Kornimate/medical-research-clean huggingface dataset:
study comparing the efficacy of mek162 versus dacarbazine in unresectable or metastatic nras mutation-positive melanoma

Conditions: Metastatic or Unresectable Cutaneous Melanoma

Summary: two-arm, randomized, prospective, open-label, multi-center, phase iii study to compare the efficacy and safety of mek162 (45 mg bid) versus dacarbazine (1000 mg/m2 iv every 3 weeks) in patients with advanced (stage iiic) unresectable or metastatic (stage iv) nras q61 mutation-positive cutaneous or unknown primary melanoma. the mutation analysis will be performed at a central laboratory. only those patients with q61 mutation per central laboratory and meet all eligibility criteria will be randomized. a total of 393 patients will be randomized 2:1 to receive either mek162 or dacarbazine. patients will be stratified according to ajcc stage (iiic, ivm1a, and ivm1b versus ivm1c), ecog performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). this study will use an interactive response technology (irt). the primary end point of the study is progression-free survival. key secondary end point is overall survival


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary ajcc stage iiic or iv (uveal and mucosal melanoma are excluded) * presence of nras q61 mutation in tumor tissue prior to randomization as determined by a novartis designated central laboratory * naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma * evidence of at least one measurable lesion as detected by radiological or photographic methods * adequate bone marrow, organ function, cardiac and laboratory parameters * normal functioning of daily living activities exclusion criteria: * any untreated cns metastases * uveal or mucosal melanoma * history of or current evidence of retinal vein occlusion (rvo) or risk factors of rvo * patients with washout period \< 6 weeks from the last dose of ipilimumab or other immunotherapy. * previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma. * history of gilbert's syndrome * prior therapy with a mek- inhibitor * impaired cardiovascular function or clinically significant cardiovascular diseases * uncontrolled arterial hypertension despite medical treatment * hiv positive or active hepatitis a or b * impairment of gastrointestinal function * patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure; * patients with neuromuscular disorders that are associated with elevated ck. * pregnant or nursing (lactating) women * medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study other protocol-defined inclusion/exclusion criteria may apply

Keywords: melanoma cutaneous melanoma skin disease skin cancer skin neoplasms neoplasm metastasis
use of ceftaroline in hospitalized patients with community acquired pneumonia

Conditions: Community Acquired Bacterial Pneumonia

Summary: community-acquired bacterial pneumonia, which is often called cap, is a bacterial infection in the lungs and is treated with antibiotics. sometimes people need to be in the hospital to be treated for cap. usually, hospitalized persons with cap are given two antibiotics together. these antibiotics usually include a cephalosporin and a macrolide. the most commonly used cephalosporin at albany medical center hospital is ceftriaxone. the most commonly used macrolides at albany medical center hospital are azithromycin and doxycycline. this research is being done to find out how well a new cephalosporin antibiotic, called ceftaroline, works in combination with a macrolide for the treatment of cap. ceftaroline is similar to ceftriaxone. ceftaroline was recently approved by the fda to treat pneumonia in hospitalized patients based on two research studies. in one study, ceftaroline was better than ceftriaxone. in the second study, ceftaroline was just as good as ceftriaxone. ceftaroline was very well tolerated in both clinical studies and it was found to be as safe as ceftriaxone.


Eligibility criteria:
inclusion criteria: * age 18 years or older * met ats/isda criteria rule of cabp * cabp requiring hospitalization and treatment with a iv antimicrobial * anticipated hospitalization for \> 48 hours * received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for \> 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission * pneumonia patient outcomes research team (port)risk class iii or iv exclusion criteria: * cabp port risk class i, ii, iii * cabp requiring admission to an icu * cabp suitable for outpatient therapy with an oral microbial agent * confirmed or suspected respiratory tract infection attributed to a source other than cabp pathogens * noninfectious case of pulmonary infiltrates or pleural empyema * infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen * previous therapy with another intravenous beta-lactam for cabp for between 24 and 96 hours prior to randomization * receipt of chronic concomitant systemic steroids \> 40 mg of prednisone equivalent * significant hepatic disease * hematologic disease * immunological disease * history of a hypersensitivity reaction to beta-lactams * pregnant or nursing females

Keywords: pneumonia community acquired bacterial pneumonia cap cabp bacterial pneumonia
an adhesion reduction plan in the management of the surgical open abdomen

Conditions: Open Abdomen

Summary: the purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

adhesions are a common consequence of abdominal surgery. trauma and emergency general surgery patients may require an open abdomen and undergo a series of abdominal operations, which may be increasingly complicated by the presence of adhesions. adhesions appear soon after the initial operation and gradually mature within days. the effects of adhesion development on subsequent surgery may include: increased procedure time; difficulty differentiating, exposing, and accessing tissue planes; and increased risk of inadvertent enterotomy. complications of adhesions include enteric obstruction and enterocutaneous fistulae. this study will determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the extent and severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Eligibility criteria:
inclusion criteria: * trauma patients with open abdomen after initial laparotomy * emergency surgery patients with open abdomen after initial laparotomy * able to obtain consent from patient or lar before any research initiated exclusion criteria: * seprafilm application at initial laparotomy * patient is a prisoner * inability to obtain informed consent * consentable person does not speak english

