Kornimate/medical-research-clean huggingface dataset:
a first-in-human (fih) study to evaluate the safety and tolerability of vvd-159642 in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: a fih study to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and preliminary anti-tumor activity of vvd-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (ras-pi3kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.


Eligibility criteria:
key inclusion criteria: * for part 1 dose escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (pdac), colorectal cancer (crc), non-small cell lung cancer (nsclc), or any solid tumor that harbors a rat sarcoma viral oncogene (ras) alteration \[kirsten rat sarcoma viral oncogene homolog (kras), neuroblastoma ras viral oncogene homolog (nras), harvey rat sarcoma viral oncogene homolog (hras)\] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (egfr) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (her2) overexpression (immunohistochemistry \[ihc\] 3+ or ihc 2+/fluorescence in situ hybridization \[fish\] positive) as per local/historical testing. * have histologically or cytologically confirmed metastatic or unresectable solid tumors. * measurable disease by recist version 1.1 as assessed by the investigator. * eastern cooperative oncology group (ecog) performance status ≤1. * adequate bone marrow, kidney, and liver function as defined in the protocol. * able to take oral medications. key exclusion criteria: * active central nervous system (cns) malignancies. * history of cardiac diseases as defined in detail in the protocol. * uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion). * history of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study. * active hepatitis b infection \[positive for hepatitis b surface antigen and hepatitis b virus deoxyribonucleic acid (dna)\]. * active hepatitis c infection (positive anti-hepatitis c virus \[hcv\] antibody and quantitative hcv ribonucleic acid (rna) results greater than the lower limits of detection of the assay).

Keywords: ras pi3k kras mek phase i solid tumors kras g12c her2
comparison of coronary ct with ivus in heart transplant population

Conditions: Heart Transplantation

Summary: to compare results of intravascular ultrasound (which occurs during cardiac catheterization) with computed tomography (ct) scan to detect blockages or narrowing of the arteries that feed the heart. these will be studied in the cardiac transplant population.


Eligibility criteria:
inclusion criteria: * heart transplant patients coming to the cardiac cath lab for their yearly angiogram which includes intravascular ultrasound (ivus) exclusion criteria: * patients with a history of allergic reactions to contrast material creatine \>1.5 clinical or hemodynamic instability those who are unable to consent for enrollment into the study

Keywords: blocked arteries narrowing arteries ivus ct
pku skin stripping

Conditions: Phenylketonurias

Summary: purpose of study: to determine if a non-invasive skin stripping technique can be used to detect individuals with phenylalanine abnormalities, and to monitor dietary and/or drug effects over time.

this study will determine if a non-invasive skin stripping technique can be used to detect individuals with phenylalanine abnormalities, and to monitor dietary and/or drug effects over time. to do this 50 children and adults with phenylalanine abnormalities and up to 50 unaffected controls will be recruited to this study. the 50 affected individuals will have their metabolomic profile analyzed from up to 3 skin-stripping samples over time and compared to their serum amino acid profile in both dried blood spots and a typical blood sample. the unaffected controls will provide one skin-stripping sample. clinical data regarding compliance with dietary therapy and other medications will be collected to determine other effects on the metabolome.

Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of pku that is confirmed by elevated serum phenylalanine. 2. any age. 3. subject or the subject's legal authorized representative has given written informed consent to participate in the study. exclusion criteria: * not applicable.
peer intervention for social skills (brain injury)

Conditions: Brain Injuries

Summary: to investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (abi).

an earlier pilot study tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction (nct02211339). following amendments to the pilot study protocol, twelve new participants with severe abi were recruited from a residential post-acute rehabilitation centre. an experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). the groups met twice a week for 8 weeks. a peer with severe abi was trained separately to facilitate interaction the peer-led group. the training took place in 16 individual sessions over 4 weeks. group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.

Eligibility criteria:
inclusion criteria: * diagnosis of severe traumatic brain injury (tbi) or severe abi with similar cognitive presentation to tbi * minimum of 6 months post injury * evidence of social communication impairment as a result of injury * ability to tolerate group activity exclusion criteria: * significant aphasia * severe depression or psychiatric disorder * insufficient english to converse with peer * profound cognitive impairment
piperacillin/tazobactam in critically ill patients with severe sepsis and septic shock

Conditions: Early Phase of Severe Sepsis and Septic Shock

Summary: this is prospective study to assess the pharmacodynamics (t\>mic) of 4.5 g every 6 h of piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following administration by a 30 min infusion. clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, apachae ii score, bun, cr and fluid balance will be collected. fifty patients will be enrolled in this study. piperacillin pharmacokinetic study will be carried out during the piperacillin/tazobactam therapy. each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy. concentration of piperacillin in plasma will be simulated in monte carlo technique to get pk/pd index and reported to % pta and % cfr.


