Kornimate/medical-research-clean huggingface dataset:
the comparison of single and multi-incision mie for esophageal cancer

Conditions: Esophageal Cancer

Summary: minimally invasive esophagectomy (mie) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in mie (simie).the preliminary clinical results showed that simie can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to mie performed with multi-incision (mimie). the goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of simie and mimie.

surgery remains the main stay of treating esophageal cancer. however, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. minimally invasive esophagectomy (mie) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. the standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. the procedure of mie including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in mie (simie). the preliminary clinical results showed that simie can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to mie performed with multi-incision (mimie). the goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of simie and mimie.

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of esophageal cancer 2. age between 35 to 75 years old 3. resectable tumor as evaluation by preoperative imaging studies. exclusion criteria: 1. previous surgery in the chest or abdomen. 2. receiving definitive chemoradiation (5500 cgy or more). 3. tumor invasion to the trachea, spine or aorta. 4. liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, child c classification. 5. previous history of cerebral vascular attack.

Keywords: esophageal cancer minimally invasive esophagectomy (mie) single-incision minimally invasive esophagectomy (simie)
lesion contiguity in very high power-short duration ablation

Conditions: Atrial Fibrillation

Summary: this observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (lge-cmr). patients with paroxysmal or early persistent atrial fibrillation (af) scheduled for pulmonary vein isolation (pvi) undergo point-by-point ablation using the qdot micro catheter applying qmode+ (90w over 4 seconds). all patients receive an lge-cmr 3 months after the procedure for ablation lesion assessment. contiguity of lge-cmr-detected ablation lesions will be compared with a matched control group of patients that have undergone pvi accomplished by ablation index-guided ablation with 40 w following the close protocol.


Eligibility criteria:
inclusion criteria: * paroxysmal or early persistent (max. 3 months) atrial fibrillation * scheduled for pvi-only catheter ablation exclusion criteria: * long-standing persistent atrial fibrillation * previous left atrial ablation * claustrophobia preventing cmr * sever renal insufficiency (gfr \>30 ml/min) * gadolinium contrast allergy * presence of implantable devices not compatible with magnetic resonance * pregnancy and lactation

Keywords: catheter ablation
early propranolol after traumatic brain injury: phase ii

Conditions: Traumatic Brain Injury

Summary: the primary objective of this study is to determine in patients with traumatic brain injury (tbi) the safe dosing of propranolol. safety will be measured by episodes of bradycardia (heart rate \< 60 beats per minute), hypotension (defined as systolic blood pressure \< 90) or decreased cerebral perfusion pressure (defined as cpp less than 60mmhg) that are refractive to brain trauma foundation guidelines for treatment. a no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.


Eligibility criteria:
inclusion criteria: * patients who present within 6 hours of traumatic brain injury who have 1) a glasgow coma scale (gcs) score of ≤8 or a gcs of 9-12 with computerized tomography brain scans demonstrating brain injury. exclusion criteria: * pregnancy, * patients already treated with beta-blockers, * patients treated for antiarrhythmic, immunosuppressive or antiinfective treatment, * myocardial infarction during the last 3 months, * unstable or severe heart disease, * severe chronic obstructive pulmonary disease, * serious liver disease, * cardiac ischemia that prevents the initiation of vasopressors, * signs of cardiac arrhythmia or heart block on ekg, * ischemic limb disease that prevents the initiation of vasopressors, vasopressors at maximum dose defined as norepinephrine at 40µg/min or neosynephrine at 300µg/min.
intraoperative pathological evaluation for surgical treatment & staging for endometrial cancer

Conditions: Endometrial Cancer

Summary: complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. to date, the mayo clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the university of kentucky utilizing intra-operative consultation (ioc). the preliminary data at the university of kentucky for ioc and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. a surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk ec patients put them at significantly increased perioperative risk for complete lymphadenectomy.


