Kornimate/medical-research-clean huggingface dataset:
perfusion ct as a predictor of treatment response in patients with rectal cancer

Conditions: Rectal Cancer

Summary: a research study of rectal cancer perfusion (how blood flows to the rectum over time). we hope to learn whether perfusion characteristics of rectal masses may be predictive of response to treatment and whether rectal perfusion characteristics can be used to follow response to treatment.

recent advances in computed tomography (ct) technology have made ct perfusion imaging feasible for the assessment of tumor perfusion in solid tumors of the abdomen. ct perfusion has shown promising results in serving as a noninvasive method of predicting response to therapy in cancer patients. ct perfusion parameters have also been found to correlate with immunohistologic markers of angiogenesis in a number of solid tumors, suggesting a possible role for ct perfusion as a noninvasive biomarker of tumor angiogenesis. the goals of the investigators study are twofold: first, to determine the relationship between baseline ct perfusion characteristics of rectal cancers and their response to treatment, and second, to determine if perfusion ct can be used to subsequently monitor tumor response to treatment. the investigators hope to enroll those patients with locally advanced rectal cancer undergoing standard ct for pre-treatment planning, integrating ct perfusion imaging into the current abdomen/pelvis imaging protocol with close clinical and radiologic follow-up after treatment to determine response to therapy and time to disease progression.

Eligibility criteria:
inclusion criteria: * patients with suspected or biopsy-proven, locally advanced rectal cancer will be eligible for enrollment. * patients must be 18 years or older. patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant. * no life expectancy restrictions. * ecog and karnofsky performance status will not be employed. * patients with renal failure are ineligible for this study (gfr must be \> 60) * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * patients who have undergone prior treatment for rectal cancer are ineligible for enrollment. * no restrictions regarding use of other investigational agents. * patients with severe contrast allergy are ineligible. * patients who are pregnant or are trying to become pregnant are excluded from this study. * patients who are cancer survivors or hiv-positive will not be excluded.
long-term safety study of rimegepant in pediatric subjects for the acute treatment of migraine

Conditions: Acute Treatment of Migraine

Summary: the purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).


Eligibility criteria:
inclusion criteria: 1. history of migraine (with or without aura) for ≥ 6 months before screening. 2. history of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening. 3. 1 or more migraine days requiring treatment during the observation phase. 4. prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the screening visit. 5. ability to distinguish between migraine and other types of headaches. 6. weight \> 15 kg. for eu countries only: participants 12 to \ 25kg. 7. adequate venous access for blood sampling. 8. male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the baseline visit). exclusion criteria: 1. history of cluster headache or hemiplegic migraine headache. 2. confounding and clinically significant pain syndrome. 3. current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the screening visit (lifetime history of psychosis and/or mania are excluded). 4. history of suicidal behavior or at risk of self-harm/harm to others. 5. history of major psychiatric disorder. 6. current diagnosis or history of substance abuse 7. reported current use of or tested positive at screening for drugs of abuse.

Keywords: long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
post-surgical non-small cell lung cancer (nsclc) follow-up

Conditions: Non-Small-Cell Lung Carcinoma

Summary: the follow-up of patients operated on for lung cancer is heterogeneous. an intensive follow-up including routine clinic visits, chest x-rays, chest computed tomography (ct) scans and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and second cancers. however, as it appears in the american society of clinical oncology (asco) recommendations, a large randomized study is necessary to evaluate the survival impact of such a follow-up strategy. this is the main objective of this ifct-0302 study, which is a large randomized controlled study conducted in france comparing this intensive follow-up to a follow-up with only routine clinic visits and chest x-rays.


