Kornimate/medical-research-clean huggingface dataset:
a study to evaluate incb186748 in participants with advanced or metastatic solid tumors with kras g12d mutation

Conditions: Solid Tumors

Summary: the purpose of this study is to evaluate incb186748 in participants with advanced or metastatic solid tumors with kras g12d mutation.


Eligibility criteria:
inclusion criteria: * ≥18 years old. * locally advanced or metastatic solid tumor with kras g12d mutation. * for part 1 and part 2 combination group 1: disease progression on or after prior standard treatment, or intolerance to or ineligibility for standard treatment, or no standard available treatment to improve the disease outcome. * for part 2 combination groups 2 and 3: no more than 1 prior standard treatment. * cohort-specific requirements as follows: * parts 1a and 1d: histologically or cytologically confirmed malignant solid tumor of any tissue origin. * part 1b * disease group 1: diagnosis of pdac and at least 1 but no more than 2 prior standard systemic regimens for pancreatic cancer. * disease group 2: diagnosis of crc. * part 1c: confirmed diagnosis of pdac or crc. * parts 2a and 2b * combination group 1 (incb186748 in combination with cetuximab): * diagnosis of pdac or * diagnosis of crc and ∘ prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and * in part 2a: ≤ 3 prior standard regimens. * in part 2b: ≤ 2 prior standard regimens. * combination group 2 (incb186748 in combination with gemnabp) and * combination group 3 (incb186748 in combination with mfolfirinox): * diagnosis of pdac. * ≤ 1 prior standard systemic regimen for pancreatic cancer. * measurable disease according to recist v1.1. * ecog performance status score of 0 or 1. exclusion criteria: * prior treatment with any kras inhibitor. * known additional invasive malignancy within 1 year of the first dose of study drug. * history of organ transplant, including allogeneic stem cell transplantation. * significant, uncontrolled medical condition. * history or presence of an ecg abnormality. * inadequate organ function. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: incb186748 krasg12d mutation pancreatic ductal adenocarcinoma (pdac) colorectal cancer (crc)
investigating bone and skeletal muscle interaction in men with prostate cancer

Conditions: Prostate Cancer

Summary: the overall goal of this pilot project is to test the hypothesis that a decline in muscle strength precedes the decline in bone strength in men undergoing androgen deprivation therapy (adt) for prostate cancer. the investigators will measure changes in serum biomarkers involved in muscle-bone crosstalk, anatomic changes in muscle and bone structure and strength that could ultimately contribute to fractures. the findings from this research will inform design of interventions to reduce falls and hip fractures in patients undergoing adt as well as application to broader populations of at risk patients.

twenty-five men from urology clinic with prostate cancer will be recruited and enrolled prior to initiating adt and studied at three time points. baseline (before first does of adt), and at approximately weeks 6 and 24 while receiving adt for prostate cancer. study measures will be the same during each of three data acquisition time points and include ascertainment of venous blood to determine serum biochemical markers of muscle and bone metabolic activity, mri and ct imaging studies to assess muscle strength, volume, composition, bone volume, density and strength, and validated tests of muscle strength. subjects will serve as their own controls.

Eligibility criteria:
inclusion criteria: • dx with prostate cancer and planned adt therapy exclusion criteria: * contraindication to mri * limited life expectancy * inability to participate in exercise testing * severe functional impairment * chronic kidney disease 4 or worse * hgb \< 9 * use of anti-resorptive agent * non-english speaking * bone metastasis

Keywords: androgen deprivation therapy sarcopenia bone loss
transcutaneous electrostimulation for intermittent claudication supervised walking therapy for intermittent claudication

Conditions: Intermittent Claudication; Peripheral Arterial Disease

Summary: prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.

the investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (set) and additional transcutaneous electric stimulation (tes) of the calf muscle. set program consists in once weekly walking training for 75 min under supervision of a professional trainer. patients are encouraged to continue the training modules at home. tes is performed using the mobile "veinoplus arterial" device (adrem technology, france) on a daily base for 60-120 min at home. patient outcome will be compared to the retrospectively analyzed results of patients, that received the same set program alone in the past.

