Kornimate/medical-research-clean huggingface dataset:
etomidate vs. midazolam for sedation during ercp

Conditions: Choledocholithiasis; Cholangiocarcinoma; Pancreatitis; Pancreatic Cancer

Summary: recently up-coming drug, etomidate which is a modulator of gaba(gamma-aminobutyric acid)-a receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system. the investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ercp procedure.

ercp (endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. most ercp procedure had been performed in sedation using tranquilizers and pain-killers. until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. meanwhile, recently up-coming drug, etomidate which is a modulator of gaba-a receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system. for these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. however, research on the efficacy during ercp was not yet published. in this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ercp procedure.

Eligibility criteria:
inclusion criteria: * all patients who are scheduled diagnositic or therapeutic ercp. * age : more than 20 and less than 90 years old * asa(american society of anesthesiologists) classificiation : i, ii, iii exclusion criteria:patients following * refuse to be enrolled * asa american society of anesthesiologists)classification iv, v * breast feeder * the mentally ill * drug abuser * hypersensitivity to sedative or opioids * alcohol intoxication or dependency * body mass index (bmi) 36kg/m2 or more * unstable vital sign 1. tachypnea, respiration rate more than 25/min or less than 10/min 2. oxygen saturation : 90% or less 3. systolic blood pressure : less than 90 mmhg or more than 180 mmhg 4. diastolic blood pressure : less than 50 mmhg or more than 100 mmhg 5. heart rate : more than 120 beat/min or less than 50 beat/min.

Keywords: endoscopic retrograde cholangiopancreatography (ercp) conscious sedation etomidate midazolam
vitamin b12 status and response to vitamin b12 supplementation in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: based on parkinson's disease (pd)/vitamin b12 deficiency symptom overlap and pd patients' propensity to avoid protein (the dietary source of vitamin b12), this study proposes to prospectively investigate the vitamin b12 status of pd patients over time. in addition, this study will provide critical pilot data evaluating the efficacy of treating those patients considered to have below-normal vitamin b12 levels in serum. further, it will also explore the concept that supplementing pd patients having "low-normal" vitamin b12 levels with vitamin b12 improves either the non-motor pd symptoms or homocysteine levels in pd patients receiving levodopa. study hypotheses: 1. serum cobalamin (b12) concentrations in patients with parkinson's disease (pd) are significantly lower than b12 concentrations in a) cohabiting spousal caregiver controls; and b) population-based, age-matched controls. 2. supplementation with b12 in levodopa-treated pd patients with low (\<200 pg/ml) or low-normal (200-300 pg/ml) serum b12 levels is associated with significant improvement in their non-motor symptoms and reduces total plasma homocysteine concentration \[hcy\], a known biomarker for risk of dementia and cerebrovascular disease.


Eligibility criteria:
inclusion criteria: * patients seen in emory healthcare system at least once between 1/1/2002 and 05/31/2006 with idiopathic parkinson's disease (defined as): * \>2 of cardinal signs/symptoms of parkinson's disease (bradykinesia, tremor, rigidity) * \>50% improvement of symptoms when dopaminergic therapy started * cohabiting spousal caregivers (without parkinson's disease) of patients enrolled in study are also eligible (but not required) to participate * coexisting depression, if present, is stable * normal thyroid screen (done at screening visit or at emory healthcare system within 3 months of screening visit) * males must have normal fasting testosterone levels (done at screening visit or within 6 months of screening visit) exclusion criteria: * unstable medical conditions (terminal cancer, angina, etc) which could interfere with study assessments or put patient at risk for not completing the assessments. * dopaminergic-unresponsive parkinsonism (i.e., patient has suspected multiple systems atrophy (msa), vascular or another form of parkinsonism) * prior history of vitamin b12 deficiency or taking vitamin b12 supplements or injections (single multivitamin supplements are not an exclusion criteria) * untreated testosterone or thyroid abnormality
an mhealth strategy to improve medication adherence in adolescents with sickle cell disease

Conditions: Sickle Cell Disease; Sickle Beta Zero Thalassemia; Sickle B+ Thalassemia; Sickle Cell Hemoglobin C

Summary: the primary objective of this study is to evaluate a potential behavioral intervention (med-go app). to meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of med-go app in adolescents and young adults (aya) with sickle cell disease (scd). the long-term goal of this research is to promote medication adherence behavior and improve health outcomes in aya with scd.

