Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic and pharmacodynamic study of a novel sublingual aspirin tablet

Conditions: Cardiovascular Diseases

Summary: the objective of the study is to compare the pharmacokinetics and pharmacodynamics of a new sublingual formulation of aspirin with that of oral aspirin when administered to healthy volunteers under fasting conditions. the test product is sublingual aspirin 80 mg manufactured by vita green health products co. ltd, hong kong and the reference product is oral aspirin 80mg tablet manufactured by synco (hk) ltd, hong kong.


Eligibility criteria:
inclusion criteria: 1. male, 18 to 55 years of age 2. body mass index between 18-27kg/m2 3. accessible vein for blood sampling 4. high probability for compliance and completion of the study 5. no significant abnormalities in general physical examination 6. subjects must agree to take effective contraceptive methods to prevent his partner pregnant during the time of first dose of study medication until one week of last dose administration exclusion criteria: 1. history of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening 2. clinically relevant abnormality in physical examination, ecg evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator 3. positive results for hepatitis b at screening 4. moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing) 5. moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing) 6. blood donation of more than 350 ml within 4 weeks prior to start of first drug dosing 7. treatment of aspirin within 4 weeks before first dosing 8. volunteer in any other clinical drug study within 2 months prior to start of first dosing 9. hypersensitivity to aspirin or other drug in its class
reboa in nontraumatic ohca

Conditions: Cardiopulmonary Arrest

Summary: the investigators propose a multicenter randomized controlled trial in south korea and taiwan to observe the clinical effects of reboa on nontraumatic out-of-hospital-cardiac-arrest (ohca) patients. while reboa has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.

nontraumatic ohca patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. if the patient meets the enrollment criteria, he/she will be randomized into the control group (treatment with conventional acls according to the 2020 aha guideline) or the reboa group (acls according to the 2020 aha guideline with reboa application). a sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. this is followed by insertion of the reboa catheter, if the patient is allocated into the intervention group. the aortic balloon is inflated. if rosc is achieved, the balloon is deflated slowly. patients who achieve rosc will receive post cardiac arrest management according to the 2020 aha guideline.

Eligibility criteria:
inclusion criteria: * adult nontraumatic ohca * witnessed arrest * arrival at er from 9am to 5pm (in south korea) and 8am to 8pm (in taiwan) exclusion criteria: 1. age below 20 years old or over 80 years old, 2. traumatic cardiac arrest, 3. those with unwitnessed cardiac arrest, 4. pregnant patients, 5. patients who have already achieved rosc upon arrival at the emergency department 6. pre-cardiac arrest cerebral performance category of 3-4 7. those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding) 8. those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ed arrival or have a previous history of aortic disease 9. whose legal representative has requested termination of resuscitation efforts before study enrollment 10. declared dead at scene before randomization 11. patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ecpr), and therefore the decision is made to perform ecpr, will not be enrolled. the ecpr criteria applies when all of the following criteria are met: pre-cardiac arrest cpc of 1-2, witnessed cardiac arrest with bystander cpr, ages between 20-70, initial shockable rhythm, ecmo pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.

Keywords: advanced cardiopulmonary resuscitation (acls) cardiopulmonary resuscitation (cpr) resuscitative endovascular balloon occlusion of the aorta (reboa)
reverse shoulder arthroplasty vs rotator cuff repair for 60+

Conditions: Shoulder Injuries; Shoulder Pain

Summary: to compare the one year outcomes between 60 year old patients with a three tendon tear treated as part of their standard of care with either a reverse total shoulder arthroplasty or rotator cuff repair surgery.

a retrospective record review will be completed to identify eligible subjects who had either a reverse total shoulder arthroplasty or rotator cuff repair to treat their three tendon tear. medical record abstraction of standard of care will be completed among the reverse total shoulder arthroplasty cohort. rotator cuff repair subjects will be contacted with a study invitation and scheduled for a single study visit to collect three patient reported outcomes, assess range of motion and complete a ten-minute magnetic resonance imaging exam following signed consent.

