Kornimate/medical-research-clean huggingface dataset:
butyrate in pediatric inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: the first prospective randomised placebo-controlled study in the ibd pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in ibd.

butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (ibd) population. this study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed ibd. this was a prospective, randomized, placebo-controlled multicentre study. patients aged 6-18 years with colonic crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group a) or placebo (group b). the primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.

Eligibility criteria:
inclusion criteria: * 6 to 18 years of age; * newly diagnosed, based on the modified porto criteria, ibd with colon involvement; * informed consent of the child's parents or guardians to participate in the study. exclusion criteria: * age \<6 years; * taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment; * lack of consent of parents or guardians to participate in the study.

Keywords: crohn's disease ulcerative colitis sodium butyrate
multicenter asthma research collaboration

Conditions: Asthma; Lung Diseases

Summary: to study the epidemiology of emergency asthma by focusing on three multicenter asthma research collaboration (marc) databases collected over a two-year period in adult and pediatric emergency departments.

background: the multicenter airway research collaboration (marc) was created by 12 emergency physicians in may 1996 to determine the best management of acute asthma in the emergency department. the principal investigator of marc, dr. carlos camargo, formed the marc steering committee to help guide this collaboration. the marc coordinating center is based at the massachusetts general hospital (boston, ma). financial support for marc has come from a variety of sources, including government, foundations, and industry. the nhlbi study used marc databases. design narrative: five representative aims were to: 1) characterize acute asthma management in urban emergency departments (eds) and then compare current practice with that recommended in the 1997 national guidelines; 2) examine gender differences in acute asthma; 3) identify reasons why minority patients with asthma go to (and possibly prefer) the ed for their asthma care; 4) characterize important clinical subgroups, such as acute asthma among pregnant women and patients with sudden-onset severe acute asthma; and 5) examine risk factors for asthma hospitalization and for relapse after ed discharge. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
intervencion trial

Conditions: Blood Pressure, High

Summary: this trial is designed to: 1. assess the response to montherapy with : a thiazide diuretic (hctz), a calcium-channel blocker (ccb, amlodipine) and an angiotensin-receptor blocker (telmisartan), among hypertensive subjects who live at sea level, at medium altitude above sea level and at high altitude above sea level. 2. to test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level 3. to assess the hemodynamic characteristics of hypertension in populations that live at sea level, at medium altitude above sea level, and at high altitude above sea level.


Eligibility criteria:
inclusion criteria: 1. age 45-75 years. enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level 2. leaving in the enrollment cities for at least 2 years 3. untreated hypertension for at least 2 weeks 4. systolic bp between 140 and 160 mmhg and/or diastolic bp between 90 and 99 mmhg, in the absence of therapy. exclusion criteria: 1. diabetes mellitus. 2. chronic kidney disease (estimated glomerular filtration rate \<60 ml / minute / 1.73 m2 of body surface area. 3. smoking. 4. lung disease, liver disease or active cancer 5. any factor that, in the opinion of the investigator, decreases short-term survival 6. psychiatric illness 7. inability to provide informed consent 8. established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia) 9. history of cerebrovascular disease 10. history of orthostatic hypotension. 11. history of syncope. 12. history of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.
genetic characteristics of metastatic breast cancer patients

Conditions: Metastatic Breast Cancer

Summary: genomic analysis for metastatic breast cancer(mbc) patients * participant (inclusion criteria) 1. patients who diagnosed metastatic/stage iv breast cancer 2. patients who were not received treatment for metastatic breast cancer on palliative setting * process (1) tissue/ blood sample * at diagnosis, mbc tissue / blood sample (20cc) will be obtained. * at disease progression after 1st line treatment for mbc, blood sample (20cc) will be obtained (tissue; optional) (2) wes, rnaseq, ctdna, exosome * we will analyze genomic characteritics using wes, rnaseq, ctdna, exosome.


Eligibility criteria:
inclusion criteria: * patients who diagnosed ad metastatic breast cancer * patients who were not received treatment on palliative setting exclusion criteria: * patients who did not agree this study * patients who did not have any pathologic specimen at mbc diagnosis.
treatment of non-small cell lung cancer with cytokine-induced killer (cik) cells blocked by pd-1 antibody

Conditions: Non-small Cell Lung Cancer

Summary: to evaluate the prognosis of non-small cell lung carcinoma patients under cik cellular treatment with pd-1 blocking on top of the standard therapy


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer; * more than 50% tumor tissues positive with pd-l1; * egfr and alk wild type * no other tumors exclusion criteria: * with systematic diseases shortening survival
safety, pharmacodynamics, and pharmacokinetics of different dosing regimens of mk-8266 in participants with hypertension (mk-8266-008)

Conditions: Hypertension

Summary: this was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. the study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of different doses and dose regimens of mk-8266. only part i of the study was completed.