Eligibility criteria:
inclusion criteria: * completely resected stage i, ii, iiia, and t4 due to satellite tumor nodule(s) n0-2 nsclc exclusion criteria: * stage iiib to iv nsclc

Keywords: post-surgical non-small cell lung cancer
a study on drug-drug interactions in patients treated with anticancer agents for a prostate cancer in real life setting

Conditions: Prostatic Neoplasm

Summary: this will be a national observational, non-randomised, multicentre study, conducted in france. patients will be recruited in routine clinical practice by office- or hospital-based urology and/or oncology specialists when a first line treatment for their castrate resistant prostate cancer is initiated. the decision to treat patients with either agent preceding study enrolment will be left to the investigator's decision, per routine clinical practice. the nature of treatment and clinical care of patients will not be influenced by their participation in the study. all patients meeting the study criteria who visit the study physician will be consecutively invited to participate in the study to minimise recruitment bias. all medications administered will be collected. this is a non-interventional study. the investigators are free to choose products, and modalities of administration in accordance with the local summary of product characteristics therefore, the decision to prescribe one of these therapies must be made prior to and independently from the decision to enrol patients in this non interventional study. potential ddi will be identified using electronic screening methods (micromedex software and theriaque software). this design will enable assessment of treatment and subsequent outcomes based on local standards, and is likely to encompass a wider range of therapeutic decisions compared with the stricter, defined limits on therapy required by investigational study protocols. decisions and outcomes made in real-world conditions are likely to be more widely applicable to clinical practice than those from interventional studies. following french regulation there is no need for an approval of ethic committee for this type of observational study.


Eligibility criteria:
* males aged ≥18 years; * histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate * for patients with a nmcrpc, documented castration resistance with progression of prostate cancer on androgen deprivation therapy (adt) (surgical or chemical); * initiation of first- line systemic therapy (with abiraterone, apalutamide, darolutamide, docetaxel or enzalutamide) for a non metastatic castrate-resistant or a metastatic castrate naïve prostate cancer according to the approved labels and current guidelines. the metastatic status is based on conventional imaging (ct scan, bone scan). patients are not eligible if they are receiving an investigational treatment for prostate cancer of any kind.
very low frequency magnetic fields in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.


Eligibility criteria:
inclusion criteria: * fibromyalgia diagnosed according to the criteria proposed by the american college of rheumatology (acr 2010) * subjects aged between 18 and 60 years exclusion criteria: * pregnant patients * patients with pacemaker or other metal implants * systemic infectious disorders * neoplastic disorders * epilepsy * severe heart disease

Keywords: fibromylgia magnetic fields pain visual analogue scale
molecular, pathologic intra tumoral heterogeneity in malignant pleural mesothelioma

Conditions: Mesothelioma, Malignant; Gene Abnormality; Pleural Mesothelioma

Summary: malignant pleural mesothelioma (mpm) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. to enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. one of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. the goal of the scith-meso study is to harvest larges pieces of tumour during a routine surgical procedure of mpm diagnosis by mean of pleural biopsies during vats surgery. operating samples will increase a tissue bank collection (crb).


Eligibility criteria:
inclusion criteria: * age \>18 * suspected mpm requiring vats biopsy after multidisciplinary oncologic board validation * patient able to understand study objectives and able to give an informed consent * patient affiliated to an healthcare society. exclusion criteria: * pregnancy * mental disease, psychiatric disorder * patient under protection regimen

Keywords: malignant pleural mesothelioma intra tumoral heterogeneity genetic abnormalities
melatonin degradation rate in human milk

Conditions: Preterm Infant; Lactation

Summary: our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants. prior to testing this, we need to learn the pharmacokinetics of melatonin in vitro. in this preliminary research we would like to check the levels of melatonin in breast milk pumped during the night, and evaluate the rate of degradation of the melatonin to determine the half life of melatonin in pumped breast milk (in vitro).

the study includes 10 nursing women. each woman will bring a frozen 5 ml sample of breast milk that was pumped at 03:00 am. the samples will be collected at the nicu department of carmel medical center and will be stored at deep freeze (-20°c). the samples will be numerically coded and will be kept anonimously. after defrosting the samples, melatonin concentration will be checked in the hospital laboratory every hour, for 4 hours. if meltonin levels will be detectable after 4 hours, continous measurements will be done at 8 hours and at 12 hours after defrosting. the samples will be tested with ibl melatonin elisa kit. for control we will use breast milk that was pumped at 10:00 am (when melatonin excretion is minimal). at the end of the analysis the samples will be thrown away.

