Kornimate/medical-research-clean huggingface dataset:
a study to evaluate tovorafenib in pediatric and young adult participants with relapsed or progressive low-grade glioma and advance solid tumors

Conditions: Low-grade Glioma; Advanced Solid Tumor

Summary: this is a phase 2, multi center, open-label study to evaluate the safety and efficacy of type ii raf (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. qualifying genomic alterations will be identified through molecular assays as routinely performed at clinical laboratory improvement amendments (clia) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. the study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (eot) visit(s), a safety follow-up visit, and long-term follow-up assessments.


Eligibility criteria:
inclusion criteria: * low grade glioma \& low-grade glioma extension: a relapsed or progressive lgg with documented known activating braf alteration. * advanced solid tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating raf fusion. * participants must have histopathologic verification of malignancy at either original diagnosis or relapse. * must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression. * must have at least 1 measurable lesion as defined by rano (arms 1 \& 2) or recist v1.1 (arm 3) criteria exclusion criteria: * participant's tumor has additional previously-known activating molecular alterations. * participant has symptoms of without radiographically recurrent or radiographically progressive disease. * known or suspected diagnosis of neurofibromatosis type 1 (nf-1) via genetic testing or current diagnostic criteria. other inclusion/exclusion criteria as stipulated by protocol may apply

Keywords: low-grade glioma advanced solid tumor firefly-1 day101 tovorafenib
study to investigate the causes of fever in children living in urban dar es salaam and rural ifakara

Conditions: Fever; Children; Infectious Diseases

Summary: the goal is to improve the evidence-based management of fever cases seen in outpatient clinics in malaria endemic countries, through a better understanding of the value of accurate malaria diagnosis, and through an improved understanding of the other causes of fever in children. the objective is to describe systematically (as much as possible) the etiologies of fever in children in an urban and in a rural environment of sub-saharan africa.


Eligibility criteria:
inclusion criteria: * axillary temperature of 38°c or more * first consultation for the present problem * history of fever lasting for one week or less * main complaint was not an injury or trauma * no report of an antimalarial or antibiotic medicine taken during the previous week exclusion criteria: * severe malnutrition * categorized as p1 (requiring immediate live saving procedures)

Keywords: fever children non-malaria fevers diagnosis
evaluation of the portal pressure by doppler ultrasound in cirrhotic patients before and after simvastatin

Conditions: Portal Hypertension

Summary: portal hypertension is not a disease in itself. rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm hg.

indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic c infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. it might even improve survival of patients with cirrhosis after variceal bleeding.

Eligibility criteria:
inclusion criteria: * positive diagnosis of cirrhosis by us (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins) * clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade i-ii) exclusion criteria: * pregnancy * hepatic encephalopathy grade iii-iv * hepatocellular carcinoma * treatment with statins in the previous 3 months * hypersensitivity to statins * previous surgical shunt or tips * treatment with calcium channel blockers
safety and efficacy of the combination of empagliflozin and linagliptin compared to linagliptin alone over 24 weeks in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this trial compare the use of two different doses of empagliflozin to placebo, in t2dm patients on 16 wks linagliptin treatment and metformin background therapy.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus. 2. male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label. 3. hba1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit. 4. age 18 years or more at screening. 5. body mass index lower or equal to 45 kg/m2 at screening visit. 6. signed and dated written informed consent. exclusion criteria: 1. uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast. 2. use of any other antidiabetic drug (except metformin background therapy). 3. acute coronary syndrome, stroke or tia within 3 months prior to informed consent. 4. indication of liver disease. 5. impaired renal function. 6. gastrointestinal surgery. 7. treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight. 8. current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
feasibility study: evaluation of ulthera versus thermage for treating the face and neck

Conditions: Skin Laxity; Wrinkles

Summary: up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. group a will receive ultherapy™ on the right side of the face and neck and thermage on the left side. group b will receive thermage on the right side of the face and neck and ultherapy™ on the left side. follow-up visits will occur at 90 and 180 days post-treatment. study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

this is a prospective, single-center, double-blinded, split-face, randomized pilot study. a triple ultherapy® treatment and standard thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. patient satisfaction questionnaires will also be obtained.

