevacizumab) in combination with taxane-based chemotherapy as first line treatment in patients with her-2 negative breast cancer

Conditions: Breast Cancer

Summary: this single-arm study assessed the efficacy and safety of first-line treatment with avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with her-2 negative breast cancer. patients received avastin 10 mg/kg iv, paclitaxel 150 mg/m\^2 iv, and gemcitabine 200 mg/m\^2 iv on day 1 and day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.


Eligibility criteria:
inclusion criteria: * female patients, ≥ 18 years of age. * breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only. * her-2 negative disease. * candidates for chemotherapy. * eastern cooperative oncology group (ecog) performance status ≤ 2. exclusion criteria: * previous chemotherapy for metastatic or locally advanced breast cancer. * previous radiotherapy for treatment of metastatic breast cancer. * any prior adjuvant treatment with anthracyclines completed \< 6 months prior to enrollment. * chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (\> 325 mg/day) or clopidogrel (\> 75mg/day).
etv versus shunt surgery in normal pressure hydrocephalus

Conditions: Hydrocephalus

Summary: the purpose of this study is to test and compare the efficacy of endoscopic third ventriculostomy with shunting of cerebrospinal fluid (csf)for treatment for patients of normal pressure hydrocephalus.

normal pressure hydrocephalus is a reversible disorder of cognition and gait disorder.currently the shunting of csf is the recommended treatment of these patients. even though shunts are known to be beneficial treatment of hydrocephalus they often need treatment or revision for infection or malfunction. endoscopic third ventriculostomy is a treatment without complications of shunt and is known to benefit obstructive forms of hydrocephalus.few studies have also shown that it may be efficacious treatment normal pressure hydrocephalus.

Eligibility criteria:
inclusion criteria: * patients with nph * meet at least 2 of 3 hakim and adams diagnostic criterion for nph (dementia, gait instability and urinary incontinence) * ventriculomegaly defined by ct or mri, evans' index \> 0.3 * clinical improvement after 3 day trial of csf drainage. * mmse\>24 * informed consent from patient

Keywords: normal pressure hydrocephalus communicating hydrocephalus gait disorder cognition shunt endoscopic third ventriculostomy.
monitoring devices in prediction of fluid responsiveness in severe sepsis and septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: comparison of noninvasive cardiac output monitor (nicom, cheetah medical) with edwards flotrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in sepsis and septic shock.

study will evaluate ability of passive leg raise test to predict fluid responsiveness in patients in septic shock, on vasopressors, using both the nicom and flotrac devices. an increase in ci, svi, or pulse pressure of \>10% in response to the passive leg raise will be considered a positive passive leg raise test, and the same indicators will be considered a significant response to a fluid challenge with either crystalloids or colloids.each device will be evaluated independently, but simultaneously.

Eligibility criteria:
inclusion criteria: * all adult patients with severe sepsis or septic shock, who have arterial catheter placed with flotrac monitor, with or without a central venous catheter. exclusion criteria: * declination of consent * known allergy to adhesive * pregnancy * contraindication to raising legs or head to 45 degrees for 3 minute intervals
acute exposure of simulated hypoxia on cognitive function

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary hypertension (pah, cteph) to assess the acute response to simulated altitude (fio2:15.1, equivalent to 2500m above sea level) on cognitive functions.

low altitude baseline measurements will be performed in zurich (460m asl) including echocardiography, right heart catheterization, six-minute walk test (6mwt), pulmonary function test, clinical assessment and blood gas analysis. randomly assigned to the order of testing, the participants will be tested under simulated altitude (fio2: 15.1% with the "amc altitrainer") and shamed altitude with the same device. during the exposure to simulated altitude (fio2: 15.1%) of approximately 1 hour, the participants will perform cognitive function test . the results will be compared under hypoxic and normal conditions.

