Kornimate/medical-research-clean huggingface dataset:
treatment with atra-iv and depakote in patients with advanced solid tumor malignancies

Conditions: Solid Tumor Malignancies

Summary: the purpose of this study is to find out the highest tolerated dose of depakote in combination with liposome encapsulated all-trans retinoic acid (atra-iv) in patients with advanced solid tumor malignancies.

to determine the maximum tolerated dose of depakote in combination with liposome encapsulated all-trans retinoic acid (atra-iv) in patients with advanced solid tumor malignancies. this will be a 2-step dose escalation study. once the patient starts therapy at a designated dose level, it will not be escalated for that patient. three patients at each dose level must complete 4 weeks of therapy before escalating to the next higher level. if none of the patients experience dose limiting toxicity (dlt), then 3 new patients will be treated with the next higher dose level.

Eligibility criteria:
inclusion criteria: * patients with histologic confirmation of a solid tumor malignancy with clinical evidence of metastatic disease. * patients must have failed at least one standard therapy, if available, for their malignancy. patients may be entered on the trial without prior therapy if there is no standard effective therapy available. * no active brain metastases or epidural tumor. exclusion criteria: * concomitant administration of steroids. * irradiation or chemotherapy within 14 days of start of protocol. * evidence of another active cancer, except for non-melanoma, carcinoma of the skin and in-situ carcinoma of the cervix curatively treated, stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for greater than 5 years. * women who are pregnant or lactating. women or men of reproductive age who are unwilling to use two forms of effective contraception. * patients with clinically significant cardiac, renal or hepatic disease; severe debilitating pulmonary disease; or history of diabetes mellitus prone to ketoacidosis. * patients with a history of pancreatitis. * patients with known hypersensitivity to retinoids or retinoic acid derivatives. * patients with coagulation disorders, such as thrombophlebitis or pulmonary embolism. * patients with pre-existing psychiatric condition, especially depression or a history of severe uncontrolled psychiatric disorder. * patients with pre-existing thyroid abnormalities whose thyroid function cannot be maintained in the normal range. * patients with chronic moderate to severe nausea. * patients with history of epilepsy or a seizure disorder taking anti-convulsant medication.

Keywords: solid tumor malignancies
optimizing attention and sleep intervention study

Conditions: Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Hyperactivity Disorder; Child, Preschool; Sleep; Sleep Disturbance

Summary: the goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (pbi) to a modified sleep focused pbi (sf-pbi) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early adhd symptoms. the main aims are to: aim 1: demonstrate the acceptability, feasibility, and appropriateness of the sleep focused pbi (sf-pbi) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for adhd. aim 2: examine change in target engagement (sleep) and adhd symptoms among preschool-aged children at elevated risk for adhd receiving sf-pbi compared to standard pbi.

sleep problems may be one mechanism through which young children may be at risk for developing adhd, although first line adhd interventions, including parent behavioral interventions (pbis), do not address sleep. investigators will test a modified version of a pbi to target sleep disrupting behaviors for children 3-5 years old at elevated risk for adhd. the intervention will be delivered by behavioral health therapists embedded in pediatric primary care to increase families' access to intervention. this pilot effectiveness trial is the first step towards developing an early intervention targeting sleep as a mechanism to reduce the prevalence, symptoms, and impairments associated with childhood adhd.

Eligibility criteria:
inclusion criteria: parent/caregiver: * (1) legal guardian is at least 18 years of age * (2) reads and speaks english child: * (1) 3-5 years of age * (2) caregiver report of 4 or more adhd symptoms * (3) caregiver reports child's sleep as a "moderate" or "serious problem" * (4) english speaking * (5) child receives care from participating pediatric primary care office exclusion criteria: * (1) sleep interfering medical diagnoses (e.g., narcolepsy, obstructive sleep apnea) * (2) severe neurodevelopmental disorder
corneal crosslinking treatment study

Conditions: Progressive Keratoconus

Summary: three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.