Eligibility criteria:
inclusion criteria: * male or female, age 30 to 65 years. * subject in good health. * skin laxity on the area(s) to be treated. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * excessive subcutaneous fat in the area(s) to be treated. * excessive skin laxity on the area(s) to be treated. * significant scarring in the area(s) to be treated. * open wounds or lesions in the area(s) to be treated. * severe or cystic acne on the area(s) to be treated. * presence of a metal stent or implant in the area(s) to be treated. * inability to understand the protocol or to give informed consent. * microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study. * marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated. * bmi equal to or greater than 25.

Keywords: ulthera® system ultherapy™ treatment ulthera, inc. ultrasound treatment for skin tightening
hemodynamic measurements at different inclinations of the head

Conditions: Hypovolemic Shock

Summary: the purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

* check if values of central venous pressure (cvp), pulse pressure variation (δpp), heart rate (hr), mean arterial pressure ((pam) vary in different angles headboards * compare values of cvp, δpp, hr and map as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

Eligibility criteria:
inclusion criteria: * being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure \<90 mmhg or need for vasoactive drugs, urine output below 0.5 ml / kg / h. * being under sedation, assessed by the scale of richmond agitation and sedation (rass) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, peep to 8 cm h2o. * tue signing the informed consent by legal guardian. exclusion criteria: * presence cardiac arrhythmias. * presence of abdominal or thoracic trauma. * contraindication for passive elevation of the members. * hypoxia significant pao2/fio2 \< or equal 100.

Keywords: fluid administration cardiac output right atrial pressure resuscitation
bacteremia and procalcitonin levels in peroral endoscopic myotomy for achalasia

Conditions: Esophageal Achalasia

Summary: peroral endoscopic myotomy (poem) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional heller's myotomy. however, the issue of antibiotic prophylaxis in poem has evoked considerable controversy recently. therefore, we conduct this study to elucidate the status of poem-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

objective: to elucidate the status of poem-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed. interventions: patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for poem are randomized to either use antibiotic prophylactically or not. main outcome measurements: blood culture positive incidence; secondary outcomes are procalcitonin levels, c-reactive protein levels, white blood cell counts and so on.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of esophageal achalasia * ready to have the treatment as poem and no contraindication of poem * ability to get informed consent exclusion criteria: * patients who had indications for antibiotic prophylaxis as determined by the american society for gastrointestinal endoscopy * patients who had received antibiotics for any reason within the previous 7days * patients who had possible signs of any infection at the time of the procedure * patients who had chronic inflammatory diseases need hormonotherapy : such as rheumatic arthritis or inflammatory bowel diseases.

Keywords: esophageal achalasia antibiotic prophylaxis blood culture procalcitonin levels
adventure: teacher delivered personality-targeted interventions for substance misuse

Conditions: Alcohol Abuse; Drug Abuse; Depression; Panic Disorder; Conduct Disorder

Summary: several personality factors have been shown to be associated with risk for alcohol and substance misuse, and differentiate substance abusers based on clinical profile, treatment response and susceptibility to other forms of mental illness. personality-targeted interventions have been found to have significant preventative effects on onset and growth of drinking, binge-drinking and drinking problems in adolescents attending mainstream schools (conrod, castellanos \& mackie, 2008). the interventions concurrently reduced personality-specific emotional and behavioural problems (castellanos \& conrod, 2006), and prevented the onset and escalation of drug-use over a two-year period (conrod, castellanos-ryan \& strang, 2010). this cluster randomised controlled trial aims to examine whether these results can be replicated when interventions are delivered by trained educational professionals. in addition, the trial will evaluate the broader impact of the programme on cigarette smoking, school attendance, academic achievement and school-wide behaviours.

