Kornimate/medical-research-clean huggingface dataset:
pet/ct* vs. cardiac ct for detecting coronary atherosclerotic disease [*pet: positron emission tomography; ct: computed tomography]

Conditions: Coronary Artery Disease; Atherosclerosis; Coronary Atherosclerosis of Native Coronary Artery

Summary: early detection of coronary atherosclerotic disease facilitates adequate prevention. the purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (naf-pet/ct) with those of conventional and ultra-high-resolution-ct (uhr-ct) in patients with suspected coronary artery disease. for this purpose, the investigators plan to include 33 patients with symptoms concerning for cad who have been referred for cardiac ct testing.

early detection of coronary atherosclerotic disease facilitates adequate prevention. 18 fluoride (f) -sodium fluoride pet/ct (naf-pet/ ct) has been shown to detect aortic microcalcification as early manifestation of atherosclerosis in experimental and early clinical investigations. the capability of naf-pet/ct to detect coronary atherosclerotic disease in humans remains unclear. given its sensitivity to detect vascular microcalcification undetectable by conventional ct, naf-pet/ct may be an attractive, noninvasive test for early detection of coronary atherosclerosis. the purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (naf-pet/ct) with those of conventional and ultra-high-resolution-ct (uhr-ct) in patients with suspected coronary artery disease (cad). for this purpose, the investigators plan to include 33 patients with symptoms concerning for cad who have been referred for cardiac ct testing. in addition to the clinically indicated and performed cardiac ct scan, participants will be asked to also undergo naf-pet/ct for comparison of atherosclerosis assessment among the two tests (single center, prospective diagnostic accuracy study).

Eligibility criteria:
inclusion criteria: * male or female patients * 18 years or older * referred for coronary ct angiography because of suspected coronary heart disease (chd) with stable symptoms exclusion criteria: * the patient has a history of coronary heart disease, defined by prior myocardial infarction or prior coronary artery revascularization. * pregnancy. * atrial fibrillation. * morbid obesity defines as a body mass index of \>40. * the patient has any other clinically significant medical condition that in the opinion of the investigator could impact the patient's ability to successfully complete the trial.

Keywords: coronary imaging prevention early detection
pediatric fast fluid trial 2

Conditions: Resuscitation; Shock; Fluid Therapy; Pediatrics

Summary: the purpose of this study is to determine which of two commonly used methods of manual pediatric fluid resuscitation (the "push-pull technique" vs. the "disconnect-reconnect technique") allows for the most rapid administration of normal saline when this is urgently required.


Eligibility criteria:
inclusion criteria: * health care providers working or training at mcmaster children's hospital, including staff nurses, staff physicians, postgraduate medical trainees, nursing students, and medical students * may be asked to perform manual fluid resuscitation as part of their clinical care activities exclusion criteria: * inability to understand english * limited manual dexterity, specifically resulting in an inability to perform manual fluid resuscitation involving syringes * have acted in a physically strenuous capacity that may result in significant hand fatigue in the 30 minutes immediately prior to performance of the intervention. where this is the only criteria limiting subject participation, rescheduling of an alternate testing time will be permitted.

Keywords: resuscitation shock fluid therapy pediatrics
correlation between multiple sclerosis functional composite (msfc) and expanded disability status scale (edss) in patients with multiple sclerosis (ms) in argentina

Conditions: Multiple Sclerosis

Summary: this observational study is being conducted to evaluate the usefulness of the msfc and its relationship with edss scores in subjects with ms in argentina.

this observational, open-label study is being conducted to correlate change in edss score with the change in msfc scores at the end of a 2-year follow-up period for subjects with ms in argentina. measurement of disability is an indispensable parameter in assessing the efficacy of experimental therapeutic agents in ms as well as in trying to determine possible individual evolution of the disease. clinical scales are being used as primary or secondary outcome measures for recording disease progression in clinical trials. kurtzke's edss is still used as a gold standard for measuring impairment and disability in ms. the msfc is an examination-based quantitative scoring of neurological impairment. this study aims to establish a correlation between the usefulness of both scales. objectives primary objective: * to evaluate the change in msfc score with change in edss scores at end of 2 year follow-up period for subjects with ms in argentina secondary objectives: * to evaluate the cross-sectional correlations in msfc score at baseline and at 24 months with edss score at baseline and at 24 months * to describe the msfc score for ms phenotype in this population * to evaluate the predictive validity of msfc score of a subsequent edss change in a subgroup of ms patients in argentina

