Kornimate/medical-research-clean huggingface dataset:
myocardial injury and outcomes following covid-19 vaccination (myovax study)

Conditions: Myocardial Injury; Myocarditis; COVID-19 Vaccination; SARS-CoV-2; Cardiac MRI

Summary: the study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after covid-19 vaccination. ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.

coronavirus disease 2019 (covid-19) vaccination frequently leads to minor side effects that may be more intense after the second dose, including fatigue and pain. however, there are emerging reports of more serious side effects in a minority of patients including myocarditis. given the recent introduction of covid-19 vaccination, there is limited understanding of: (i) prevalence and pattern of myocardial injury post vaccination, (ii) the risk factors for myocardial injury and adverse cardiac events post vaccination, and (iii) imaging and blood biomarkers for early recognition of patients at risk of adverse outcomes. this study will address the above-mentioned knowledge gaps by focusing on patients who have received at least one dose of a covid-19 vaccine. the study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after covid-19 vaccination. ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.

Eligibility criteria:
inclusion criteria: 1. age ≥ 17 years (both cohort a and b) 2. received at least one dose of a covid-19 vaccine in the past 6 months (both cohort a and b) 3. developed new clinical signs or symptoms suggestive of myocarditis/myocardial injury within one month of covid vaccine administration without other known cause (cohort a, only) exclusion criteria: 1. contraindications to cardiac pet/mri 2. current history of covid-19
pivotal study in nosocomial pneumonia suspected or confirmed to be due to pseudomonas

Conditions: Pneumonia

Summary: this is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects


Eligibility criteria:
key inclusion criteria: * subject has received mechanical ventilation for at least 48h at the time of the randomisation or at least 2 of the following signs or symptoms presenting within 24 hours prior to randomization: new onset of cough or worsening of baseline cough and/or dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial infection or a worsening in character of purulent appearance * acute physiology and chronic health evaluation (apache) of 8 to 25, inclusive, within 24h prior to randomization * presence of new or progressive infiltrate on chest x-ray * presence of clinical criteria consistent with pneumonia * strong clinical suspicion of pneumonia due to p. aeruginosa key exclusion criteria: * known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia * known hypersensitivity to any component of ertapenem, meropenem or to other drugs in the same class or demonstrated anaphylactic reactions to beta-lactams or a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors * severe liver or renal impairment * expected survival \< 72 hours * evidence from an available surveillance culture of co infection with ertapenem , meropenem or piperacillin tazobactam resistant gram negative pathogen(s) * women who are pregnant or nursing
a study of ly900014 versus insulin lispro (humalog) on high blood sugar in participants with type 1 diabetes who use insulin pumps

Conditions: Diabetes Mellitus, Type 1

Summary: the main purpose of this study is to compare ly900014 to insulin lispro (humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. for each participant, the study will last about two to nine weeks.


Eligibility criteria:
inclusion criteria: * male or female participants with type 1 diabetes * body mass index (bmi) between 18.5 and 30.0 kilograms per square meter, inclusive * hemoglobin a1c (hba1c) less than or equal to 8.5 percent (%) * using csii and stable insulin regimen for at least 3 months prior to inclusion into the trial exclusion criteria: * known or suspected hypersensitivity to investigational medical product(s) or related products * receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial * known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption * proliferative retinopathy or maculopathy as judged by the investigator based on a recent (less than 1.5 years) ophthalmologic examination * widespread subcutaneous lipodystrophy in the abdomen * current use of any glucose-lowering agents other than insulin within 3 months prior to screening * chronic or recent use of corticosteroids
phase 2a study to evaluate optimum dosage and stability of dw-3101 in gastric inflammation patients

Conditions: Acute and Chronic Gastric Inflammation Patients

Summary: the purpose of this study is to find optimum dosage of dw-3101 by evaluating efficacy and safety of each dosage group in korean patients with acute and chronic gastric inflammation.