the adventure study aims to examine whether educational professionals such as teachers, mentors or individuals in a pastoral role, who are trained in carrying out personality-targeted interventions will be effective in reducing problem behaviours in a group of adolescents. 20 schools in london, u.k. were recruited for the trial, and over 2000 adolescents (mean age 13.7 years) consented to participate in the survey and intervention phases of the trial. schools were randomly assigned to control or intervention condition, and students in intervention schools who met the criteria for any of the 4 personality risk subscales of the substance use risk profile scale (negative thinking, anxiety sensitivity, sensation seeking and impulsivity) were invited to participate in a personality-targeted intervention by trained members of staff from their schools. all participants were invited to complete follow-up surveys at 6-month intervals for 2 years. the remaining 55% of low risk students in the grad were also followed to examine population-level effects of the intervention as well. the main outcome measures of this rct are alcohol and illicit drug outcomes. secondary measures include mental health symptoms, risky behaviour, school attainment and attendance, and school-wide behaviours. it is hypothesised that teacher-delivered personality-targeted interventions will have similar preventative effects on alcohol and drug use as reported by conrod et al (2008, 2010), in addition to the personality-specific intervention effects reported by castellanos \& conrod (2006). in addition, broader effects of the intervention on academic achievement and school-wide behaviour will be examined in this trial, both at the individual level and at the population-level.

Eligibility criteria:
inclusion criteria: * secondary school student exclusion criteria: * none
optical measurements of the skin surface to infer distinctions in myofascial tissue stiffness

Conditions: Tissue Pain

Summary: this study involves imaging the skin movements of surface tissue on the back. a clinician will perform assessment and intervention procedures manually, using manual and light movements of stretch and compression.

this study includes a demographic questionnaire, self-report on level of pain, application of ink to the skin, manual clinical assessments, and a massage intervention. the study will take place entirely in olsson hall. all information collected will be recorded using a randomized identification number. 1. upon arrival for the study, a participant will be asked to read, review, and sign this informed consent agreement. 2. next, the participant will be asked verbally to complete a demographic questionnaire. 3. the study team will verbally ask the participant to rate the current level of pain. 4. the participant will have been asked to bring clothes (e.g., sports bra, halter top, or swimming suit, etc.) to expose the upper back/neck region, and will change into those in an isolated room and within the overall laboratory space. a gown will be provided for additional privacy. 5. two researchers will be in the room during the session, with the gender of the researchers taken into account per participant. for example, for a male participant, the investigators plan to have a male researcher present during the session along with the female physical therapist. for a female participant, the investigators plan to have both the female physical therapist and a female researcher present. 6. the study team will apply non-toxic, washable ink to the participant's back in two 10 by 10 cm areas near the shoulder blades on either side of the body. 7. the participant will lie flat on a massage table. 8. a camera system will record the movements of the fingers of the physical therapist, along with the movements of the skin. the investigators will videotape the upper part of the participant's back. a participant's face will never be videotaped, nor will audio be recorded. 9. the physical therapist will conduct standard assessment procedures for about 2 minutes per side of the body, where the skin tissue will be compressed and slightly stretched 10. a soft tissue intervention, or massage, lasting about 15 minutes will take place in the participant's upper back/neck region. 11. another assessment like that prior will be performed. 12. the participant will again be verbally asked about the current level of pain.

Eligibility criteria:
inclusion criteria: * healthy or diagnosed with benign, non-vascular headache and associated cervical musculoskeletal dysfunction (e.g. tender spots, trigger points, stiffness. * adult male and female. exclusion criteria: * migraine headaches. * known cardiovascular, pulmonary, or metabolic disease. * any co-morbidities that could contribute to back or neck pain (e.g., head trauma, cancer, seizures, tumors, radiculopathies, rheumatoid arthritis, systemic auto-immune or inflammatory conditions).

Keywords: myofascial tissue skin surface optical imaging deformation
b cell functions in periodontitis