Eligibility criteria:
inclusion criteria: * all patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy. * patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation. * preoperative evaluation to rule-out extra-uterine disease may include ct scan, mri, or ultrasound. preoperative imaging is not mandatory for study enrollment. * patients may have received prior systemic chemotherapy. such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. patients must not have received neoadjuvant chemotherapy for the present disease. * patients must have gog performance status 0, 1, or 2. * patients must have an estimated survival greater than or equal to 3 months * patients who have met the pre-entry requirements specified in section 7.0. * patients must have signed an approved informed consent and hipaa authorization. exclusion criteria: * patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam. * patients who have received previous vaginal, pelvic, or abdominal irradiation. * patients who received chemotherapy directed at the present disease. * patients who have circumstances that will not permit completion of this study or the required follow-up. * patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments. * patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years. * patients with gog performance grade of 3 or 4.

Keywords: endometrial cancer intraoperative consultation
oasis: retrospective analysis on eegs for identifying seizure susceptibility in paediatrics using biomarkers

Conditions: Epilepsy; Epilepsy in Children

Summary: the goal of this retrospective study is to validate a set of computational biomarkers (bioep) for seizure susceptibility on retrospective routinely collected non-contributory eegs in paediatric participants with epilepsy. the main objectives are: primary: to validate a set of computational biomarkers (bioep) for seizure susceptibility on retrospective routinely collected non-contributory eegs in paediatric participants with epilepsy. secondary: to examine whether the use of bioep could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed


Eligibility criteria:
inclusion criteria: * ≥2-\<18 years age. * patients who have had a confirmed epilepsy diagnosis for ≥1+ year. * non contributary first eeg: including routine eeg, sleep eeg (natural, melatonin induced, sleep deprived), 24-hour ambulatory eeg. * patients who have been diagnosed with a self-limited and or focal epilepsy \[\*\] who have had a first non-contributary (no ieds present, negative) outpatient eeg. * patients who have been diagnosed with idiopathic generalised epilepsy \[†\] who have had a first non-contributary (no ieds present, negative) routine eeg. * neurodiverse patients with epilepsy can be included in the study \[‡\] * patients with epilepsy and co-morbidities can be included in the study (anxiety, mood disorders etc) * controls should be eegs taken from patients who have been referred for a paroxysmal disorder, received an eeg as part of their diagnostic work up and subsequently received an alternate diagnosis. epilepsy should have been excluded from their differential diagnosis and the alternate diagnosis should have remained stable for ≥1+ year. exclusion criteria: * developmental and/or epileptic encephalopathies \[§\] * patients with global development delay of unknown origin. * patients with profound and multiple intellectual disabilities * participants with a known hepatic/renal encephalopathy. * patient diagnosed with possible nead and epilepsy (dual diagnosis). * participants taking part in another clinical trial of an investigational medicinal product (ctimp) (qualitative/observational studies are acceptable). * patients with any breaches of skull (plates, burr holes, shrapnel).
factors that influence blood vessel regulation during exercise in humans

Conditions: Ischemic Preconditioning; Dietary Exposure

Summary: this study will examine two separate interventions: 1) the effects of ischemic preconditioning or 2) a high fat meal on the capacity of the brachial artery to overcome sympathetic activation and dilate during exercise (also known as functional sympatholysis). participants will be asked to complete rhythmic handgrip exercise with and without the application of -20 mmhg lower body negative pressure to increase sympathetic activation. doppler ultrasound will be used to continuously measure brachial artery blood flow. participants will complete the handgrip exercise and lower body negative pressure before and after the applications of each interventions. participants may elect to only complete one intervention rather than complete both protocols. intervention one is active or control ischemic preconditioning. intervention two is high or low fat meals.


