Kornimate/medical-research-clean huggingface dataset:
prevention of contrast renal injury with different hydration strategies

Conditions: Contrast Medium-induced Nephropathy

Summary: using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.

the study population will be recruited from subjects undergoing cardiac catheterization. subjects will be randomized to one of two hydration protocols: 1. normal saline at 3 ml/kg for one hour prior to contrast exposure and 1.5 ml/kg/hr during and for four hours post procedure. 2. normal saline at 3 ml/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (lvedp). the fluid rate based upon the lvedp measurement is maintained during the procedure and for four hours post procedure. the lvedp hydration strategy follows: (2a) \ 18 mmhg, 1.5 ml/kg during and four hours post procedure. renal function assessment will be made using standard laboratory measures post procedure.

Eligibility criteria:
inclusion criteria: * estimated gfr less than or equal to 60 ml/min/1.73 m\^2 * age greater than 18 years * at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years. exclusion criteria: * patients unable to give consent * undergoing emergency cardiac catheterization * on renal replacement therapy * exposure to contrast media within the prior two days * pulmonary edema or active congestive heart failure * kidney transplant status * severe valvular abnormalities * change in serum creatinine greater than 15% over the prior two days

Keywords: contrast nephropathy cardiac catheterization angiography percutaneous coronary intervention is
effect of metabolic modulation on a post-acute covid-19 vaccination syndrome (pacvs) cohort

Conditions: Vaccine Adverse Reaction; Post Acute Covid-19 Vaccination Syndrome

Summary: the goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute covid-19 vaccination syndrome (pacvs), a condition characterized by persistent fatigue and exercise intolerance attributed to covid-19 vaccination and confirmed by laboratory testing. the main questions it aims to answer are: does the combined nutraceutical intervention improve quality of life (measured by the pac-19qol questionnaire) in pacvs patients? does the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., hba1c, blood lactate, crp, spike protein levels, heart rate variability, 6-minute walk distance)? researchers will compare the intervention group (receiving the vital scan nutraceutical) to a placebo group (receiving rice protein powder with vitamin c) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles. participants will: take the assigned supplement daily for 3 months (vital scan or placebo) attend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring complete quality of life and health behavior questionnaires undergo measurements of metabolic and inflammatory markers (hba1c, lactate, crp, spike protein) record supplement intake this study is currently pending irb approval and aims to enroll 100 adults with pacvs for a randomized, placebo-controlled trial.


Eligibility criteria:
inclusion criteria: * persistent fatigue lasting more than 6 months * received at least one dose of a covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination) * laboratory result showing persistent spike protein in blood or presence of spike protein antibodies with sars-cov-2 nucleocapsid antibodies negative. exclusion criteria: * pregnant * history of schizophrenia * currently using antidepressant medication

Keywords: post acute covid-19 vaccination syndrome metabolic modulation amino acids
design and usability testing of a tailored intervention about sleep and sleep disorders among transportation workers

Conditions: Obstructive Sleep Apnea

Summary: the objective of this protocol is to conduct a focus group to identify osa beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.

transportation shift workers (tsw, e.g., overnight, on-call, or rotating) have been identified as a high-risk group for health conditions (e.g., obesity, cardiovascular disease). also, tsw are at risk for obstructive sleep apnea (osa). according to one study, approximately 36% of tsws have osa, a condition that exacerbates health risks and daytime sleepiness. a recent report from the american academy of sleep medicine (aasm) showed that those with untreated osa cost on average $4,261 more than those without osa. also concerning, workers with osa who are non-adherent to recommended osa treatment (i.e., continuous positive airway pressure, cpap) are at particularly high risk for motor vehicle accidents compared to those who are adherent. this protocol outlines focus groups that will aim to identify knowledge, attitudes, and beliefs about osa among tsw. results of these focus groups will be used in future research to design a tailored website for relaying osa information to tsw.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. access to a smartphone device 3. commitment to completing all study activities 4. score 4 or higher (mild or higher on osa risk) according to the apnea risk evaluation system (ares) questionnaire. exclusion criteria: 1. significant medical or psychiatric illness according to the promis short form (sf-12) 2. no osa risk (a score below 4 on the ares).
paracetamol (acetaminophen) for closure of pda in preterm infants

Conditions: PDA

Summary: there is a report that acetaminophen may have a role in pharmacological closure of pda (patent arterial duct) in preterm infants. the investigators conducted this open label non randomized and non control study to try to support that report.

in-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left. after birth, systemic pressure rises and pulmonary pressure declines. as oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. in preterm infants, the arterial duct may remain open after birth. at this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion. ibuprofen is the treatment of choice for pda in preterm infants. yet, ibuprofen is not effective after two weeks of age. moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails. lastly, there was a report that acetaminophen may have a role in pharmacological closure of pda in preterm infants. the investigators conducted this open label non randomized and non control study to try to support that report.