Eligibility criteria:
inclusion criteria: * intermittent claudication due to peripheral arterial disease * ankle brachial index \</=0.9 * occlusion or stenosis of the superficial femoral artery exclusion criteria: * rest pain or peripheral arterial lesions * contraindications for supervised walking therapy * non-vascular conditions that limit patients´ walking ability * patients that have already received supervised walking therapy * occlusion of the deep femoral artery * occlusion or high-grade stenoses of the iliac arteries * stroke in the last 12 months * premenopausal women * diabetes mellitus, dialysis, sclerodermia and other conditions that impair leg perfusion * active cilostazol therapy or alprostadil-infusion in the last 3 months * pacemaker, defibrillator systems, life vest * visible muscle contraction is not achieved without pain
effect of interceptive strategies on the clinical outcome of maxillary impacted canines

Conditions: Tooth, Impacted

Summary: this study aims to investigate the effect of 3 randomly applied interceptive measures (slow maxillary expansion, extraction of deciduous canines and no intervention) on maxillary canine impaction in patients with early mixed dentition and lack of space in the dental arch. additionally, these groups are compared with a control group with adequate space. patients with at least one impacted maxillary canine, presence of deciduous canines and absence of crossbite were included. the canine position is assessed by measuring five variables (sector of the canine cusp, canine to midline angle, canine to first premolar angle, canine cusp to midline distance, and canine cusp to maxillary plane distance) on 2 panoramic radiographs at 0 (t1) and 18 months (t2).

the detailed information regarding methodology has been entered in following sections

Eligibility criteria:
inclusion criteria: * all patients presenting at the intake consultation of the department of orthodontics of university hospitals leuven, belgium from september 2016, with at least one maxillary permanent canine impaction are invited to participate. canine impaction is diagnosed based on a panoramic radiograph, taken for standard evaluation of dental development and associated pathology. a maxillary canine is considered to be impacted when the canine to midline angle was ≥15° (alqerban et al. 2014; warford et al. 2003). only impacted maxillary canines with incomplete root formation and with persisting deciduous canines are included. exclusion criteria: * presence of uni- or bilateral posterior dental crossbite, * upper permanent canines showing root malformation, ankylosis or fully erupted, * evidence of root resorption of adjacent teeth, previous orthodontic treatment, * craniofacial syndromes, * systemic disease that would impede orthodontic treatment/surgery and recent exposure to radiotherapy. * large eruption follicles seen on the permanent canines

Keywords: interceptive orthodontics maxillary canines maxillary expansion tooth extraction deciduous tooth
effect of aerobic exercise associated with abdominal radiofrequency on on adipose tissue in women:

Conditions: Cardiovascular Risk Factor; Metabolic Disease

Summary: the purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with radiofrequency in lipolytic activity and lipid profile.

the adipose tissue is the main energetic reserve, being constituted by adipocytes, cells that accumulate lipids inside its cytoplasm, in the form of triglycerides. fat deposition can occur both in the subcutaneous compartment and in the visceral compartment and is the result of a positive energy balance in which there is an imbalance between the amount of calories consumed and the amount of calories expended. thus, an excess of energy storage occurs in the form of triglycerides in adipose tissue, which results from a sedentary lifestyle and a diet based on lipid rich nutrients. when fat deposition occurs in abdominal adipose tissue may favor the development of metabolic disorders. recently the effectiveness of an innovative physiotherapeutic intervention - radiofrequency on adipose tissue has been studied. this therapeutic modality stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. in this way, radiofrequency seems to aid in the reduction of adiposity. in addition, it assists in the reduction of the inflammatory process related to obesity, by reducing the pro-inflammatory cytokines. the aerobic exercise, due to its low-moderate intensity, enhances the stimulation of lipolysis, by decreasing plasma insulin concentration and elevating the level of catecholamines. in this way, it influences the lipid metabolism, seeming to improve the lipid profile, through the degradation of the triglycerides as energetic substrate. in addition, the regular practice of physical exercise seems to promote a decrease in the inflammation state due to metabolic changes, through the reduction of pro-inflammatory cytokines, namely interleukin-6 and, consequently, c-reactive protein. this study purpose understanding whether an aerobic exercise session associated with abdominal radiofrequency increases the level of lipolytic activity; to analyse the effect of four intervention sessions on abdominal adipose tissue

Eligibility criteria:
inclusion criteria: * body mass idex between 18,5 kg/cm2 and 29,9 kg/cm2 exclusion criteria: * pregnant or intending to be in a period of an year * participants with smoking habits * participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations * participants with electronic devices * participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies) participants under the effect of beta-blockers or other drugs which influence heart rate participants submitted to other fat reduce procedure
molecular pet/mr imaging in vivo validation of biomarker for human prostate cancer