Eligibility criteria:
inclusion criteria: * sepsis patient (defined by 2011 sccm/esicm/accp/ats/sis international sepsis definition conference) * severe sepsis or septic sock was defined by * severe sepsis (sepsis with organ dysfunction) * septic shock (sepsis with systolic arterial pressure\ 40 mmhg from base line) exclusion criteria: * patients who are pregnant. * patients who have documented hypersensitivity to beta-lactam * patients who are dialysis * patients who are severe sepsis or septic shock more than 24 hour

Keywords: piperacillin/tazobactam critically ill severe sepsis septic shock
vascular responses after percutaneous coronary intervention with stenting in patients with obstructive sleep apnea

Conditions: Coronary Artery Disease; Obstructive Sleep Apnea of Adult

Summary: obstructive sleep apnea (osa) is an increasingly common chronic disorder in adults. compared to the general population, osa occurs more often in patients with coronary artery disease (cad), with a reported prevalence of 38% to 65%. emerging evidence indicates osa initiates and exacerbates coronary atherosclerosis. moreover, several observational studies indicate the presence of osa was associated with higher rate of restenosis and repeat revascularization (mainly attributed non-culprit lesion revascularization) after percutaneous coronary intervention (pci). osa might initiate endothelial injury by repetitive bursts of sympathetic activity that occur with apneas and hypopneas. moreover, untreated osa reduces endothelial repair capacity. whether osa could exacerbate neointimal proliferation and plaque progression in the non-culprit lesion after drug-eluting stent (des) implantation remains less studied. the investigators aimed to evaluate neointimal proliferation and strut coverage within stent segment as well as changes of plaque volume and morphology in the non-culprit lesion by optical coherence tomography (oct) in patients with versus without osa at 12-month follow-up.


Eligibility criteria:
inclusion criteria: 1. 18 to 80 years old 2. patients undergoing pci with stenting in at least one de novo lesion in a native coronary artery 3. 3-vessel oct was available visually (at least one pullback/vessel) 4. written informed consent exclusion criteria: 1. predominantly central sleep apnea (csa, ≥50% central events or central apnea hypopnea index ≥10/h) 2. previous or current use of continuous positive airway pressure (cpap) 3. cardiogenic shock (systolic arterial pressure \<90mmhg), congestive heart failure (nyha or killip≥3) 4. stemi within 1 week 5. prior pci or cabg 6. chronic kidney disease \[egfr\<60ml/(min\*1.73m2)\] 7. aortic-coronary ostial lesion 8. left main lesion 9. chronic total occlusion 10. in-stent restenotic lesion 11. a tortuous vessel and/or severely calcified lesion or severe stenosis and the oct catheter could not pass across the lesion 12. massive residual thrombus on angiography despite thrombus aspiration or thrombectomy 13. planned elective pci within 12 months 14. severe comorbidities: eg. malignancy (life expectancy \<2 years) 15. known or planned pregnancy

Keywords: coronary artery disease obstructive sleep apnea optical coherence tomography vascular response
ultra-sound assisted management of heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation.

the purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. the use of hand carried ultrasound is expected to reduce hospital length of stay, heart failure re-admission rates, emergency room visits and in hospital complications such as renal failure. the hypothesis tested is as follows: null: the use of hand carried ultrasound in the management of heart failure patients did not change outcome. alternative: the use of hand carried ultrasound in the management of heart failure patients did change outcome. the study endpoints are as follows: 1. a primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay. 2. the secondary endpoint will be 30 days re-admission following heart failure hospitalization, emergency room visits and in hospital complications such as renal failure. this is a randomized controlled un-blinded study that poses very minimal risk because patients will only undergo an ultrasound measurement of inferior vein cava (ivc) and internal jugular vein diameter and compressibility. also, the society will benefit greatly with the prospect of reducing hospitalization and medical complications, optimizing healthcare delivery to heart failure patients, and reducing hospitalization cost. the results of this study/study procedure will only direct medical therapy that heart failure patients usually receive through routine care such as dose and frequency of diuresis.

