Kornimate/medical-research-clean huggingface dataset:
a phase i/ii clinical study of cts3497 in patients with mtap deficient malignacies

Conditions: Solid Tumor; Lymphoma

Summary: the primary objective of phase i of this study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d) of cts3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (mtap)-deficient solid tumors and lymphomas. the primary objective of phase ii of this study is to evaluate the efficacy of cts3497 in patients with metastatic or locally advanced mtap-deficient solid tumors and lymphomas.

the primary objective of phase i of this study is to evaluate the safety, tolerability, pk, pd and efficacy to determine the maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d) of cts3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (mtap)-deficient solid tumors and lymphomas. the primary objective of phase ii of this study is to evaluate the efficacy and safety of cts3497 in patients with metastatic or locally advanced mtap-deficient solid tumors and lymphomas.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age at the signing of icf. * patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who cannot be treated surgically and have failed standard of care (soc). or patients with refractory/relapsed lymphomas. * mtap deficiency is confirmed by ihc or ngs. * at least one evaluable tumor lesion at screening for patients in escalation part, and at least one measurable tumor lesion for patients in expansion part. * ecog performance status of 0 to 1. * adequate hematopoietic function, cardiac function, liver function, renal function, and coagulation function per local laboratory. exclusion criteria: * female patients in pregnancy or lactation. * patients with dysphagia; or a condition that seriously affects gastrointestinal absorption. * allergic or intolerant to the active ingredients or excipients of the investigational product. * anti-tumor therapy within 28 days of study day 1. * prior treatment with an methionine adenosyltransferase 2α (mat2a) inhibitor or a protein arginine methyltransferase 5 (prmt5) inhibitor. * central nervous system (cns) metastasis at screening. * live vaccine therapy within 4 weeks before study drug administration. * use of therapeutic anti-coagulation for treatment of active thromboembolic events. * use of prescription medications that are known strong inducers or inhibitors of cytochrome p450 3a4 (cyp3a4) within 14 days or 5 half-lives (whichever is longer) before study day 1. * unresolved toxicity from prior anti-cancer therapy. * active infection of hiv, hbv or hcv. * patients who are judged by the investigator to have a history of other serious systemic diseases, or not suitable for participating in the trial for any other reason.

Keywords: prmt5
neurologic function post intubation

Conditions: Intubation Complication

Summary: the frequency of oxygen desaturation during emergency intubation is not uncommon. however, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients. providing knowledge on whether the degree of hypoxia during emergency intubation is associated with worse neurologic outcomes, will guide clinical practice to ameliorate that level of hypoxia

critically ill patients undergoing emergent endotracheal intubation are at risk for oxygen desaturation in a variety of acute care settings. such complication could arise from patient, operator, or procedure related factors. evidence suggests that rapid sequence intubation (rsi) improves first-pass success and reduces complications in the critically ill. nonetheless, the procedure is not without risks. in fact, emergency intubation is associated a reported oxygen desaturation rate of 10.9% - 33.5%. high quality pre-oxygenation has been shown to prolong time to desaturation during emergency airway management. despite advances preoxygenation techniques, a significant number of patients undergoing emergency intubation still experience desaturation. most of the time this is transient and easily reversible. occasionally however, desaturation becomes critical and may result in devastating complications such as dysrhythmias or cardiopulmonary arrest. the brain consumes a significant amount of energy and is exquisitely sensitive to hypoxia and hypoperfusion. hypoxic brain injury occurs whenever oxygen delivery to the brain is compromised. the role of secondary brain insults including hypoxia and hypotension, in traumatic brain injury (tbi) is well established. previous literature has demonstrated that a single event of hypoxemia in a head-injured patient substantially increases morbidity and mortality. this has resulted in airway management being a cornerstone in the care of unconscious tbi patients, to ensure adequate oxygen delivery to the injured brain. however, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients.