Eligibility criteria:
inclusion criteria: * 18 years or older * healthy exclusion criteria: * history of smoking (tobacco or cannabis), defined as any smoking within the past 3 months * diagnosed cardiovascular or metabolic disease(s) * recent musculoskeletal injury handgrip exercise * prescription of chronic medications other than oral contraceptives * history of hypertension or presence of arrhythmia
a study to evaluate the safety, tolerability, pharmacokinetics (pk), and antitumor activity of alk202 in participants with advanced solid tumors

Conditions: Advanced Cancer; Advanced Solid Tumor

Summary: tthis is a first-in-human (fih), open-label, multicenter dose escalation and expansion study of alk202. the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and antitumor activity of alk202 as a monotherapy in adult participants with advanced solid tumors. the study will also identify recommended dose(s) for subsequent clinical studies of alk202.


Eligibility criteria:
inclusion criteria: * men and women ≥18 and ≤75 years old on the day of signing the icf * at least 1 measurable lesion per recist v1.1 * expected survival ≥3 months * ecog ps score of 0 or 1 * adequate organ function * female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the icf until at least 6 months after the last dose of alk202, and during this period, male participants are not allowed to donate sperms. exclusion criteria: * received organ transplant or hematopoietic stem cell transplant previously * vaccinated with live vaccines within 4 weeks prior to the first dose * primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges * pregnant or lactating women * pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage. * evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: first-in-human
effects of health and wellness app on employee productivity

Conditions: Sleep Disturbance; Mental Health Wellness 1

Summary: the purpose of this study is to test the effects of using the calm app + coaching concierge (one 20-min session) and/or calm coaching for sleep program on sleep, mental health, and work productivity outcomes in employees. employees (n=5,000) will be randomized into one of two groups for 8-weeks.

workplace stress is highly prevalent and is linked to poor health outcomes including depression and anxiety. depression impacts a person's physical ability to complete job tasks about 20% of the time while reducing cognitive performance 35% of the time. mental health issues are not often properly identified and less than half of people receive treatment. the calm app is a mindfulness meditation mobile app and has been evidenced to reduce stress, improve sleep, and reduce anxiety/depressive symptoms in a range of populations (e.g., college students, cancer patients, sleep-disturbed adults). the calm app provides daily, 10-minute, guided meditations grounded in mindfulness-based stress reduction (mbsr) and vipassana meditation. uniquely, the calm app also offers "sleep stories", narrated fictional tales that use mindfulness- inspired techniques to help users sleep. however, the effects of the calm app in employees among worksites has not yet been explored. the purpose of this study is to test the effects of using the calm app + coaching concierge (one 20-min session) and/or calm coaching for sleep program on sleep, mental health, and work productivity outcomes in employees. employees (n=5,000) will be randomized into one of two groups for 8-weeks. the research team will randomize the employee sites into one of two groups 1. intervention group (n=2,500): calm app + concierge (one live 20-minute coaching session) a. calm coaching for sleep subsample (n=100): participants with elevated sleep disturbance (determined as a score of \>10 with the isi) and interest in calm coaching for sleep will be assigned to the calm coaching for sleep program in addition to having the calm app + concierge 2. waitlist control group (n=2,500): following 8-weeks from the study start date, employee receives access to the calm app a. calm coaching for sleep subsample (n=100): participants with elevated sleep disturbance (determined as a score of \>10 with the isi) and interest in calm coaching for sleep will be assigned to the calm coaching for sleep program in addition to having the calm app + concierge

Eligibility criteria:
inclusion criteria: * 18 years or older * employee of company * only english speakers * willing to download the calm app to their smartphone exclusion criteria: • greater than 60 minutes/month of meditation for the past six months
evaluation of copeptin levels in elective cesarean section with different anesthetic technique

Conditions: Fetal Distress

Summary: in this study, investigators aimed to investigate the effects of general and spinal anesthesia techniques on copeptin levels during cesarean section and their relation with fetal distress.

during the delivery process, the mother and the baby generate some endocrine responses to this emotional and physical stressful action. arginin-vasopressin prohormone (copeptin), which is more stable and measurable in blood, is used as an endogenous stress indicator. copeptin levels have been shown to be significantly increased in vaginally delivery when compared to cesarean section (c / s). in a caesarean section; it is a known fact that when the general anesthetic method and the used anesthetic substances are taken into consideration, it gives a significant stress to the mother and the baby. spinal anesthesia with no impaired fetal oxygenation and without orotracheal intubation and neuromuscular blockers may reduce fetal distress. however, there was no study investigating the effect of the anesthesia techniques in elective cesarean section on the fetal stress and the level of copeptin, in the literature review. therefore investigators aimed to compare spinal and general anesthesia technique in elective cesarean section, to evaluate level of copeptin and their relation with fetal distress.investigators hope that this study will guide the anesthesia method that can be chosen primarily in caesarean section.