Conditions: Prostate Adenocarcinoma

Summary: primary objective: to correlate the blood/urine metabolomic biomarkers with pet/mr imaging. secondary objectives: 1. to evaluate the sensitivity and specificity of the pet/mr in diagnosis of prostate cancer. 2. to examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects. 3. to interrogate the metabolomic alterations with the molecular pet/mr to develop workable panel biomarkers.

according to 2015 national comprehensive cancer network (nccn) guideline, medical imaging plays important roles for detection and staging for pca, in addition to blood or urine biomarkers. although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (trus), computed tomography (ct), magnetic resonance (mr) imaging and spectroscopy, or 18f-fdg positron emission tomography (pet), none of these have gained a dominant role as the optimum method for all clinical scenarios.the recently added armamentarium, pet/mr, might improve diagnosis in this regard. therefore, we conduct this trial to identify the ability of \[11c\]choline pet/mr to evaluate the patients with prostate cancer, especially under the circumstance of elevated psa level.

Eligibility criteria:
inclusion criteria: * males * 40-85 years of age * patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia * able to tolerate \[11c\]choline pet scan and mri scan * written informed consent from the patient exclusion criteria: * acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months. * history of aids in the period prior to the screening.3 * contraindications to \[11c\]choline pet/mr scans 1. surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at cgmh 2. metallic prosthesis of the hip or pelvic region 3. renal function impairment with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 4. claustrophobia 5. medical drugs with choline 6. previous allergy to carbon-labeled radionuclide * active other malignancy within the last 2 years * subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety. * prisoners or patients with mental illness

Keywords: prostate cancer metabolomics molecular imaging pet mri 11c-choline tracer
immuno 1: immune reconstitution following conventional or high-dose chemotherapy with stem cell transplant

Conditions: Leukemia; Medulloblastoma

Summary: the purpose of this study is to conduct an analysis of the influences of 1. conventional chemotherapy 2. high-dose chemotherapy followed by autologous stem cell transplant 3. high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of the immune system. detailed analysis will help to better understand the pathways of recovery of the immune system following chemotherapy as well as the pathways of recovery of the immune system following autologous or allogeneic stem cell transplantation.

detailed analysis will be performed at preselected time points following therapy by * standard flow cytometry in combination with intracellular cytokine/antigen staining * spectratype analysis * trec assays

Eligibility criteria:
inclusion criteria: * acute leukemia treated according to current all-bfm 2002 protocol * solid tumor treated according to current gpoh-protocol * medulloblastoma treated according to hit-2000 protocol * high-dose chemotherapy followed by autologous stem cell transplantation * high-dose chemotherapy followed by allogeneic stem cell transplantation * written consent according to our institutional guidelines exclusion criteria: * no written consent

Keywords: prospective analysis of immune function, spectratype immunoscope trec analysis solid tumor
rapamycin for prevention of chronic graft-versus-host disease

Conditions: Graft Versus Host Disease

Summary: the objective of this study is to evaluate feasibility, toxicity and efficacy of using rapamycin to prevent chronic graft-versus-host-disease (gvhd) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant. our hypothesis is that the t cells that can cause chronic gvhd are suppressed but not eliminated by calcineurin inhibitors. therefore, when the calcineurin inhibitors are discontinued, the t cells may get activated and result in gvhd. rapamycin on the other hand will allow anergy formation and thus when discontinued, t cells should not get activated. the schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.


Eligibility criteria:
inclusion criteria: * age ≥18 years * received an allogeneic msd or mud pbsct * 24 weeks post sct * currently on tacrolimus for gvhd prophylaxis * deemed eligible for tapering off of tacrolimus by primary bmt physician exclusion criteria: * relapsed disease * ongoing gvhd * patients whose immunosuppression is being stopped early to treat or prevent relapse * patients with pure red cell aplasia due to abo mismatched donor * ongoing thrombotic microangiopathy * allergy to rapamycin * women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment
novel inflammatory markers in different phenotypes of severe asthma