Eligibility criteria:
inclusion criteria: * good baseline neurologic function (modified rankin scale: 1-3) * emergency departments * critical care units * in-patient floors * patients undergoing emergent intubations as determined by the treating physician * age\> 17 years old * good baseline modified rankin scale (mrs 1-3) exclusion criteria: * pediatric patients (17 years of age of less) * pregnant patients * intubations occurring in the operating room * prisoners * trauma * status epilepticus * primary intracranial pathology * cardiopulmonary arrest * poor baseline neurologic function (modified rankin scale: 4-5) * pre-hospital intubation

Keywords: emergency intubation hypoxia neurologic function
b memory cell response to vaccination with the 13-valent pneumococcal conjugate vaccine in asplenic individuals

Conditions: Asplenia; β-thalassemia Major

Summary: the purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (pcv13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to pcv13 in this group.


Eligibility criteria:
inclusion criteria: * asplenia * β-thalassemia major * older than 18 years exclusion criteria: * no previously recorded allergy to pcv * no intravenous immunoglobulin (ivig) given within the previous 6 months * no other vaccine given within the previous 6 months
adhesiolysis in chronic abdominal pain

Conditions: Chronic Abdominal Pain

Summary: laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. there has been only one previous controlled study, that stated laparoscopy alone had the same benefits than laparoscopic adhesiolysis. the aim of this study is to compare laparoscopic adhesiolysis with a placebo-procedure in chronic abdominal pain.


Eligibility criteria:
inclusion criteria: * age 18-65 years * abdominal pain at least 6 months * previous abdominal surgery and/or significant abdominal trauma and/or abdominal infection * asa class i-ii exclusion criteria: * psychiatric disorder * significant other somatic diseases (asa class iii-v) * refusal to participate
dexmedetomidine versus propofol for prolonged sedation in critically ill trauma and surgical patients

Conditions: Delirium

Summary: the purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.

design: open-label, single-center prospective study. setting: trauma/surgical intensive care unit (tsicu) at a level i academic trauma center. patients: patients 18 years of age or older requiring mechanical ventilation and admitted to the tsicu interventions: patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.

Eligibility criteria:
inclusion criteria: * patients were included in the study if they were 18 years of age or older, * mechanically ventilated, * placed on the institutional sedation protocol, * expected to require sedation lasting 24 hours after randomization, and * admitted to the tsicu and followed by the trauma/surgical service. exclusion criteria: patients were excluded for any of the following: * 72 hours or greater since sedation protocol initiation, * treatment per the institutional traumatic brain injury (tbi) protocol, * concomitant continuous infusion of a neuromuscular blocking agent, * heart rate less than 50 beats per minute, * mean arterial pressure less than 55 mmhg despite fluid resuscitation and vasopressors, and * use of other alpha-2 agonists within 24 hours of randomization.
tranexamic acid versus adrenaline for controlling iatrogenic endobronchial bleeding

Conditions: Bleeding; Hemoptysis

Summary: endobronchial bleeding is a relatively common complication of diagnostic bronchoscopy. both tranexamic acid and adrenaline are used topically for the control of endobronchial bleeding. the aim of this study is to compare the efficacy of tranexamic acid with adrenaline in controlling iatrogenic endobronchial bleeding after diagnostic bronchoscopy.


Eligibility criteria:
inclusion criteria: * patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°c) normal saline (3 aliquots of 5ml during 60sec) exclusion criteria: * any patient with a contraindication for diagnostic flexible bronchoscopy * coagulopathy (pv inr \>1.3) * thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/l) * direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy * thrombophilia, history of pulmonary embolism or deep vein thrombosis * contraindication for endobronchial application of adrenaline * coronary heart disease, cerebrovascular disease, history of tachyarrhythmia * uncontrolled pulmonary hypertension * cardiovascular decompensation * severe hypoxia (pao2 \ =60%)

Keywords: bronchoscopy tranexamic acid adrenaline
multiple ascending doses of rozibafusp alfa (amg 570) in adults with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a study to evaluate safety and tolerability and characterize the pharmacokinetic (pk) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * body mass index: 18-35 kg/m\^2 * diagnosed with ra (disease duration of at least 6 months) * stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks) * immunizations up to date * willing to use highly effective contraception during treatment and through end-of-study exclusion criteria: * uncontrolled, clinically significant systemic disease other than ra (i.e., diabetes mellitus, liver disease, asthma, cardiovascular disease, hypertension) * malignancy within 5 years * presence of serious infection, recurrent/chronic infections * class iv ra according to american college of rheumatology/ (acr) revised response criteria * diagnosed with felty's syndrome * known or suspected sensitivity to mammalian cell-derived products * history of alcohol and/or substance abuse within the last 12 months * receipt of rituximab at any time in the past * evidence of renal disease
the role of p-cresol and related protein fermentation metabolites in chronic kidney disease patients