Eligibility criteria:
inclusion criteria: * 60 years of age or more at time of surgery * one year post-reverse total shoulder arthroplasty or one year post-rotator cuff repair involving all three tendons (infraspinatus, supraspinatus, subscapularis) * surgery completed by dr. tyler brolin or dr. thomas throckmorton exclusion criteria: * less than 60 years of age at time of surgery * less than one year post-reverse total shoulder arthroplasty or post-rotator cuff repair * procedure completed by another provider than dr. brolin or dr. throckmorton * worker's compensation * fewer than three tendon tear
early enteral nutrition in severe acute pancreatitis

Conditions: Pancreatitis

Summary: to compare different time points for enteral nutrition in sap patients

there is increasing evidence that indicates early enteral nutrition（een） may be associated with improved outcome in acute pancreatitis patients. however, some sap patients failed to een. the researchers of this study aim to investigate the opportunity of een on the clinical outcomes of sap patients.

Eligibility criteria:
inclusion criteria: 1. diagnosis of pancreatitis: typical pain increase in serum lipase or amylase 2. onset of abdominal pain within \<=72h before admission 3. moderate severe or severe acute pancreatitis according to atlanta criteria revisited in 2012 ffff exclusion criteria: * 1. pregnancy 2.tumor 3. acute onset of chronic pancreatitis 4. chronic disease of any organ （heart lung gastrointestinal renal etc.） 5. pre-existing disease with life expectancy \< 3 months 7.receive parenteral nutrition or enteral nutrition before admitting

Keywords: pancreatitis enteral nutrition
diabetes prevention with lifestyle intervention and metformin escalation

Conditions: Diabetes

Summary: specific aim: implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of caribbean-descent to reduce the incidence of diabetes. hypothesis: this study seeks to test the hypothesis that implementation of a lifestyle intervention, with escalation to metformin therapy will lower the incidence of diabetes among the highest risk pre-diabetic individuals of caribbean-descent.

the investigators propose to conduct a pragmatic trial that tests the effectiveness of lifestyle modification and metformin use in minority populations. our study population is caribbean-descent individuals in region 2, trinidad and barbados. the investigators will have five clinical intervention sites situated in new york - 2, puerto rico -1, barbados -1, trinidad -1 and us virgin islands -1. these sites were chosen because of the investigators' strong research network in these locations, and to enable us to address diabetes disparities due to geographic differences. the investigators will first modify an established lifestyle modification workshop series developed by the east harlem partnership for diabetes prevention (ehpdp) for use in the community, 10to target the population at the involved clinical sites. the investigators plan to adapt the d-clip protocol and escalate to metformin therapy for the highest risk pre-diabetic patients whose hemoglobin a1c (hba1c) has not improved or who remain morbidly obese. the investigators will leverage our existing robust research infrastructure and network at the five sites through our eastern caribbean health outcomes research network (echorn) and now the yale transdisciplinary collaborative center for health disparities focused on precision medicine (yale-tcc). echorn is a research collaboration funded by the nimhd (u2458849938) to address the burden of chronic disease in usvi, pr and the eastern caribbean. the yale-tcc (u54md010711) leverages the infrastructure and knowledge of the echorn, expands to include new york and new jersey and focuses on diabetes and hypertension. the investigators' network includes community advisory boards as well as policy delegations that are well suited to inform this project and its expansion into routine healthcare practice and policy. the control arm of this study was never activated due to covid-19 restrictions.

Eligibility criteria:
inclusion criteria: * bmi\>25 or wc\>88/102cm * no history of type i or type ii diabetes or gestational diabetes * not on blood sugar altering medication * ability to attend weekly sessions * hba1c 6-6.4% exclusion criteria: * pregnant * egfr\<45 ml/min/1.73 m2 * prescribed metformin and randomized to the control arm
study with intravenous busulfan and fludarabine myeloablative conditioning regimen for hla identical sibling donor hsct

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Myeloproliferative Disorders; Chronic Myeloid Leukemia

Summary: analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing hla identical sibling allogeneic hsct for myeloid malignancies.

in this study the investigators evaluate a conditioning regimen consisting in fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). no busulfan pharmacokinetic monitoring is performed. graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. graft products obtained from bone marrow or peripheral blood of hla identical sibling donors are not manipulated in their cellular content before transplantation. blood products were leukocyte depleted and irradiated before transfusion. supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures. the main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at hsct and comorbidities.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia * myelodysplastic syndrome * myeloproliferative disorders * chronic myeloid leukemia exclusion criteria: * performance status ecog\>2 * cardiomyopathy (lvef \<39%) * pulmonary dysfunction (dlco\<39%) * hepatic dysfunction grade \>1 * renal dysfunction grade \>1 (creatinine \> 1.6 mg/dl) * hiv infection * other active neoplasm

Keywords: allogeneic hsct busulfan fludarabina
oral and perioral herpes simplex virus infection type i in a five-month-old infant: a case report

Conditions: Herpes Simplex Virus Infection

Summary: a five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles.

the investigators present the case of a five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles. the investigators discuss the pathophysiology of primary herpes simplex virus infection and the effect of maternal antibodies on the infant's immune system. in addition, the investigators explain the diagnosis, management, and prognosis of herpes simplex virus infection in young infants.