Eligibility criteria:
inclusion criteria: * subjects with definite diagnosis of ms, according to mcdonald's criteria * all clinical types: relapsing-remitting ms (rrms), primary progressive ms (ppms) and secondary progressive ms (spms). stable disease course without any relapse for at least the previous 3 months * subjects treated or not with disease modifying drugs * ages between 18 and 65 years and is capable of understanding and complying with protocol requirements * subject has a stable residence with no planned move during the entire investigation period exclusion criteria: * life expectancy less than 5 years at admission * diagnosis of clinically isolated syndrome (cis) * other clinical conditions that mimic ms * psychiatric diseases * alcohol or drug abuse * pregnancy * the subject is unwilling or unable to comply with the protocol or scheduled appointments * subject is unable to understand the language in which the approved informed consent is written * the subject is a study site employee, or an immediate family member (i.e., spouse, parent, child, sibling) of a study site employee, involved in conduct of this study

Keywords: relapsing-remitting multiple sclerosis (rrms) primary progressive multiple sclerosis (ppms) secondary progressive multiple sclerosis (spms) multiple sclerosis functional composite (msfc) expanded disability status scale (edss)
efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp

Conditions: Actinic Keratosis (AK)

Summary: this is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

all subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete ak lesions within a contiguous 25 cm2 treatment area on the face or scalp. eligible subjects will be randomised in a 1:1 ratio to the following treatment groups: * treatment group a: ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. at 8 weeks after treatment initiation, subjects who present with existing aks or newly emergent aks in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days. * treatment group b: diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Eligibility criteria:
inclusion criteria: 1. following verbal and written information about the trial, subject must provide informed consent documented by signing the informed consent form (icf) prior to any trial related procedures 2. subjects with 4 to 8 clinically typical, visible and discrete aks within a contiguous 25 cm² treatment area on the face or scalp exclusion criteria: 1. location of the selected treatment area: * on the periorbital skin * on the perioral skin/around the nostrils * within 5 cm of an incompletely healed wound * within 10 cm of a suspected bcc or scc or other neoplasia
optimizing gvhd prophylaxis after allogeneic hematopoietic cell transplantation

Conditions: Hematological Malignancies; Graft-versus-Host Disease (GVHD)

Summary: this study will compare post-transplant health-related quality of life following the use of standard versus attenuated dose of post-transplant cyclophosphamide in addition to two-drug graft-versus-host disease (gvhd) prophylaxis among recipients of allogeneic hematopoietic stem cell transplant.

this is a single-center phase ii study of 126 participants (63 per arm) with hematological malignancies. participants will be randomized to receive high doses (standard arm) or attenuated doses of cyclophosphamide in addition to two-drug gvhd prophylaxis. participants will be monitored for health-related quality of life \[functional assessment of cancer therapy-bone marrow transplant, fact-bmt(1)\], functional outcomes (karnofsky performance scale (kps), activities of daily living, instrumental activities of daily living, clock-in-the-box test, fried frailty index, fall history, bmi, and geriatric depression scale-15, gvhd, relapse, survival, and toxicities (using common terminology criteria for adverse events, ctcae version 5.0).

Eligibility criteria:
inclusion criteria: * adults aged 60 years or older * diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation * planned to receive any reduced-intensity conditioning regimen (any graft source is acceptable) and availability of human leukocyte antigen (hla)-matched donor at hla loci a, b, c, and hla-dr beta chain antigen (drb1) * karnofsky performance status (kps) of 70% or higher. exclusion criteria: * previous history of one or more prior allogeneic stem cell transplants (i.e., second or third allogeneic transplant) * planned use of high doses of cyclophosphamide (e.g., a total cyclophosphamide dose of approximately 50 mg/kg or more) as part of the conditioning regimen prior to allogeneic stem cell transplant. a lower dose of cyclophosphamide (e.g., fludarabine, cyclophosphamide, and low-dose total body irradiation regimen that uses 2 doses of cyclophosphamide at 14.5 mg/kg) is acceptable. * known diagnosis of liver cirrhosis or other advanced liver disease that may impact cyclophosphamide metabolism. * diagnosis of myelofibrosis * creatinine clearance less than 40 ml/min/1.73 m², which may increase the risk of hemorrhagic cystitis with post-transplant cyclophosphamide (ptcy) * systolic cardiac dysfunction with an ejection fraction of less than 45%. * use of a haploidentical or mismatched donor. * any other condition judged by the physician to increase the risk of toxicities associated with ptcy.