Conditions: Chronic Kidney Disease

Summary: study on the natural history of uremic retention solutes in patients with mild-to-moderate chronic kidney disease

protein-bound uremic retention solutes are increasingly recognized to play a role in the pathophysiology of the uremic syndrome. numerous in vitro findings are indicative for their implication in the biochemical and physiological changes of uremia. several of these protein-bound retention solutes originate from bacterial protein fermentation in the colon. p-cresyl sulfate, a fermentation metabolite of the amino acid tyrosine, is considered a prototype of this group of uremic solutes. the protein binding of this molecule was shown to be about 90% in end-stage renal disease patients. several data have suggested that p-cresol plays a role in the immunodeficiency of uremia. recently, a link between the molecule and endothelial dysfunction has been demonstrated. also other members of the class of protein-bound solutes have been found to be associated with immune dysfunction, endothelial cell dysfunction and, closely related to the latter, oxidative stress. free serum levels of p-cresol were shown to be greater in stage 5 chronic kidney disease (ckd) patients treated with hemodialysis (hd) hospitalized for infectious disease. furthermore, a positive relationship was found between serum total p-cresol level and a uremic symptom score in patients treated with peritoneal dialysis (pd), whereas a correlation with small water-soluble solutes and the middle molecule β2-microglobulin was absent. a recent prospective observational study in stage 5 ckd patients treated with conventional hd (3 x 4 hours per week) indicated that the accumulation of p-cresol is a risk factor for overall mortality. data on the serum concentrations of p-cresol in chronic kidney disease patients are lacking. the investigators hypothesise that the serum concentration of p-cresol is an independent predictor of progression to end stage renal disease and is an independent predictor for cardiovascular disease.

Eligibility criteria:
inclusion criteria: * informed consent * chronic kidney disease, stage 1-4 kdoqi exclusion criteria * age below 18 * kidney transplant recipient

Keywords: chronic kidney disease cardiovascular disease risk stratification
outcomes of stem cells for cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

the aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at vinmec international hospital, hanoi, vietnam.

Eligibility criteria:
inclusion criteria: * cerebral palsy of any types caused by oxygen deprivation. exclusion criteria: * epilepsy * hydrocephalus with ventricular drain * coagulation disorders * allergy to anesthetic agents * severe health conditions such as cancer, failure of heart, lung, liver or kidney * active infections

Keywords: cerebral palsy stem cells
omentopexy after sleeve gastrectomy in children and adolescences.

Conditions: Morbid Obesity; Pediatric Obesity; LAP

Summary: laparoscopic sleeve gastrectomy (lsg) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. postoperative gastrointestinal complications are agonizing in patients underwent this procedure. most of these complications can be prevented by omentopexy in association with sleeve gastrectomy. the primary aim of this study to assess the effectiveness of omentopexy during laparoscopic sleeve gastrectomy in reducing post-operative complication.

this study was a carried out as a prospective study of 48 patients with obesity between january 2015 and october 2024. the patients were divided into 2 groups; group 1: included 24 patients managed with lsg with omentopexy and group 2: included 24 patients managed with lsg without omentopexy. pre- operation data and post operation outcomes were taken for all patients in each group.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 40 kg/m2 or * bmi of 35 kg/m2 due to at least 1 comorbid condition exclusion criteria: * secondary obesity * more than 18 years * previous operation
drug-drug interaction (ddi) study for tpn171h

Conditions: Erectile Dysfunction

Summary: the primary objective of this study was to assess the effect of rifampicin,a cytochrome p450 3a4 enzyme (cyp3a4) induction, on the pharmacokinetics (pk) of tpn171h in chinese healthy male subjects ,and assess the effect of itraconazole，cytochrome p450 3a4 enzyme (cyp3a4) induction on the pk of tpn171h in chinese healthy male subjects