Eligibility criteria:
inclusion criteria: * five-months-old infants or younger exclusion criteria: * six-months-old infants or older

Keywords: herpetic gingivostomatitis herpes simplex virus perioral lesions infants case report herpes simplex virus type 1 oral lesions
effects of interferon-gamma on cavitary pulmonary tuberculosis in the lungs

Conditions: Tuberculosis; AIDS-related Complex

Summary: this study will evaluate the lung's immune response to mycobacterium tuberculosis (mtb) infection and will modulate that response with interferon-gamma.

background: mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. patients with bilateral pulmonary tuberculosis (tb), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse. design narrative: cavitary pulmonary tb will be studied and interferon-gamma will be used as the intervention. the outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (bal) cells. the primary outcome will be sputum conversion, which will be measured at weeks 4 and 8. the key secondary outcomes of this study will include a chest computerized tomography (ct) scan and bal to measure the flow of cytometry and cytokine levels. both outcomes will be measured at baseline and at month 4.

Eligibility criteria:
inclusion criteria: * positive acid-fast bacillus (afb) smear within 14 days prior to randomization * cluster of differentiation 4 greater than 200 if hiv positive * ability to sign consent * bilateral, cavitary pulmonary tb exclusion criteria: * multidrug-resistant (mdr) tb * extrapulmonary tb * hiv positive with opportunistic infection within 30 days of study entry * cancer * asthma * pregnant or lactating women * chronic heart disease * chronic liver disease * chronic renal disease * seizure disorder * bleeding or clotting disorder * diabetes mellitus
low gi diet in children and adolescents with all

Conditions: Acute Lymphoblastic Leukemia, Pediatric; Obesity, Pediatric

Summary: the study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.

acute lymphoblastic leukemia (all) is the most common childhood malignancy with survival exceeding 90%. however, treatment-related toxicity remains a clinical challenge during and after treatment. evidence-based, nutritional interventions may minimize the development of nutrition-related toxicities, such as bone morbidities, hypertriglyceridemia, and obesity. to date, no effective interventions are available to prevent nutrition-related morbidities in children with all. clinical studies evaluating the glycemic indices in other pediatric conditions have been encouraging. it is plausible that reducing the glycemic indices of diets during cancer treatment may have a profound clinical effect in this vulnerable pediatric population. prior to the design and implementation of randomized, controlled trials, epidemiological data describing the glycemic index (gi) and glycemic load (gl) and the association with clinically important outcomes is needed. additionally, the feasibility of a dietary intervention must also be explored within the setting of pediatric cancer. this study aims to determine the feasibility, measured by compliance to a low-gi diet, of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for all. the proposed work will be used for the design and implementation of a multi-center nutritional intervention aimed at improving dietary intake during treatment and its effect on clinically important outcomes. importantly, the information will be used to drive the formation of evidence-based nutritional guidelines for children with cancer, which will expand into the emerging field of individualized medicine for patients with cancer.

Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (b-cell, t-cell, or mixed phenotype) * within 3 days of starting the induction phase of treatment for acute lymphoblastic leukemia * proficient in english or spanish exclusion criteria: * diagnosis of relapsed acute lymphoblastic leukemia * not meeting all of the inclusion criteria

Keywords: glycemic index acute lymphoblastic leukemia dietary change pediatric oncology
eye masks and earplugs for delirium and pain prevention in pediatric intensive care unit

Conditions: Pain Management; Pediatric Intensive Care Unit; Non-Pharmacological Interventions; Critical Care Nursing; Pediatric Delirium

