Kornimate/medical-research-clean huggingface dataset:
avatrombopag for hcc patients with thrombocytopenia who intend to undergo tace and/or haic

Conditions: Thrombocytopenia; Hepatocellular Carcinoma

Summary: this study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in patients with hepatocellular carcinoma (hcc) who intend to undergo transarterial chemoembolization (tace) and/or hepatic arterial infusion chemotherapy (haic).

this is a single-center, prospective study to evaluate the efficacy of avatrombopag for thrombocytopenia in hcc patients who intend to undergo tace and/or haic. 30 hcc patients with thrombocytopenia will be enrolled in this study. avatrombopag (platelet count \[plt\] \<40×10\^9/l, 60mg p.o. qd; plt of 40-75×10\^9/l, 40mg p.o. qd) will be administered to the patients and last 5-10 days. when the plt reaches ≥100×10\^9/l, the treatment will be discontinued. the primary end point of this study is the proportion of patients with plt \>75×10\^9/l or doubling from baseline. the secondary endpoints are the proportion of patients with plt \>75×10\^9/l, the proportion of patients with plt doubling from baseline, the increace in plt, the proportion of patients who successfully receive tace/haic, .adverse events.

Eligibility criteria:
inclusion criteria: * hcc with diagnosis confirmed pathologically or clinically * patients who need to receive tace and/or haic, or have plans to undergo another treatment (3-6 weeks after the previous treatment) * child pugh class a or b * ecog ps 0-2 * plt ≤ 75×10\^9/l (10 days before interventional therapy) exclusion criteria: * thrombocytopenia caused by hematological diseases, non chemotherapy related thrombocytopenia (excluding liver cirrhosis with hypersplenism) * plt \<30×10\^9/l * history of hepatic encephalopathy, refractory ascites, or hepatorenal syndrome * history of arterial or venous thrombosis within 6 months * uncontrolled severe infections * pregnant or breastfeeding female patients * immune deficiencies, such as autoimmune diseases, hiv infected individuals, etc * anticoagulation or antiplatelet therapy witch cannot be suspended during the treatment period: heparin, warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, ticlopidine, clopidogrel, glycoprotein iib/iiia antagonists, erythropoietin, etc; * administration of blood products within 7 days prior to the baseline visit (excluding albumin infusion) * allergy to avatrombopag or any of its formulations * history (such as gastrointestinal bleeding within 3 months, high risk of thrombosis, such as portal vein main flow velocity\<10cm/s) which may affect the safety of the patients or their ability to complete the study

Keywords: thrombocytopenia hepatocellular carcinoma transarterial chemoembolization hepatic arterial infusion chemotherapy
defining the functional and neuro-protective potential of acthar in acute optic neuritis

Conditions: Optic Neuritis

Summary: the goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following acthar treatment.

determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following acthar treatment.

Eligibility criteria:
inclusion criteria: * unilateral acute demyelinating optic neuritis * able to provide informed consent * age 18 or older * can perform the above listed electrophysiologic diagnostic testing * can perform high and low contrast visual acuity and visual field perimetry exclusion criteria: * prior diagnosis of remitting/relapsing multiple sclerosis(rrms) * secondary progressive ms(spms) * primary progressive ms (ppms) * undergoing treatment with medications approve for treatment of rrms(except corticosteroids for a condition not involving central nervous system demyelination) * prior diagnosis of systemic lupus erythematosis * mixed connective tissue disease * vasculitis * sarcoidosis * neuro-myelitis optica

Keywords: acute optic neuritis
clinical study of desmoteplase in japanese patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to japanese patients with acute ischemic stroke

the study is a safety and tolerability study of desmoteplase in japanese patients with acute ischemic stroke. the study will test two doses