Keywords: adhesions open abdomen laparotomy
guadecitabine extension study

Conditions: Acute Myeloid Leukemia; Myeloid Dysplastic Syndrome

Summary: this is a multicenter, open-label extension study for participants who participated in a previous astex-sponsored guadecitabine clinical study \[including but not limited to sgi-110-01 (nct01261312), sgi-110-04 (nct02348489), sgi-110-06 (nct02920008), and sgi-110-07 (nct02907359)\].

participants who were still receiving treatment with guadecitabine and in the opinion of the investigator were still benefitting from treatment at the time of database close of the original study will be eligible to participate in this extension study. approximately 250 subjects could be enrolled. participants will attend clinic visits on days 1-5 of each 28-day cycle to receive treatment with guadecitabine. data collection will be limited to treatment exposure, adverse events, concomitant medications, limited laboratory parameters, and survival status.

Eligibility criteria:
inclusion criteria: 1. previous participation in an astex-sponsored guadecitabine clinical trial \[including but not limited to sgi-110-01 (nct01261312), sgi-110-04 (nct03603964), sgi-110-05, sgi-110-06 (nct02920008), and sgi-110-07 (nct02907359)\], in which the participant was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study. 2. participant is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator. 3. able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure. 4. women of child-bearing potential (according to recommendations of the clinical trial facilitation group \[ctfg\]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures while receiving treatment with guadecitabine and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving study treatment and for at least 3 months after completing guadecitabine treatment. exclusion criteria: * 1. any participant who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits.

Keywords: guadecitabine
long-term registry of patients treated with loncastuximab tesirine

Conditions: B-Cell Lymphomas

Summary: retrospective and prospective multi-center observational study of patients with b-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.

the purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
inclusion criteria: * must be ≥ 18 years of age at the time of consent. * initiated or initiating commercially available loncastuximab tesirine treatment. * written informed consent must be obtained prior to any registry activities. exclusion criteria: * prior loncastuximab tesirine exposure in clinical trials.

Keywords: diffuse large b-cell lymphoma loncastuximab tesirine non-hodgkin lymphoma relapsed/refractory diffuse large b-cell lymphoma
supine versus prone pnl in pediatric

Conditions: Urolithiasis

Summary: to compare the safety and efficacy of pnl in a modified flank-free supine position versus prone position in pediatric patients

incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in the developed ones. the 5-year recurrence rate of about55% (range, 38%-70%). fernstrom and johansson first introduced percutaneous nephrolithotomy (pnl) in 1976. since that pnl has become widely used for multiple indications. pediatric pnl was done in the prone position with more rapid and easy puncture point determination, wider field for renal puncture, free application of multiple accesses, and avoidance of visceral injuries, especially the colon. pnl in the supine position has several advantages as, similar success rate and a shorter operative time than conventional pnl. the amplatz sheath is oriented downward, maintaining a low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the fragmented stones. furthermore, it's easier for the anesthesiologist to control the airway and reduce the neural and ophthalmologic pressure lesions than the prone position. desoky et al in 2012 described the flank-free modified supine position (ffmsp) and claimed that this position overcomes the mechanical limitation of ordinary supine position because of ample space for puncture, dilatation, multiple tracts, and maneuverability of the system with the nephoscope. moreover, the surgeon can comfortably sit during the operation, and x-ray exposure is reduced because puncture and dilatation are quite perpendicular to the body, and the operator's hands are outside the fluoroscopic field. it's better to do supine pnl in case of retro renal colon. as we see the supine position in pediatric is still under research and few trials about it had been done with no clear recommendation, so we will compare pnl in pediatric age group in modified free flank supine position versus prone position.

Eligibility criteria:
inclusion criteria: age ≤ 18 years old. renal stones are amenable for pnl with guy's stone score 1-2. exclusion criteria: congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. patient refusing participation. patients with pcn.
epinephrine nebulization prior to nasotracheal intubation

Conditions: Nasal Bleeding

Summary: this randomised, prospective study performed in ain shams university hospitals over 126 patients asa i and asa ii, trauma patients who suffered isolated mandibular fractures and necessitated nasal intubation during general anesthesia. the patients were randomly assigned to one of two equal groups: nasal lidocaine drops followed by oxymetazoline nasal drops group (ol) or epinephrine mixed with lidocaine as nebulization session (el) group.

one group received epinephrine mixed with lidocaine as nebulization session (el group) and the other group received nasal lidocaine drops followed by oxymetazoline nasal drops group (ol). before the preparation of the airway, we examined the nasal cavity by using a light source to select the target nostril; if we could not determine, we chose the right nostril. no premedication was administered. group (el) (63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 martindale pharma, an ethypharm group company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia. group ol (63 patients): these patients received five drops of lidocaine hydrochloride (xylocaine 2%, 20 mg/ml; astrazeneca, london, uk) using a prefilled dropper, followed by six drops of hydrochloride oxymetazoline (otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; novartis consumer health, uk ltd, 980 great west road, brentford, middlesex, tw8 9gs, uk) in each nostril in the