Keywords: allogeneic hematopoietic stem cell transplantation gvhd prophylaxis sirolimus mycophenolate mofetil (mmf) health-related quality of life (hrqol) randomized controlled trial
highcycle study: effect of high altitude on acute mountain sickness in women related to their menstrual cycle phase

Conditions: Acute Mountain Sickness

Summary: prospective cohort study investigating the menstrual cycle phase (mcp)-dependent incidence of acute mountain sickness (ams) in women travelling to 3600 m.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives). * bmi \>18 kg/m2 and \<30 kg/m2 * born, raised and currently living at altitudes \<1000 m * written informed consent * premenopausal, eumenorrheic cycle exclusion criteria: * other types of contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others) * pregnancy or nursing * anaemic (haemoglobin concentration \<10g/dl) * any altitude trip \<4 weks before the study * allergy to acetazolamide and other sulfonamides

Keywords: women hypoxia prevention acetazolamide altitude
work of breathing in nasal cpap versus high flow nasal prong in infants with severe acute bronchiolitis

Conditions: Bronchiolitis

Summary: nasal continuous positive airway pressure (ncpap), widely used in neonatal intensive care is also more and more used in infants with severe acute bronchiolitis. there is no evidence that ncpap improves outcome, but several studies showed that it reduces work of breathing (wob), improves gas exchange and decreases intubation rate. high flow nasal prong (hfnp) therapy, also used in neonatal units, has recently been suggested for bronchiolitis management. this technique allows warmed and moist gas administration protecting nasal mucosa, and preventing variations of inspired gas fio2. hfnp also creates a continuous positive pressure, reducing wob, and seems much more comfortable and better tolerated by babies than ncpap. there are no studies comparing both techniques for bronchiolitis management. the main objective of this study is to compare wob with ncpap and hfnp therapy in infants with severe bronchiolitis in pediatric intensive care unit. secondary purpose is to compare efficacy and tolerance of both techniques. we propose to lead an open, single center, crossover randomized study. each patient will receive the two treatments. three consecutive periods will be studied: first one (minimum 2 hours), with the first technique cpap or hfnp according to randomization (treatment 1); second period (2 hours) with the second technique (treatment 2); third period (6 hours) with the second technique. the primary endpoint will be the comparison of wob (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts periods. efficacy and tolerance of each technique will be evaluated and compared by compared measuring respiratory rate, heart rate, fio2, spo2, transcutaneous pco2, modified wood score, and edin score during the third period. nine subjects by groups are required.


Eligibility criteria:
inclusion criteria: * infants less than 3 months * infants hospitalized in the pediatric intensive care unit of the hospital in northern marseille for an episode of acute viral bronchiolitis, defined by the french consensus conference of 2000 (1) clinical signs of infection of the upper airways with tachypnea, brake expiratory and / or wheezing auscultation, signs of struggle * infants with acute respiratory distress score with wood changed\> 3 and requiring ventilatory support * infants whose parents or legal guardians have accepted their participation in the research and signed informed consent. * with social security exclusion criteria: * - clinical condition requiring immediate intubation before the start of treatment to the: * severity of respiratory distress: fio2\> 60% to maintain spo2\> 92% * hemodynamic instability * the occurrence of apneas désaturantes (respiratory pauses greater than 20 seconds duration associated with desaturation \<80% and / or bradycardia \<80/min) * the presence of neurological disorders with altered consciousness * presence of co-morbidities: * chronic respiratory failure * heart
a study to evaluate cc-486/onureg in participants with moderate or severe hepatic impairment compared with normal hepatic function in participants with myeloid malignancies

Conditions: Hepatic Insufficiency; Neoplasms

Summary: the purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.