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute ischemic stroke * provided informed consent * male or female * aged between 20 and 85 years inclusive * treatment within 3-9 hr after onset of stroke symptoms. * nihss score of 4-24 inclusive with clinical signs of hemispheric infarction * must receive imp within 60 minutes after brain imaging * cerebral artery occlusion or high-grade stenosis in mca exclusion criteria: * pre-stroke mrs score of \>1 * previously exposed to desmoteplase * scores \>2 on nihss question 1a indicating coma * history or clinical presentation of ich, subarachnoid haemorrhage (sah), arterio-venous malformation (avm), moyamoya disease, cerebral neoplasm or aneurysm * current use of oral anticoagulants and a prolonged prothrombin time (inr \>1.6) * treated with heparin in the previous 48 hours and has a prolonged partial thromboplastin time * baseline platelet count \<100,000/mm3 * baseline haematocrit of \<0.25 * baseline blood glucose \ 200 mg/dl * uncontrolled hypertension defined by a blood pressure, systolic \>185 mmhg or diastolic \>110 mmhg on at least 2 separate occasions at least 10 minutes apart * patient has hereditary or acquired hemorrhagic diathesis * gastrointestinal or urinary bleeding within the past 21 days * arterial puncture in a non-compressible site within the previous 7 days * another stroke or a serious head injury in the past 6 weeks * major surgery or serious injury, including other sites than the head, within the preceding 14 days * seizure at the onset of stroke * acute myocardial infarction (ami) within the previous 3 weeks * thrombolytic within the previous 72 hr * pregnant other inclusion and exclusion criteria may apply.

Keywords: acute ischemic stroke desmoteplase japan safety stroke tolerability
efficacy and safety of midostaurin in patients with aggressive systemic mastocytosis or mast cell leukemia

Conditions: Leukemia

Summary: the purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with aggressive systemic mastocytosis (asm) or mast cell leukemia (mcl) with or without an associated hematological clonal non-mast cell lineage disease (ahnmd).


Eligibility criteria:
key inclusion criteria: * patients ≥ 18 years of age who provided written informed consent, eastern cooperative oncology group (ecog) performance status of 0-3 and a life expectancy of \>12 weeks, electrocardiogram with a qtcf of ≤ 450 ms, with a diagnosis of sm and sub-variants based on who criteria. * patients with asm or mcl were to have one or more measurable clinical findings (termed "c-findings") and defined as those attributable to the mast cell disease component and not to ahnmd or any other cause. * patients with mcl were to have bm aspirate smears with ≥ 20% immature mcs. patients with ahnmd were eligible if it was not life-threatening or in an acute stage. key exclusion criteria: * patients with cardiovascular disease including congestive heart failure class iii or iv according to the new york heart association classification, left ventricular ejection fraction (lvef) of \<50%, myocardial infarction within the previous 6 months, or poorly controlled hypertension. * patients with a heart block of any degree at screening (for canada only). * patients with an ahnmd who required immediate cytoreductive therapy or targeted therapy (other than midostaurin). * patients who had demonstrated relapse after 3 or more prior regimens of sm treatment regardless of treatment regimen for supportive care (e.g., symptom-limiting therapies). * patients who had received any investigational agent, targeted therapy, chemotherapy, interferon-α, or 2 chlorodeoxyadenosine within 30 days prior to start of midostaurin treatment. * patients who had asm with eosinophilia and known positivity for the fip1l1- pdgfrα fusion unless they had demonstrated relapse or disease progression on prior imatinib therapy. * patients who had received any treatment with midostaurin prior to study entry. * patients who had received hematopoietic growth factor support within 14 days of day 1 of midostaurin treatment. * patients who had any surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) within 14 days of day 1 of midostaurin treatment. * patients with any pulmonary infiltrate, including those suspected to be of infectious origin. in particular, patients with resolution of clinical symptoms of pulmonary infection but with residual pulmonary infiltrates on chest x-ray were not eligible until the pulmonary infiltrates had completely resolved. exception: patients with asm/mcl ± ahnmd-related pleural effusion as judged by the investigator and approved by the ssc chairperson or designee were permitted to enter the study.

