Kornimate/medical-research-clean huggingface dataset:
quantitative assessment of sucking for early diagnosis of brain injury in infants at high risk

Conditions: Hypoxic-Ischemic Encephalopathy; Hypoglycemia; Neonatal Abstinence Syndrome

Summary: the main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury.

this research will address the current lack of objective tools for the reliable assessment of oral sucking and feeding in clinical practice, and the insufficient evidence that relates early measures of abnormal sucking activity with the underlying neurological impairment. the main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury. we aim to study three groups of infants who are inpatients on the neonatal intensive care unit (nicu) at boston children's hospital (bch), the nicu or newborn nursery at beth israel deaconess medical center (bidmc), the special care nursery (scn) or newborn nursery at winchester hospital as follows: (i) group a consisting of preterm infants (gestational age of \<37 weeks), (ii) group b consisting of term infants admitted to the nicu at bch and bidmc for therapeutic hypothermia who are at risk of developing hypoxic ischemic injury (hie); admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted to the nicu, scn or newborn nursery at bch, bidmc and winchester hospital at risk of abnormal neurodevelopment such as those with hypoglycemia or neonatal abstinence syndrome (nas) and; (iii) group c consisting of healthy term infants admitted to the nicu, scn or nursery who had an initial uncomplicated postnatal course that will serve as the control group. additionally, those infants who have mri of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.

Eligibility criteria:
inclusion criteria: * preterm infants with ga\<37 weeks * term infants with ga\>37 weeks and at risk of brain injury * healthy term infants with ga= 37-41 weeks, appropriate birth weight, 5 minute apgar score\>7, and an initial uncomplicated postnatal course exclusion criteria: * major congenital anomalies * craniofacial malformation * short bowel syndrome

Keywords: hypoxic ischemic encephalopathy bottle feeding hypoglycemia neonatal abstinence syndrome abnormal neurodevelopment
pain after strabismus surgery

Conditions: Strabismus

Summary: at ann \& robert h. lurie children's hospital of chicago (lurie children's), the current practice is to prescribe children with oral tylenol as needed every 4-6 hours post strabismus surgery. prescribing tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. this study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give tylenol every 4-6 hours as needed for 48 hours after surgery. to date, there have been no studies comparing patient outcomes between those taking tylenol regimen and those receiving tylenol as needed after pediatric surgery.

main hypothesis: children ages 4-12 years will feel significantly less pain and discomfort when given regimented tylenol every 6 hours for 48 hours after strabismus surgery (surgery to correct misaligned eyes) compared to controls whose parents are instructed to give tylenol every 4-6 hours as needed for 48 hours after surgery. primary objective at lurie children's, the current standard practice is for patients to be prescribed oral acetaminophen as needed every 4-6 hours after strabismus surgery. however, making the acetaminophen "as needed" leaves room for error for parents to be underdosing their children and, thus, leads to increased pain felt by these pediatric patients. to date, there have been no studies comparing patient satisfaction outcomes between a group taking a course of scheduled acetaminophen every 6 hours and to a group instructed to take as needed. the investigators plan to study the differences between these two groups by using the parent's post-operative pain measure (pppm) questionnaire to survey parents and the faces pain scale-revised to survey children at their post-operative appointment.

Eligibility criteria:
inclusion criteria: * children between 4-12 years old * children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at lurie children's hospital in chicago, il * asa classification 1 or 2. note: asa is a physical status classification system (scale of 1-6) created by the american society of anesthesiologists to describe patients prior to surgery. asa 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery. exclusion criteria: * asa classification 3 or higher (patient has severe systemic disease or worse) * contraindication to toradol (anesthesia) * contraindication to acetaminophen * previous strabismus surgery

Keywords: pain strabismus surgery
amgen megakaryopoiesis protein 2 (amg 531) in thrombocytopenic subjects with immune thrombocytopenic purpura (itp)

Conditions: Thrombocytopenic Purpura

Summary: the purpose of this study is to assess the safety and tolerability of amg 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.


Eligibility criteria:
inclusion criteria: * greater than or equal to 3 months history of itp, regardless of splenectomy status, and completion of at least 1 prior treatment for itp * 2 of 3 pretreatment platelet counts that were less than 30 x 10\^9/l (if not currently on itp therapy) or less than 50 x 10\^9/l (if currently receiving corticosteroids for itp therapy) * ability to give informed consent exclusion criteria: * known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder

Keywords: immune thrombocytopenic purpura idiopathic thrombocytopenic purpura itp thrombocytopenia
invasive infections in children with hemoglobinopathies

Conditions: Thalassemia; Sickle Cell Anemia

Summary: patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. the purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.


Eligibility criteria:
inclusion criteria: * all patients treated in the pediatric hematology unit.