Conditions: Chronic Periodontitis; Aggressive Periodontitis

Summary: the inflammatory response involves many players from the immune response, including b lymphocytes. these cells are responsible for the synthesis of immunoglobulins in response to the presence of an antigen. they are characteristic of chronic inflammation. there are several subsets of b cells characterized by specific membrane markers. once activated, these cells express many factors contributing to tissue destruction seen in periodontitis and particularly in osteoclastogenesis (receptor activator of nuclear factor kappa-b ligand, tumor necrosis factor, interleukin-6, macrophage inflammatory protein-1α and monocyte chemoattractant protein-3). during the establishment of a periodontal disease, an important inflammatory infiltrate is observed in the gum. this infiltrate is characterized by the presence of many b lymphocytes. b cell subsets in the blood and the gum of patients with periodontitis have been little studied. however, the number of autoreactive b cells (cluster of differentiation (cd)19+, cd5+) has been reported to be higher in the blood of patients with periodontal disease. in the gum, the rate of b and t cells increases with the level of inflammation and is correlated with the severity of the inflammatory process. activation of b cells is a prerequisite for the progression of gingivitis to periodontitis. b cell distribution could then be an indicator of disease progression, but also allow to study the response to treatment. the aim of this pilot study is to characterize b cell subsets in the blood and the gum of patients with periodontitis, according to disease activity. analysis of b cells in the blood could highlight the association of a particular subpopulation with aggressive periodontal disease and evidence a particular biological profile of the host response. the investigators also wish to observe the evolution of this phenotype following an unconventional surgical therapy. this study would better understand the pathogenesis of periodontal disease and refine the diagnosis, prognosis and treatment of periodontitis, and thus participate in the development of personalized medicine. biological monitoring of therapeutic effects may be initiated and allow more effectively prevent recurrence.


Eligibility criteria:
inclusion criteria: * requiring periodontal surgery * in good health * having signed consent exclusion criteria: * minor * patient having taken antibiotics in the previous 3 months * patients with systemic diseases including chronic inflammatory disease * pregnancy * orthodontic treatment ongoing
investigating the relationship between triglycerides and fetal overgrowth in gestational diabetes

Conditions: Fetal Macrosomia; Obesity Complicating Childbirth; Gestational Diabetes

Summary: this is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.

gestational diabetes (gdm) is a condition of impaired insulin resistance which causes increased morbidity for mothers and newborns due to fetal overgrowth. traditionally, gdm is diagnosed with a glucose tolerance test, and treatment subsequently focuses singularly on glucose management. however, both glucose and triglycerides (tag) are fuels for fetal overgrowth. the central hypothesis is that the most effective understanding of fetal overgrowth needs to include both carbohydrates and triglycerides. the study will focus recruitment on patients who have gdm and bmi \> 35. the specific aims are 1) determine the relationship between tag levels during pregnancy and offspring size, 2) explore the relationship between tag levels during pregnancy and adipose tissue accrual (birth weight, body composition and adipose tissue distribution) from birth to six months old, and 3)examine the relationship between maternal tag levels and cord c-peptide levels. mothers are asked to check their serum triglycerides at the time of diagnosis of gdm and at the end of pregnancy. fingerstick blood measurements of triglycerides are also measured every 2 weeks at prenatal visits. at delivery, cord blood is collected. infants are examined at 0.5, 3, and 6 months after birth.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * diagnosis of gdm between 24-32 weeks * bmi \>= 30 exclusion criteria: * conditions known to impact fetal growth.these conditions can develop after study enrollment but cannot be present at enrollment. * autoimmune conditions treated with medication * chronic hypertension requiring medication * preeclampsia * fetal growth restriction diagnosis * smoking * illicit drug use * major fetal anomalies * fetal genetic conditions

Keywords: fetal macrosomia large for gestational age infant gestational diabetes maternal obesity triglycerides fatty acids fetal overgrowth
changes in high sensitive c reactive protien with different treatment modalities in acute pancreatitis

Conditions: Pancreatitis, Acute

Summary: changes in high sensitive c reactive protien with different treatment modalities in acute pancreatitis


Eligibility criteria:
inclusion criteria: * age\>=18 years * diagnosis of acute pancreatitis confirmed by at least 2 of the following: 1. typical epigastric abdominal pain 2. elevation amylase/lipase \>3 times upper limit normal and/or 3. confirmatory findings on cross-sectional imaging 4. enrollment within 8 hours of presentation exclusion criteria: * class ii or greater nyha heart failure * oxygen dependent copd * chronic kidney disease\>stage 2 * existing necrosis on abdominal ct * organ dysfunction prior to enrollment * sepsis * acute respiratory distress syndrome * malignancy not in remission for at least 5 years * active drug use * known allergy to dexamethasone * altered mental status * insulin-requiring diabetes * abdominal surgery within 60days