Kornimate/medical-research-clean huggingface dataset:
multidimensional prehabilitation in pancreatic surgery for pancreatic and periampullary neoplasms

Conditions: Pancreatic Neoplasms; Periampullary Carcinoma

Summary: randomized clinical trial investigating multidimensional prehabilitation in pancreatic surgery for participants with pancreatic and periampullary neoplasms

frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. the majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. this randomized controlled trial (rct) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.

Eligibility criteria:
inclusion criteria: * participants \> 18 years old with ecog performance status 0-2 and asa score ≤3 * requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms * surgery scheduled at least 2 weeks after the initial surgical evaluation * fluency in english * willingness to answer questionnaires, complete daily exercise \& nutrition log, as well as participate in follow-up telephone calls * screening: physical activity readiness - questionnaire (par-q+) * par-q+ assesses participants comorbidities and symptoms with current activities. if participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and copd/asthma, to determine their ability to participate in physical activity. exclusion criteria: * screening: physical activity readiness - questionnaire (par-q+) * participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/copd, that may prevent participation will also be excluded. * inability to provide own informed consent * inability to read or verbally understand questionnaires in english * impaired hearing that creates a barrier for telephone follow-up * visual deficit that would cause exercise to be hazardous * emergent or urgent surgeries
a study of es101 (pd-l1x4-1bb bispecific antibody) in patients with advanced malignant thoracic tumors

Conditions: Thoracic Tumors; Non-small Cell Lung Cancer; Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety, rp2d and pk/pharmacodynamic profile of es101 monotherapy in patients with advanced nsclc and to further evaluate the antitumor efficacy of es101 in advanced malignant thoracic tumors, including nsclc and sclc.


Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent form. * eastern cooperative oncology group performance status (ecog ps) of 0 or 1. * at least one measurable lesion is required (recist v1.1) * phase 1b: subjects with pathologically or cytologically confirmed recurrent or metastatic nsclc without known egfr mutation and alk and ros1 gene rearrangements. * phase ii: subjects with pathologically or cytologically confirmed recurrent or metastatic malignant thoracic tumours who have received 1-2 lines of systemic anti-tumour therapy, including platinum regimens, and have failed, including at least 2 cycles of chemotherapy. exclusion criteria: * prior exposure to 4-1bb agonists. * receipt of any anticancer investigational product or any approved drug(s) or biological products (except hormone-replacement therapy, testosterone or oral contraceptives) within 4 weeks prior to the first dose of study drug. previous exposure to oral fluorouracils or small molecular targeted drugs require a minimum washout period of 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer). previous exposure to mitomycin c or nitrosourea requires a minimum washout period of 6 weeks prior to the first dose of study drug. * receipt of pd-l1 therapy within 24 weeks prior to the first dose of study drug. * known allergies to cho-produced antibodies, which in the opinion of the investigator suggests an increased potential for an adverse hypersensitivity to es101. * grade ≥ 3 immune-related adverse events (iraes) or irae that lead to discontinuation of prior immunotherapy. some exceptions as defined per protocol apply. * subject has not recovered from all aes of previous anticancer therapies to baseline or ≤ grade 1 per ctcae v5.0 before teh first dose of study drug. certain exceptions as defined in protocol apply. * active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. certain exceptions as defined in protocol apply. * active interstitial lung disease (ild) or pneumonitis or a history of ild or pneumonitis requiring treatment with steroids or other immunosuppressive medications. * systemic anti-infectious drug treatments within 4 weeks prior to the first dose of study drug. * pregnant or nursing females.

