Kornimate/medical-research-clean huggingface dataset:
icp-248 in combination with orelabrutinib in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma

Conditions: Hematologic Malignancies

Summary: evaluate the safety, tolerability and pharmacokinetics of icp-248 in combination with orelabrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 80 years. 2. cll/sll is diagnosed by histopathology and/or flow cytometry according to the 2016 world health organization (who) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 international workshop on chronic lymphocytic leukemia (iwcll 2018): 3. having an indication for treatment that meets the criteria for iwcll 2018 4. subjects must have measurable lesion according to the lugano 2014 assessment criteria. 5. patients with an eastern cooperative oncology group (ecog) performance status (ps) score of ≤ 2 and a life expectancy of ≥ 6 months. 6. adequate hematologic function 7. patients with basically normal coagulation function 8. patients with adequate hepatic, renal, pulmonary and cardiac functions 9. subjects are able to communicate with the investigator well and to complete the study as specified in the study. 10. before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written informed consent form (icf). exclusion criteria: 1. central nervous system involvement. 2. concomitant richter transformation. 3. prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis. 4. requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days. 5. history of allogeneic stem cell transplantation. 6. major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial. 7. presence of active infection that requires intravenous anti-infective therapy. 8. hepatitis b or c virus infection. 9. history of immunodeficiency disease or significant cardiovascular disease 10. central nervous system disorders or severe bleeding disorder 11. alcohol or drug dependence. 12. mental disorders or poor compliance.
fistula laser closure

Conditions: Fistula;Rectal

Summary: the anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function. for several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence. recently there is one of them , named filac using a clip system not yet evaluated. the purpose is to assess the success rate of his new surgery technique.


Eligibility criteria:
inclusion criteria: * patient with anal fistula drained at least 3 months before inclusion. exclusion criteria: * fistula not well drained
research framework exploring sleep health

Conditions: Sleep; Sleep Apnea; Obesity; Mood

Summary: this is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. we are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * residing within the united states * ability to use the refresh app on the participant's own smartphone device exclusion criteria: * in-ability to consent
the effect of a pre-meal snack and/or exercise on post-prandial glycemic excursions in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the investigators aim to test the feasibility and effectiveness of a pre-meal snack to reduce the postprandial glycemia (ppg) excursion after a breakfast consumption in adult patients with cystic fibrosis (cf). the investigators also want to investigate the impact of a postprandial exercise to reduce the ppg excursion. an improvement in ppg excursions can improve the condition of cf patients primarily by delaying the onset of cystic fibrosis related diabetes (cfrd) and / or by reducing the risk of lung function loss.

the investigators are proposing a randomized pilot study to explore the impact of a soy beverage of carbohydrates and protein early in the morning, to stimulate and initiate secretion of insulin to reduce ppg excursions of the following a lunch in adult patients with cf. investigators will also study the impact of a post meal exercise on the ppg excursion. fourteen participants will be included and will each perform a 4-hour intervention in cross over design according to those 4 following experimental conditions: 1. consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (cho) for men and 80g for women; sedentary activities throughout the study \[condition control\] 2. consumption of 200ml of soy beverage + 90g of carbohydrate (cho) breakfast for men and 80g for women; sedentary activities throughout the study \[snack effect on ppg excursion\] 3. consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (cho) for men and 80g for women + physical activity practice (3min walk at 60% vo2max every 30 minutes, x5); \[exercise effect on the ppg excursion\] 4. consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (cho) breakfast for men and 80g for women + physical activity practice (3min walk at 60% vo2max every 30 minutes, x5). \[combined snack and exercise effect on the ppg excursion\] main result: plasma glucose area under the curve. the underlying mechanisms, insulin, incretin hormones (glp-1 and gip), acceptability and side effects (mealtime hyperglycaemia) should also be measured. at the end of this pilot project, the investigators will have established a pre-meal snack and/ or postprandial exercise have a positive impact on ppg.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis, * be over 18 years old. exclusion criteria: * pharmacological treatment for cystic fibrosis related diabetes. * signs of secondary infection: the test will be practiced at least 1 month after the end of infection treatment * people with severe gastrointestinal illness (crohn's disease, celiac disease and a recent history (\<1 year) of bowel obstruction). * allergy to one of the ingredients of the menu (example: celiac disease) * according to the judgment of the investigator, medications or conditions that could interfere with glucose metabolism (eg: oral steroids) * pregnancy in progress * corrector or potentiator prescribed whose dose is not stable the last 2 months.