Eligibility criteria:
inclusion criteria: * participant has essential hypertension who is in grade 1 or 2 hypertension according to the european society of hypertension (esh) as delineated in the european society of cardiology (esc) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study. * otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator * participant is generally in good health with the exception of hypertension * participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months exclusion criteria: * participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study * participant has a history of stroke, chronic seizures, or major neurological disorder * participant has a disability that can interfere with rising from a semi-recumbent position to the standing position * participant has a personal or family history of a bleeding or clotting disorder * participant has a history of frequent nosebleeds or recurrent or active gingivitis * participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study * participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage * participant is categorized as class ii or greater according to the new york heart association (nyha) functional classification for heart failure * participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as st. john's wort) during the study * participant anticipates using phosphodiesterase (pde5) inhibitors \[sildenafil (viagra®), tadalafil (cialis®), or vardenafil (levitra®)\] during the study * participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day) * participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study * participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food

Keywords: high blood pressure
efficacy and safety study of beriplex® p/n (kcentra) compared with plasma in patients with acute major bleeding caused by anticoagulant therapy

Conditions: Blood Coagulation Disorders; Acute Major Bleeding

Summary: the purpose of this study is to evaluate efficacy, safety and tolerance of beriplex® p/n (kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of inr (international normalized ratio)and to stop an acute major bleeding.


Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 18 years * subjects who have received oral vitamin k-antagonist therapy * subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (hb) level ≥ 2g/dl, bleeding requiring blood product transfusion * inr ≥ 2 within 3 hours before start of study treatment * informed consent has been obtained exclusion criteria: * expected survival of less than 3 days, or expected surgery in less than 1 day * acute trauma for which reversal of vitamin k antagonists alone would not be expected to control the acute bleeding event * use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion * for patients with ich: glasgow coma score (gcs) \ 30cc as assessed by abc/21; for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ich location; epidural hematomas; intraventricular extension of hemorrhage; modified rankin score (mrs) of \>3 prior to ich * history of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment * known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies * suspected or confirmed sepsis at time of enrollment * administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study * large blood vessel rupture (e.g. in advanced cancer patient) * pre-existing progressive fatal disease with a life expectancy of less than 2 months * known inhibitors to coagulation factors ii, vii, ix, or x; or hereditary protein c or protein s deficiency; or heparin-induced, type ii thrombocytopenia * treatment with any other investigational medicinal product within 30 days prior to inclusion into the study * presence or history of hypersensitivity to components of the study medication * pregnant or breast-feeding women * prior inclusion in this study or any other csl behring-sponsored beriplex study

Keywords: anticoagulant reversal prothrombin complex concentrate coagulopathy induced by coumarin derivatives kcentra
high dose somatostatin analogues in neuroendocrine tumors

Conditions: Respiratory Tract Neoplasms; Thymic Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Multiple Endocrine Neoplasia

Summary: octreotide (oct) is a somatostatin analogue (ssa) available in a long-acting formulation, conventionally administered every 28 days at the maximum dose of 30 mg. together with lanreotide, it is considered the therapy of choice in the control of endocrine syndromes associated with neuroendocrine tumors (net)s. a complete or partial clinical response to ssa therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome. many studies reported a clinical response in 70-90% of functioning nets. in about 36-50% of the patients with progressive advanced well differentiated net (wdnet), a stabilization of disease occurs after treatment with subcutaneous oct. by developing long-acting slow-release ssa formulation, long-acting oct (lar), lanreotide-sr, lanreotide-autogel, the patient's compliance to ssa therapy was improved and escape from treatment, which was common with the subcutaneous formulation, was avoided. however, rate of objective response was not significantly improved as compared to short-acting ssa. on the other hand, it has to be remarked that long-acting ssa are being used in net patients at doses correspondent to the low doses of short-acting formulation. the higher commercially available doses of lar is 30 mg, which is assumed to be comparable to 300 µg of short-acting oct in the therapy of acromegaly. only one study was designed to investigate the use of high-dose lar (160 mg every 28 days). in this study, objective and hormonal responses in patients with progressive metastatic ileal net non-responder to standard doses, was significantly elevated. however, this compound has never been commercialized and, of consequence, this first preliminary observation has not been confirmed by further studies. no systematic studies were performed with the commercially available long-acting ssa used in high-dose treatments. in patients with progressive locally advanced or metastatic net, increase of the dose or reduction of the interval between injections is a relatively common "empirical" clinical practice, but no studies have been performed to evaluate safety and efficacy of this treatment schedule.

the patient population will include the patients with a histologically documented diagnosis of wdnet, defined according to the last who classification criteria for net of gastro-entero-pancreatic, bronchial, thymic or other origin; and showing tumor progression under a standard dose treatment with lar (30 mg every 28 days) for at least 6 months. progressive disease will be defined as increased tumor size according to recist definitions.

