Kornimate/medical-research-clean huggingface dataset:
drug interaction study with dabigatran etexilate and dronedarone in healthy subjects

Conditions: Healthy

Summary: the objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the p-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects exclusion criteria: 1. any relevant deviation from healthy conditions
risc panel remnant sample collection

Conditions: Arthritis, Inflammatory

Summary: the primary objective of this study is to evaluate the usability and clinical utility of the synovasure® risc™ panel. the secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain and/or inflammation to be used for future research.

the synovasure® risc panel™ constitutes a single source of pre-operative biomarker testing with high predictive value for the diagnosis of single or multiple arthritis conditions, that may correspond to a relative level of inflammation and post-operative complication and infection risk in patients with knee pain and/or inflammation. the aim of this clinical performance post-market clinical follow-up (pmcf) study is to evaluate the usability and clinical utility of the synovasure® risc panel™ using comparative analyses between the suspected diagnosis, patient demographics, conditions, symptoms, medical history and the synovasure® risc panel™ results. the secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain and/or inflammation to be used for future research. investigators will perform arthrocentesis as part of the patient's standard of care. remnant samples will be transferred in the tubes included with the synovasure® arthritis specimen transportation kit, in accordance with instructions and the requisition form. additional case report forms (crfs) to collect demographic, and clinical data beyond what is included in the requisition form and the panel results accession identification (id) will be provided. sample collection and shipment to cd laboratories (cdl) may be limited to monday-wednesday. a maximum of three samples per transportation kit will be shipped as soon as the samples are collected. cdl will perform risc™ panel testing and identifiable results will be provided to enable the centers to pair the test results with clinical outcome data. de-identified leftover remnant samples will be frozen and all data, including any available clinical outcome data, will also be entered into a de-identified database of results and made accessible to all participating investigators for research purposes.

Eligibility criteria:
inclusion criteria: * patients with knee pain and/or inflammation and planned arthrocentesis exclusion criteria: * patient is unwilling or unable to give oral consent * patient has any condition that would, in the judgment of the investigator, place the patient at undue risk or interfere with the study * patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant) * patient had an arthrocentesis of the index joint less than 2 weeks from the planned arthrocentesis * insufficient synovial fluid sample of \< 1.5 ml * patient age \ 89
standard infusion carboplatin versus prophylactic extended infusion carboplatin in patients with patients with recurrent, ovary, fallopian tube, and primary peritoneal cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: patients who have this kind of cancer are often treated with several drugs. carboplatin is one that seems to work for many treatment cycles. even though it may work against the cancer, the patient can become allergic to it. if that happens, they would have to stop taking the drug. the standard way to give carboplatin is by vein over 30 minutes. some people have been given carboplatin over 3 hours rather than 30 minutes and had fewer allergies than expected. the purpose of this study is to: find out if giving carboplatin over three hours can prevent the allergy. see if medicine given before the carboplatin can help reduce the risk of allergic reactions.


Eligibility criteria:
inclusion criteria: * mskcc histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma. * patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen * age ≥ 21 years old * karnofsky performance status (kps) \> or = to 70% * adequate hematologic, hepatic and renal function as defined below: * hemoglobin ≥ 7.0 g/dl * absolute neutrophil count ≥ 1,000/mm3 * platelet count ≥ 100,000/mm3 * serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 ml/min exclusion criteria: * prior carboplatin or cisplatin hypersensitivity reaction * uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary. * patients receiving other investigational agents * patients with hiv disease will be permitted, only if they are on effective antiretroviral therapy, have a cd4 count greater than 400, and have had no opportunistic infections within the past 6 months * pregnant or lactating women * life expectancy of less than 12 weeks

Keywords: bevacizumab (avastin) carboplatin dexamethasone gemcitabine lipodox(liposomal doxorubicin) montelukast (singular) taxol (paclitaxel fallopian tubes 10-184
ls301 uptake in tumors of patients undergoing liver, pancreas, or gastric surgery

Conditions: Pancreatic Cancer; Liver Cancer; Gastric Cancer; Gastrointestinal Stromal Cancer; Metastatic Cancer