Keywords: glycemia
a feasibility trial of tazemetostat plus car t cell therapy in b-cell lymphomas

Conditions: Follicular Lymphoma; B-Cell Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma

Summary: this is a clinical trial to evaluate the feasibility and safety of giving tazemetostat followed by standard of care car t cell infusion in previously treated diffuse large b-cell lymphoma (dlbcl), follicular lymphoma (fl), and mantle cell lymphoma (mcl). the investigators hypothesis is that this combination has the potential to significantly improve the ability of cart cells to recognize and kill lymphoma cells without a significant impact on safety. participants will receive the tazemetostat pills before and after receiving their car t cell therapy, for up to 12 months after car t cell administration. patients will be followed for up to 5 years.

this is a single arm, open label, clinical trial to evaluate the feasibility and safety of oral tazemetostat followed by standard of care car t cell infusion in previously treated dlbcl, fl, and mcl. the investigators hypothesis is that this combination has the potential to significantly improve the ability of cart cells to recognize and kill lymphoma cells without a significant impact on safety. tazemetostat 800 mg will be given twice daily by mouth for at least 1 week prior to apheresis, during the period between apheresis and car t infusion, and following lymphodepletion chemotherapy until day 7 post-car t therapy. once patients' platelets and neutrophil counts recover, tazemetostat will be resumed. tazemetostat treatment will continue for up to 6 months in patients with complete responses and up to 12 months in patients with partial responses. a 3+3 trial design will be implemented for the first six patients enrolled. the regimen will be considered feasible if at least 12 out of 15 subjects are able to receive at least 2 weeks of tazemetostat, generate the car t cell product and receive car t cell therapy.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of dlbcl, fl, or mcl * eligible to receive standard of care car t cells * have received at least 1 prior therapies exclusion criteria: * active viral infection with hiv or hepatitis type b or c * active, uncontrolled systemic fungal, bacterial or viral infection * active treatment for another cancer * pregnant or breastfeeding * unable to take oral medication * certain significant past medical history, such recent stroke, pulmonary embolism, myocardial infarction, congestive heart failure, uncontrolled hypertension, or certain arrhythmias

Keywords: car t-cell tazemetostat fl mcl dlbcl
squeeze trial: a trial to determine whether septic shock reversal is quicker in pediatric patients randomized to an early goal directed fluid sparing strategy vs. usual care

Conditions: Septic Shock

Summary: the purpose of the squeeze trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. in this study, eligible children will be randomized to either the 'usual care arm' or the 'fluid sparing arm'. children will receive treatment according to current accm septic shock resuscitation guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve accm recommended hemodynamic targets.

please see published pilot trial protocol for more information about the squeeze trial and rationale for this study.

Eligibility criteria:
inclusion criteria: inclusion criteria for 1 and 3 must be answered yes to be eligible for study. * age 29 days to less than 18 years of age * patient has persistent signs of shock including one or more of the following: * vasoactive medication dependence * hypotension (systolic blood pressure and/or mean blood pressure less than the 5th percentile for age) * abnormal perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output) * suspected or confirmed septic shock (shock due to suspected or confirmed infectious cause) * patient has received initial fluid resuscitation of: minimum of 40 ml/kg of isotonic crystalloid (0.9% normal saline and/or ringer's lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing less than 50 kg, or minimum of 2 litres (2000 ml) of isotonic crystalloid (0.9% normal saline and/or ringer's lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing 50 kg or more. * patient has fluid refractory septic shock as defined by the presence of all of 2a, 2b, and 2c. exclusion criteria: * patient admitted to the neonatal intensive care unit (nicu) * patient requiring resuscitation in the operating room (or) or post-anesthetic care unit (pacu) * full active resuscitative treatment not within the goals of care * shock secondary to cause other than sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock) * previous enrolment in this trial, where known by the research team

Keywords: sepsis shock septic shock fluid therapy resuscitation pediatrics emergency medicine critical care
craving to biologics used in severe asthma

Conditions: Asthma

Summary: some patients treated with biologics for severe asthma experience a craving to the next biological administration. this phenomenon has never been described before. in this study, the researchers aim to further elucidate the feeling of needing the next administration of a biologic for severe asthma.