Eligibility criteria:
inclusion criteria: * 18-40 years of age * asa i-ii * 36-40 gestational weeks * bmi ≤ 40 * undergoing elective cesarean section exclusion criteria: * coagulopathy * known central or peripheral nerve disease * fetal anomalies * birth weight less than 2000 grams and above 4500 grams, * infants with a risk of meconium or amniotic fluid aspiration * kidney failure, diabetes mellitus, hypertension, cardiac disease, antepartum hemorrhage, asthma bronchiole, rh incompatibility, congenital malformations

Keywords: copeptin levels cesarean section general anesthesia spinal anesthesia
blood volume assessment of hepatocellular and metastatic carcinomas in the liver

Conditions: Hepatocellular Carcinoma; Metastatic Carcinoma to the Liver

Summary: this project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with hepatocellular carcinoma (hcc) and liver metastases from pancreatic or colorectal cancer compared to normal liver from dynact acquisitions on an interventional platform.

this project will enroll patients with non-diffuse liver disease who are candidates for chemo or radioembolization to treat or manage the disease during an image guided intervention. subjects will undergo a ct perfusion study of the liver prior to the radioembolizaiton mapping procedure or prior to the chemoembolization treatment. during the radioembolization mapping or chemoembolization procedure, 2 dynact acquisitions on the interventional c-arm will be acquired (the second during an injection of an iodinated contrast material) and will be processed using siemens' pbv software to generate blood volume maps. the diagnostic accuracy of the two approaches to assess the vascularity of the tumors will be assessed.

Eligibility criteria:
inclusion criteria: * hcc or metastatic liver disease * candidate for radioembolization or chemoembolization exclusion criteria: * pregnant * iodine allergy

Keywords: liver perfusion dynact perfusion radioembolization chemoembolization
pain detecting and analgesic stimulating device on low back pain

Conditions: Chronic Low Back Pain

Summary: purpose of study is to test in a randomized controlled trial (rct) the effects of the nervomatrix device on various clinical outcomes of patients with low back pain, as well as its mechanisms of action.

this will be a matched randomized-controlled trial - rct. using random numbers from a random number generator, pairs of patients will be randomized to either the nervomatrix stimulation (experimental group) or to sham stimulation (controls). matching of pairs will be done based on the baseline data of the primary outcomes - pain and disability, as well as on other treatments received.

Eligibility criteria:
inclusion criteria: * chronic low back pain persisting for at least 3 months exclusion criteria: * patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and neurological diseases) * initiated a new conventional therapy during the study period * pregnant * patients having a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device

Keywords: low back pain chronic pain sensitization treatment trigger points
a study in participants with first-line nivolumab plus ipilimumb therapy combined with two cycles of chemotherapy for metastatic non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of the study is to collect real-life data during the early post-market authorization approval period in germany. the study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported quality of life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage iv non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * diagnosis of stage iv non-small cell lung cancer (nsclc) (histologically or cytologically confirmed stage), without known epidermal growth factor receptor (egfr)- or anaplastic lymphoma kinase (alk)-alterations (according to label approved by eu) * decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of nsclc according to the german label has been made independently of the study exclusion criteria: * current primary diagnosis of a cancer other than nsclc that requires systemic or other treatment * participants with known egfr- or alk-alterations other protocol-defined inclusion/exclusion criteria apply

Keywords: non-small cell lung cancer nsclc nivolumab ipilimumab chemotherapy metastatic