Eligibility criteria:
inclusion criteria: * preterm infants with symptomatic pda who could not be treated with ibuprofen exclusion criteria: * none

Keywords: paracetamol acetaminophen pda preterm infants
a study to efficacy and safety of cwp-0403 in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: this trial is to evaluate the efficacy and safety of cwp-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.


Eligibility criteria:
inclusion criteria: * type 2 dm patients * subjects who couldn't control the blood glucose despite of a dietary and exercise therapy more than 6 weeks at screening visit * fpg ≤ 270mg/dl at screening visit * patients who consent to participate in this trial by written informed consent form exclusion criteria: * type 1 dm or secondary diabetes * subjects who are administrating insulin or need to insulin therapy * history of oral anti-hyperglycemic drugs within 6 weeks before screening visit * body mass index \ 40.0kg/m2 * subjects who are assessed to be inappropriate for this trial by investigator

Keywords: cwp-0403 type 2 dm efficacy safety phase 3
community-based evaluation of a pilot pmtct project in kafue district

Conditions: Death; HIV Infection

Summary: in this study, the investigators will assess the population effectiveness of using routine haart as a pmtct strategy, through a community-based survey. the survey will be done in the catchment areas of four health clinics in rural zambia both before and after giving routine art in the clinics, so as to estimate population hiv-free survival among infants born in each target community. the investigators hypothesize that incorporation of routine art into pmtct will increase the hiv-free survival of exposed infants to 75%.

the primary objective is to determine the incremental benefit of a routine art strategy for pmtct on a population basis, when compared to short-course zidovudine and single-dose nevirapine (the current pmtct standard of care). we will take advantage of planned implementation of a pilot project for routine art across four primary care centres in rural zambia (kafue district). using a community-based survey modeled after the demographic and health survey, we will measure hiv-free survival among children under two years of age in the catchment areas surrounding these pilot sites, both before and after implementation of services. we will use before-after comparisons in each of these four communities to better understand the incremental benefit of providing these services.

Eligibility criteria:
inclusion criteria: * household where a child has been born in the past two years. exclusion criteria: * household where there no child has been born in the past two years.

Keywords: hiv-free survival community based evaluation pregnancy under 2 child survival pmtct pediatric hiv infection haart routine art hiv seronegativity
resistance training to prehabilitate patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease (copd) have been linked to impaired muscle function, reduced exercise capacity, and increased mortality associated with this disease. muscle dysfunction also contributes to dyspnea intensity and the ability to sustain exercise, making aerobic exercise training intolerable at the intensity and/or volume required to achieve clinically important changes. resistance training (rt) is an attractive exercise modality because it is efficacious and more tolerable initially. no work has examined whether a short-term rt program can reduce exertional symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with copd.

skeletal muscle dysfunction is common in patients with copd and has been recognized as a contributing factor to reduced exercise capacity, health related quality of life and increased mortality associated with this disease. several structural changes in the limb muscles of patients have previously been reported and have been linked to the known reductions in muscle strength and endurance commonly reported in copd. muscle dysfunction, lower extremity muscle strength, and muscle fatigue also contribute to the intensity of dyspnea and the ability to sustain exercise mostly through stimulation of type iii and iv muscle afferents. as such, many patients who primarily perform aerobic exercise training as part of pulmonary rehabilitation are unable to tolerate the intensity and/or volume of exercise required to achieve clinically important changes in exercise capacity or symptom relief. resistance training (rt) is an attractive exercise modality for patients with copd because it is efficacious and often more tolerable initially. to our knowledge no one has examined whether similar benefits to those elicited by longer rt programs can be attained in just 4 weeks using multi-joint, multi-muscle exercises and individualized progression. if a short term rt program can improve muscle quality, enhance endurance, and reduce type iii and iv afferent activity then it would reduce the drive to breathe and thus dyspnea. these adaptations would likely translate into improved exercise tolerance making it feasible to "pre-habilitate" copd patients with tolerable rt, allowing them to achieve a higher volume/intensity of endurance training, thus making pulmonary rehabilitation more effective.

