Kornimate/medical-research-clean huggingface dataset:
a study of gsk2118436 in braf mutant metastatic melanoma

Conditions: Melanoma

Summary: brf113710 is a phase ii, single-arm, open-label study to assess the efficacy, safety, and tolerability of gsk2118436 administered twice daily as a single agent in subjects with braf mutant metastatic melanoma. subjects will receive 150 mg of gsk2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * must have histologically confirmed cutaneous metastatic melanoma (stage iv) that is braf mutation-positive (v600 e/k) as determined via central testing with a braf mutation assay. * is treatment naive or has received prior treatment for metastatic melanoma. * must have measurable disease according to response evaluation criteria in solid tumors (recist 1.1). * women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment. * women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication. * men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication. * must have eastern cooperative oncology group (ecog) performance status of 0-1. * adequate organ function. exclusion criteria: * previous treatment with a braf or mek inhibitor. * cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of gsk2118436. * a history of known human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection. * history or evidence of brain metastases on mri or head ct if mri is not able to be performed. * history of other malignancy. subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * certain cardiac abnormalities.

Keywords: metastatic melanoma braf mutant melanoma braf mutant metastatic melanoma
clinical evaluation of tissue sampling bias in histologic evaluation of sentinel lymph nodes in breast cancer

Conditions: Breast Neoplasms; Breast Diseases

Summary: this is a study to evaluate the incidence of sampling bias during pathologic assessment of sentinel lymph nodes (sln) when they are cut at a certain thickness (1 mm) and the tissue slices are completely analyzed by histopathology (at 200 µm sections). the sponsor and investigators would like to determine how often small cancer deposits are present in one slice but not the other. the data will provide an empirical estimate of the incidence of tissue sampling bias inherent in using different tissue sections for analysis. the data will also show how varying degrees of detail in evaluating the sentinel lymph nodes (sln) with histopathology methods will impact the degree of agreement.


Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * diagnosed pre-surgically with t1 or t2 breast cancer and scheduled for surgery including sentinel lymph node dissection * subjects (or the subject's legal representative) who have read, understood (to the best of their ability) and signed the informed consent form. exclusion criteria: * subjects diagnosed pre-surgically with large or locally advanced (t3 \& t4) breast cancer * pregnant subjects, confirmed by interview with either subject or treating physician * subjects diagnosed with inflammatory breast cancer * subjects diagnosed with ductal carcinoma in situ (dcis) when breast conservation is to be done * subjects with clinically suspicious, palpable axillary lymph nodes * subjects previously treated for or previously diagnosed with another type of invasive cancer. subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma * subjects who have received pre-operative systemic therapy * subjects who are incapable of providing written informed consent * subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).

Keywords: metastasis
austrian registry on transjugular intrahepatic portosystemic shunts

Conditions: Portal Hypertension

Summary: patients with tips will be recruited in this prospective registry study. the clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.

patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. implantation of a transjugular intrahepatic portosystemic shunt (tips) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. however, there are few data on long-term outcome after tips implantation.this prospective registry study will assess the clinical course of patients after undergoing tips intervention and biomarkers for complications after tips implantation.

Eligibility criteria:
inclusion criteria: * age 18-99 years * portal hypertension * anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (tips) * informed consent exclusion criteria: * retraction of consent

Keywords: cirrhosis advanced chronic liver disease ascites variceal hemorrhage transjugular intrahepatic portosystemic shunt
suction drain in axillary lymph node dissection for malignant melanoma

Conditions: Malignant Melanoma

Summary: postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (alnd) for malignant melanoma. we analyzed the impact of time-to-drain removal and drainage volume on seroma formation after alnd.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignant melanoma * underwent axillary lymph node dissection (level i-iii) * daily drainage volume records over a two-week period available exclusion criteria: * daily drainage volume records over a two-week period not available
muscle function and tenderness differences in headache patients

Conditions: Migraine; Tension Headache; Posttraumatic Headache

Summary: this cross-sectional study aims to compare muscle function of the neck, and shoulder and muscle tenderness in three groups of headache patients: migraine, tension-type headache, and posttraumatic headache. the study will evaluate muscle tenderness through the total tenderness score (tts) and muscle function through maximum voluntary isometric contraction (mvic) and rate of force development (rfd). additionally, functional assessments such as the cranio-cervical flexion test (ccft) and ito test will be performed.