Eligibility criteria:
inclusion criteria: * adult males/females aged 20\~75 years * patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents * subjects who voluntarily agree to participate in this clinical test with written consent exclusion criteria: * patients impossible gastroscopy * in case accompanied with gastric ulcer(scar excepted) or reflux esophagitis * patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) * patients with malignant tumor on digestive organ * patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)
implementing genomics in practice (ignite) proof of concept study: genotyping in family medicine clinics

Conditions: Pain

Summary: this study will examine the effect of having genotype information on pain management and pain control for patients treated in family medicine clinics. this study will also examine physician-perceived usefulness of genotype information. patients will be enrolled from family medicine clinics serving as either implementation sites or control sites. patients from implementation sites will undergo genotyping, while those from control sites will not by genotyped.

codeine and tramadol are opioid analgesics that depend on cytochrome p450 2d6 (cyp2d6) for bioactivation to morphine and o-desmethyltramadol, respectively. morphine and o-desmethyltramadol have much greater affinity for the opioid receptor and thus are more powerful analgesics. individuals with genotypes associated with low cyp2d6 activity (poor metabolizers) are unable to convert sufficient amounts of codeine or tramadol to their active metabolites and may fail to derive sufficient pain relief. at the opposite extreme, individuals with genotypes associated with increased cyp2d6 activity (ultra-rapid metabolizers) are at risk for serious toxicity with usual codeine or tramadol doses. the cyp2d6 genotype also has implications for response to other drugs, such as tricyclic antidepressants (tcas), which are commonly used for neuropathic pain. patients will be recruited from family medicine clinics, serving as either implementation sites or control sites. patients from implementation sites will undergo cyp2d6 genotyping, with results placed in the medical record to assist with prescribing of pain medications. pain medications prescribed from baseline to 3 months will be assessed through medical record review. a pain assessment questionnaire will be administered to patients enrolled from both sites at baseline and 3 months. at the end of the study, a 20-item survey will be administered to physicians at the implementation sites. we will assess whether having cyp2d6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective. we will also assess medicines prescribed to patients enrolled from both sites over the 12-month period after enrollment from medical record review and determine the number of patients who were prescribed a medication that has genetic information in its fda-approved label.

Eligibility criteria:
inclusion criteria: * treated in family medicine clinic * history of pain for at least 3 months * prescribed medication for pain relief exclusion criteria: * pain for less than 3 months * not currently prescribed any medication for pain

Keywords: pain cyp2d6
an efficacy and safety study for yondelis (trabectedin) in patients with advanced relapsed ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of the study is to compare the progression-free survival (pfs) of the combination of trabectedin + doxil with doxil monotherapy in patients with ovarian cancer.

this is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), phase 3 study comparing the combination of trabectedin + doxil with doxil monotherapy in patients with advanced ovarian cancer (who were previously treated and for whom first-line platinum-based chemotherapy regimen has failed). approximately 650 patients will be randomly assigned to 1 of the treatment arms (doxil and doxil + trabectedin) over 2 years. at the time of randomization, patients will be stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and baseline eastern cooperative oncology group performance status score (0 to 1 or 2. safety will be evaluated on the basis of adverse events, clinical laboratory tests, physical examination, vital signs assessment and cardiovascular safety assessment. an interim analysis of overall survival will be performed in conjunction with progression-free survival analysis during the study. treatment will be continued until disease progression occurred or until patients experienced a confirmed complete response for at least 2 cycles. continuation of treatment in select individual patients beyond this study end date will be allowed if the investigator determined that the patient is benefiting from treatment, is eligible to receive further therapy, and consents to treatment. if disease progression has not occurred at treatment termination, then disease assessment will continue every 8 weeks until there is evidence of disease progression or death, or until the clinical data cutoff date, or until the start of first subsequent anticancer therapy, whichever is earlier.

Eligibility criteria:
inclusion criteria: * histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer * prior treatment with only 1 platinum based chemotherapy regimen * eastern cooperative oncology group status of not more than 2 * progression more than 6 months after the start of initial chemotherapy treatment exclusion criteria: * treatment with more than 1 prior chemotherapy regimen * progression within 6 months after starting initial chemotherapy * prior exposure to anthracyclines * unwilling or unable to have central venous catheter * known clinically relevant central nervous system metastasis

Keywords: ovarian cancer trabectedin yondelis advanced relapsed ovarian cancer doxil caelyx
lifestyle intervention for adults with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. the investigators developed a lifestyle intervention based on individual's home activity patterns. the goal of the study is to test the efficacy of this intervention among older adults with diabetes. in addition to physical activity, the investigators will also assess if the intervention will improve social participation.