sickle cell disease is the most common genetic disorder in the us, affecting about 100,000 americans, and about 1 in 400 african american live births, incurring annual health care costs of $335 million. scd can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.these complications lead to significant declines in health-related quality of life (hrqol) and other patient-reported outcomes (pros), culminating in early mortality, particularly among aya. hydroxyurea (hu), at present, is the main fda approved medication for scd that reduces morbidity and mortality, improves hrqol and lowers healthcare utilization.however, adherence to hu remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among aya with scd. low hu adherence has been associated with worse health outcomes, poor hrqol and increased healthcare utilization. low hu adherence is multifactorial, especially in aya with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. aya have adopted text messaging and smartphone apps at a fast pace, including those who have scd.existing evidence indicates that mobile health (mhealth) behavioral interventions are feasible and acceptable with modest efficacy at improving medication adherence and self-management in aya, including scd. the specific aim for this study is to test the feasibility and acceptability of the med-go app as an mhealth behavioral intervention to improve hu adherence among aya with scd.

Eligibility criteria:
inclusion criteria: * age 12-21 years old * any sickle cell disease genotype * on steady state of hydroxyurea for 2 months * own of have access to a smartphone during the study period exclusion criteria: * recent hospitalizations within the past 7 days

Keywords: sickle cell disease hydrxoyurea mhealth intervention
acceptability and feasibility of combination treatment for cervical precancer among south african women living with hiv

Conditions: Cervical Cancer; CIN2; CIN3; Human Immunodeficiency Virus; Human Papillomavirus

Summary: the purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with hiv infection.

there are currently no medical therapies recommended to promote the clearance of humanpapilloma virus (hpv) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (cin). human immunodeficiency virus (hiv) -infected women are at higher risk of hpv infection, with rates as high as 45% - 90%. despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia \[cin2/3\]), and invasive cervical cancer also occur more frequently in hiv infected women. this study is testing whether topical 5-fluorouracil (5fu) can be used as a patient-controlled adjuvant treatment for cervical precancer (cin2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent cin2/3 and progression to cervical cancer among hiv-infected women.

Eligibility criteria:
inclusion criteria: * confirmed hiv-1 infection * on antiretroviral therapy (art), for at least 90 days prior to enrollment * cervical biopsy demonstrating cin2/3 within the preceding 120 days. exclusion criteria: * pregnancy, * breastfeeding, * intend to become pregnant within 180 days of enrollment * have an active sexually transmitted infection (women may participate once treated) * have a surgically absent cervix * have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer * have a medical comorbidity that would interfere with study participation.

Keywords: 5-fluorouracil cream loop electrosurgical excision
study of vx-809 alone and in combination with vx-770 in cystic fibrosis (cf) patients homozygous or heterozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (pk) and pharmacodynamic (pd) effects of lumacaftor (vx-809) alone and when coadministered with ivacaftor (vx-770) in participants with cystic fibrosis, homozygous or heterozygous for the f508del-cftr mutation.


Eligibility criteria:
inclusion criteria: * male or female participants with confirmed diagnosis of cf * must have the f508del-cftr mutation on at least 1 allele. * fev1 greater than equal (\>=) 40% of predicted normal for age, gender, and height (knudson standards)(cohort 1, 2, and 3); fev1 40-90% of predicted normal for age, gender, and height (hankinson standards (cohort 4) * participant of child-bearing potential and who are sexually active must meet the contraception requirements exclusion criteria: * history of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the participant (e.g., cirrhosis with portal hypertension). * an acute illness including acute upper or lower respiratory infection, pulmonary exacerbation or changes in therapy (including antibiotics) for pulmonary disease within 14 days (cohort 1, 2, and 3) or 28 days (cohort 4) before receiving the first dose of study drug. * history of solid organ or hematological transplantation. * history of alcohol abuse or drug addiction in the past year, including cannabis, cocaine, and opiates. * ongoing participation in another therapeutic clinical study, or prior participation in an investigational drug study without appropriate washout * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception * participants enrolled in cohort 1 or cohort 2 will not be eligible for cohort 3 * ongoing or prior participation in an investigational drug study within 30 days of the screening visit * heterozygous participants who participated in cohort 2 and meet the eligibility criteria for cohort 4 may participate in cohort 4 * evidence of lens opacity or cataract as determined by the ophthalmologic examination (cohort 4 only)
rebound pain after peripheral nerve blocks in total knee arthroplasty