Eligibility criteria:
inclusion criteria: * well differentiated neuroendocrine tumors in disease progression exclusion criteria: * well differentiated neuroendocrine tumors without disease progression * patients with intolerance to somatostatin analogues

Keywords: neuroendocrine tumors octreotide somatostatin analogues
plication of the rectus abdominis in two planes and in one continuous suture plan

Conditions: Disorder of Abdomen

Summary: thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group i) or using a continuous barbed suture (group ii). operative time was recorded. all patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. the force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.

inclusion criteria were female gender; 25 to 50 years of age; history of at least one pregnancy; body mass index (bmi) between 18 and 30 kg/m2; desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries; deformities of the skin and subcutaneous tissues in the abdominal region; and musculoaponeurotic defect. non-inclusion criteria were smoking habit; abdominal wall scar (except for a pfannenstiel scar related to a cesarean section); abdominal wall hérnias; history of deep-vein thrombosis; chronic obstructive pulmonary disease; câncer; hypertension; diabetes or other chronic systemic diseases; and use of corticosteroids. patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study. primary outcome: get a technique that provides a safe correction with lasting results and in every segment of time. secondary clinical outcome: confirms the plication of a single layer as positive in women patients at two years of surgery compared to two planes.

Eligibility criteria:
inclusion criteria: * female gender * age: 25 to 50 years of age * history of at least one pregnancy * body mass index (bmi) between 18 and 30 kg/m2 * desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries * deformities of the skin and subcutaneous tissues in the abdominal region * musculoaponeurotic defect exclusion criteria: * smoking habit; * abdominal wall scar (except for a pfannenstiel scar related to a cesarean section); * abdominal wall hérnias; * history of deep-vein thrombosis; * chronic obstructive pulmonary disease; * câncer; * hypertension; * diabetes or other chronic systemic diseases; * use of corticosteroids. * patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study

Keywords: abdominoplasty sutures abdominal deformities plication monofilament nylon suture barbed suture
anesthesia tumescent for surgical management of tenosynovitis.

Conditions: Tenosynovitis

Summary: the aim of this study is to evaluate the effectiveness of the tumescent anesthesia technique in the surgical management of hand tenosynovitis. for this, an open clinical trial was conducted, which included patients with hand tenosynovitis (carpal tunnel syndrome, trigger finger and quervain syndrome), which were randomly assigned to a group. the control group was released pulleys and ligaments with local anesthetic technique and hemostasis with pneumatic tourniquet; while the study group was released from the pulleys and ligaments with tumescent anesthesia. the study variables were: anesthesia time, trans-surgical bleeding, pain, total procedure time and tissue reperfusion time.

introduction: the walant technique (wide awake local anesthesia no-torniquet) proposes the use of local anesthesia, epinephrine and tourniquet in the areas of the hand to be repaired, making costs and time and comfort more efficient. objective: evaluation of the effectiveness of the walant technique versus regional anesthesia with tourniquet in pain control, surgical management of stenosing tenosynovitis. material and methods: open clinical trial including patients with the trigger finger, tunnel syndrome in the operating room, candidates for surgery, and excluding previous surgeries at the site of the injury, hemodynamic instability, peripheral vascular diseases, smoking, anxiety, or psychiatric diseases. the anesthetic method was applied to the incision sites according to the diagnosis and the proposed procedure. at the end of the test, tumescent solution and control, 1% lidocaine plus pneumatic tourniquet on the forearm at 250mmhg. the main variables were: type of anesthesia and pain during the procedure. descriptive and inferential statistics were applied (xi2, t-student or mann-whitney u).

Eligibility criteria:
inclusion criteria: * right holders of the mexican social security institute * over 18 years * trigger finger diagnosis * diagnosis of carpal tunnel syndrome * diagnosis of quervain syndrome * acceptance and signature of informed consent exclusion criteria: * necessity for concomitant surgery * previous surgeries on the injured site * hemodynamic instability * history of peripheral vascular diseases * do not wish to participate in the study * hypersensitivity to medication * smoking

Keywords: tumescent anesthesia tenosynovitis visual analog scale tourniquets epinephrine
genetic testing in elective single embryo transfer (getset): a randomized clinical trial

Conditions: Infertility, Female

Summary: the getset trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (pgt-a) in elective single embryo transfer in women between 35 and 40 years of age.

in this randomized controlled trial, a total of 240 patients divided evenly across the two participating ivf center will be recruited. patients will be randomized to a control and to a treatment group, each containing 120 participants. only patients with at least one evaluable blastocyst will be randomized. patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by ivf center. in the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. all other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. pgt-a results of the untransferred embryos will be revealed to the patient after the outcome of the initial et is known. in the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and pgt-a. pgt-a will be performed regardless of the number of blastocysts available. patients will undergo frozen transfer of the single, best quality euploid blastocyst. if the initial transfer results in a non-conception cycle and additional embryos are available for transfer.

Eligibility criteria:
inclusion criteria: women undergoing ivf of between 35 and 40 years of age at ivf cycle start utilization of intracytoplasmic sperm injection icsi (recommended) or traditional ivf utilization of ejaculated or testicular sperm utilization of autologous or donor sperm all controlled ovarian hyperstimulation (coh) protocols exclusion criteria: utilization of donor oocytes utilization of gestational carrier recurrent pregnancy loss (rpl) defined as ≥ 3 consecutive miscarriages recurrent implantation failure (rif) defined as ≥ 3 more failed embryo transfers preimplantation genetic testing for monogenic/single gene disorders (pgt-m) translocation carriers