Conditions: Asthma; Nasal Polyps

Summary: asthma is a highly prevalent chronic airway inflammatory disease characterized by airway hyper-responsiveness, reversible airflow obstruction and increased mucus secretion, involving large and small airways. an emerging sub-phenotype of severe asthma is the late onset disease associated with nasal polyposis, a frequent co-morbidity that significantly impacts lung function and symptom control. on the basis of the infiltrate found in the sputum, asthma can be divided into four distinct phenotypes: eosinophilic, neutrophilic, mixed granulocytic and pauci-granulocytic. the majority of patients with eosinophilic asthma are sensitive to corticosteroids, and biological therapies targeting eosinophils (anti-interleukin (il)-5 and anti-il5r) have been recently approved. however, it is known that some asthmatics, particularly those who have severe disease and are resistant to corticosteroids, have elevated neutrophil counts in the airway where they play a vital role in the exacerbation of the disease. however, the precise role of neutrophils in severe asthma and the mechanisms involved in neutrophil-induced tissue damage have not been clarified yet. the hypothesis of the study is that neutrophils and eosinophils can contribute to the severity of asthma by changing their phenotypes according to the airway environment. thus, a better understanding of the roles of neutrophils and eosinophils in severe asthma may lead to the identification of novel biomarkers and the development of new therapeutic approaches in different phenotypes of severe asthma.


Eligibility criteria:
inclusion criteria: * male or female * age (18-65 years) * diagnosis of severe asthma according to the european respiratory society (ers) and american thoracic society (ats) definition, with and without nasal symptoms * normal pulmonary function post-therapy (fev1 post-bronchodilation: greater than 80% of the predicted value, with fev1/ vital capacity (vc) \> 88-89% - for males and females, respectively - of the predicted value) * non reversible chronic airflow limitation (fev1 post-bronchodilation: lower than 70% of the predicted value, with fev1/vc \< 88-89% of the predicted value) * signing of the informed consent exclusion criteria: * referred pregnancy * use of therapy with beta-blockers * smoking (current or within the previous 3 months) * negation to participate to the study * current upper and lower airways infectious diseases * current systemic infectious diseases

Keywords: asthma eosinophils neutrophils
genetic assessment of early to late macular degeneration study

Conditions: Age-related Macular Degeneration

Summary: the purpose of this study is to determine if polymorphisms at rs11200638 on htra1 and rs1061170 on cfh are associated with an accelerated progression to advanced amd (wet amd or ga) in patients with early amd (soft confluent drusen\>120 microns ) in the study eye, and with either early amd or advanced amd in the non-study eye.

age-related macular degeneration (amd) is the leading cause of blindness in the developed world. to date, two major polymorphisms on the htra1 and cfh genes have been associated with amd. progression and vision loss need to be followed and treated promptly in order to preserve vision. this study will provide more information on the genetics of disease progression and may lead to future guidelines for patient follow-up and treatment. this study consists of a blood draw and observation of eye conditions. consented, enrolled patients will come in every four months as per standard of care. at each visit, visual acuity measurement, slit lamp exam, indirect ophthalmoscopy, fundus photos, and spectral domain optical coherence tomography will be performed. every 8 months, or per standard of care, fluoroscein angiography will be performed. dna extraction and genotyping will be performed, and correlations between htra1 and cfh genotypes and the progression to bilateral advanced amd will be analyzed.

Eligibility criteria:
inclusion criteria: * subjects will be eligible if the following criteria are met: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 45 years * disease related considerations * subjects with a diagnosis of advanced amd in one eye (either cnv or geographic atrophy) and soft confluent drusen in the study eye or subjects with bilateral large soft drusen. exclusion criteria: * subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of amd
randomized study of tauroursodeoxycholic acid in prophylactic therapy of total parenteral nutrition associated cholestasis in infants

Conditions: Cholestasis

Summary: objectives: i. determine whether infants treated with tauroursodeoxycholic acid (tudca) have a lower peak direct bilirubin, alt, ast, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm. ii. determine the significance of lower birth weight and longer duration of total parenteral nutrition (tpn) on increasing risk of tpn associated cholestasis and increasing benefit from tudca therapy. iii. determine whether tudca therapy leads to significant reduction in the appearance of biliary tract sludge and/or stone formation in these infants. iv. determine whether tudca therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of tpn.

protocol outline: this is a randomized study. patients are stratified by birth weight. patients are randomized in pairs by birth weight to receive either a placebo in arm i or tauroursodeoxycholic acid (tudca) in arm ii. tudca is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. after 2 weeks of therapy, a bile sample is obtained via a duodenal tube. an ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) or resection (necrotizing enterocolitis, volvulus) * no evidence of biliary tract abnormalities * no evidence of other forms of cholestatic liver disease --patient characteristics-- * renal: no life threatening renal disease * cardiovascular: no life threatening cardiovascular disease * other: no multiple congenital abnormalities

Keywords: cholestasis gastrointestinal disorders rare disease