Keywords: thalassemia sickle cell anemia splenectomy infections streptococcal pneumonia
a study to investigate a transdermal continuous glucose monitoring system in diabetic patients for a period of 28 days

Conditions: Diabetes (DM)

Summary: single-centre, open label (unblinded). a maximum of 48 patients will be enrolled in 4 cohorts of 10 patients and 2 potential replacements each. diabetic patients (type 1 and 2). duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 days, depending on sensor functionality) and 1 week of follow up (7 days)

this study is an investigational study, which will be conducted only at one site in germany. the investigators, the patient and the sponsor will be unblinded. the eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. the screening results are valid up to 42 days. within that time the first measurement visit including the insertion of the device should be performed. if the first measurement visit is delayed a re-screening has to be performed. should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded. the trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase. screening/enrolment phase: up to 6 weeks (42 days), 1 visit insertion/measurement phase: up to 4 weeks (28 days), up to 6 in-house measurement visits follow-up phase: 1 week (7 days), 1 visit

Eligibility criteria:
inclusion criteria: * body mass index within the range of 19-40 kg/m2, inclusive * diabetes type 1 and 2 * females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study * negative urine pregnancy test immediately before sensor insertion (only women of childbearing potential) * signed written informed consent exclusion criteria: * inability to follow the protocol schedule * participating in another clinical trial * pregnant or lactating females, , including positive urine pregnancy test immediately before sensor insertion * any known hypersensitivity to any of the products used in the study, including preservatives etc. especially hypersensitivity against legumes * tattoos at the abdominal or upper arm skin area where the fiber sensor is supposed to be placed * malignancies requiring therapy during the study * severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study * acute severe infection disease at the time of enrolment * alcohol and/or drug addiction * vulnerable patients (e.g. persons kept in detention) * poorly controlled diabetes mellitus with hemoglobin a1c higher than 10%

Keywords: diabetes management continuous glucose monitoring
a study of the efficacy of cannabidiol in patients with multiple myeloma, glioblastoma multiforme, and gi malignancies

Conditions: Cancer of Pancreas; Cancer of Liver; Cancer of Rectum; Cancer of Colon; Cancer, Gall Bladder; Myeloma Multiple; Glioblastoma Multiforme

Summary: a randomized, double-blind, placebo-controlled, parallel, multi-center study to assess the efficacy of brcx014 combined with standard-of-care treatment in subjects with glioblastoma multiforme, multiple myeloma, and gi malignancies

several studies have shown a potential anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. in phase i trials, cannabinoids have been shown to enhance the uptake of chemotherapy into malignant cells without affecting normal cells. the investigators seeks to demonstrate that the combination of chemotherapy with brcx014 will have a greater anti-tumor and anti-proliferative activity when compared to standard of care alone.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent 2. male and females age 18 to 80 years old at the time of screening 3. confirmed tissue diagnosis of multiple myeloma, gi malignancy by a licensed pathologist 4. a performance status 0-1 on the eastern cooperative oncology group (ecog) scale. 5. females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device \[iud\]) 6. male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube) exclusion criteria: 1. subject is pregnant or plans to become pregnant or actively lactating/nursing 2. hypersensitivity to any ingredient in the study product 3. initial laboratory values as determined by the principal investigator to be clinically significant 4. a substance abuse history within the last five years 5. any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results 6. .close affiliation with the investigational site (e.g., a close relative of the investigator), dependent person (employee or student of investigational site, or sponsor's staff) 7. currently enrolled in another investigational clinical study 8. a known history of severe depression or psychiatric disorders or active suicidal ideation 9. inability or unwillingness to cooperate with the study procedures for any reasons
type of needle bevel on pain perception in children during inferior alveolar nerve block anesthesia

Conditions: Anesthesia, Local

Summary: fear of the discomfort that comes with anesthetic needle insertion. for dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection. objective of the study: the purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation. materials and methods: the study will be a double-blind randomized controlled clinical trial, with a parallel design. a total of sixty-six healthy children will be selected from the pediatric dentistry and dental public health clinic, faculty of dentistry, alexandria university, egypt. children will be selected with scores 3 or 4 frankel behavioral rating scale. written consent will be obtained from the legal guardian. participants will be randomly allocated into two groups according to the type of needle bevel that will be used. group i (test group) will receive inferior alveolar nerve block (ianb) using a double scalpel blade bevel needle, while group ii (control group) will receive ianb using a standard blade bevel needle. all the procedures will be videotaped. pain reaction will be evaluated subjectively using a face scale modified from the maunuksela scale and objectively using the sensory, eye, and motor (sem) scale. after the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.


Eligibility criteria:
inclusion criteria: * healthy children with asa i, ii classification. * children with no learning disabilities. * positive or definitely positive behavior according to the frankl scale. * patient requiring local anesthetic injection ianb for dental treatment. * written consent of the legal guardian. exclusion criteria: * medically compromised patient. * children with emergency treatment needs, such as abscess, cellulitis and space infection. * hypersensitivity to local anesthetic drugs
chidamide plus chemotherapy in the treatment of peripheral t-cell lymphoma

Conditions: Peripheral T Cell Lymphoma

Summary: this is a single arm, prospective trial to evaluate the efficacy and safety of chidamide in combination with previous chemotherapy in peripheral t cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.


