Kornimate/medical-research-clean huggingface dataset:
a study of repotrectinib in combination with other anticancer therapies for the treatment of subjects with kras-mutant solid tumors

Conditions: KRAS Mutation-Related Tumors; Metastatic Solid Tumor; Advanced Solid Tumor

Summary: a phase 1b/2 study of repotrectinib in combination with other anticancer therapies for the treatment of subjects with kras-mutant advanced solid tumors (trident-2)

phase 1 dose escalation: to evaluate tolerability of repotrectinib at increasing dose levels in combination with other anticancer therapies for the treatment of subjects with locally advanced or metastatic kras-mutant solid tumors phase 2 efficacy evaluation: investigate the anti-tumor efficacy and safety of repotrectinib in combination with other anticancer therapies for the treatment of patients with locally advanced or metastatic kras-mutant solid tumors.

Eligibility criteria:
inclusion criteria: * age ≥ 18 (or as required by local regulation). * histological or cytological confirmation of unresectable or metastatic solid tumor malignancy harboring a kras mutation. * no more than 3 prior standard treatments appropriate for tumor type and stage of disease. * ecog performance status ≤ 1. * existence of measurable disease (according to response evaluation criteria in solid tumors \[recist v1.1\] criteria). * subjects with asymptomatic cns metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible. * adequate organ function. exclusion criteria: * major surgery within four weeks of the start of treatment. * previous other cancer requiring treatment within the previous two years. * clinically significant cardiovascular disease. * any of the following cardiac criteria: * mean resting corrected qt interval (qtc) \> 470 msec obtained from three ecgs and any factors that increase the risk of qtc prolongation or arrhythmic events * any clinically important abnormalities in rhythm, conduction, or morphology of resting ecg * known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including hiv positivity). * gastrointestinal disease or other malabsorption syndromes that would impact drug absorption. * subjects being treated with or anticipating the need for treatment with strong cyp3a inhibitors or inducers.

Keywords: kras kras-mutant metastatic solid tumor advanced solid tumor advanced/metastatic disease
characterization of the immunological profile patients with post-polio syndrome

Conditions: Poliomyelitis Sequelae

Summary: many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. in these patients, there is a denervation process associated with insufficient reinnervation. the frequency of this syndrome post-polio (spp) is of the order of 20 to 60% according to the studies. in the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of t cells in the bloodstream. in this context, the use of immunomodulatory immunoglobulin iv treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. in the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. on the other hand, depending on the results found, referral to targeted therapies could be considered.


Eligibility criteria:
inclusion criteria: subjects with post-polio syndrome : * age ≥ 18 years * meeting the definition of the spp according to the criteria of halstead et al. (1995) controlled subjects : * age ≥ 18 years * matched on sex and age (+/- 5 years) with subjects with pps exclusion criteria: * intercurrent neurological pathology, * uncontrolled cardiovascular risk factors * pulmonary comorbidity * endocrine disorders * systemic inflammatory pathology, autoimmune disease, dry syndrome, * renal failure * anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature, * patients with spp who received polyvalent iv immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants
a study to evaluate the safety and efficacy of pac-14028 cream in seborrheic dermatitis

Conditions: Seborrheic Dermatitis

Summary: this study is a phase ii, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. all subjects will receive bid topical applications of pac-14028 cream or vehicle for up to 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female patients aged between 19 and 65 years old * clinical diagnosis of seborrheic dermatitis in the facial area with erythema severity ≥ 2 and scaling severity ≥ 2 * ige (investigator's global evaluation) score 2 or 3 exclusion criteria: * patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis * patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area * patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks * patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks * patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks * pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study
a pharmacokinetic study of nutri-peitc jelly in head and neck cancer survivors

Conditions: Head and Neck Cancer

Summary: this research aims to evaluate the absorption and elimination profile of a bioactive compound peitc in the matrix of nutri-jelly - a novel edible nutritious gel. thus, the investigators conducted a pharmacokinetic study in 12 head and neck cancer survivors. after consumed a serving of nutri-jelly containing 20 mg peitc, plasma levels of peitc at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by liquid chromatography-mass spectrometry (lc-ms/ms). non-compartmental pharmacokinetic analysis was performed.

β-phenylethyl isothiocyanate (peitc) is a phytochemical found in cruciferous vegetables with anti-cancer properties in vitro and in vivo. however, its pharmacokinetic profile in cancer survivors were unknown. a pharmacokinetic study was conducted in head and neck cancer survivors to evaluate the absorption and elimination profile of peitc in the matrix of nutri-jelly - a novel edible nutritious gel. twelve head and neck cancer survivors consumed a serving of nutri-jelly containing 20 mg peitc. plasma levels of peitc at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by lc-ms/ms. non-compartmental pharmacokinetic analysis was performed. pharmacokinetic parameters including cmax, tmax, half-life, clearance were analyzed.