Keywords: aggressive systemic mastocytosis mast cell leukemia c-findings tyrosine kinase inhibitor kit mutation ahnmd systemic aggressive
quality of control and sleep in children with diabetes, using new technology

Conditions: Diabetes Mellitus, Type 1

Summary: the study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (sap) with a predictive algorithm to suspend temporarily insulin administration (640g® with the smart guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, freestyle libre ® ) on the time in glucose target , in hypo- and hyperglycemia. exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.

optimising metabolic control in children with type 1diabetes mellitus (t1dm) is essential to prevent late complications. fear of nocturnal hypoglycemia is pervasive amongst parents of children with t1dm, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. this leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes. in this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640g medtronic pump (r)) and with alerts , or without impact on insulin administration and without alerts.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * duration of diabetes ≥ 6 months * insulin pump treatment ≥ 6 months * hba1c ≤ 11% * parental written informed consent exclusion criteria: . no parental consent * physical or psychological disease likely to interfere with an appropriate conduct of the study * current drug therapy knowing to interfere with glucose metabolism * chronic sleep medication in the primary caregiver or the patient -
the efficacy of different bupivacaine concentrations in pediatric patients undergoing transversus abdominis plane block

Conditions: Transversus Abdominis Plane Block

Summary: this study is designed to compare the analgesic efficacy of different bupivacaine concentrations in pediatric patients undergoing ultrasound-guided transversus abdominis plane (tap) block for unilateral inguinal hernia repair. in recruited 74 patients; group 1 (n:37) received 1 mg/kg bupivakain 0.25% and group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided tap block following standard general anaesthesia induction. flacc (face, legs, activity, cry, consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. tramadol 1 mg/kg was administered intravenously as rescue analgesic when flacc score was ≥4. total analgesic requirement, length of hospital stay and side effects were recorded.

transversus abdominis plane (tap) block is a safe and effective analgesia technique for paediatric patients. this study is designed to compare the analgesic efficacy of different bupivacaine concentrations in paediatric patients undergoing ultrasound-guided tap blocks for unilateral inguinal hernia repair surgery. seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled for this study after obtaining institutional ethics committee approval and written informed consents from parents or legal guardians (2016/1281). group 1 (n:37) received 1 mg/kg bupivakain 0.25% and group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided tap block following standard general anaesthesia induction. all patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively. flacc (face, legs, activity, cry, consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. tramadol 1 mg/kg was administered intravenously as rescue analgesic when flacc score was ≥4. total analgesic requirement, length of hospital stay and side effects were recorded.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) status i/ii * children between 1 to 8 years of age * patients undergoing unilateral inguinal hernia repair surgery exclusion criteria: * denial of parents * patients who are allergic to local anesthetics

Keywords: transversus abdominis plane block bupivacaine concentration postoperative analgesia inguinal hernia repair surgery
gait analysis in ponseti clubfoot

Conditions: Clubfoot

Summary: patients with clubfoot treated with the ponseti method from a prospective database are evaluated using gait analysis including a foot model and a disease specific instrument score and compared to a group of healthy children.

patients with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the ponseti method beginning in 2002 are considered for this study. thereby patients will typically have a follow up of nearly three to eight years after initial clubfoot correction. patients with unilateral or bilateral idiopathic clubfoot are included. patients with clubfoot associated with syndromes or neurological diseases, with mild clubfoot that required fewer than three casts for initial correction, who first presented at an age older than three months, who were living outside of the country, and who were initially treated elsewhere with more than three casts are excluded. an invitation letter to participate in the study was sent out at the end of 2011, with a second letter being sent out three months after the first. after the second letter patients had a time frame of three more months to participate before the study was closed. to comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study. each patient will be physically examined, active and passive range of motion (rom) of the ankle joint will be measured with a hand-held goniometer. ability to walk on the heels and on tiptoes will be recorded. the disease-specific instrument questionnaire, which will be blinded for the treating physician will be handed out to fill in. patients will undergo gait analysis, including video recordings with a vicon motion capture system (vicon, oxford, uk) with kinetic data collected from three amti force plates (advanced mechanical technology, inc., watertown, ma). placement of markers will be a combination of cleveland (lower extremity), plugingait (upper body), and oxford foot (movement within the foot) models.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral idiopathic clubfoot treated with the ponseti method exclusion criteria: * clubfoot associated with syndromes or neurological diseases * mild clubfoot that required fewer than three casts for initial correction * clubfoot patients that first presented at an age older than three months * clubfoot patients who were living outside of the country * clubfoot patients who were treated elsewhere with more than three casts

Keywords: clubfoot gait analysis outcome questionaire ponseti method
a study to assess the effect of oral belumosudil on inhibition of various proteins in the fed state in healthy male subjects

Conditions: Immune System Disorder (Healthy Volunteers)

Summary: the purpose of this study is to evaluate safety and pharmacokinetics (pk) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (ugt)1a1 (part 1), p glycoprotein (p-gp) (part 2) and breast cancer resistance protein (bcrp)/organic anion transporting polypeptide (oatp)1b1 (part 3) inhibition in the fed state in healthy male subjects.

part 1: the estimated time from screening until the follow-up phone call is approximately 6 weeks per subject. part 2: the estimated time from screening until the follow-up phone call is approximately 7 weeks per subject. part 3: the estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects.