Eligibility criteria:
inclusion criteria:criteria: inclusion criteria: * aged 18 to 65 years. * diagnosis of migraine, tension-type headache, or posttraumatic headache, occurring at least 10 days per month. * for tension-type headache patients, maximum of 3 days per month with migraine. exclusion criteria: * pregnancy. * significant psychiatric comorbidities (e.g., severe depression). * medication-overuse headache. * severe osteoarthritis in the neck or shoulder, or cervical disc herniation. exclusion criteria: -
insulin sensitizers role in control of pcos vicious cycle.

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: pcos is a common and complex disease affecting women of reproductive age. it is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. pcos is highly associated with various metabolic and endocrinal disorders. metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (dm), gestational dm, and pcos. myo-inositol (mi) protects against mafld through reduction of hepatic accumulation of triglycerides.


Eligibility criteria:
inclusion criteria: * age; * residence; * level of education \& type of work; * marital and fertility statuses, and if infertility was the main complaint; * presence of risk factors as sedentary lifestyle; * emotional stress and family history of pcos; * obesity-related medical disorders especially dm or mafld; * history of previous treatment for pcos and its outcomes; * menstrual pattern such as infrequent menstrual periods. exclusion criteria: * women had other manifestations of metabolic syndrome: * cardiac manifestations of pcos; * maintained on other therapies or prepared for /received laparoscopic intervention for pcos; * receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications; * had morbid obesity with body mass index (bmi) \>35 kg/m2; * causes other than pcos for infertility, manifest dm, hepatic or pancreatic diseases.
social determinants of health, medication use, and quality of life in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: optimizing health related-quality of life (hrqol) for patients with inflammatory bowel disease (ibd), who often experience a relapsing disease course, is an essential component of care. improving ibd disease control is linked to increased health-related quality of life. even as many effective pharmacotherapies to promote disease control are available, evidence suggests that hispanic and non-hispanic black ibd patients may not receive full benefit from these therapies compared to their non-hispanic white counterparts. underlying mechanisms that contribute to observed disparities in the use of ibd medical therapies are likely multifactorial. adequate access to treatment has been implicated. hispanic and non-hispanic black ibd patients are more likely to be medicaid-insured, and medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal ibd control. medication adherence has also been proposed as a potential mediating factor. ibd therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. while previous studies suggest black ibd patients have lower medication adherence than non-hispanic white patients, it is unclear the extent to which social factors contribute to this observation. the purpose of this study is to evaluate the association between social determinants of health, medication adherence, and hrqol among hispanic and non-hispanic black ibd patients. understanding potentially modifiable psychosocial factors that contribute to medication adherence and hrqol will provide targets for later intervention towards the goal of health equity.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of crohn's disease, ulcerative colitis, or indeterminate colitis ≥ 3 months investigator confirmed on the basis of supportive clinical data such as colonoscopy, pathology and/or radiology * age 18 years or older * ability to provide informed consent in english or spanish * basic computer proficiency (i.e. to complete online survey) exclusion criteria: * race and ethnicity self-identified as other than hispanic, non-hispanic black, or non-hispanic white
the effect of oral polymeric diet enriched with tgf-beta 2 (modulen) on clinical response and mucosal healing in adult patients with newly diagnosed crohn's disease

Conditions: Crohn Disease

Summary: the aim of this study is to evaluate prospectively a possible effect of an oral polymeric diet enriched with tgf-beta 2 (modulen) as compared to budesonide (one of the commonly accepted treatments for crohn's disease) on clinical response, mucosal healing and intestinal microbiota in adult patients with newly diagnosed crohn's disease using a capsule endoscopy.