Eligibility criteria:
inclusion criteria: * cases with american society of anesthesiologists (asa) classes i and ii. * patients scheduled for elective oral isolated mandibular fracture fixation requiring nasotracheal intubation. exclusion criteria: * nasal abnormality history (such as polyp , surgery or nasal trauma). * frequent epistaxis history. * patients suffering valvular heart disease, hypertension, ischemic heart disease or arrhythmias. * patients using drugs (anticoagulation therapy, non-steroidal anti-inflammatory drugs, and oral decongestants). * patients receiving medications known to alter the parameters under investigation including β-blockers, calcium channel blockers, or vasodilators. * patients known to have hypersensitivity to medications used in this study.

Keywords: nasotracheal intubation, nebulized epinephrine, epistaxis.
single ascending dose and multiple ascending dose study in healthy participants and proof of mechanism study in patients with ulcerative colitis

Conditions: Healthy Volunteers; Ulcerative Colitis

Summary: the primary purpose of this study is to determine if single and multiple doses of bms-986184 are safe and well tolerated in healthy male and female subjects. the primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug * diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis) exclusion criteria: * any bacterial, fungal or viral infection, including tuberculosis, hiv, hepatitis b or hepatitis c * subjects with history of cancer, lymphoproliferative disease, class iii or iv congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease other protocol defined inclusion/exclusion criteria could apply
an observational study of fecal calprotectin as clinical tool in monitoring moderate-to-severe crohn's disease on adalimumab induction therapy: a korean experience (fair)

Conditions: Crohn's Disease

Summary: the objective of this observational study was to assess changes in fecal calprotectin levels and its suitability as a monitoring tool in participants with moderate-to-severe crohn's disease who were treated with adalimumab.


Eligibility criteria:
inclusion criteria: 1. crohn's disease participants were defined as: 1. active luminal, moderate-to-severe crohn's disease with crohn's disease activity index (cdai) greater than 220, who started adalimumab treatment in a normal clinical practice setting. 2. fecal calprotectin greater than or equal to 150 microgram/g. 3. ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas. exclusion criteria: 1. disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract. 2. participants who had undergone colectomy other than ileocecal resection. 3. pregnancy or breast feeding. 4. contraindication to any anti-tumor necrosis factors (tnf) agent. 5. any drug dependency.

Keywords: fecal calprotectin crohn's disease adalimumab
effect of cryotherapy and laser application on post-operative pain in single visit endodontically treated symptomatic apical periodontitis cases

Conditions: Irriversible Pulpitis With Apical Peridontitis; Hot Tooth

Summary: this study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain .

one of the most popular complications after single visit endodontic treatment is pain either spontaneous or on biting so in this study we choose one of the most difficult and challenging cases " hot tooth " to compare lasers and cryotherapy different applications to reduce post operative pain after single visit endodontic treatment

Eligibility criteria:
inclusion criteria: * • vital teeth display symptomatic apical periodontitis (symptomatic apical periodontitis was determined based on the clinical symptoms of severe preoperative pain (visual analogue scale \[vas\] \> 60) and severe percussion pain (vas \> 60). * teeth, with a periapical index score (pai) of 2 or 3 indicating small changes in bone structure and slight mineral loss respectively. * mobility less than 1 mm in either direction. * absence of periodontal pocket around the tooth. * symptomatic pulpitis with spontaneous pain or lingered by cold or heat. * teeth without pus or inflammatory exudates draining through the canal. * teeth without anatomic variations exclusion criteria: * • patient with any systemic disease. * immunocompromised patients. * pregnant or lactating patients. * apparently narrow roots in which apical preparation with the #40 file would be overzealous. * retreatment cases. * necrotic painful teeth with absence of sinus tract for drainage. * patients on analgesics or sedative medication up to 6 hours before treatment

Keywords: cryotherapy low level laser therapy lllt single visit endodontic treatment irriversible pulpitis apical peridontitis
inflammatory response and pregnancy outcome in women with type 2 diabetes or overweight

Conditions: Inflammation

Summary: purpose: the purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. at the same time we, the investigators at rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.

material and method: this study falls in two fields: first 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. the correlation between these variables and the pregnancy and delivery progress is evaluated. 280 overweight (body mass index \[bmi\] \> 30 kg/m2) pregnant women with no medical conditions are examined in the same way. the women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly. both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.

Eligibility criteria:
inclusion criteria: * bmi \> 30 kg/m2 * bmi \< 45 kg/m2 * healthy * over 18 years of age * no earlier preterm delivery (before 37) * singleton pregnancy * 14 weeks +/- 1 week of gestation exclusion criteria: * bmi \> 45 kg/m2 * earlier preterm delivery (before 37) * not singleton pregnancy * medically treated diseases