Eligibility criteria:
inclusion criteria: 1. women that are breast feeding and will pump and freeze a milk sample at 03:00 am 2. women at least one week after delivery exclusion criteria: 1. a sample that will not be freezed right after the pump 2. women that are taking hypnotic drugs 3. women that are taking melatonin

Keywords: melatonin breast milk
rapid immunoassay tests for the detection of ruptured membranes

Conditions: Premature Rupture of Membranes

Summary: the aim of the study is to demonstrate substantial equivalence of igfbp-1/afp tests with the "predicate device" amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.

premature rupture of membranes (prom) is defined as spontaneous rupture of membranes (rom) before the onset of uterine contractions. its diagnosis is often obvious with the woman presenting with leakage of amniotic fluid, but it could also turn out to be a difficult diagnostic dilemma. the diagnosis of fetal membrane rupture is conventionally made using a clinical assessment. first, by speculum examination, the clinician looks for amniotic fluid leaking from the cervical os. if clear fluid is visualized leaking from the cervical os, the diagnosis is positive for fetal membrane rupture. more commonly, leaking is absent, and a more extensive workup is required, which includes nitrazine/ph testing, visual inspection of pooling of fluid in the posterior fornix, and a microscopic evaluation of the collected specimen (ferning). although this approach is considered the standard of care, it is fraught with inaccuracies, requires an intrusive examination and may not provide a rapid diagnosis. rapid, point of care, qualitative immunochromatographic tests (ie., amnisure®, actimprom®, amnioquick® complete and rom plus®) that detect proteins found in amniotic fluid at high concentrations, have been used to diagnose the rupture of membranes (rom) for several years. in many hospitals, amnisure® has replaced the sterile speculum exam as the standard of care for diagnosing rom. it identifies placental alpha microglobulin-1 (pamg-1), a 34 kd fetal glycoprotein, in cervicovaginal secretions. rom plus® actimprom®and amnioquick® complete+ are newer additions into the market for testing for prom. both these tests use a monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations. they detect placental protein-12 (also known as insulin-like growth factor binding protein-1 - igfbp-1) as well as alpha fetoprotein (afp). the aim of the study is to demonstrate substantial equivalence of igfbp-1/afp tests with the "predicate device" amnisure®. stated in statistical terms, the aim is to demonstrated that igfbp-1/afp tests are non-inferior to amnisure® in terms of sensitivity and specificity when both are compared in a paired-sample fashion to a common referent standard (gold standard), which is clinical assessment.

Eligibility criteria:
inclusion criteria: * any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment exclusion criteria: * known placental previa * active vaginal bleeding
effects of hiit in tolerance to exercise of individuals with hf and coexisting copd

Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: introduction: the complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. it is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. objective: to compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. methods: this is a clinical, controlled, randomized and blinded trial. peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. expected results: incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.


Eligibility criteria:
inclusion criteria: * sedentary individuals with heart failure of all etiologies; * diagnosed moderate and severe chronic obstructive pulmonary disease; * clinical stability; * no change in the medication class within three months before the beginning of the research. exclusion criteria: * unstable angina; * myocardial infarction; * previous cardiac surgery up to three months before the beginning of the study; * hemodynamic instability; * orthopedic and neurological diseases; * psychological and/or mental impairment.
safety and effectiveness of the atc system in the treatment of acute pe

Conditions: Pulmonary Embolism Acute

Summary: this study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the atc system in subjects with acute pulmonary embolism (pe).