riboflavin does not penetrate the intact corneal epithelium. corneal cross linking (cxl) is typically performed using the so-called "dresden protocol". the dresden protocol states 30 minutes of uva-radiation (3mw/cm2) but a 10 minute irradiation protocol (9mw/cm2) is frequently used. both of the protocols involve mechanical removal of the epithelium over the central 8 mm of the corneal surface. the first days after treatment therefore involves some degree of pain, often intense, and the presence of a healing epithelial defect may be associated with development of infiltrates in the cornea. a number of approaches have been evaluated in order to promote riboflavin penetration through the intact epithelium, of which iontophoresis appears most promising. keratoconic corneas are thin at the cone location and sometimes it is difficult to maintain the safety margin of 400 microns during corneal crosslinking. instead of using isotonic standard riboflavin, a swelling effect of the cornea can be obtained by using hypotonic riboflavin. however, the latter has been indicated as less effective in the process of inducing cross links. eighty-one of 81 patients of various degrees of keratoconus will be randomised to one of the following groups: 1) cxl (uva 9mw/cm2) using isotonic riboflavin, or 2) cxl (uva 9mw/cm2) using hypotonic riboflavin or 3) iontophoresis with ricrolin with following cxl (uva 9mw/cm2). hypothesis: i) cxl with hypotonic riboflavin or cxl with ricrolin administered by iontophoresis or cxl with isotonic riboflavin is non-inferior compared to standard cxl with isotonic riboflavin. ii) the morphological structure post-cxl in the three different groups will be similar without any significant differences. the iontophoresis-assisted treatment arm has been interrupted due to low efficacy in halting disease progression. the results have been published.

Eligibility criteria:
inclusion criteria: * progress in keratoconic eye. we define progress as an increase in kmax of 1.0 diopter in 1 year or 0.5 diopter in 6 months. this increase in kmax will be accepted as progression if concomitant changes tomographic parameters. exclusion criteria: * concurrent ocular infection or corneal disease other than keratoconus. * pregnancy. * treatment with isotretinoin.

Keywords: corneal crosslinking
liposomal doxorubicin and estramustine phosphate: study in taxane resistant, hormone refractory advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research study is to test the safety, tolerability, and effectiveness of the drug combination of doxil (doxorubicin) and estramustine when used to treat prostate cancer that is resistant to hormones and to a chemotherapy type called taxanes. the primary hypothesis is to reduce the measurable disease or prostate-specific antigen (psa) level by at least 50% from baseline.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed advanced, prostate cancer * patients must have evaluable disease that may be evaluated by psa or measurement. * patients must be hormone refractory as defined in this protocol. * patients must be taxane refractory as defined in this protocol. * patients have had no prior chemotherapy other than a taxane or estramustine phosphate. * patients may have had prior radiation therapy (rt) if it has been \>/= 4 weeks since completion. * patients on bisphosphonates may be included. * patients must be at least 18 years of age or older. * patients must have the ability to speak and understand english. * patients must have an ecog performance status of 2 or less. * patients must have adequate bone marrow function: platelets \> 100,000 cells/mm3; hemoglobin \> 9.0 g/dl; and absolute neutrophil count (anc) \> 1,000 cells/mm3. * patients must have adequate renal function: creatinine \< 2.5 mg/dl. * patients must have adequate liver function. * ejection fraction of \> 50% within 42 days of first dose of study drug. * ability to complete the mcgill-melzack pain intensity scale. exclusion criteria: * patients with unstable medical conditions such as liver, renal dysfunctions, blood clots or heart disease. * history of hypersensitivity to doxorubicin. * history of class ii cardiac disease or evidence of congestive heart failure. * rt within the past 4 weeks of study entry or a radiopharmaceutical within the past 8 weeks of study entry. * prior malignancy within the past 5 years except for non-melanotic skin cancers.

Keywords: hormone refractory taxane refractory
app for strengthening services in specialized therapeutic support

Conditions: Autism Spectrum Disorder

Summary: in partnership with a digital health software company, the university research team created two versions of a mobile application to help behavioral health technicians (bht's) who work with students with autism collect data. the first version comprises a basic electronic platform for data collection. the second version has the same basic electronic platform for data collection, plus additional features designed to increase motivation to collect data and ease the burden of data collection.