Eligibility criteria:
inclusion criteria: * age 20 or above * diagnosed with head and neck cancer * completed radiation or chemotherapy since at least 4 weeks ago * normal physical exam * eastern cooperative oncology group (ecog) performance status 0 - 2 * life expectancy \> 3 months * normal kidney function evidenced by serum creatinine, blood urea nitrogen (bun), no kidney stone, no history of renal dialysis * normal liver function evidenced by serum bilirubin, aspartate transaminase (ast), alanine amino transferase (alt) * not pregnant or breastfeeding * no psychiatric symptoms * normal vital sign and normal blood chemistry including complete blood count cbc) * provide voluntary inform consent exclusion criteria: * unable to communicate * reject to take nutri-jelly * unable to refrain from vegetable intake for 3 days prior to the test * take paracetamol during 2 days prior to the test * body weight less than 35 kg or higher than 65 kg * oral infection such as candidiasis interfering with normal oral intake
immersive virtual reality based exersice in post-mastectomy lymphedema patients

Conditions: Lymphedema Arm

Summary: to determine the effect of immersive virtual reality on shoulder proprioception and rom of post-mastectomy lymphedema patients.

research question: does immersive virtual reality based exercise effective in improving shoulder proprioception and rom for post-mastectomy patients? assessment: the digital goniometer will be used in measuring shoulder extension, flexion, adduction, abduction, internal rotation and external rotation before the sessions and after one month of sessions. also, shoulder proprioception will be assessed by the digital goniometer.the measurement will be taken for both the edematous side and the non-affected side. treatment: study group: the patients will receive eight sessions of immersive virtual reality based exercise, 2 sessions per week for 4 weeks besides the traditional physical therapy. control group: the patients will receive eight sessions of the traditional physical therapy, 2 sessions per week for 4 weeks.

Eligibility criteria:
inclusion criteria: * all the patients will be females. * patients with lymph node dissection. * start at least 2 weeks after operation. exclusion criteria: * vision problems. * medically instable patients. * balance disorders. * other musculoskeletal condition of shoulders.
rabies virus neutralizing activity and safety of cl184, a monoclonal antibody cocktail, in simulated rabies post-exposure prophylaxis in healthy adults

Conditions: Rabies

Summary: study design: single-blind (subject and observer-blinded), active-controlled, randomized \[6:2:1:2:1; cl184 + purified vero cell rabies vaccine (pvrv) vs. human rabies immune globulin (hrig) + pvrv vs. placebo + pvrv vs. cl184 + human diploid cell vaccine (hdcv) vs. placebo + hdcv\], mono-center study study objectives: primary: to evaluate the safety of cl184 in combination with pvrv in healthy adult subjects. secondary: to evaluate the safety of hrig or placebo in combination with pvrv and to evaluate the safety of cl184 or placebo in combination with hdcv in healthy adult subjects. to evaluate the rabies virus neutralizing activity (rvna) after administration of cl184 or placebo in combination with pvrv, of hrig in combination with pvrv, and of cl184 or placebo in combination with hdcv in healthy adult subjects. to evaluate the pharmacokinetics of the monoclonal antibodies (mabs).

this study was designed to explore and obtain further safety and rvna data on cl184 in comparison to hrig and placebo as part of a classical post-exposure prophylaxis (pep) regimen. this regimen will be applied as simulated pep regimen to healthy subjects (i.e. in a pre-exposure setting) in this study. a comparison with placebo combined with each rabies vaccine was included to differentiate between the contribution of immune globulin and vaccine and to investigate potential interactions between immune globulin and vaccine. rvna provided by cl184 or hrig, as well as vaccination response will be checked regularly during the study and booster doses can be applied after the study, if necessary. in addition pharmacokinetic data will be collected.

Eligibility criteria:
inclusion criteria: * male or female subject aged ≥18 to ≤55 years * subjects free of obvious health-problems or with stable conditions or medications * body mass index between ≥18 to ≤30 kg/m2 * abstinence from sexual intercourse or use of adequate contraception from the date of screening up to day 90 * male subjects must agree that they will not donate sperm from the first check-in until day 90 * subject signed written informed consent exclusion criteria: * prior history of active or passive rabies immunization * clinically significant acute illness or infection including fever (≥38 °c) within 2 weeks before first dosing * history and/or family history of clinically significant immunodeficiency or auto-immune disease * planned immunization with live vaccines during the coming 3 months after first dosing * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Keywords: monoclonal antibody rabies post-exposure prophylaxis
drug-coated balloon versus drug-eluting stent for de novo lesions in large coronary arteries guided by optical coherence tomography

Conditions: Angioplasty; Coronary Artery Disease

Summary: oct allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. this prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by oct guided is not inferior to drug-eluting stent.