Summary: the preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by the cancer vision googles (cvg) with ls301 in animal models. in this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. the underlying hypothesis is that the accurate detection of all cancer cells highlighted by ls301 during surgery will reduce the number of patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 15% in pancreatic cancer, for example. the pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full phase i clinical trial.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with gastrointestinal cancers, including pancreas, liver, gastric cancer, gastrointestinal stromal tumors, and metastatic cancers undergoing surgical resection as standard of care treatment. * at least 18 years of age. * for the first cohort of patients enrolled, must have an ecg with no prolonged intervals. * able to understand and willing to sign a written informed consent document. exclusion criteria: * contraindications for surgery. * receiving any investigational agents. * history of allergic reactions attributed to icg or other agents used in the study, include known iodide or seafood allergy. we do not expect many of these adverse reactions with ls301 because it is not radioactive and does not possess iodinated counterions. * presence of underlying lung disease. * pregnant. female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation. * breastfeeding. patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ls301.
relationship between tissue markes in patients with post cardio respiratory syndrome

Conditions: Cardiac Arrest

Summary: there is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.

evaluation of the serum carbon dioxide gradient (gapco2), central venous saturation (scvo2) and the clearance of serum lactate (clac) in predicting hospital mortality after cardiac arrest syndrome (post-pcr). prospective study, unicenter - intensive care unit - hnsc. period: may/2010 to june/2011. serial assessment of gapco2 of scvo2 clac and the first 72 hours post-pcr. excluded under 18, survival of less than 6hs, pregnant women, traumatized, post-operative hypothermia and liver disease. t-student test, 95% (p \<0.05).

Eligibility criteria:
inclusion criteria: * all patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace exclusion criteria: pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease. * patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest * less 18 years old

Keywords: cardiac arrest
secondary cancer risk after radiation therapy for rectal cancer

Conditions: Neoplasms, Second Primary

Summary: retrospective study comparing dose distribution of 3d conformal radiotherapy (3dcrt) and volumetric-modulated arc therapy (vmat) to estimate secondary cancer risk for patients having had radiation therapy for rectal cancer. twenty-five patients are included in this study. planning ct scans are used for comparison of dose distribution and calculation of second cancer risk.

a model-based analysis calculating the organ-specific excess lifetime attributable risk using the planning ct data sets of 25 patients to estimate second cancer risk for patients after radiotherapy for rectal cancer comparing conventional 3dcrt with vamt techniques.

Eligibility criteria:
inclusion criteria: * male/female \> 18 years of age * pre or postoperative radiation therapy for rectal cancer * planning ct exclusion criteria: * planning ct not available
a research study looking at how cagrilintide works on the heart rhythm in healthy participants

Conditions: Obesity

Summary: the study tests if treatment with cagrilintide delays the transmission of electrical signals in the heart compared to treatment with placebo. to confirm the sensitivity of the methodology, the drug moxifloxacin is also compared to a placebo in 2 treatment arms. cagrilintide is being developed for the treatment of obesity and weight management. moxifloxacin is an approved antibiotic for the treatment of bacterial illnesses. the study lasts for up to 17 weeks for each participant.


Eligibility criteria:
inclusion criteria: * male or female. * aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 23.0 and 29.9 kilogram per meter\^2 (kg/m\^2) (both inclusive) at screening. exclusion criteria: * known or suspected hypersensitivity to trial products or related products, or to electrocardiogram (ecg) electrodes. * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * history of seizures, epilepsy, repeated syncopes, cardiac arrest, cardiac arrhythmia or torsades de pointes (tdp), 2nd or 3rd degree atrioventricular (a-v) block or structural heart disease. * family history of long qt syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative).
alt-801 in overweight and obese subjects with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes

Summary: this is a phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (pd) and pharmacokinetics (pk) of alt-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * written informed consent signed prior to the performance of any study procedures * male or female volunteers, age 18 to 65 years, inclusive * overweight to obese (bmi 28.0 - 40.0 kg/m2) * type 2 diabetes mellitus (t2dm), on stable regimen, for at least 3 months prior to screening, of any combination of (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (sglt-2) therapy * female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control exclusion criteria: * type 1 diabetes mellitus (dm) and/or insulin-dependent t2dm, or uncontrolled t2dm defined as hemoglobin a1c (hba1c) ≥ 9.5% or c-peptide ≤ 8 ng/ml * history of acute or chronic pancreatitis or hypersensitivity reaction to glp-1 analogues

Keywords: obese overweight t2dm
notes transvaginal cholecystectomy and appendectomy

Conditions: Gallbladder Diseases; Appendicitis

Summary: natural orifice translumenal endoscopic surgery (notes) is considered by many leading expert surgeons to be the next step in mis (minimally invasive surgery). this is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. in this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. notes offers all the advantages of minimally invasive surgery (mis) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. a notes procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma. in this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. the operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.


Eligibility criteria:
inclusion criteria for group #1 transvaginal cholecystectomy: 1. females between the ages of 18 and 50 2. diagnosis of gallstone disease which requires cholecystectomy 3. asa class 1 exclusion criteria for group #1 transvaginal cholecystectomy: 1. pregnant women 2. morbidly obese patients (bmi \> 35) 3. patients who are taking immunosuppressive medications and/or immunocompromised 4. patients with severe medical comorbidities will be excluded. 5. patients with a presumed gallbladder polyps, mass or tumor 6. patients with a history of prior open abdominal or transvaginal surgery. 7. patients with a prior history of peritoneal or vaginal trauma 8. patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis 9. patients with known common bile duct stones 10. patients on blood thinners or aspirin or abnormal blood coagulation tests inclusion criteria for group #2 transvaginal appendectomy: 1. clinical diagnosis of appendicitis 2. emergency room evaluation within 36 hours of the onset of pain 3. asa classification exclusion criteria for group #2 transvaginal appendectomy: 1. pregnant women 2. morbidly obese patients (bmi \>35) 3. patients who are taking immunosuppressive medications or are immunocompromised 4. patients with evidence of an abdominal abscess or mass 5. patients who present with a clinical diagnosis of sepsis or peritonitis 6. patients who have a history of prior open abdominal surgery or prior transvaginal surgery. 7. patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (pid), or severe endometriosis 8. patients with diffuse peritonitis on clinical exam 9. previous trauma to the perineal area 10. patients on blood thinners or aspirin or abnormal blood coagulation tests
fiasp® versus novorapid® in children with type 1 diabetes on minimed 640g pump with sensor

Conditions: Type 1 Diabetes

Summary: this is an exploratory, single-center, open label, randomized, complete cross-over trial comparing safety and efficacy of fiasp® versus novorapid® when used in the medtronic minimed 640g system in pediatric subjects with type 1 diabetes mellitus

this study is designed to compare fiasp® to novorapid® in children with t1dm wearing minimed 640g system equipped with smartguardtm technology and accompanied with enlitetm sensor and guardiantm 2 link transmitter in terms of glycemic control with a focus on post-prandial ½-hour and 1-hour plasma glucose levels. the investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the fiasp® treatment period. half, randomized subjects will have a 4 weeks screening period using novorapid® and then 4 weeks treatment period with fiasp® whereas the rest of the participants will start the trial period with 4 weeks using fiasp® followed by 4 weeks in novorapid®.

Eligibility criteria:
inclusion criteria: 1. informed consent obtained by parents or legal caregivers before any trial-related activities. 2. any age, age ≥ 2 years and age \<18 years at the time of signing informed consent 3. documented diagnoses of t1dm ≥ 3 months prior to the beginning of the study 4. using the medtronic minimed 640g system equipped with smartguardtm technology and accompanied with enlitetm sensor and guardiantm 2 link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial. 5. ability and willingness to use the same insulin infusion sets throughout the trial 6. using the same insulin for at least 30 days prior to screening 7. hba1c \< 9.0% as assessed by local laboratory at screening 8. ability and willingness to adhere to the protocol including performing smbg (self monitoring blood glucose) profiles, attending visits, uploading pump and sensor data to the carelink platform exclusion criteria: 1. participation in another clinical trial within 28 days before the screening visit. note: clinical trials do not include non-interventional studies 2. treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening 3. anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial 4. any diabetic complication including renal disease, retinopathy, etc 5. history of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening 6. any condition which, in the opinion of the investigator, might influence patient's safety or compliance with the protocol
sequential coronary ct-angiography and biomarkers

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: currently, cardiac computed tomography angiography (ccta) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. besides conventional ct-reading, ccta is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional ct-reading. in addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.