Conditions: Total Knee Arthroplasty; Postoperative Pain; Rebound Pain; Peripheral Nerve Block; Pain Management

Summary: this prospective observational study aims to determine the incidence and clinical impact of rebound pain after peripheral nerve blocks in patients undergoing total knee arthroplasty. rebound pain is defined as a sudden, severe pain (nrs ≥7) emerging after block resolution. primary outcome is the incidence of rebound pain; secondary outcomes include pain severity, rescue analgesia use, nausea, vomiting, sleep quality, and patient satisfaction.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * asa physical status i to iii * scheduled for elective unilateral total knee arthroplasty under spinal anesthesia * peripheral nerve block (pnb) planned as part of multimodal analgesia * ability to understand and provide written informed consent * willingness and ability to complete the postoperative pain diary exclusion criteria: * known allergy or hypersensitivity to local anesthetics * contraindication to regional anesthesia * asa physical status iv or higher * neurological or psychiatric disorders interfering with study participation or pain reporting * use of anticoagulants or presence of coagulopathy * use of medications that may alter pain perception or rebound pain response * local infection at the block site * emergency surgeries * inability or unwillingness to complete the postoperative pain diary or follow-up
pregabalin treatment of peripheral neuropathic pain associated with diabetic peripheral nep (dpn), postherpetic neuralgia (phn), hiv-related nep (hiv), and chemotherapy induced nep

Conditions: Diabetic Peripheral Neuropathic Pain (DPN); Postherpetic Neuralgia (PHN); HIV-related Neuropathic Pain (HIV); Chemotherapy Induced Neuropathic Pain

Summary: management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy. exclusion criteria: * severe pain associated with conditions other than diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain. * skin condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.
molecular predictors of pemetrexed and carboplatin response in malignant pleural mesothelioma (mpm) patients

Conditions: MALIGNANT PLEURAL MESOTHELIOMA

Summary: the aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of mpm patients extracting the dna and genotyping for the tser polymorphism.

malignant pleural mesothelioma (mpm) is an aggressive tumor that usually has a poor prognosis. the combination of cisplatin and pemetrexed has recently become the standard of care in the first-line treatment of mpm. for patients who are unfit to receive a cisplatin-based chemotherapy, pemetrexed alone \[7\] or combined with carboplatin \[8\] has been proposed as an alternative treatment choice. the identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

Eligibility criteria:
inclusion criteria: * mpm diagnosis * availability of tumor tissue to perform analysis exclusion criteria : * other primary diagnosis * no archival tissue available
brain stimulation for patients with parkinson disease

Conditions: Parkinson Disease

Summary: the aim of this crossover study is to investigate the efficacy of non-invasive brain stimulation (transcranial pulse stimulation; tps) in adults with parkinson disease (pd). participants will receive 6 sessions of tps and sham-tps, respectively, in random order. motor manifestations of pd and manual dexterity will be the primary outcome measures. outcomes will be assessed immediately post-treatment.


Eligibility criteria:
inclusion criteria: * clinically stable pd with fine skilled and/or gross motor deficits (e.g. right arm with a clinical force level \>2) * signed written informed consent * monthly pregnancy test for women in childbearing years * age \>= 18 years exclusion criteria: * non-compliance with the protocol * pregnant or breastfeeding women * relevant intracerebral pathology unrelated to the disease (e.g. brain tumor) * hemophilia or other blood clotting disorders * cortisone treatment within the last 6 weeks before first treatment * thrombosis
influence of opioid analgesia on circulating tumor cells in open colorectal cancer surgery

Conditions: Colorectal Cancer; Circulating Tumor Cell

Summary: to compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. to find correlations with other perioperative factors and clinical/pathological disease characteristics.