Eligibility criteria:
inclusion criteria: * non-smokers \>6 months * fev1/fvc \<0.7 and lower limit of normal * 30%\< fev1 pred \<70% * stable (no exacerbation for \>3 months) exclusion criteria: * cardiovascular and cerebrovascular disease * diabetes * cardiovascular contraindications to exercise * uncontrolled hypertension * currently performing regular structured exercise \>3x/week for 30 minutes

Keywords: copd resistance training exercise training dyspnea
insulin regulation and severity of severe acute respiratory syndrome covid-19 infection

Conditions: COVID-19; Diabetes Mellitus; COVID-19 Pneumonia; COVID-19 Respiratory Infection

Summary: the coronavirus disease of 2019 (covid-19) pandemic has caused an international healthcare crisis and produced a large healthcare burden. diabetes mellitus is a common disease that can be controlled via pharmacologic agents; however, many patients have poor glycemic control, leading to disease-related complications. diabetes mellitus has been reported in the literature to be associated with increasing morbidity and mortality in covid-19 patients, and some hypothesize that this is due to insulin dysregulation propagating a pro-inflammatory state. the investigators aim to contribute to the growing body of literature that assesses the associations between glucose homeostasis and covid-19 disease severity and mortality.

the coronavirus disease of 2019 (covid-19) is caused by an infection from the severe acute respiratory syndrome coronavirus 2, and the first case in the united states was documented on january 31, 2020. severe acute respiratory syndrome coronavirus 2 is a rna virus that has 82% homology with severe acute respiratory syndrome coronavirus 2, which caused a pandemic in 2003. severe acute respiratory syndrome coronavirus 2 enters cells via the angiotensin converting enzyme 2 (ace2) receptor, which is primarily expressed in the lung. covid-19 has led to a worldwide pandemic, with over six million deaths attributed to the virus, according to the world health organization. this emerging infection has caused an international healthcare crisis with a significant burden on healthcare workers. advanced age, male sex, cardiovascular disease, and diabetes mellitus are known to be associated with increasing risk for covid-19 severity and mortality. diabetes mellitus is a common disease that affects the general population by disrupting glucose homeostasis. impaired glycemic control produces a state of hyperglycemia, which leads to multi-organ injury via a chronic, pathophysiologic inflammatory state. early retrospective studies demonstrated the association of insulin dysregulation with covid-19 disease severity and mortality. with more data availability and time, many studies have been conducted to better characterize the relationships between hyperglycemia and elevated hemoglobin a1c (hba1c) with covid-19 disease susceptibility, severity, and mortality. through this retrospective analysis, the investigators investigate the associations of hba1c levels and hyperglycemia with covid-19 mortality and disease severity.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * covid-19 confirmed by laboratory testing (icd10 u07.1) * pneumonia due to covid-19 (icd10 j12.82) * diagnosis of diabetes mellitus exclusion criteria: * all patients under the age of 18 * covid in pregnancy
"stop early age-related macular degeneration (amd) from vision loss eternally" study

Conditions: Age-Related Macular Degeneration; Retinal Drusen

Summary: this study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative amd.

save study (stop early age-related macular degeneration form vision loss eternally)

Eligibility criteria:
inclusion criteria: * drusen in both eyes examined under fundoscopy * at least one of the eyes must have high-risk soft drusen * bcva below etdrs 83 letters * patient with consent to participate exclusion criteria: * prior diagnosis with choroidal neovascularization * exudative amd in at least one eye * if the patient has only one visually effective eye (last eye) * other macula or retinal diseases than age-related macular degeneration
optimized characterization of takotsubo syndrome by obtaining pressure volume loops

Conditions: Takotsubo Syndrome

Summary: aim of this prospective study is to assess the pathophysiology of takotsubo syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms


Eligibility criteria:
inclusion criteria: * confirmed takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up * sinus rhythm during invasive measurements * age ≥18 years * written informed consent exclusion criteria: * cardiogenic shock * signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging * pregnancy * participation in another trial
impact of inclusion of a therapy dog visit as part of the fibromyalgia treatment program

Conditions: Fibromyalgia

Summary: in this study the investigators hypothesize that the presence of a mayo clinic certified therapy dog will provide additional benefits above typical therapy for patients suffering from fibromyalgia currently enrolled in the mayo clinic fibromyalgia program.

the human animal bond refers an emotional relationship between animals and people. the purpose of this study is to evaluate whether the presence of a dog provide additional benefits above typical therapy for patients suffering from fibromyalgia and also to assess the emotional wellbeing state of the therapy dog.