Keywords: es101 inbrx-105 pd-l1 4-1bb pd-l1×4-1bb pdl1 41bb thoracic tumor
a phase iii study of sorafenib in patients with advanced hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of the study is: find out if patients receiving sorafenib will live longer. find out if sorafenib has any effect on patient reported outcomes. find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. determine the pharmacokinetics (pk) in patients with liver cancer.

the following abbreviations were used in the adverse event section: * international normalized ratio (inr) * common terminology criteria for adverse events (ctcae) * not otherwise specified (nos) * gastrointestinal (gi) * central nervous system (cns) * absolute neutrophil count (anc) * alanine aminotransferase (alt) * aspartate aminotransferase (ast) * creatine phosphokinase (cpk) * gammaglutamyltransferase (ggt) * genitourinary (gu) * atrioventricular (av)

Eligibility criteria:
inclusion criteria: * ages eligible for study: 18 years and above, genders eligible for study: both * patients who have a life expectancy of at least 12 weeks * patients with histologically or cytologically documented hepatocellular carcinoma (hcc) * patients must have at least one tumor lesion that meets both of the following criteria: (1) accurately measured in at least one dimension according to recist (response evaluation criteria in solid tumors) (2) not previously treated with local therapy * patients who have an ecog (eastern cooperative oncology group) ps (performance status) of 0, 1, or 2 exclusion criteria: * previous or concurrent cancer that is distinct in primary site or histology from hcc, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta \[noninvasive papillary carcinoma\], tis \[carcinoma in situ: "flat tumor"\] \& t1 \[tumor invades subepithelial connective tissue\]). any cancer curatively treated \> 3 years prior to entry is permitted * renal failure requiring hemo- or peritoneal dialysis * history of cardiac disease * active clinically serious infections * known history of human immunodeficiency virus (hiv) infection * known central nervous system tumors including metastatic brain disease * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Keywords: liver cancer cancer
open-label extension trial to characterize the long-term safety and tolerability of elamipretide in subjects with genetically confirmed primary mitochondrial myopathy (pmm)

Conditions: Primary Mitochondrial Disease

Summary: this is a phase 2 open-label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed primary mitochondrial disease who previously participated in the spimm-202 clinical trial

this open-label, non-comparative, extension trial will enroll subjects with genetically confirmed pmd who have completed the end-of-study visit in the spimm-202 trial. subjects who do not discontinue or withdraw from the trial will receive treatment with 40 mg sc elamipretide for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with pmd.

Eligibility criteria:
inclusion criteria: * investigator determines the subject can, and subject agrees to, adhere to the trial requirements for the length of the trial including self-administration (by subject or trained caregiver) of the study drug * subject completed the end-of-study visit in spimm-202 exclusion criteria: * subject has any prior or current medical condition that, in the judgment of the investigator, would prevent the subject from safely participating in and/or completing all trial requirements * subject has received any investigational compound (excluding elamipretide) and/or has participated in another interventional clinical trial within 30 days prior to the spimm-203 baseline visit (excluding spimm-202) or is concurrently enrolled in any non-interventional research of any type judged to be scientifically or medically incompatible with the trial as deemed by the investigator in consultation with the sponsor * subject experienced an adverse reaction attributed to study drug resulting in permanent discontinuation of study drug in the spimm-202 trial. * female subjects who are pregnant, planning to become pregnant, or lactating * subject has undergone an in-patient hospitalization within the 1 month prior to the spimm-203 baseline visit

Keywords: primary mitochondrial disease stealth elamipretide
diabetes prevention programming for women with a history of gestational diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate.

the purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate. there are two potential types of participants: 1. women and their children 10+ can consent to participate in the diabetes prevention programming offered through dr. hannon's center (called encourage). researchers will collect data at three time points, baseline, 4-6 months, and 12 months. 2. instead of participating in encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. additionally, researchers will consent women to obtain data from their chosen program. for instance, if a woman chooses to do a diabetes prevention program through the ymca, researchers will ask women to self report their weekly attendance and weight.