Eligibility criteria:
inclusion criteria: * patients undergoing open radical surgery for colorectal cancer * age over 18 years * signed informed consent exclusion criteria: * intolerance of the study drugs * history of crc surgery * neoadjuvant therapy * contraindications to epidural analgesia * other malignancy not in permanent remission * chronic opioid medication or opioid administration within 7 days preoperatively * immunosuppressive or corticosteroid therapy * surgery within 30 days preoperatively (except minor) * chronic or acute infection

Keywords: perioperative analgesia colorectal cancer circulating tumor cell
fascia iliaca compartment block versus anterior quadratus lumborum block

Conditions: Postoperative Pain

Summary: fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. however, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, facia iliaca compartment block will be compared to anterior quadratus lumborum block, both will be done ultrasound-guided using bupivacain0.25% for postoperative analgesia at the end of the surgery.

in this prospective, randomized, comparative study patients will be equally divided into two equal groups; groupi: patients will receive ultrasound-guided facia iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery group q: patients will receive ultrasound-guided anterior quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery

Eligibility criteria:
inclusion criteria: * asa ii to iv * both sexes * scheduled for fracture femur surgeries exclusion criteria: * patients with bleeding disorders and coagulopathy * infection at the injection site * known allergy to local anaesthetics * patients with multiple fractures * patients with pre-existing myopathy or neuropathy * patients with significant cognitive dysfunction * patients who receive long-acting opioids preoperatively
the prevalence of oral hpv infection and oral lesions in people living with hiv

Conditions: Human Immunodeficiency Virus; Human Papilloma Virus

Summary: the study will evaluate 300 people living with hiv that attend the vivent clinic for hiv care. we will characterize our population and include age, race/ethnicity, sex at birth, tobacco use, alcohol use, other comorbidities, hpv vaccination status, other hpv disease, and lab values such as cd4 count and hiv viral load. we will compare results between participants who are hpv positive and negative. we will also evaluate the relationship between hpv oral infections and lesions and the variables above to better understand possible predictors of hpv infections and lesions.

vivent health is a non-profit medical home model dedicated to the primary care of people living with hiv (plwh) and also provides pre-exposure prophylaxis (prep), hepatitis c, and sexually transmitted infection (sti) treatment. the organization has clinics in wisconsin (multiple cities), denver, st. louis, austin and kansas city. all insurances except kaiser are honored and non-insured people are able to be seen. the denver medical clinic is a designated medical home that provides adult primary medical and specialty care to approximately 1000 + plwh. in additional to medical care, this clinic has an onsite pharmacy, case management, hiv and hepatitis c prevention department, syringe access program, legal department, housing specialists, food bank, a mental health program and dental services. vivent health in denver cares for a diverse population with approximately 11% african-american, 13% latino, and a recently increasing percentage of women around 13%. this clinic has a strong electronic health record system (ehr- epic) which provides ample opportunity to recruit a robust study population to investigate the following co-morbidities which might increase the risk of oral hpv infection and related lesions. given the lack of recommended routine screening for oral hpv in the absence of established masses or lesions, there is a wealth of opportunities to investigate risk factors associated with the presence and prevalence of oral hpv which, in turn, can potentially be used to inform screening and treatment protocols. this proposal is designed to evaluate the prevalence of oral hpv infections and associated oral lesions and associated demographics in hiv treatment clinic.

Eligibility criteria:
inclusion criteria: 1. documented hiv test on any fda-approved hiv test 2. ability and willingness of participant to provide informed consent 3. capable of performing an oral swish and spit sample collection 4. willingness to have an oral exam by denver vivent health dentist 5. has had at least two visits at the vivent health denver clinic 6. study participant allows demographics and medical history/laboratory results in electronic medical records to be confidentially evaluated. exclusion criteria: 1. any medical or mental health diagnosis that the study team concludes would prohibits participation of the protocol 2. cd4 count \< 200 cells/ml 3. history of oral/tongue cancer

Keywords: hpv hiv swish
integrating conservative kidney management options and advance care planning into a pre-dialysis educational program

Conditions: Advance Care Planning; Chronic Kidney Diseases; Conservative Kidney Management

Summary: the goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced ckd.

this intervention will be randomized among patients with advanced chronic kidney disease.

Eligibility criteria:
inclusion criteria: * stage 4 or 5 ckd (defined by the ckd-epi estimation of gfr \< 30 ml/min/1.73m2) * age 65 years or greater or frail * self-reported black or white race exclusion criteria: * history of dementia * history of legal blindness * listed for kidney transplantation