Eligibility criteria:
inclusion criteria: * patients diagnosed with fibromyalgia at our fibromyalgia clinic * patients actively being seen at the fibromyalgia clinic * able and willing to give informed consent * able to speak english * able to complete questionnaires * no fear or allergy of dogs exclusion criteria * diagnoses of bipolar disorder, schizophrenia, or dementia * individuals who decline to participate in the study * individuals that are severely allergic to or fearful of dogs
assisted ambulation to improve health outcomes for older medical inpatients

Conditions: Mobility Limitation; Frailty; Hospital Acquired Condition; Weakness, Muscle

Summary: the investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (mt) up to three times daily, including weekends, to hospitalized medical patients. the aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the mts, the index hospitalization and the first 30 days post enrollment.

the investigator proposes to conduct a large randomized trial to test the impact of mts (mobility technicians) on short and intermediate term outcomes for 3000 patients aged 65 years and older at 5 hospitals in 2 health systems. patients will be randomized to receive supervised ambulation up to 3 times daily with a mt or to receive usual care. all participants will wear an accelerometer on their wrist to track their movement throughout the hospital stay. the study has 3 aims. first, the study will compare the mobility of patients at discharge (or 10 days) to assess the impact of the mts on this outcome. of particular interest is whether the use of mts will increase the proportion of patients who can go home vs.post-acute care, and whether the improvements in mobility are sustained at 30 days. second, the study will use predictive modeling to identify which patients are most likely to benefit from this intervention. third, the study will assess the impact of the intervention on overall costs associated with the episode of care, including inpatient costs and the 30 days post enrollment. this information will be important to convince health systems to adopt this approach.

Eligibility criteria:
inclusion criteria: participants must meet all of the inclusion criteria listed below to participate in this study: 1. ≥65 years of age 2. admitted to a medical service 3. complete history and physical examination on file 4. 6-clicks score of 16-23 5. insurance with traditional medicare or medicare advantage exclusion criteria: any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation: 1. significant language barrier that requires a translator (other than spanish at baystate site only) 2. discharge planned for that day or the following day 3. observation status 4. surgical procedure planned 5. patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation 6. permanent residence in a skilled nursing facility 7. comfort care measures only 8. \>48 hours since admission 9. active infection with covid-19 10. other active infection requiring contact or droplet precautions 11. order for bedrest
study of mgta-145 and plerixafor in patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: this research study is designed to investigate a new potential medicine for mobilizing stem cells and apheresis collection in patients with sickle cell disease. mgta-145, the new potential medicine, will be given with plerixafor.

this phase 2, multicenter, open-label study will be conducted in 2 parts (parts a and b). part a is intended to characterize the efficacy, safety, pk and pd of a single dose of mgta-145 and plerixafor for hsc mobilization and apheresis collection in patients with scd. part b is designed to characterize the efficacy, safety, pk and pd of 2 consecutive days of dosing with mgta-145 and plerixafor for hsc mobilization and apheresis collection in patients with scd.

Eligibility criteria:
inclusion criteria: * subject must be ≥18 to ≤35 years of age. * subject must weigh ≥30 kg. * subject must have a diagnosis of sickle cell disease. exclusion criteria: * subject must not have had a vaso-occlusive event (voe) requiring a visit to a healthcare facility within 30 days of screening. * subject must not have undergone or attempted and failed previous hematopoietic stem cell (hsc) collection. * subject must not have had a prior autologous or allogeneic transplantation, inclusive of gene therapy. * male subject must be willing or able to use a highly effective method of contraception for 3 months during and after treatment. * female subject must not be pregnant or breastfeeding. if sexually active, female subject must be willing or able to use a highly effective method of contraception for 3 months during and after treatment.

Keywords: scd mgta-145 plerixafor mobilization apheresis