Eligibility criteria:
inclusion criteria: * history of gestational diabetes in a previous pregnancy * age 18+ exclusion criteria: ·currently pregnant
clinical evaluation of sars-cov-2 (covid-19), influenza and rsv 8-well mt-pcr panel for in vitro diagnostics

Conditions: Respiratory Viral Infection

Summary: this study is a prospective accuracy observational study to evaluate the performance of the highplex system sars-cov-2, influenza and rsv 8-well in vitro diagnostic medical device panel and generate performance data. the precision of results will be evaluated in concordance with the comparator predicate device panel biofire respiratory panel 2.1 (rp2.1).

this study is a prospective accuracy observational study to evaluate the performance of the highplex system sars-cov-2, influenza and rsv 8-well in vitro diagnostic medical device panel and generate performance data. the precision of results will be evaluated in concordance with the comparator predicate device panel biofire respiratory panel 2.1 (rp2.1). this study will utilise prospective sample respiratory swabs from individuals with paired test data, presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia), as well as asymptomatic individuals. to meet the target number of 400 positive samples (50 samples per target; 8 targets in total), a required sampling size of 1000 participants will need to be screened to account for unviable samples and screen failures. prospective respiratory samples will include nasopharyngeal swabs as described in intended use of the product.

Eligibility criteria:
inclusion criteria: * the sample is derived from an individual who has the ability to provide consent or from a legally acceptable representative, parent(s), or legal guardian and have consented for their sample and demographic information to be taken * the sample is a nasopharyngeal swab * the sample is collected in universal transport media (utm) or viral transport media (vtm), using fda approved swabs * the sample is collected from an individual who has a presumptive diagnosis or is presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia) or is suspected to be asymptomatic. exclusion criteria: * sample does not meet acceptable specimen criteria in that is not a nasopharyngeal swab * the sample is collected using swabs with wood shafts or other materials known to inhibit growth of influenza viruses

Keywords: in vitro diagnostic device in vitro diagnostic multiplexed tandem polymerase chain reaction respiratory panel respiratory syncytial virus severe acute respiratory syndrome coronavirus 2 influenza virus
the effect of ketamine infusion on lumbar surgery

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to evaluate the effect of ketamine infusion for reduction of neuropathic pain and improvement of quality of life after lumbar surgery.

neuropathic pain defined as 'pain caused by a lesion or disease of the somatosensory system'. neuropathic pain is 20 - 35% of low back pain. ketamine is categorized as n-methyl d-aspartate receptor antagonist. ketamine has an analgesic effect in low dose and anesthetic effect in relative high dose. also, ketamine is used in chronic neuropathic pain as postherpetic neuralgia., phantom pain, central neuropathic pain, complex regional pain syndrome, ischemic pain. in this study, ketamine will be infused during lumbar surgery in randomized, double-blind and double-blind parallel group control trial.

Eligibility criteria:
inclusion criteria: * undergoing lumbar spine surgery due to back pain patients * american physical status classification i or ii exclusion criteria: * less than 3 month of back pain * past history of operation at lumbar area * past history of glucoma, drug abuse, alcohol abuse * pregnancy
patients with higher bmi produces more postoperative drainage volume and length of stay in cross-sectional study

Conditions: Osteoarthritis, Knee

Summary: partial knee arthroplasty theoretically produces less blood loss compared to total knee arthroplasty (tka) due to a lesser invasive procedure. medial unicompartmental knee arthroplasty (uka) is the most common partial knee arthroplasty performed due used due to the most commonly impacted medial knee. this study compared the postoperative drainage volume and length of stay (los) of tka vs uka and evaluated its comparison with patient characteristics.

theoretically, uka will produce less blood loss due to a shorter skin incision, quadriceps sparing muscle approach, persistence of cruciate ligaments, and less femorotibial dislocation.7 however, studies investigating drainage volume in uka are still limited. in this study, we compared the drainage volume of patients undergoing tka vs uka and evaluated several parameters that contributed the production. this study has not received any funding or grant.

Eligibility criteria:
inclusion criteria: * grade 4 osteoarthritis exclusion criteria: * previous trauma * infection * blood coagulation disorder
effects of acupunch exercises on the frail older adults in long-term care facilities

Conditions: Frailty; Exercise

Summary: frailty is a complex elderly problem and a precursor of functional degradation in elder adults. the aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.

frailty is a complex elderly problem and a precursor of functional degradation in elder adults. the cause of frailty is multifactorial. regular exercise intervension could improve frailty condition and general functional fitness. the acupunch exercise program was developed based on jing-luo theory of tranditional chinese medicine. the aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.