Summary: this randomized controlled clinical trial aims to evaluate the effect of nighttime application of eye masks and earplugs on the incidence of delirium and pain levels in pediatric intensive care unit (picu) patients aged 6-12 years. research questions this study seeks to answer the following key questions: do eye masks and earplugs reduce the incidence of delirium compared to standard nursing care in picu patients? do eye masks and earplugs lower pain levels compared to standard nursing care in picu patients? study design participants will be randomly assigned to one of the following groups: intervention group: participants will wear an eye mask and earplugs from 11:00 pm to 07:00 am for three consecutive nights. control group: participants will receive standard nursing care without any interventions. both groups will be assessed daily at 08:00 am using the following standardized measures: cornell pediatric delirium scale (to assess symptoms of confusion and disorientation) wong-baker faces pain scale (to measure pain levels) glasgow coma scale (gcs) (to evaluate consciousness levels) significance and impact this study investigates the impact of reducing environmental stimuli (light and noise) on delirium incidence and pain levels in critically ill pediatric patients. the findings may contribute to the development of non-pharmacological interventions aimed at improving patient comfort and care in intensive care settings. data analysis statistical analyses will be performed using spss (version 27) to compare delirium incidence and pain levels between the two groups.


Eligibility criteria:
inclusion criteria: * being between the ages of 6 and 12 years. * receiving treatment in the pediatric intensive care unit (picu). * expected to stay in the intensive care unit for more than 24 hours. * having a glasgow coma scale (gcs) score of 9 or above. * not receiving sedation. exclusion criteria: * children with diagnosed intellectual, auditory, or visual impairments. * children with a psychiatric diagnosis. * patients using hearing aids. * patients diagnosed with brain tumors. * patients requiring mechanical ventilation. * patients using benzodiazepines or other strong sedative medications. * patients with an expected icu stay of fewer than three days.

Keywords: pediatric intensive care non-pharmacological interventions delirium prevention pain management critical care nursing
analysis of metabonomics for pleural effusion

Conditions: Pleural Diseases

Summary: this is a multicenter retrospective study that collected diagnostic information of patients with pleural effusion. the overall survival (os) time of malignant patients was followed up, defined as the time from diagnosis to death. clinical data and residual pleural effusion specimens were collected from patients. metabonomics was utilized to differentiate between benign and malignant pleural effusion and to evaluate the prognosis of lung cancer patients with malignant pleural effusion.

pleural effusion (pe) is a common yet challenging problem in clinical settings. pe is a symptom caused by over 50 diseases and is typically classified as either malignant pleural effusion (mpe) or benign pleural effusion (bpe). mpe affects a significant number of individuals, with an estimated annual incidence of 500-700 cases per million population. metastatic cancer is the leading cause of mpe, and lung cancer accounts for approximately 37.5% of cases. the management of mpe is a major clinical challenge due to its association with a typically poor prognosis, with a median survival of only 3 to 12 months. however, predicting survival in mpe patients can be difficult due to significant heterogeneity in underlying malignancy and patient performance status. therefore, accurate prognostication remains a significant challenge in the management of mpe. metabonomics is an analytical technique for detecting metabolites in biological samples and has been widely used in disease diagnosis and prognosis evaluation in recent years. the aim of this study is to use metabonomics technology to compare and analyze the differences in metabolites between benign and malignant pleural effusion, and to explore its application in the prognosis evaluation of lung cancer patients with malignant pleural effusion.

Eligibility criteria:
inclusion criteria: * 18 years to 80 years; detection of pleural effusion by chest computed tomography, radiography, or ultrasonography; pathologically confirmed lung cancer in pleural effusion. exclusion criteria: * pleural effusion not caused by lung cancer or of unknown origin; other concurrent malignant diseases; incomplete information; lack of any follow-up data.
a study to assess the efficacy, safety, and tolerability of imvt-1402 as treatment for adult participants with graves' disease

Conditions: Graves' Disease

Summary: this is a multi-center, global, randomized, double-blind, placebo-controlled phase 2b study to assess the efficacy, safety, and tolerability of imvt-1402 in adult participants with graves' disease (gd) who are hyperthyroid despite antithyroid drug (atd) treatment.


Eligibility criteria:
inclusion criteria: * participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. * male or female participants aged ≥ 18 years. * participants with diagnosis of gd who are hyperthyroid despite atd treatment. * other, more specific inclusion criteria are defined in the protocol. exclusion criteria: * have previously been treated with radioactive iodine (rai) therapy or have undergone total thyroidectomy. * have an autoimmune disease other than gd requiring treatment that, in the investigator's judgment, puts the participant at undue risk. * have moderate-to-severe active thyroid eye disease (ted) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for ted during study participation. * additional exclusion criteria are defined in the protocol.

Keywords: imvt-1402 graves' disease thyroid-stimulating hormone receptor immunoglobulin g antithyroid drug