to tailor to the needs of older adults, the investigators developed an innovative lifestyle modification intervention that incorporates rehabilitation approaches to improve the participation of physical activities (pa) among sedentary older adults with type 2 diabetes. the intervention is developed based on well-established health behavior theory (i.e., self-regulation) and the conceptual framework from the world health organization, with several innovations not previously investigated in this population. the intervention: 1. is tailored based on individual's unique patterns of daily pa performed within his/her environment as opposed to the total amount of pa performed in a day or a recall of activities over some time period; 2. uses an accelerometer-assisted, field-based method to address the individual's unique physical and social environment; 3. is delivered by a trained occupational therapist in brief counseling sessions, which can be easily translated into real clinical settings; and 4. addresses participation, a patient-centered outcome that is associated with quality of life but has received limited attention outside of rehabilitation research.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * has type 2 diabetes mellitus * sedentary (less than 150 minutes of exercise in week) * english-speaking * community living (i.e., not a nursing home resident) * ambulatory with or without cane or walker * able to operate accelerometer * competent to provide informed consent exclusion criteria: * medically unstable * dementia diagnosis * currently taking any medications for memory impairment * currently participating in a physical activity program * heart attack within the past month * self-reported illness or condition that would impair the cooperation with the study team or the ability to complete the study

Keywords: physical activity
a study of hy004 treatment in adult relapsed/refractory b-precursor acute lymphoblastic leukemia (r/r b-all)

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this is a multi-center, phase i/ii trial to evaluate the safety and efficacy of hy004 treatment in adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia (r/r b-cell all).

this trial is a multi-center, open label, single-arm, phase i/ii trial to evaluate the safety and efficacy of hy004 treatment in adult (aged 18\~65 years old) patients with r/r b-cell all. the phase i part of the trial is to evaluate the safety, optimal dose of hy004, pharmacokinetics/pharmacodynamics(pk/pd)and preliminary efficacy in the treatment of adult patients with r/r b-cell all. the phase ii part of the trial is to evaluate the efficacy and safety of hy004 in in the treatment of adult patients with r/r b-cell all. the study includes screening, pre-treatment (cell product manufacture \& lymphodepletion), hy004 infusion, safety and efficacy follow-up, and survival follow-up. all subjects who have received hy004 infusion will be followed for up to 2 years.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent prior to any study procedures (patient and/or parent or legal guardian); 2. gender is not limited, and the age at the time of screening is ≥ 18 years old and ≤ 65 years old; 3. relapsed or refractory acute lymphoblastic leukemia (all); 4. documentation of cd19 and/orcd22 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening; 5. bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening; 6. ecog score 0-1 points; 7. organ function requirements: all patients must have adequate renal and liver functions. exclusion criteria: 1. active central nervous system (cns) involvement by malignancy; 2. isolated extra-medullary disease relapse; 3. patients with burkitt's lymphoma/leukemia; 4. history of concomitant genetic syndrome; 5. patients with acute graft-versus-host disease (gvhd) or moderate-tosevere chronic gvhd within 4 weeks before screening; patients with a history of allogeneic hematopoietic stem cell transplantation within 12 weeks before single collection; 6. active systemic autoimmune disease; 7. known infection with human immunodeficiency virus (hiv) or chronic infection with hepatitis b virus (hbsag positive) or hepatitis c virus (anti- hcv positive); 8. patients with active infections at screening; 9. patients who have used car-t cell therapy before screening; 10. patients with an expected lifespan of less than 3 months.

Keywords: hy004 cluster of differentiation antigen 19 and/or 22(cd19 and/or 22) cd19/22-directed car-t cells
motivational interviewing and practice of physical activity in patients with ald

Conditions: Motivational Interviewing; Chronic Disease

Summary: since 2017, ald patients can be prescribed adapted physical activity (apa) on prescription. however, this possibility of prescription remains relatively unknown and little used by doctors, while the benefits of apa in particular in chronic diseases are well established and 30% of adults in france do not reach the recommendations of who on physical activity. these obstacles to prescription are well known thanks to studies on the subject (lack of information on sport-health networks, lack of training in apa prescription, poor financial support, lack of support for deliver to patients). to overcome this lack of implementation, the city of amiens, via the office des sports d'amiens métropole (osam), has implemented since september 2022 tools to help prescribe apa: blocks pre- filled certificates of absence of contraindication and prescription of adapted physical activity. in other areas of health, such as breastfeeding, performing motivational interviewing has improved patient compliance. patients with chronical disease consult a doctor from the amiens metropolitan area recruited beforehand who informs them of the existence of the physical activity promotion program of amiens métropole. after obtaining their consent and establishing a certificate of no contraindication, the patients will be randomized by a random draw into two groups: motivational interviewing (me) and control group (gt). upon entry into the program, all patients will be seen for an assessment of their physical condition at the premises of amiens métropole by a teacher in adapted physical activity (apa) in order to be assessed and directed to a club or a approved associations. the em group will also benefit from a motivational interview at 0 and 3 months by a doctor trained in the technique. the entire cohort will complete the sf12 (perception of quality of life) and ipaq (current level of physical activity) questionnaires at 0 and 6 months during the usual appointments with the apa teacher.