recent research by kroes and colleagues on omalizumab levels has shown that approximately half of patients on long-term omalizumab therapy (\>4 months) experience a subjective craving for the next dose. these patients had a need (borg scale 3-10) for the next dose of biologic before the usual periodic dose, while other patients indicated that they had no or a low need (borg scale 0-2) for the next dose at the usual dosing moment. this so-called 'craving' has not been described in the literature before. patients in the high-requirement group had significantly lower median omalizumab trough levels than patients in the low-requirement group. there may be a relationship between blood levels of biologics and the need for the next dose. however, data is currently only available on the variability in serum trough levels of omalizumab, but not yet on the other biologics for asthma, some of which are administered as a fixed dose and some are dosed by body weight. no assays are currently available for blood level determinations from the other biologics. before investigating the relationship between blood levels and the need for biologics, it is important to fully map the 'craving'. some patients who are responders to biologic therapy based on improvements in clinical outcomes still do not have good enough control of their asthma and indicate that the dosing interval is not optimal. in addition to patients that indicate a need for the next dose, there are also patients that would like a longer dosing interval. to date, dosing interval adjustments have been made based on the patient's subjective experience and the physician's clinical judgment. this study investigates how big the problem of need for the next dose is, how patients experience this need, what this need exactly entails, whether this occurs more often in patients treated for a longer period and what possible problems patients experience in the treatment with biologics against serious problems.

Eligibility criteria:
inclusion criteria: * treated with a biologic for severe asthma in the medical centre leeuwarden for more than 4 months exclusion criteria: * not speaking dutch

Keywords: biological treatment patient-reported outcome measures treatment evaluation
intracoronary bolus only compared with intravenous bolus and 12-hours infusion of abciximab in non-st elevation myocardial infarction.

Conditions: Myocardial Infarction; Angioplasty

Summary: intracoronary bolus abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in non-st elevation myocardial infarction.


Eligibility criteria:
inclusion criteria: * non-st segment elevation acute myocardial infarction * within 48 hours presence of chest pain * troponin-t or i positive before cag * first myocardial infarction * will be performed coronary angioplasty exclusion criteria: * under 18 years of age,80 years or older * bleeding tendency * history of major surgery within 4 weeks * major stroke within 2 years * thrombocytopenia (\<120,000 / ul) * cardiogenic shock * known allergy to aspirin, heparin, or abciximab * contraindication of mri at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc) * chronic atrial fibrillation * pregnancy

Keywords: abciximab myocardial infarction angioplasty platelet
rta 402 in patients with advanced solid tumors or lymphoid malignancies

Conditions: Advanced Solid Tumors; Lymphoid Malignancies

Summary: this study assesses the tolerability, safety, efficacy and pharmacokinetics of bardoxolone methyl (rta 402) in advanced solid tumors and lymphoid malignancies.

bardoxolone methyl (rta 402) is a synthetic triterpenoid that has demonstrated significant in vivo single agent anti-cancer activity. this is an open-label phase i dose-escalation study of bardoxolone methyl (rta 402) administered orally for the first 21 days of a 28-day cycle.

Eligibility criteria:
inclusion criteria: * histopathological documentation of solid tumor or lymphoid malignancy. * advanced or metastatic cancer that is either refractory to or have relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. * ecog performance status of less than or equal to 2 * adequate liver and renal function as documented by the following laboratory test results within 14 days of starting therapy: total bilirubin ≤ 1.5 mg/dl; ast (sgot) and alt(sgpt) ≤ 2.5 uln or ≤ 5 uln if liver is involved by tumor; serum creatinine ≤2.0 mg/dl or creatinine clearance \>60 ml/min. * adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy: platelets greater than 100,000/mm3, absolute granulocyte count greater than 1,500/mm3, hemoglobin greater than or equal to 8.0 g/dl. * completion of prior chemotherapy, hormonal therapy, radiation therapy, biological therapy, or other investigational cancer therapy, for at least 4 weeks prior to study entry and must have recovered from all acute side effects (to ctc grade 1 or less) prior to initiation of rta 402. patients who were receiving mitomycin c or nitrosoureas must be 6 weeks from the last administration of chemotherapy. * agree to practice effective contraception during the entire study period. * life expectancy of more than 3 months * able and willing to sign the informed consent form. * willing and able to self-administer orally and document all doses of rta 402 ingested. exclusion criteria: * active brain metastases or primary cns malignancies. * pregnant or breast feeding * clinically significant illnesses including, but not limited to: uncontrolled diabetes; active or uncontrolled infection; acute or chronic liver disease; confirmed diagnosis of hiv infection; uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia. * psychiatric illness that would limit compliance with study requirements.
brain indices of stimulant treatment in drug-naive youth at risk for substance use disorder