Eligibility criteria:
inclusion criteria: * frail older adults * aged 65 and above * had lived in the long-term care facilities more than 3 months exclusion criteria: * dementia patient * psychiatric patient * spinal cord injury patient

Keywords: acupunch exercises frailty long-term care facilities
acute kidney injury after cardiac arrest

Conditions: Acute Kidney Injury

Summary: the development of aki (acute kidney injury) after cardiac arrest is a common factor associated with mortality. in this study, we aimed to evaluate the factors that increase the risk of developing aki after cardiac arrest. for the study, patients were evaluated for the incidence of acute kidney injury (aki), factors that increase the risk of aki, and the impact of aki on mortality. in this process, demographic data, comorbidities, hemodynamic data, laboratory data, clinical symptoms and findings recorded in the electronic decision support system were recorded and analyzed.

this retrospective study was performed on patients hospitalized in intensive care units after cardiac arrest between 2013 and 2022. patients who met the inclusion criteria were included in the study. urea, creatinine values, and whether aki was diagnosed or not were obtained from the data registry system. statistical evaluation was performed using univariate binary logistic regression analysis. demographic data, location of cardiac arrest (in-hospital, out-of-hospital), and duration of cpr were recorded. in addition, the causes of cardiac arrest, hr/map (heart rate/average arterial pressure) ratio, and whether vsp (vasopressor) or ino (inotropic) medication was needed were recorded.

Eligibility criteria:
inclusion criteria: * adult patients with spontaneous circulation after cardiac arrest and admitted to the intensive care unit exclusion criteria: * deaths in the first 48 hours * missing data * end stage ckd or first day hemadsorption * cpr time \<3 min * unwitnessed cardiac arrest * terminal malignancy * 90 years old * having a pace marker * massive bleeding * ecmo application * first day diyabetes insipitus

Keywords: cardiac arrest acute kidney injury mortality
vx-222 + telaprevir + ribavirin for 12 or 16 weeks in treatment-naive subjects with genotype 1a hepatitis c

Conditions: Chronic Hepatitis C Virus

Summary: the purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis c and have not received treatment yet.


Eligibility criteria:
inclusion criteria: * subjects must have genotype 1 chronic hepatitis c (chc) and laboratory evidence of hcv infection for at least 6 months before the screening visit * subjects will be treatment naïve * subjects must have documentation of the presence or absence of cirrhosis exclusion criteria: * history or other clinical evidence of significant or unstable cardiac disease * evidence of hepatic decompensation * diagnosed or suspected hepatocellular carcinoma * any other cause of significant liver disease in addition to hepatitis c, which may include but is not limited to malignancy with hepatic involvement, hepatitis b, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis * history of organ transplant, with the exception of corneal transplants and skin grafts
a phase 2a study evaluating the safety and efficacy of abt-981 in patients with erosive hand osteoarthritis

Conditions: Erosive Hand Osteoarthritis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of abt-981 to placebo in subjects with erosive hand osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. male or female between the ages of 35 to 80. 2. must fulfill 1990 american college of rheumatology (acr) hand osteoarthritis (oa) criteria 3. must have radiographic evidence of erosive hand oa 4. have one or more clinical signs and symptoms of active inflammation in at least three hand joints 5. subject assessment of hand pain intensity in at least one hand is ≥ 6. exclusion criteria: 1. previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, or current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug. 2. absolute neutrophil count \< 2,000 per mm3 3. diagnosis of one or more of the following: * fibromyalgia, * inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy, * psoriatic arthritis, psoriasis, * microcrystalline (including gout and pseudo gout) arthritis affecting the hands, * any oa of the hands due to an infectious origin or acute traumatic episode, secondary oa or oa linked to cartilage and bone dysplasia, * other chronic painful syndromes that could interfere with assessment of pain at the hand(s). 4. any uncontrolled medical illness or an unstable treatment or therapy. 5. any reason that prohibits a subject to undergo an mri.

Keywords: osteoarthritis joint diseases musculoskeletal diseases rheumatic diseases arthritis osteoarthritis, hand