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mean pulmonary artery pressure (mpap) ≥ 25 mmhg along with a pulmonary artery wedge pressure (pawp) ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting partial oxygen pressure (pao2) ≤7.3 kilopascal (kpa) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, high-altitude pulmonary edema (hape), etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: simulated altitude cognitive function
microcurrent and aerobic exercise effects in abdominal fat

Conditions: Obesity, Abdominal

Summary: the purpose of this study was to analyze microcurrent short term effects used with aerobic exercise on abdominal fat.

nutritional patterns have been changed during twenty-first century with sugar and fat's high proportions that allied to sedentary lifestyle increased body fat. there is already a well establish relationship between total body fat excess, cardiometabolic diseases and increased mortality, knowing that abdominal fat (android pattern), different from body index, presents an additional influence to health risks. women with their abdominal adipocytes (visceral fat) show an increased lipolytic activity that releases free fat acids to the systemic and portal circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases. aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in catecholamine's level resulting from a sympathetic system nervous activity raise. the most used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum of 30 minutes. nevertheless aerobic exercise practice reduce globally lipidic sources and not locally . electrolipolysis using microcurrent has been used in clinical practice as a technique to reduce abdominal fat. this technique can be applied transcutaneously or percutaneously seeming that the former is not so effective as skin can be an obstacle to the current effect on visceral and subcutaneous fat . abdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis.

Eligibility criteria:
inclusion criteria: * age between 18 and 30 years. exclusion criteria: * submitted to other fat reduce procedure, to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise. to present any contraindications to microcurrent and/or aerobic exercise, to take medication that influence lipid metabolism, and to be pregnant.

Keywords: abdominal fat metabolic syndrome microcurrent aerobic exercise lipolysis
mother-infant intervention for postpartum depression and associated mother-infant relationship dysfunction

Conditions: Postpartum Depression

Summary: maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. an integrated approach addressing both problems simultaneously may improve outcomes. perinatal dyadic psychotherapy (pdp) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. the purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of pdp. depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the pdp intervention or a control condition. the pdp intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. control mothers will receive usual care plus depression monitoring by phone. data will be collected at baseline, post-intervention, and 3 month follow-up. assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.


Eligibility criteria:
inclusion criteria: * first-time, english-speaking mothers of healthy singleton newborns * positive screen (\> 10) on edinburgh postnatal depression scale exclusion criteria: * suicidal ideation * currently receiving depression treatment * meets criteria for bipolar disorder and/or lifetime or current psychotic disorder
a phase i/ii study of hyperimmune ivig in slowing progression of disease in hiv-infected children

Conditions: HIV Infections

Summary: to evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-hiv immune serum globulin ( hivig ) at three dosage levels in hiv-infected children. passive antibody therapy has been used with limited success in treating advanced hiv disease in adults. hivig is manufactured from hiv antibody-rich plasma taken from asymptomatic donors. it is hypothesized that hivig will decrease the viral burden of moderately advanced hiv-positive children.

passive antibody therapy has been used with limited success in treating advanced hiv disease in adults. hivig is manufactured from hiv antibody-rich plasma taken from asymptomatic donors. it is hypothesized that hivig will decrease the viral burden of moderately advanced hiv-positive children. children are randomized to receive hivig every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.

Eligibility criteria:
inclusion criteria concurrent medication: required: * pcp prophylaxis according to cdc guidelines. allowed: * varicella-zoster immunoglobulin. * hepatitis b immunoglobulin. * prophylactic therapies not involving immunoglobulin. patients must have: * hiv infection. * cd4 count \> 200 cells/mm3 (ages 2-5 years) or \> 100 cells/mm3 (age \> 5 years). * antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry. * plasma icd p24 \>= 70 pg/ml that is stable or increasing prior to study entry. * life expectancy of at least 6 months. prior medication: required: * antiretroviral therapy for at least 6 months, with stable dose for at least 3 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of ivig. * any other condition requiring dosing with ivig (e.g., itp, hypogammaglobulinemia). * acute illness with temperature \>= 100 f and/or with iv antibiotics. * grade 3 or worse clinical toxicities. * unable to tolerate iv infusions at a minimum rate of 0.02 ml/kg/min. * concomitant participation in an experimental antiretroviral or hiv vaccine trial. concurrent medication: excluded: * ivig. * chemotherapy for an active malignancy. * mmr or rubella vaccinations. * intramuscular immunoglobulin. patients with the following prior condition are excluded: * history of severe reaction to ivig. prior medication: excluded: * ivig within the past 60 days. * chemotherapy for an active malignancy within the past year. * mmr or rubella vaccinations within the past 6 months. * intramuscular immunoglobulin within the past 60 days. ongoing drug or alcohol abuse.