Eligibility criteria:
inclusion criteria: 1. healthy male subjects between the ages of 18 and 40 years; 2. body mass index of 19 to 26 kg/m2; body weight no less than 50 kg; 3. physical examination, vital signs examination, ecg, laboratory examination results were normal or abnormal without clinical significance; 4. take reliable contraceptive measures during the trial and within three months after taking the drug; 5. fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements. exclusion criteria: 1. allergies to test preparations, any of their ingredients, and related preparations; with allergies or allergic diseases; 2. clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in b-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension; 3. blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (naion), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration; 4. a history of postural hypotension; 5. patients with blood loss ≥400 ml within 3 months before inclusion; 6. taken any prescription drugs, over-the-counter drugs, chinese herbal medicines or health care products within 2 weeks before administration; 7. participated in other drug clinical trials and received trial drugs within 3 months before administration; 8. positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 ml of beer or 45 ml of 40% spirits or 150 ml wine); 9. smoking more than 10 cigarettes per day ; 10. positive for hepatitis b surface antigen (hbsag), hcv antibody, syphilis antibody and hiv antibody; 11. patients with clinically significant chest x-ray (posterioranterior) abnormalities; 12. the investigator believes that there are other factors that are not suitable for participating in this trial.
a study of mm-121 combination therapy in patients with advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: a phase 1-2 study of mm-121 in combination with standard therapy for non-small cell lung cancer (nsclc).

phase 1: patients with non-small cell lung cancer (nsclc) may be enrolled to evaluate the safety, tolerability and recommended phase 2 dose of mm-121 in combination with standard therapy. phase 2: patients with non-small cell lung cancer (nsclc) may be enrolled to estimate the progression-free survival of the mm-121 + standard therapy.

Eligibility criteria:
inclusion criteria: * patients with locally advanced or metastatic non-small cell lung cancer. * patients must be \>/= 18 years of age. * patients must have adequate performance status (ps) as measured by ecog and adequate end organ function. exclusion criteria: * patients with a recent history (within 5 years) of another malignancy. * patients who are pregnant or nursing. * patients with clinically significant heart failure. * patients with clinically significant eye or gastrointestinal abnormalities.

Keywords: non-small cell lung cancer nsclc advanced non-small cell lung cancer metastatic non-small cell lung cancer lung cancer erlotinib tarceva mm-121 erbb3 her3 epidermal growth factor receptor anti-erbb3 human monoclonal antibody erbb3 antagonist
identification of risk factors, exposomics and genetic susceptibility of melanoma in children, adolescents and young adults

Conditions: Melanoma; Spitzoid Melanoma; Congenital Nevi

Summary: the primary objective of this study is the identification of environmental and genetic factors involved in the risk and progression of melanoma in children, adolescents and young adults (caya). the secondary objectives are to generate a model integrating the genetic and environmental factors to estimate the risk of developing melanoma and improve the primary prevention of melanoma through evidence-based interpretation of environmental risk.

by retrieving data from several epidemiological and clinical registries across europe it is aimed to integrate and maximize efforts in order to create a large dataset that serves for a comprehensive analysis of genetic and environmental factors influencing the etiology of melanoma in caya. the data will be combined with exposome information about climate and pollution for the development of a weighted risk score. furthermore, germline high risk mutations and germline low-medium risk variants will be analyzed. genome and transcriptome sequencing of blood and in selected cases tumour will provide the most comprehensive data to create a polygenic risk score for caya melanoma. transcriptome data will help to identify and characterize the effect of variants of unknown significance in coding, intronic as well as regulatory regions. tumour sequencing can provide additional information on functional relevance of variants, e.g. secondary hits in tumour tissue or second hits in tumour suppressor genes. such identification will be highly advantageous to design prevention strategies for melanoma development in caya.

Eligibility criteria:
inclusion criteria: * confirmed melanoma * age until 30 years old exclusion criteria: * no available biological material * no signed informed consent

Keywords: etiology melanoma children adolescents young adults genetic predisposition epidemiology exposomes