Eligibility criteria:
inclusion criteria: * healthy male participants aged 18 to 55 years old * must agree to use an adequate method of contraception * must be able to understand and provide a written informed consent exclusion criteria: participants are excluded from the study if any of the following criteria apply: * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients. * presence or history of clinically significant allergy requiring treatment, as judged by the investigator. hay fever is allowed unless it is active. * significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria. * failure to satisfy the investigator of fitness to participate for any other reason. the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
dose escalation and expansion study of flx475 monotherapy and in combination with pembrolizumab

Conditions: Advanced Cancer

Summary: this clinical trial is a phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of flx475 as monotherapy and in combination with pembrolizumab. the study will be conducted in 2 parts, a dose-escalation phase (part 1) and a cohort expansion phase (part 2). in part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of flx475 as monotherapy or in combination with pembrolizumab. in part 2 of the study, subjects will be initially enrolled in stage 1 of parallel expansion cohorts of flx475 as monotherapy or in combination with pembrolizumab.


Eligibility criteria:
inclusion criteria: * documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies * dose escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical hodgkin lymphoma * dose expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer * eastern cooperative oncology group (ecog) performance status 0-1 * evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts) * tumor available for biopsy exclusion criteria: * history of allergy or severe hypersensitivity to biologic agents * history of grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment * active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis * prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant * active graft-versus-host disease

Keywords: non-small cell lung cancer head and neck squamous cell carcinoma breast cancer urothelial carcinoma nasopharyngeal carcinoma cervical cancer lymphoma
cognitive behavioral therapy for african americans with uncontrolled type-2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of the study is to assess the feasibility and acceptability of a culturally-tailored cognitive behavior intervention (ct-cb) for african american patients with uncontrolled type 2 diabetes. after the baseline visit subjects will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (ct-cb) program or to general education (usual care). the intervention duration is 12 weeks.

african americans are approximately twice as likely to be diagnosed with diabetes and to experience gaps in diabetes care compared to whites. lower health literacy and socio-economic, language, and communication barriers are all associated with disparities in diabetes care. the role of behavioral theory is foundational in understanding behavior change among patients in the self-management of diabetes. further culturally tailoring increases acceptance and effectiveness of diabetes self-management. the aim of this pilot study is to test the feasibility and acceptability of a culturally tailored, cognitive behavioral intervention (ct-cb) program using a group-based vs. a web-based format, and determine if it can improve diabetes self-management among african americans compared with usual individual based care at the clinic. forty-five african american patients with uncontrolled type 2 diabetes (hba1c \> 8 %), aged \> 18 years, will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (ct-cb) program or to general education (usual care). after 12 weeks, patients will be followed for an additional three months to evaluate for diminution of treatment effects. both the group -based and the web-based cbt intervention group will be followed for an additional three months to study for possible diminution of treatment effects over time. diabetic measures like hemoglobin (hba1c) at baseline vs. 3 months; the patient health questionnaire to assess depressive symptoms; diabetes distress scale, anxiety, self-efficacy, quality of life (sf-12), diabetes health belief scale, process measures such as patient activation measure (pam-13), medication adherence questionnaire, session-participation, glucose self-monitoring, diet and physical activity are measured at each visit pre and post intervention. trained study staff will also conduct neuropsychological tests including language and memory tests, attention and executive function tests, clinical diagnosis, activities of daily living (adl).

Eligibility criteria:
inclusion criteria: * age: 18 years or older * fluency in english * african american * hba1c\>8% exclusion criteria: * subjects with no web access, * subjects using an insulin pump, * subjects that are pregnant * subjects that have active substance abuse including alcohol, * subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions

Keywords: culturally-tailored cognitive behavior intervention (ct-cb) family practice diabetes