Kornimate/medical-research-clean huggingface dataset:
efficacy and immunological evaluation of belimumab plus low dose il-2 in the treatment of systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose il-2 in systemic lupus erythematosus.

given that belimumab and low dose interleukin-2 (il-2) have been widespreadly applied in the treatment of systemic lupus erythematosus (sle), this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of belimumab and low dose il-2. sle patients were allocated in each group randomly (n=10) and regularly administered belimumab (10mg/kg) with or without il-2 (1 million iu). then, we evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.

Eligibility criteria:
inclusion criteria: - 1. male or female \>18 years of age at screening visits 2. patients meet the american-european consensus group 2002 classification criteria 3. the patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols. 4. dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed: * hydroxychloroquine, 400 mg/day; * prednisone, 10 mg/day exclusion criteria: * 1. any subject meeting any of the following criteria should be excluded: 1. laboratory abnormality: • hb≤9 g/dl • neutrophil 10 mg/d) within 1 month. 2. serious complications: including heart failure (≥ new york heart association (nyha) class iii), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum alanine transaminase (alt) or aspartate aminotransferase (ast) greater than three times the upper limit of normal, or total bilirubin greater than normal upper limit) 3. known allergies, hyperreactivity or intolerance of tofacitinib or its excipients. 4. have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, epstein-barr virus (ebv), tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment. 5. infection with hiv (hiv antibody positive serology) or hepatitis c (hep c antibody positive serology). if seropositive, it is recommended to consult a doctor who has expertise in treating hiv or hepatitis c virus infection. 6. any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation). 7. uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study. 8. pregnant, lactating women (wcbp) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
fapi-pet for tumor detection

Conditions: Malignant Neoplasm

Summary: this is a prospective observational trial investigating correlation with histopathology, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-ga-fapi pet/ct or pet/mri in patients receiving this imaging modality for tumor staging or restaging as part of clinical care.

68-ga-fibroblast-activation-protein-inhibitors (68-ga-fapi) are novel positron emission tomography (pet) tracers that were recently introduced for the imaging of patients with various cancer diseases. the fibroblast-activation-protein (fap) is highly expressed in carcinoma-associated fibroblasts (cafs) in the stroma of various tumor entities. the aim of this registry study is to collect data on fapi expression, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-ga-fapi pet/ct or pet/mri on patients receiving this imaging modality at initial diagnosis or restaging as part of clinical care.

Eligibility criteria:
inclusion criteria: 1. fapi-pet scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy 2. age ≥ 18 years. exclusion criteria: 1. patient cannot give consent for the study 2. patient can not lie flat or tolerate fapi pet imaging 3. unwillingness or inability to comply with study and follow-up procedures 4. condition of patient which is critical to participate in this study in the discretion of the investigators 5. pregnant, lactating, or breast feeding women.

Keywords: fapi cancer positron-emission-tomography fap fibroblast imaging pet
effectiveness of intravenous tranexamic acid in reducing blood loss during and after cesarean section

Conditions: Bleeding

Summary: in this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective lscs will be investigated.

to state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.

Eligibility criteria:
inclusion criteria: * - women undergoing caesarean delivery for various elective indications. * full term primiparas / multiparas. * singleton pregnancy being delivered by lscs. exclusion criteria: * - medical problems involving the heart, liver, kidney and brain . * blood disorders. * allergy to tranexamic acid. * history of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology. * multiple pregnancy, macrosomia. * polyhydromnios . * patients requiring blood transfusion due to anemia
comparative exercise-induced hypoalgesia in upper and lower limbs: a randomized controlled trial in healthy individuals

Conditions: Healthy Subjects

Summary: this randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. the exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.


Eligibility criteria:
inclusion criteria: * asymptomatic subjects aged between 18 and 64 years. exclusion criteria: * cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies. * history of epilepsy. * pregnant * pharmacological treatment. * participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.

Keywords: local hypoalgesia distal hypoalgesia aerobic exercise pressure pain thresholds
iclas™ cryoablation system post-market clinical follow-up (pmcf) study

Conditions: Atrial Fibrillation; Atrial Flutter; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Summary: a prospective, single-arm, multi-center study designed to collect real world safety and performance data of the adagio medical iclas cryoablation system in the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (paf), persistent atrial fibrillation (psaf), and atrial flutter (afl).

this post-market clinical follow-up (pmcf) study continues collecting additional information about the adagio medical iclas™ cryoablation system in real world clinical settings.

Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * planned ablation procedure according to the indication for use of the commercially available adagio iclas™ cryoablation system * subject willing to comply with study requirements and give informed consent. exclusion criteria: * in the opinion of the investigator, any known contraindication to an atrial ablation procedure with the adagio iclas™ cryoablation system as indicated in the device instructions for use (ifu). * subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor. * any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)
measuring the density of iodine in lipiodol depositions: detecting an invisible residual tumor after conventional transarterial chemoembolization for hepatocellular carcinoma

Conditions: HCC - Hepatocellular Carcinoma

Summary: abstract objective: to detect presence of a residual tumor in patients of hepatocellular carcinoma (hcc) treated with lipiodol based conventional trans arterial chemoembolization (ctace) using density measurements on follow-up computed tomography (ct) scans study design: prospective observational interventional study place and duration of study: interventional radiology department of armed forces institute of radiology and imaging (afiri) from april 2023-march 2024 methodology: 96 patients undergoing conventional tace were included in the study and followed up for residual tumor or tumor free status assessment using density measurement for iodine depositions using ct scan analysis and compared with gold standard digital subtraction angiography (dsa). primary variables measured were comparison of enhancement scores between those with a residual tumor versus tumor free as well as the volume of iodine depositions in the arterial and venous phase between both groups. sensitivity and specificity of the ct scan in assessing tumor diagnosis was compared with the gold standard digital subtraction angiography.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hcc disease * must be able to swallow tablets exclusion criteria: * insulin dependent diabetes * thyroid disease
prospective evaluation of mri biomarkers in pancreatic ductal adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: this is a prospective cohort study in participants with pancreatic adenocarcinoma who are undergoing surgical resection. participants will have up to two magnetic resonance imaging (mri) scans with and without intravenous contrast. the mri will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. these contrast agents are routinely used in body mri and are on formulary at this institution. parameters will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. the purpose is to establish a standard protocol for future clinical trials of treatments that would use mri parameters as quantitative markers of treatment effect.

this is a prospective cohort study of dynamic contrast enhanced mri (dce-mri), which includes diffusion weighted imaging (dwi-mri) in participants with pancreatic adenocarcinoma who are undergoing surgical resection. participants will have up to two mri scans with and without intravenous contrast. the mri will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. these contrast agents are routinely used in body mri and are on formulary at this institution. quantitative parameters of volume transfer coefficient (ktrans) and apparent diffusion coefficient (adc) will be calculated from the mri sequences and each parameter will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. the influence of the contrast agent (extracellular and macromolecular) on agreement between imaging parameters and histopathology will be assessed and agreement in ktrans as derived from a one compartment and a two-compartment model will be assessed. if a participant is unable to receive intravenous contrast due to renal dysfunction or refuses iv contrast, the non-contrast portion of the exam will be used for analysis. the purpose is to establish a standard protocol for future clinical trials of treatments that would use mri parameters as quantitative markers of treatment effect.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age. 2. biopsy proved pancreatic ductal adenocarcinoma (pda) and/or a pancreatic mass with imaging features suggestive of pancreatic adenocarcinoma planned for surgical resection. 3. no contraindication to mri such as severe claustrophobia (not alleviated by oral anti-anxiolytics) or metal/mechanical devices in their body not considered magnetic resonance (mr) compatible at 1.5 tesla (departmental mri safety screening form) 4. no known allergy to gadolinium based contrast agent 5. for contrast enhanced studies, participant has an estimated glomerular filtration rate (gfr) \>30 mg/dl using the modification of diet in renal disease (mdrd) formula. if the participant has an estimated gfr ≤30 mg/dl, they can still participate but no intravenous contrast will be administered. exclusion criteria: 1. contraindication to mr imaging 2. pregnancy

Keywords: pancreatic adenocarcinoma pancreatic cancer
get social media and risk-reduction training

Conditions: Infant Death; Sudden Infant Death

Summary: this study examines the implementation of the todaysbaby™ mobile safe sleep intervention program in us hospitals. the main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.


Eligibility criteria:
inclusion criteria: * must speak english or spanish * must live in the united states * must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth * must plan to care for infant and live in the same household as infant after birth * must enroll in the todaysbaby program by the time their infant is 7 days of age exclusion criteria: * a prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.

Keywords: safe sleep mobile messaging
a study of experimental medication bms-986231 in patients with different levels of kidney function

Conditions: Myocardial Failure; Cardiac Failure; Congestive Heart Failure; Kidney Failure; Renal Failure

Summary: the purpose of this study is to investigate experimental medication bms-986231 in patients with different levels of kidney function.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * body weight ≥ 45 kg and ≤ 120 kg * bmi ≥ 18 kg/m\^2 and ≤ 35 kg/m\^2 * heart rate ≥ 50 bpm and \< 95 bpm * stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent egfr assessment * no changes in medication within 30 days prior to study drug administration exclusion criteria: * clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ecg, or laboratory tests * history of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months * history of headaches related to caffeine withdrawal * history of migraine or cluster headaches * patients requiring dialysis will not be enrolled in this study other protocol defined inclusion/exclusion criteria could apply
a safety study of retinal gene therapy for choroideremia with administration of biib111

Conditions: Choroideremia

Summary: the objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of biib111 in adult male participants with choroideremia (chm).