Eligibility criteria:
inclusion criteria: * newly diagnosed crohn's disease * mild to moderate severity exclusion criteria: * patients who received systemic steroid or budesonide or biological treatment * recent bowel surgery * colostomy, ileostomy * short bowel syndrome * obstructive symptoms * pregnancy, lactation * cardiac pacemaker or defibrillator * swallowing problems * uncontrolled metabolic diseases or any other condition that can be exacerbated by steroids
atg-008 combined with toripalimab in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is an open-label, single-arm study with dose-escalation and expansion phases to access atg-008 combined with toripalimab in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. know and voluntarily sign informed consent. 2. age 18-70 years old (including 18 and 70 years old), weight ≥45 kg. 3. at least one measurable lesion according to the recist 1.1 and rano evaluation criteria. 4. ecog performance status score is 0 or 1. 5. blood chemistry test results, meet the following results: 1. aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 × normal upper limit (uln) 2. total bilirubin ≤ 1.5 × uln 3. serum albumin\> 29 g / l 4. creatinine ≤ 1.5 × uln or 24-hour serum creatinine clearance ≥ 50 ml / min 5. lipase and amylase ≤ 2 × uln. 6. adequate bone marrow function and meets the following results: 1. absolute neutrophil count (anc) ≥ 1.5 × 109 / l 2. platelets ≥ 75 × 10\^9 / l 3. hemoglobin ≥ 90 g / l. 7. except for hearing loss and hair loss, all toxicity caused by previous anti-tumor therapy must have returned to ≤ grade 1 (according to nci-ctcae version 5.0). 8. life expectancy is longer than 3 months. exclusion criteria: 1. have a history of hepatic encephalopathy. 2. have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase). 3. active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months. 4. have a history of hiv infection and/or acquired immunodeficiency syndrome 5. major surgery has been performed within 4 weeks before the first dose, or is expected during the study period. 6. have a history of organ transplantation (eg., liver transplantation). 7. poorly-controlled pleural or pericardial effusion during the screening period. 8. other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies 9. suffering from active or previously recurring autoimmune diseases or under such a risk. 10. systemically immunosuppressive drugs are currently used within 14 days of the first dose. 11. the investigator considers that the complications or other situations of the subject may affect compliance with the protocol, or are not suitable for participation in this study. 12. subjects with diabetes or glycated hemoglobin (hba1c)\> 7%.
gastroplasty and electrical impedance tomography

Conditions: Gastropathy

Summary: worldwide there is a high prevalence of morbid obesity with a progressive increase in incidence in recent years, causing serious consequences for the health services. approximately 12% of the world population is obese and brazil is in 77º without world ranking of countries in cases of obesity. in this context, bariatric surgery appears as an effective method of treating refractory obesity. support of high fractions of oxygen administered during anesthesia is produced, it accepts the use of positive positive positive pressure (peep) through the alveolar recruitment maneuver (arm), which has been used allowing small fractions inspired by oxygen, which reduces intra-and postoperative atelectasis and optimizes gas exchange during anesthesia. in order to better monitor ventilatory mechanics, electrical impedance tomography (eit) appears as a cheap imaging method when compared to a non-invasive magnetic resonance imaging (ct) or mri, with no side effects and recent studies shown in its life as pneumothorax , mra monitoring, collapse detection, and peep titration. the aim of this study is to evaluate the impact of arm and its repercussions on lung function and respiratory mechanics. this is a randomized controlled clinical trial with patients undergoing videolaparoscopic gastroplasty surgery, of both sexes. patients were randomly assigned to control group and experimental group. patient evaluation is performed without before, during and postoperative, through a pulmonary function test and eit.