Eligibility criteria:
inclusion criteria: * participants must be working as a paraprofessionals or behavioral health technicians * currently providing individual support to children with autism * currently providing services in philadelphia preschools, schools, day cares, or homes. exclusion criteria: * n/a

Keywords: data collection autism behavioral health technician (bht) behavioral economics implementation implementation strategy implementation science therapeutic support staff (tss)
to study the pathophysiological features of multiple sclerosis

Conditions: Multiple Sclerosis; Neurofilament Light Chain; Glial Fibrillary Acidic Protein

Summary: multiple sclerosis (ms) is the most common chronic inflammatory disease of the central nervous system1, whose demyelination is the pathological hallmark. ms is characterized by neuroinflammation, demyelination, axonal damage, and neurodegeneration2. the demyelination state in brain and the clinical course are difficult to predict in the early stage of disease. recently, several neuroimaging and fluid biomarkers had been explored in ms. using brain amyloid positron emission tomography (pet) in active ms had showed that both the damage sites and normal appearance white matter had a lower intensity than non-active ms. the result suggests a predictive role that the intensity from amyloid pet could reflect the disease activity and link to early myelin damage. the levels of tau protein in cerebrospinal fluid (csf) had also been showed a negative correlation with brain atrophy, which is a prognostic marker for ms. in fluid biomarkers, both neurofilament light chain (nfl) and glial fibrillary acidic protein (gfap) had been used in ms and reported correlations with disease severity, the extent of neuroinflammation and progression. in current study, investigator will enroll 38 participants with ms and evaluate their clinical severity; measure the wm lesion and disease activity by magnetic resonance imaging (mri); myelination state and amyloid deposition by amyloid pet scan; tau deposition by state of-art tau pet scan. investigator also measure the serum levels of nfl and gfap as the index of axonal injury and disease activity. the relationship between disease severity, brain myelination, tau deposition and serum levels of nfl will be discuss.


Eligibility criteria:
inclusion criteria: 1. age between 20-75 years old 2. multiple sclerosis patients exclusion criteria: 1. implantation of metal devices including cardiac pacemaker, intravascular metal devices. 2. major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous severe head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases. 3. major psychiatric disorders, drug or alcohol abuse and major depression 4. pregnant women or breast- feeding women. 5. patients in whom mri was contraindicated or patient had claustrophobia. 6. history of severe allergic or anaphylactic reactions particularly to the tested drugs. 7. history of positive test for human immunodeficiency virus (hiv). 8. indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase \[ast\] and alanine aminotransferase \[alt\] ≧ 3x the upper limit of normal values).
aerosol deposition in asthmatic obese women using heliox

Conditions: Obese; Asthma

Summary: background: the aim of this study was to assess pulmonary deposition and distribution of radio-aerosol in obese and normal women, using 2-d planar scintigraphy. methods: after inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mtc - dtpa) with an activity of 1 mci in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler.

background: obese asthmatics are difficult to treat effectively, worse asthma control, and do not respond as well to standard therapy as lean asthmatic. medical aerosols an important route of drug delivery in asthma, but narrowing in the airway cause by the obesity, can provoke turbulence and the effectiveness of the treatment could be compromise. aim: to assess pulmonary deposition, distribution of radio-aerosol and analyze upper way dimension in obese and normal weight women, using 2-d planar scintigraphyand and computed tomography. methods: 20 obese women, 10 asthmatics and 10 non-asthmatics took part of the first part of the study. anthropometric and clinical assessments were carried out, than lung function was performed. after randomization of the sequence of gas (sequence 1- oxygen and heliox; sequence 2-heliox and heliox) that would be used to inhale an aerosol with technetium labeled diethylenetriamine penteacetic acid (99mtc - dtpa) with an activity of 1 mci in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler. all patients inhaled two times with one week of washout between then to eliminate risk of residual trace radiation and to avoid the possibility of bias.

Eligibility criteria:
inclusion criteria: * were women with body mass index (bmi) ≥30kg/m2 for obese and bmi =18.5 - 24.9 kg/m2 for the control group * age between 18 to 60 years old * with and without moderate to severe asthma * positive response to bronchodilator (improvement in fev1 and/or fvc of at least 12% and 200ml). exclusion criteria: * were women with active pulmonary disease other than asthma * neuromuscular diseases * smokers and those incapable of performing procedures were excluded.
femoral blood gas and prediction of postoperative bleeding

Conditions: Postoperative Hemorrhage; Blood Transfusion

Summary: postoperative bleeding is still an important concern after major abdominal surgery. postoperative bleeding is the most important determinant of morbidity and death. it results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. the purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible.