Eligibility criteria:
inclusion criteria: * patients with chronic disease (ald) * aged 18 and over, autonomous in their ability to move * living in the metropolis of amiens exclusion criteria: * contraindication to the practice of physical activity; * patient under guardianship, curators, * safeguard of justice ; * patient deprived of liberty ; * pregnant woman ; * patient who not benefiting from a social security scheme

Keywords: motivational interviewing physical activity practice chronic disease ipaq score sf12 score
joint inflation with nominal-pressure and stability approach in des optimization

Conditions: Acute Coronary Syndrome; De Novo Stenosis

Summary: to achieve the stent optimization following "keep it simple and safe" coronary intervention is recommended. a protocol of joint inflation with nominal-pressure and stability (jins) approach in coronary drug-eluting stent (des) implantation by intracoronary imaging (ici) guidance could provide additional benefits in reducing unnecessary radiation exposure, and post-dilatation balloon angioplasty-related complications.

variable types of stent inflation protocol to achieve evidence and consensus-based coronary drug-eluting stent (des) optimization could improve clinical outcomes. the investigators aim to evaluate whether the jins approach could be adopted in chinese daily practice. the investigators will perform ici (oct or ivus)-guided des implantation in coronary de novo lesions by jins protocol, described as inflating stent balloon with nominal-pressure (+1\~2atm) without decay for at least 30 seconds.

Eligibility criteria:
inclusion criteria: * patients with acute coronary syndrome (ua/nstemi/stemi) plan to undergo oct- or ivus-guided des implantation in de novo lesion. * patients provide written informed consent prior to enrollment. exclusion criteria: * left main, ostial right coronary artery lesion. * high thrombus burden at the index primary percutaneous coronary intervention. * active bleeding or bleeding diathesis, thrombocytopenia (platelet \<100,000/ml), or hemoglobin \<10 g/dl * hepatic dysfunction (serum liver enzyme\>3 times the normal limit) * renal failure (egfr \<15 ml/min/1.73m2 or requiring dialysis) * life expectancy \< 1 year

Keywords: jins; intracoronary imaging; stent optimization; outcomes
comparative effects of jandas's approach with and without post isometric relaxation technique

Conditions: PELVIS Syndrome

Summary: posterior lower crossed syndrome is a perplexing puzzle of muscular imbalance, manifests as an intricate interplay between weakened glutes and tight flexors. the aim of the study will be to determine the effects of jandas's approach with and without post-isometric relaxation technique on pain, muscle flexibility, and functional disability in patients with the posterior lower crossed syndrome.

a randomized controlled trial will be conducted at physical therapy department of rabia welfare hospital lahore, fmh physiotherapy clinic lahore and shafaeen physiotherapy clinic lahore through convenient sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into group a and group b. group a will be treated with janda's approach and group b will be treated with combination of post isometric relaxation technique for illiopsoas and janda's approach at the frequency of 3 sets with 10 repetitions and twice a week. outcome measures will be conducted through pain,muscle flexibility, pelvic tilt and disability questionnaire after 4 weeks. data will be analysed using spss software version 25.after assessing normality of data by shapiro-wilk test, it will be decided either parametric or nonparametric test will be used within a group or between two groups.

Eligibility criteria:
inclusion criteria: * age:20-60 years * gender: both males and females * nprs (numerical pain rating scale): \< 7 * positive finger to floor test : \> 48cm in males, \>50cm for females * positive modified thomas test: greater than zero * patients with anterior pelvic tilt exclusion criteria: * preexisting spinal pathology * congenital abnormality * neurological deficits, * recent spinal or lower-limb trauma or surgery * spasm of the trunk or lower-limb muscles * lower-limb radiculopathy * pregnancy

Keywords: disability pain flexibility