Eligibility criteria:
inclusion criteria: * patients submitted to videolaparoscopy gastroplasty surgery, of both sexes exclusion criteria: * severe pneumopathies; * congestive heart failure (nyha class iii or iv); * coronary artery disease, and those who, for any clinical, surgical and psychosocial reasons, require intervention by laparotomy and those with hemodynamic instability (pam) \<60 mmhg) at the time recorded for performing the alveolar recruitment maneuver.
observational study for feasibility and performance of sub-millisievert coronary computed tomography angiography (ccta) for coronary artery anomalies (caa) in paediatric patients

Conditions: Coronary Artery Anomaly, Congenital

Summary: congenital heart defects are the most frequent manifestation of congenital diseases (8 per 1000 live births). imaging modalities play an increasing role in their diagnosis, follow-up, and pre/post-surgery check-up. echocardiography usually provides a first line diagnosis, but coronary ct angiography (ccta) also demonstrated its usefulness whenever accurate modelling of anatomic structures is required. ccta is well defined for adult patients. this is not the case for paediatric population, which rises two main difficulties: * the use of ionising radiation in young subjects involves a very radio-sensitive population, potentially subject to multiple exams during their follow up. * technical issues related to young patients: no breath-holding, uncontrolled movements during acquisition, very high heart rates (making ecg gating more complex) and very small structures. these conditions usually result in a deteriorated image quality or in radiation dose increase (retrospective gating). these two outcomes are not acceptable for both, clinician and patient. in this study, investigators make the hypothesis that despite difficult conditions stated above, ultra-low dose acquisitions may results in diagnostic quality acquisition, thanks to state of art ct technologies combined with acquisition parameters specially designed for that purpose. investigators aim to demonstrate feasibility and performances of such exams.

fifty paediatric patients are to be enrolled in this study. all these patients were prescribed a coronary angiography ct as part of their follow up for a known or suspected coronary artery anomaly. computed tomography acquisitions are performed on a revolution ct (ge healthcare) using a wide detector aperture (160 mm), last generation of iterative reconstruction algorithm and specific reconstruction software reducing cardiac motion artefacts. a rotation time of 0.28 sec is used, with a slice thickness of 0.625 mm and a 0.625 mm reconstruction interval. the acquisition is ecg-gated (prospective) with kv and mas depending on bmi, heart rate and heart rate variability of patients.

Eligibility criteria:
inclusion criteria: * patients from 0 to 18 years old * known or suspected coronary artery anomalies * ccta prescribed for regular follow up of the pathology * no-objection of parents/legal representative of the patient * covered by social security
the prevalence of directional preference in the lumbar stenosis population

Conditions: Lumbar Stenosis

Summary: this will be a prospective cohort observational study observing patients with low back pain with leg pain who present for outpatient physical therapy care at rusk rehabilitation at nyu langone ambulatory care lake success. patients are eligible if they present with imaging of stenosis in their lumbar spine on mri or ct scan and note radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks.


Eligibility criteria:
inclusion criteria: * neurogenic claudication (pain in the buttock, thigh, or leg during ambulation) or radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks. * confirmatory cross-sectional magnetic resonance imaging (mri) or computed tomography (ct) imaging demonstrating the presence of either central or lateral lumbar spinal stenosis at one or more levels was required. * age \>48 years old * willing and able to consent * scheduled to receive physical therapy that includes the collection of patients outcomes, functional tests, and may include the conduct of a two-stage treadmill test exclusion criteria: * radiographic evidence of instability, degenerative spondylolisthesis, fracture, or scoliosis of more than 15°. * comorbid health conditions precluding surgical management, prior lumbar surgery, progressive neurological deficit, any inflammatory conditions such as rheumatoid arthritis or indication of a potential non-musculoskeletal spinal condition (e.g., active malignancy, infection, etc.)
a clinical study to compare an aliskiren based hypertensive regimen with a ramipril based one followed by a randomized withdrawal.

Conditions: Hypertension

Summary: to compare the aliskiren regimen versus the ramipril regimen on reduction in blood pressure.


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients who are eligible and able to participate in the study exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined inclusion exclusion criteria also apply.

Keywords: hypertension, aliskiren, blood pressure, ramipril, hydrochlorothiazide