Eligibility criteria:
inclusion criteria: * patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as ccta. * age older than 18 years and competent to perform written informed consent. * at least 2 coronary segments with plaques: * 1 proximal lesion. * at least one coronary plaque consisting of a non-calcified or mixed component. exclusion criteria: * unstable angina. * renal insufficiency: calculated estimated glomerular filtration rate \<45ml/min. * iodine allergy. * pregnancy. * known history of atrial fibrillation. * inconclusive baseline computed coronary ct-angiography. * patients which are currently on oral vitamin k antagonists. * patients which are currently using selective anticoagulants. * previous pci. * previous or planned coronary artery bypass grafting. * patients whereby the baseline ccta was performed by a retrospective ecg-gated 'helical' protocol due to a high (\>90bpm) or irregular heart rate.

Keywords: biological markers multidetector computed tomography
mgta-456 in patients with inherited metabolic disorders undergoing hematopoietic stem cell transplantation (hsct)

Conditions: Inherited Metabolic Disorders (IMD)

Summary: this study is designed to assess the safety and efficacy of using mgta-456 in patients with inherited metabolic disorders (imd) undergoing stem cell transplantation.

this phase 2 study is designed to evaluate the safety and efficacy of mgta-456 in patients with imd after receiving myeloablative conditioning and hsct. mgta-456 is an expanded cd34+ cell therapy product candidate given to induce rapid and sustained hematopoietic engraftment. in patients with selected imds, transplant is expected to replace defective or missing protein and preserve neurodevelopment. since mgta-456 offers increased numbers of hscs over standard umbilical cord blood, it is expected to reduce the risks of prolonged neutropenia and thrombocytopenia and graft failure, and potentially transplant-related mortality (trm). patients with hurler syndrome (also referred to as mucopolysaccharidosis-1h (mps-1h)), cerebral adrenoleukodystrophy (cald), metachromatic leukodystrophy (mld) or globoid cell leukodystrophy (gld) (also referred to as krabbe disease) are eligible for this study.

Eligibility criteria:
inclusion criteria: * age \< 2.5 years with hurler syndrome, age 2-17 years with cerebral adrenoleukodystrophy (cald), age \< 16 years with metachromatic leukodystrophy (mld) and age ≤ 10 years with globoid cell leukodystrophy (gld) (also referred to as krabbe) * cord blood grafts require genetic testing and/or demonstration of enzyme activity for patients with hurler syndrome, mld or gld and are tested for very long chain fatty acids (vlcfa) to confirm there is no evidence of vlcfa consistent with ald * adequate organ function * availability of eligible donor material exclusion criteria: * availability of a matched-related donor who is not a carrier of the same genetic defect * active infection at screening * prior myeloablative conditioning * history of human immunodeficiency virus (hiv) infection

Keywords: inherited metabolic disorders cerebral adrenoleukodystrophy hurler syndrome globoid cell leukodystrophy krabbe disease metachromatic leukodystrophy hematopoietic stem cells hematopoietic stem cell transplant umbilical cord blood umbilical cord blood transplant mgta-456 myeloablative conditioning regimen bone marrow transplant mucopolysaccharidosis-1h
positron emission tomography (pet)-computed tomography (ct) in inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Diseases

Summary: the main hypothesis is that pet-ct will be a valuable diagnostic tool in diagnosing and evaluating treatment for ibd.


Eligibility criteria:
inclusion criteria: * patient with either crohn's disease or ulcerative colitis whose disease is flaring exclusion criteria: * indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to pet-ct