Conditions: Attention Deficit Disorder With Hyperactivity; Conduct Disorder; Substance Abuse

Summary: childhood adhd and comorbid oppositional defiant disorder (odd) and conduct disorder (cd) are considered risk factors for subsequent substance abuse, and youth with both adhd and odd/cd are at greatest risk. however, the effects of treatment of adhd with stimulant medications such as methylphenidate (mph) and mixed amphetamine salts (mas) on risk for substance abuse are poorly understood. the study team propose to use fmri to study the effects of extended release mixed amphetamine salts (mas-xr) in drug-naïve youth 7-12 years at low risk (i.e., adhd only) and high risk (i.e., adhd + odd/cd) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.


Eligibility criteria:
inclusion criteria: * general: pre-pubertal (e.g. tanner stage 1 or 2) * age 7-12 inclusive * signed consent/assent * parent communicates sufficiently in english * has adhd as determined by parent interview * adhd-rating scale-5 total score (interview with parent) of 1.5 sd \> age/sex norms * youth with cd or severe odd: cd or odd + 2 symptoms of cd exclusion criteria: * major neurological/medical illness * history of head injury * fetal exposure to alcohol/drugs; * diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, tourette's disorder, ptsd, autism spectrum disorder) current suicidal ideation or past history of suicide attempt * wechsler abbreviated scale of intelligence (wasi) score \<75; 7) * current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline; youth who had a past, brief stimulant medication exposure of no more than about a month, and not within the past 6 months may be included .) * current or past alcohol/drug use (interview; urine toxicology) * psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity) * metal in the body that cannot be removed * visual disturbances that may impair task performance * precocious puberty (e.g. tanner stage \>2).

Keywords: adhd substance abuse risk adderall fmri adhd treatment medication
outcome of laparoscopic appendicectomy versus open appendicectomy in sudanese patients

Conditions: General Surgery

Summary: background: laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. it affords a direct diagnosis of the problem, allows determination of the appropriate treatment. open appendectomy is global treatment of acute appendicitis can be done by many incisions, and associated with considerable complications. materials and methods: this is a cross sectional descriptive hospital-based study to study the outcome of laparoscopic appendectomy versus open appendectomy at elmak nimer university hospital over the study period. all patients in the study period who underwent appendectomy was included, data is collected through standard structured data collection sheet and analyzed by using spss v24.0.


Eligibility criteria:
inclusion criteria: * all patients in the study period who underwent appendectomy were included. exclusion criteria: * patientspresented with complicated appendicitis * acute appendicitis with comorbiditites * pregnant ladies * patients of stump appendicitis . * patient with inadequate data
evaluation of the physiopathological phenomena and the haemodynamic and cerebral metabolic effects from semi-seated position to lying position in patients with brain trauma

Conditions: Traumatic Brain Injury

Summary: brain trauma is an important burden in traumatologic intensive care. in these patients the treatment is guided by a cluster of multimodal monitoring parameters. despite this it is difficult to assess the actual physiopathologic status of the brain. changing the position of these patients (semi-seated to lying position) causes changes in the hémodynamics brain conditions, so in monitoring parameters . the analysis of these changes can givr us valuable clinically informations.

severe brain trauma (cgs \< 8 ) are included. pic, pa, pvc, ekg, airway pressure, sjo2 and nirss are continuously monitored. the patients are in semi seated (30°) position. once a day they are in supine (0°) for 30 minutes. we record every parameters before and at the end of this supine period. after time domain and frequency domain signal processing, this parameters are compared to deduct clinical relevant conclusions.

Eligibility criteria:
inclusion criteria: * patients with a severe head trauma estimated by the glasgow coma scale and by the glasgow outcome scale * age \> 18 exclusion criteria: * other neurological pathology