Eligibility criteria:
inclusion criteria: 18 to 75 years old patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） . reference vessel diameter ≥3.0 mm, and \<4.5mm. lesion length of ≤20 mm written informed consent exclusion criteria: myocardial infarction within 4 weeks, including st-elevation myocardial infarction and non-st-elevation myocardial infarction cardiogenic shock (systolic arterial pressure \<90mmhg), congestive heart failure (nyha=4，ef≤35%) severe valvular heart disease life expectancy no more than 1 year or factors causing difficulties in clinical follow up intolerance to aspirin and/or clopidogrel, ticagrelor known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, co-cr alloy or platinum-chromium alloy leukopenia or thrombopenia a history of peptic ulcer or gi bleeding in the previously stroke within 6 months prior to the operation a history of severe hepatic or renal failure stents covering a major side branch (≥2.5 mm need to intervention) left main lesion graft lesion aortic-coronary ostial lesion in-stent restenotic lesion chronic total occlusion severe calcified lesions. visible angiographic thrombus

Keywords: coronary heart disease large coronary vessel optical coherence tomography drug-coated balloon drug-eluting stent
validation study of combined positron emission tomography/computer tomography to diagnose infection and inflammation

Conditions: Bacterial Infections; Bacteremia; Gram-Positive Bacterial Infections; Inflammation

Summary: the overall aim is to validate the current use of fdg pet/ct for the diagnosis of infection and inflammation and examine the usefulness of pet/ct applying also other tracers. the results should allow us to confirm our primary hypothesis: "fdg-pet/ct is better than established methods to confirm or exclude the diagnosis of infection/inflammation".

the study include several part projects, each contributing to the evaluation of the value of fdg-pet/ct in the diagnosis of infection and inflammation. the aims are to establish the diagnostic value in terms of sensitivity, specificity, positive and negative predictive values, interobserver and intraobserver variation. part project a fdg-pet/ct in patients with blood culture positive for staphylococcus aureus and unresolved origin of infection. part project b fdg-pet/ct in patients with fever of unknown origin. part project c fdg-pet/ct in patients suspected of vascular graft infection. additionally, we wish to establish an optimal imaging protocol (necessity of fasting, consequences of antibiotic therapy prior to imaging, and the need of contrast), interpretation criteria, and the value of standard uptake values (suv).

Eligibility criteria:
inclusion criteria: part project a • blood culture positive for staphylococcus aureus and unresolved origin of infection. part project b * fever of unknown origin * referred for fdg-pet/ct at the department of nuclear medicine, odense university hospital. part project c * suspected vascular graft infection * referred for fdg-pet/ct at the department of nuclear medicine, odense university hospital. exclusion criteria: * patients incapable of giving, refusing or revoking consent * patients less than 18 years of age * patients from other regions than the region of southern denmark * patients who cannot cooperate to pet/ct scan.
a study of cc-97540 (bms-986353), cd19-targeted nex-t car t cells, in participants with active sle despite immunosuppressants (breakfree-sle)

Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis

Summary: the purpose of this study is to evaluate the efficacy, safety and drug levels of cc-97540 in participants with active systemic lupus erythematosus (sle) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.


Eligibility criteria:
key inclusion criteria * participants must meet eular/acr 2019 criteria for sle. * participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * participants must have active disease when signing icf. key exclusion criteria: * participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of cc-97540 in sle. * uncontrolled or clinically significant cardiovascular conditions or cns pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies. * iocbp who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study. * participants must not have prior treatment with car t cell therapy, genetically modified t cell therapy, or stem cell transplant. washout periods may be required. * participants must not have received live vaccines within 6 weeks before cc-97540 administration. * participant must not have inadequate organ function. * other protocol defined inclusion/exclusion criteria apply.

Keywords: lupus sle ln car t cell therapy cd19 car t cd19 cd19 nex-t cd19 next cd19 nex t
evaluation of the repeatability and reproducibility of angiovue

Conditions: Normal, Glaucoma & Retinal Pathology

Summary: the purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on angiovue volume scans in normal subjects, glaucoma patients, and retina patients.


Eligibility criteria:
inclusion criteria: 1. normal * age \> 18. * no retinal pathology or glaucoma. 2. glaucoma patient * age \> 18. * have glaucoma. 3. retina patient * age \> 18. * have retina pathology. exclusion criteria: 1. normal * unable to complete required exams. * poor quality image data. 2. glaucoma patient * unable to complete required exams. * poor quality image data. * retinal pathology. 3. retina patient * unable to complete required exams. * poor quality image data. * glaucoma.
clinical study to investigate safety and performance of neurx dps in patients undergoing bilateral lung transplantation

Conditions: Chronic Obstructive Airway Disease

Summary: this study is a prospective, single-center feasibility study to acquire more knowledge regarding the neurx dps and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the intensive care unit in patients after bilateral lung transplant.

this study is a prospective, single-center feasibility study to acquire more knowledge regarding the neurx dps and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the intensive care unit in patients after bilateral lung transplant. the objectives are to evaluate the safety and technical performance of dps by assessing: * the immediate safety and technical surgical results of implantation * the safety and tolerability of use and removal until patient discharge from the intensive care unit (icu) or hospital * the effects of diaphragm pacing on mv interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (emg)

Eligibility criteria:
inclusion criteria: * patient is undergoing bilateral lung transplantation * signed written informed consent has been obtained prior to any study related procedure exclusion criteria: * diaphragm malformation which makes the electrode insertion impossible * presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma * participation in other clinical studies that could interfere with the results in the ongoing study

Keywords: diaphragm pacing respiratory assistance lung transplant