Eligibility criteria:
inclusion criteria: * patients with major abdominal surgery * postoperative intensive care unit following * accepting to participate in research exclusion criteria: * age under 18 years old * pregnant patients * do not accept to participate of study

Keywords: abdominal surgery postoperative hemorrhage blood transfusion
physical therapy for liver cirrhosis

Conditions: Liver Cirrhosis, Biliary

Summary: patients with liver cirrhosis have severe physical deconditioning. aim: to compare between the effect of neuromuscular electric stimulation(nmes) and exercises (ex)on treatment of patients with liver cirrhosis.

70 patients have been chosen from department of internal medicine, cairo university hospitals, egypt. 5 patients refused to participate .65 patients divided randomly into 2 groups. all the procedures were explained to patients.2 patients refused to sign informed consent and excluded from the study. 31 patients in group1 and 32 patients in group2. 1patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed. thirty patients in each group signed an informed consent and complete the treatment program.

Eligibility criteria:
inclusion criteria: * positive for anti-hcv. * not under antiviral therapy at entry. * positive for chronic hepatitis or compensated cirrhosis. * negative for hepatitis b surface (hbs) antigen. * free of co-infection with hiv. * not pregnant. * systolic blood pressure of less than 180 mmhg or diastolic blood pressure of less than 110 mmhg. * (viii)no ischemic heart disease or severe arrhythmia exclusion criteria: * significant cardiac disease (ejection fraction \<60% or history of coronary artery disease). * chronic renal failure on dialysis. * hemoglobin \<11.0 g/l. * human immunodeficiency virus infection. * hepatocellular carcinoma. * active non-hepatocellular carcinoma related malignancy. * myopathy. * any physical impairment or orthopedic abnormality preventing ex, or post-liver transplantation

Keywords: liver cirrhosis exercises neuromuscular electric stimulation exercise capacity quality of life
acute hemodynamic response to carvedilol predicts survival in aclf patients

Conditions: Acute-On-Chronic Liver Failure

Summary: clinically significant portal hypertension (csph) is defined as hvpg \>10 mmhg. patients with csph are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). hvpg is calculated by subtracting the free hepatic venous pressure (fhvp), a measure of systemic pressure, from the wedged hepatic venous pressure (whvp), a measure of hepatic sinusoidal pressure. hvpg is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (pht) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. acute hemodynamic response to intravenous propranolol with hvpg values coming down to \ 20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. hence we are planning the current work to study the acute hemodynamic response to carvedilol predicts survival in aclf patients - "act - c aclf study

to assess whether acute hemodynamic response to oral carvedilol can predict short term outcome in aclf patients. • to determine the best cut off to define acute hemodynamic response in aclf patients primary outcome - predictive value of acute hvpg change by carvedilol for 28 day transplant free survival in patients of aclf secondary outcome - (1) complications \[pht related bleed, aki, infections, he, hypotension, cardiac side effect\] within 90 days (2) transplant-free survival rate at 90 days (3) correlation with evolution of aarc score by 2 week (b) methodology study population: patients of age 18 to 70 years with aclf fulfilling the conditions as per inclusion and exclusion criteria baseline parameters that will be recorded: 1. baseline characteristics: 2. history and etiology of liver disease 3. symptomatology, evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc) 4. clinical and demographic profile 5. endoscopy stopping rule of study: 1. progression to exclusion criteria 2. in case of hypotension(\<90/60mmhg) or heart rate \<60 after carvedilol 3. potential liver transplant within 90 days

Eligibility criteria:
inclusion criteria: 1. age 18-70 yrs 2. aclf diagnosis (aarc criteria) exclusion criteria: 1. contraindications to nsbb (heart rate \< 65 /min, bp \< 110/65 mm hg, asthma, heart failure, aki, large ascites, sbp, s. na \< 125meq/l) 2. pvt 3. hcc 4. bcs 5. he grades 2-4 6. nsbb therapy within 5 days 7. pregnancy 8. lactation 9. planned for lt in the next 12 weeks 10. no consent.