this study was previously posted by nightstarx ltd. in october 2020, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: 1. are willing and able to give informed consent for participation in the study to have both eyes treated. 2. have documentation of a genetically-confirmed diagnosis of chm. 3. have active disease clinically visible within the macular region of both eyes. 4. have a bcva of ≥34 etdrs letters (20/200 or better snellen acuity) in both eyes, or in the untreated eye, if the other eye was previously treated with biib111\* \*if previously treated with biib111 in an antecedent study, participants may be eligible for participation following sponsor approval. 5. for participants who received treatment with biib111 in an antecedent study, have biological samples available to complete an adequate immunology profile. key exclusion criteria: 1. have a history of amblyopia or inflammatory disorder in either eye. 2. are unwilling to use barrier contraception methods or abstain from sexual intercourse for a period of 3 months following treatment with biib111 in either eye. 3. have had previous intraocular surgery performed within 3 months of the screening visit in either eye. 4. have any other significant ocular or non-ocular disease/disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the results of the study or the participant's ability to participate in the study. this includes but is not limited to a potential participants: * with a contraindication to oral corticosteroid (e.g., prednisolone/prednisone) * with clinically significant cataract in either eye * who, in the clinical opinion of the investigator, is not an appropriate candidate for sub-retinal surgery. 5. have participated in another research study involving an investigational product in the past 12 weeks or received a gene/cell-based therapy at any time previously, except if treated within an antecedent study with biib111. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: nightstarx nsr-rep1 chm gene therapy aav rep1 timrepigene emparvovec
asthma action at erie trial

Conditions: Asthma; Children

Summary: the asthma action at erie trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (chw) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. this trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma chws into clinical practice.

the asthma action at erie trial will test the ability of a community health worker (chw) intervention with three important modifications to achieve asthma control in high-risk children. these modifications are: 1) chws will be integrated into both the clinical and the home setting, 2) a system for directly addressing mental health and psychosocial barriers will be provided, and 3) participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. to test this intervention, a two-arm behavioral randomized controlled trial (n=220) will be conducted in partnership with a federally-qualified health center (fqhc) serving a low income, minority population that is at high-risk for significant asthma morbidity. the intervention arm will receive an integrated chw home intervention for pediatric asthma education. the comparison arm will received clinic-based certified asthma educator (ae-c) services. primary aim 1 is to assess the efficacy of the integrated chw home asthma intervention, relative to clinic-based ae-c education over 12-months, as demonstrated by asthma control. specific aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. specific aim 3 is to determine the cost-effectiveness at 12-months of chw and ae-c intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. specific aim 4 is to assess the efficacy of the integrated chw home asthma intervention relative to clinic-based ae-c education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.

Eligibility criteria:
inclusion criteria: * child is a patient at erie family health center * child is age 5-16 at the start of the study * child lives with the index caregiver at least 5 days out of the week * child has uncontrolled asthma. this is defined as a score of 1.25 or greater on the asthma control questionnaire, or report of oral corticosteroid use in the past year * family has a working telephone exclusion criteria: * exclusion criteria include family not fluent in english or spanish, family lives in temporary housing such as a shelter, caregiver does not have permanent custody of child, or child has significant developmental delays or co-morbidities that would limit their ability to participate in the program.
mrna based-covid-19 vaccine effects on blood glucose levels

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hyperglycemia; Vaccine Adverse Reaction

Summary: to determine if patients with a history of diabetes mellitus type i or ii developed a change in blood glucose levels as reported on continuous glucose monitoring devices (cgms) within the first week following administration of each dose of the covid-19 vaccine.

a retrospective review of all patient data from the dexcom and libre cgms devices available at a single site, solo endocrinology practice will be obtained. this data will include fasting morning glucose, postprandial glucose, and daily glucose area under the curve for seven days following vaccination administration, as well as daily glucose area under the curve seven days prior to vaccine administration that will be used as a control. patients \>=18 y/o with a history of diabetes mellitus type i or type ii will be selected. brand of vaccine administered (moderna or pfizer-biontech) and the change in average blood glucose, peak blood glucose, and percentage of time spent in normal range as well as above average range of blood glucose level following vaccine administration will be assessed. patients will fill out a visual analog symptom scale based on how symptomatic and uncomfortable they were following each dose of the covid-19 vaccine. patients will describe side effects that they experienced following each dose of the covid-19 vaccine.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes mellitus type i or type ii * received the moderna covid-19 vaccine or pfizer-biontech covid-19 vaccine exclusion criteria: * patients \<18y/o. * patients that did not receive a covid-19 vaccine. * patients who did not have a cgms downloaded for a week prior and a week after vaccination.

Keywords: mrna vaccine hyperglycemia hypoglycemia diabetes mellitus, type 2 diabetes mellitus, type 1 covid-19 vaccine