Eligibility criteria:
inclusion criteria: 1. patient is ≥ 18 and ≤ 90 years old 2. clinical signs and symptoms consistent with acute pe for \< 14 days 3. cta evidence of proximal pe 4. rv/lv ratio \> 0.9 5. systolic bp ≥90 mmhg without the need for vasopressors 6. stable heart rate (hr) \< 130 bpm prior to procedure 7. patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment 8. subject or legally authorized representative (lar) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures exclusion criteria: 1. prior pe \< 180 days from index procedure 2. thrombolytic use \< 30 days prior to baseline cta 3. pulmonary hypertension with peak pulmonary artery systolic pressure (pasp) \>70 mmhg by right heart catheterization 4. fio2 requirement \>40% or \>6 lpm to keep oxygen saturation \>90% 5. hematocrit \<28% 6. platelets count \<100,000/µl 7. serum creatinine \>1.8 mg/dl 8. international normalized ratio (inr) \>3 9. major trauma injury severity score (iss) \>15 prior to screening assessment 10. presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment 11. cardiovascular or pulmonary surgery within 7 days of index procedure 12. actively progressing cancer treated by chemotherapeutics 13. known bleeding diathesis or coagulation disorder 14. left bundle branch block 15. history of severe or chronic pulmonary arterial hypertension 16. history of chronic left heart disease with left ventricular ejection fraction ≤ 30% 17. history of decompensated heart failure 18. history of underlying lung disease that is oxygen dependent 19. history of chest irradiation 20. history of heparin-induced thrombocytopenia (hit) 21. contraindication to systemic or therapeutic doses of anticoagulants 22. known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 23. imaging evidence or other evidence that suggest, in the opinion of the investigator, the subject is not appropriate for aspiration thrombectomy intervention 24. life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe covid infections 25. female who is pregnant or nursing 26. current participation in another investigational drug or device treatment study.
initial feasibility study to treat resectable pancreatic cancer with a planar ldr source

Conditions: Pancreas Cancer; Cancer

Summary: this is a phase i evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration. this study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.


Eligibility criteria:
inclusion criteria: * subject signed informed consent * age \>/= 18 years * biopsy confirmed adenocarcinoma pancreatic cancer * patient capable of undergoing anesthesia * patient is a surgical candidate * patient selected to undergo pancreatic cancer resection * patient will have known or suspected close/positive surgical margin * confirmed diagnosis of resectable pancreatic adenocarcinoma * will be prescribed standard gemcitabine 1000 mg/m2 chemotherapy cycle exclusion criteria: * pregnant or breast feeding * patient has metastatic disease * patient has had prior radiation therapy to the region for separate cancer * patient has had prior chemotherapy * any other invasive cancer in the past 5 years, except basal cell skin * recurrent or previously resected tumors * alcoholism/drug abuse

Keywords: whipple brachytherapy civasheet civatech oncology radiation intraoperative radiation iort resectable pancreatic cancer pd-103
effects of erector spinae plane block and intrathecal morphine administration on intraoperative sevoflurane consumption

Conditions: Postoperative Pain; Anesthesia

Summary: in our study, the investigators aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either esp block or itm in the preoperative period with a control group.

the amount of volatile anesthetic agents used for anesthesia maintenance can be significantly reduced with potent and long-acting analgesic interventions administered during the preoperative period. such interventions enable the maintenance of anesthesia with more optimal levels of agents during surgery, providing significant advantages in terms of both patient safety and cost. studies have recommended multimodal analgesia approaches involving the erector spinae plane (esp) block and intrathecal morphine (itm) injection for various surgical procedures. these two methods, through different mechanisms of action, not only reduce intraoperative anesthetic agent consumption but also play a critical role in postoperative pain management. although studies have investigated the effects of esp block and itm injection on intraoperative volatile anesthetic consumption, there is limited research directly comparing their impacts on volatile anesthetic consumption and postoperative analgesic requirements. in our study, we aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either esp block or itm in the preoperative period with a control group.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years * patients receiving general anesthesia * patients with an asa score of i-ii * patients undergoing elective surgery for single-level lumbar disc herniation * patients who provided informed consent after being informed exclusion criteria: patients who did not provide informed consent after being informed * patients over 65 years of age * patients with an asa score of iii or higher * patients with recurrent lumbar disc herniation (ldh) * patients undergoing surgery for multi-level ldh * patients with a body mass index (bmi) of 30 or higher * patients with allergies to morphine or bupivacaine * patients with major cardiac, respiratory, hepatic, renal, neurological, or psychiatric diseases * patients with a history of alcohol or substance abuse * patients with a local infection at the injection site * patients with bleeding diathesis * patients with a history of anticoagulant medication use * patients with contraindications to spinal or regional anesthesia

Keywords: erector spinae plane block intrathecal morphine