Keywords: acquired immunodeficiency syndrome aids-related complex immunoglobulins, intravenous immunization, passive
a study to evaluate the long-term safety of m207 in the acute treatment of migraine

Conditions: Migraine

Summary: this is an open-label, twelve-month safety study. there is a screening period followed by a run-in period to record migraine activity. qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. using the electronic diary (ediary) to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and respond to questions in the ediary post treatment administration.

this is an open-label, twelve-month safety study. there is a screening period followed by a run-in period (14 to 21 days) to determine eligibility for treatment with study medication based on daily ediary data collection. qualified subjects will receive study medication on day 1 for up to twelve months for the treatment of migraine headaches. migraines will be treated with a single dose, consisting of two patches, but subjects can treat multiple migraine attacks throughout the 12 months. using the ediary to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and continue to respond to questions in the ediary for 48 hours post treatment administration.

Eligibility criteria:
main inclusion criteria: 1. women or men 18 to 75 years of age 2. greater than 1 year history of episodic, migraine (with or without aura) with onset prior to 50 years of age. 3. migraine history during the prior 6 months must include: 1. at least 2 migraines per month 2. no more than 8 migraines per month 3. no more than 15 headache days per month 4. women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial. 5. willing and able to treat a minimum of 2 migraines per month with study medication and consistently complete ediary for up to 12 months. main exclusion criteria: 1. contraindication to triptans 2. use of selective serotonin reuptake inhibitors (drugs like prozac®) or serotonin or norepinephrine reuptake inhibitors (drugs like effexor®) or anti-coagulants (drugs like coumadin®) 3. known allergy or sensitivity to zolmitriptan or its derivatives or formulations 4. known allergy or sensitivity to adhesives and/or titanium 5. women who are pregnant, breast-feeding or plan a pregnancy during this study 6. three or more of the following cardiovascular risk factors: * current tobacco use * hypertension or receiving anti-hypertensive medication for hypertension * hyperlipidemia or on prescribed anti-cholesterol treatment * family history of premature coronary artery disease * diabetes mellitus 7. history or current abuse or dependence on alcohol or drugs

Keywords: migraine migraine headache acute migraine acute migraine headache
radiation therapy in treating patients with stage ii cancer of the vocal cord

Conditions: Head and Neck Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known which radiation therapy regimen is more effective in treating patients with stage ii cancer of the vocal cord. purpose: randomized phase iii trial to compare two regimens of radiation therapy in treating patients who have stage ii cancer of the vocal cord.

objectives: * compare the local response rate in patients with stage ii invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy. * compare the acute and late toxic effects of these regimens in this patient population. * compare the overall and disease-free survival patterns in this patient population treated with these regimens. outline: this is a randomized study. patients are stratified according to substage (t2a vs t2b). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks. * arm ii: patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1.6 weeks. patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon). patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 240 patients will be accrued for this study within 3.2 years.

Eligibility criteria:
disease characteristics: * histologically proven invasive squamous cell carcinoma of the true vocal cord * stage ii (t2a/b n0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas * no verrucal carcinoma or adenocarcinoma * no extension to pre-epiglottic space or pyriform sinus * no fixed cord or cartilage invasion * no evidence of adenopathy, including any of the following: * nodes larger than 1 cm by radiography * nodes containing a low central density consistent with necrosis by radiography * clinically palpable nodes larger than 1 cm and firm in consistency * no recurrent or persistent disease * no evidence or suspicion of distant metastases patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other malignancy within the past 5 years except nonmelanomatous skin cancer * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy to the mid-neck or larynx surgery: * no prior complete stripping or laser excision of all gross disease

Keywords: stage ii squamous cell carcinoma of the larynx
adverse event scale in patients with epilepsy (aescape) - a european survey for physicians with epilepsy patients

Conditions: Epilepsy

Summary: the purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment. adverse effects and considerations to modify the therapy will be assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy with different seizure types


Eligibility criteria:
inclusion criteria: * male and female patients from the age of 4 years * confirmed diagnosis of epilepsy requiring aed treatment * patients already receiving daily aed treatment as a monotherapy or a polytherapy with maximum 2 aeds within the terms of marketing authorization with the following medications: carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, tiagabine, topiramate, valproate, zonisamide * treatment must be stable for at least 3 months prior to assessment * absence of other severe and/or uncontrolled symptomatic chronic illness

Keywords: non-interventional surveillance adverse effects antiepileptic drug treatment