Eligibility criteria:
inclusion criteria: 1. new admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, cxr showing pulmonary vascular congestion/pulmonary edema, elevated ntprobnp, dyspnea not secondary to infectious process (pneumonia). 2. heart failure nyha class iii, iv 3. age\>=18 years old exclusion criteria: 1. end stage renal disease on dialyses (esrd on hd) or stage v ckd (defined as gfr\<15) 2. end stage heart failure on chronic inotrope (example milrinone) 3. renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive) 4. morbid obesity bmi \> 40 5. incarcerated patients (prison) tdc. 6. pregnant patients 7. patients with dyspnea not mainly due to heart failure, esrd patients, intubated patients 8. aged less than 18 years.
comparison of pulmonary vein isolation using smarttouch® catheter with or without real-time contact force data

Conditions: Atrial Fibrillation; Atrial Fibrillation Ablation; Pulmonary Vein Isolation

Summary: the most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation catheter to deliver targeted burns on the inner surface of the heart. the aim of this approach is to cause electrical isolation of the pulmonary veins. the purpose of this study is to evaluate whether the information which can be derived from the latest catheter technologies - on the degree of contact force between the catheter and the heart - affects the time to perform the procedure, or the outcomes as a result of it. patients undergoing pulmonary vein isolation will be randomised to having their procedure performed with the contact force information available to the operator, or not available. the time taken to achieve pulmonary vein isolation is the primary end-point of the study.


Eligibility criteria:
inclusion criteria: age \> 18 years, symptomatic paroxysmal atrial fibrillation (defined as ecg proven episodes of atrial fibrillation which are self limiting and last less than 7 days on each occasion) exclusion criteria: inability or unwillingness to receive oral anticoagulation previous ablation procedure for atrial fibrillation unwillingness or inability to complete the required follow up arrangements persistent atrial fibrillation prior prosthetic mitral valve replacement or severe structural cardiac abnormality known severe left ventricular systolic function (ejection fraction \<35%) known hypertrophic or infiltrative cardiomyopathy

Keywords: atrial fibrillation contact force ablation
safety and efficacy of hmi-203 in ert-treated adults with mps ii

Conditions: Mucopolysaccharidosis II

Summary: phase 1, open-label, sequential ascending dose-escalation study. designed to evaluate the safety and efficacy of a single iv infusion of investigational gene therapy hmi-203. males, ages 18 to 45 years inclusive, with mps ii (hunter syndrome) currently receiving idursulfase ert (or the equivalent) are eligible to participate. participants will be followed for safety and efficacy for 5 years.

this phase 1 study will evaluate the safety and efficacy of hmi-203 gene therapy in adult male participants with mps ii currently being treated with standard-of-care idursulfase ert or equivalent. participants will receive a single dose of hmi-203 administered intravenously. there are 3 planned dose cohorts which will consist of 3 participants each. entry into the first dose cohort will be separated by a 60-day dosing interval between each participant to allow the homology medicines medical monitor to review safety and efficacy data prior to the second and third participants being enrolled. enrollment of subsequent participants, in cohorts 2 and 3, will be separated by a 21-day dosing interval between each participant for review of safety and efficacy data. escalation to the next dose cohort will occur after 21 days of safety, efficacy, and biomarker data have been reviewed by the homology medicines independent dmc. this entire study is comprised of 5 years, with the most frequent follow up visits occurring in the first year.

Eligibility criteria:
key inclusion criteria: * adult males 18-45 years of age at the time of informed consent * has capacity and is able to understand the purpose and risks of the study and is willing, able and committed to comply with all study procedures for the duration of the trial (a total of 5 years after gene therapy administration) * diagnosis of mps ii based on historically decreased i2s enzyme activity and elevated urine gags and/or presence of hemizygous ids pathogenic variant * kaufman brief intelligence test-second edition (kbit2) score ≥ 80 * compliance with regular treatments of ert for mps ii for at least 12 months prior to enrollment * clinically stable relative to urinary gag levels, ambulation, and cardiopulmonary status for 12 months preceding enrollment key exclusion criteria: * multiple sulfatase disorder as determined by abnormal activity of another lysosomal sulfatase * unresponsive and/or intolerant to idursulfase treatment * history of bmt, stem cell transplant, or gene therapy * presence of anti-capsid neutralizing antibodies * alt or ast \> uln; total or direct bilirubin \> uln * international normalized ratio (inr) \>1.2 uln * hematology values below the normal range * hemoglobin a1c ≥ 6.5% or fasting glucose ≥126 mg/dl * contraindication to corticosteroid or tacrolimus use * any condition that would not allow the potential participant to complete follow-up examinations during the course of the study or, in the opinion of the investigator, makes the potential participant unsuitable for the study