Eligibility criteria:
inclusion criteria: * documented diagnosis of myelodysplastic syndrome, acute myeloid leukemia, non-acute promyelocytic leukemia, chronic myelomonocytic leukemia, philadelphia-negative myeloproliferative neoplasms, myelodysplastic syndrome myeloproliferative neoplasms overlap, accelerated phase and blast phase myeloproliferative neoplasms, blastic plasmacytoid dendritic cell neoplasm according to the world health organization (who) 2016 classification * life expectancy of ≥ 3 months * stable renal function without dialysis for at least 2 months prior to investigational product administration * has moderate or severe hepatic impairment as defined by national cancer institute organ dysfunction working group criteria exclusion criteria: * chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first day of investigational product administration * persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to \< grade 2 * any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study * history of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity other protocol-defined inclusion/exclusion criteria apply

Keywords: cc-486 azacitidine hepatic impairment onureg myeloid malignancies
the use of a novel vaginal speculum for cervical cancer screening in sunrise community health patients

Conditions: Cervical Cancer Screening

Summary: the specific aim of this research is to determine if the bouquet speculum tm , compared to the existing 2-bladed vaginal speculum, provides better visualization of the cervix, is easier for the provider to use and is more comfortable for the patient. additionally, the clinician's experience with vaginal speculum exams and the patient's last vaginal speculum exam, parity and self-reported weight classification will be surveyed to see what effect, if any, it has on visualization of the cervix, ease-of use, and comfort level for the patient. the objective of this project is to investigate the use of a novel, fda-cleared, 5-petaled vaginal speculum in cervical cancer screening (pap test and/or hpv probe) on 200 patients from sunrise community health clinics in the denver-metro area.

the bouquet speculum tm will be used by a variety of clinicians at sunrise clinics including physicians, pas, and nps for routine cervical cancer screening including pap tests and/or hpv probes. 200 women will be selected from the sunrise clinics in the denver-metro area. women who do not have a cervix or have never had a vaginal speculum exam will be excluded. the inclusion criteria is women ages 18-65. the clinician will be provided with a one-page instructions for use document and a 2-minute instructional video on how to use the bouquet speculum tm. the clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1. visualization of the cervix 2. ease-of-use 3. experience with speculum exams. the patient will be consented and de-identified and assigned a number to their survey of four questions: 1. comfort level 2. last vaginal speculum exam 3. self-reported description of weight (underweight, normal, overweight, obese) 4. parity (number of births). the length of the study is anticipated to be three months. the surveys will be collected and tabulated and then evaluated by dr. mark payton who has experience with the pakistan study. the bouquet speculum has been fda-cleared and is a class ii medical device and poses a non-significant risk for use in humans. proprietary name: bouquet vaginal speculum classification name: retractor, vaginal product code: hdl device class:2 regulation number: 884.4520 medical specialty: obstetrics/gynecology registered establishment name: viospex registered establishment number:3012447313 owner/operator: viospex owner/operator number:10051911 establishment operations: manufacture

Eligibility criteria:
inclusion criteria: * women, gender diverse patients with an intact cervix * women ages 18-25 exclusion criteria: no prior vaginal speculum exam * under age 18 or over age 65 * lack of a uterine cervix * no prior vaginal speculum exam

Keywords: vaginal speculum cervical cancer screening
rectus sheath block with liposomal bupivacaine versus thoracic epidural analgesia for pain control following pancreatoduodenectomy

Conditions: Duodenal Neoplasm; Pancreatic Neoplasm

Summary: this phase ii trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (tea) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may help with pain relief during and after surgery. tea uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication, such as bupivacaine and hydromorphone, to treat pain in the thoracic and upper abdominal areas during and after surgery. epidurals have been successfully used to treat pain after surgery, however, it does have a risk of low blood pressure which may limit the use in the thoracic approach. rectus sheath blocks with liposomal bupivacaine may be as effective as tea in reducing pain in patients following a pancreatoduodenectomy.

primary objective: i. to determine if rectus sheath blocks with liposomal bupivacaine provide non-inferior analgesia compared with thoracic epidural analgesia (tea) for patients undergoing pancreatoduodenectomy. outline: patients are randomized to 1 of 2 groups. group epidural (e): prior to pancreatoduodenectomy, patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively. patients also receive iopamidol via epidural and undergo x-ray imaging on study. group rectus sheath (rs): prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.

Eligibility criteria:
inclusion criteria: * adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the university of minnesota will be included in the study exclusion criteria: * patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection) * patients with chronic opioid use (at least 30 milligram morphine equivalents \[mme\] for 3 or more weeks leading up to surgery) * patients unable to understand the quality of recovery survey intellectual barriers. this will be determined by the primary investigator/attending anesthesiologist's discretion * patient refusal and those who have opted out of research * pregnant patients - will be assessed through review of the medical record