Keywords: mps ii hunter syndrome
biomarkers & infection after prophylactic antibiotic in cardiac implantable electronic device implantation

Conditions: Heart Block; CIED Related Infection; CIED-related Infections; Antibiotic Prophylaxis; Biomarkers

Summary: effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers


Eligibility criteria:
inclusion criteria: * indication of cied implantation * no infection at the time of implantation exclusion criteria: * refuse to participate in the study * allergy to ampicillin sulbactam * cied debridement

Keywords: heart block cied related infection antibiotic prophylaxis biomarkers
air optix daily wear contact lenses

Conditions: Refractive Errors

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to assess long term performance and safety of air optix aqua, air optix plus hydraglyde sphere, and air optix plus hydraglyde toric soft contact lenses in a real-world setting when worn as daily wear.

this is a non-interventional/observational study designed as a retrospective chart review. study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. the baseline visit will be defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for the study or comparator contact lenses was released. subjects meeting the eligibility criteria will be enrolled in the study.

Eligibility criteria:
key inclusion criteria: * manifest refraction cylinder less than or equal to 0.75 diopter (d) in each eye at baseline (sphere wearers only); * best corrected visual acuity (bcva) of 20/25 snellen or better in each eye at baseline; * must have worn or be wearing air optix aqua sphere, air optix plus hydraglyde sphere, air optix plus hydraglyde toric, biofinity sphere or biofinity toric for at least 1 year in a daily wear modality, as determined by the investigator; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * have worn or be wearing air optix aqua sphere, air optix plus hydraglyde sphere, air optix plus hydraglyde toric, biofinity sphere, or biofinity toric contact lenses in an extended wear modality; * any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline; * use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection; * slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear; * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
advanced geriatric evaluation and quality of life in colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) disproportionately affects patients aged 70 years and older. surgery is the main treatment modality for crc, but is associated with increased risk of postoperative morbidity, disability and loss of health related quality of life (hrql).frailty is an age related state of functional decline and considered to be an important risk factor for adverse outcome in geriatric oncology.risk models for adverse outcome may be used for treatment decisions in the elderly, but are often not designed to predict patient related outcome measures and do not include frailty characteristics.

multicentre, prospective, observational cohort study with a follow up time of one year. after initial diagnosis of crc subjects will be screened for frailty using validated questionnaires, physical tests and non-invasive measurements. frailty characteristics and hrql are determined by geriatric 8 (g8), hospital anxiety and depression scale(hads), euroqol- 5 dimensional (eq-5d), lawton instrumental activity of daily living scale(iadl), mini nutrition assessment (mna), 6 item cognitive impairment test (6-cit), identification of seniors at risk - hospitalized patients(isar-hp) and the eortc-qlq-c30/cr29 (hrql in crc patients). physical tests include the timed to get up (tug) test and the hand grip strength test. furthermore, the non-invasive measurements consist of a sarcopenia analysis using an existing ct/mri scan and measurement of advanced glycation endproducts (age reader). additional patients characteristics including medication use, medical history, tumor characteristics, neoadjuvant therapy and laboratory results of preoperative routine blood sampling will be collected. at three, six and twelve months after diagnosis, eortc qlq-c30/eortc qlq-cr29 and eq-5d questionnaires are used to determine hrql and disability free survival.

Eligibility criteria:
inclusion criteria: * age ≥ 70 years * histologically proven non-metastatic colorectal cancer * signed informed consent exclusion criteria: * - emergency surgical procedures * insufficient understanding of the dutch language
portopulmonary hypertension treatment with macitentan - a randomized clinical trial

Conditions: Portopulmonary Hypertension

Summary: 24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.


Eligibility criteria:
main inclusion criteria: * male or female of at least 18 years of age * confirmed diagnosis of portopulmonary hypertension main exclusion criteria: * severe hepatic impairment * severe obstructive or restrictive lung disease * pulmonary veno-occlusive disease * systolic blood pressure (sbp) \< 90 mmhg at screening * alt/ast \>= 3 x uln * bilirubin \>= 3 mg/dl at screening * any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results