Eligibility criteria:
inclusion criteria: * pathologically verified peripheral t-cell lymphoma, partial response or stable disease after 3 cycles of ceop (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or ceop(cyclophosphamide,vincristin,epirubicin and prednisone)/ive (ifosfamide, epirubicin, etoposide)/gdp(gemcitabine, cis-platinum, dexamethasone) * age ≧16 years, ≦75 years * ecog (eastern cooperative oncology group) =0,1,2 * no previous history of malignancy * radiologically measurable disease * life expectancy\>6 months * informed consented exclusion criteria: * active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy * lab at enrollment(unless caused by lymphoma) * neutrophile\<1.5\*10\^9/l * platelet\<75\*10\^9/l * hemoglobulin\<90g/l * alt(alanine aminotransferase) or ast (aspartate aminotransferase ) \>2\*uln,akp(alkaline phosphatase) or bilirubin \>1.5\*uln (upper limit of normal ) * creatinine\>1.5\*uln * other uncontrollable medical condition that may that may interfere the participation of the study * not able to comply to the protocol for mental or other unknown reasons * pregnant or lactation * hiv infection
a phase ii study of apatinib in sts patients

Conditions: Soft Tissue Sarcoma

Summary: apatinib is a kind of innovative medicines approved by china food and drug administration（cfda）, which was researched by jiangsu hengrui pharmaceutical co., ltd. apatinib is a kinase inhibitor of receptor tyrosine with vegfr2. the protocol is to explore apatinib for the effectiveness of advanced soft tissue sarcoma and safety.


Eligibility criteria:
inclusion criteria: * signed informed consent. * histologically proven advanced soft tissue sarcoma, at least one measurable lesion. including: synovial sarcoma, leiomyosarcoma, alveolar soft part sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, angiosarcoma, spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, ewing's sarcoma of soft tissue/primitive neuroectodermal tumor. excluding: malignant peripheral nerve sheath tumor, chondrosarcoma, dermatofibrosarcoma protuberans, gastrointestinal stromal tumor, inflammatory myofibroblastic sarcoma, malignant mesothelioma. * must have evidence of unresectable residual disease. * in the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment. * ecog ps≤2. * life expectancy: more than 3 months. * prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mtor or egfr pathway. * not pregnant or nursing；fertile patients must use effective contraception. * hematopoietic * hb≥90g/l * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 80,000/mm\^3 exclusion criteria: * uncontrollable hypertension; * has influence of oral drugs; * patients with high risk of gastrointestinal blooding; * inr\>1.5×uln，aptt\>1.5×uln; * allergic to any ingredient of this product; * less than 1 month since last major surgery; * brain metastases; * with the second cancer.
gastric emptying of water and sports drink in labor

Conditions: Pregnancy; Gastric Emptying

Summary: to determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.

this is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink. cohorts women in early labor who have not received pain medication will be enrolled in the study. this will be called the 'unmedicated' group. a second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. this will be the 'epidural' group. study intervention subjects in each group will drink one of two drinks: water or sports drink. the changing volume in the stomach will be measured using ultrasound over the next 60 minutes. subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. subjects will be free to consume as per obstetric protocols. the study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink. hypothesis the primary hypothesis is that water will empty faster than the sports drink. a second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.

Eligibility criteria:
inclusion criteria: * gestational age of 36 weeks or greater * american society of anesthesiology physical status 2 or 3 * induction of labor or early labor (cervical dilation \< 6cm) * singleton gestation exclusion criteria: * recent food ingestion (\<3 hours) * preeclampsia * receiving magnesium sulfate * having received narcotics within 12 hours * diabetes mellitus * multiple gestations * active nausea or reflux symptoms
new strategies for assessment of the persistence of viable bacilli in latent and active tuberculosis

Conditions: Latent Tuberculosis; Persistent Infection; Mycobacterium Tuberculosis

Summary: current diagnostic tools such as interferon gamma release assay (igra) and purified protein derivative (ppd) can not distinguish patients with latent tuberculosis infection (ltbi) and persistence of live mycobacteria. this inability to rule out living mycobacteria in patients investigated for ltbi leads to unnecessary and potentially harmful treatment regimes all around the globe. the goal of this observational study is to identify candidate biomarkers for viable bacilli in latent tuberculosis in order to decrease the use of unnecessary and ineffective antibiotic treatment.

tuberculosis (tb) is the second leading cause of death due to a single infectious agent, with the main burden in resource-limited settings and in vulnerable populations. it is estimated that approximately 25% of the global population is infected with tb. ltbi is a condition where the mycobacteria rests within the body instead of creating active disease. about half of the active tb cases develop within 2 years of exposure and the other half reactivates as distant as several decades post exposure. persistence of viable bacilli is a prerequisite for the reactivation of tb. through sampling of peripheral blood the investigators will investigate how selected cytokines, enzyme activity and gene expression changes during course of treatment, 4-6 months, and during follow up, 1 year. these patterns will be compared to the patterns of patients with: latent tb without treatment, active tb with treatment as well as healthy controls. samples will be drawn at 0, 1, 6 and 12 months, after treatment initialization when applicable. healthy controls will only be sampled once. most of the analysis will be performed on tb-antigen stimulated blood. the investigators hypothesize that there is a substantial fraction of latent tb patients who do not harbor live mycobacteria and that this is reflected in study outcome measures when given treatment. furthermore, the investigators hypothesize that this fraction of latent tb patients will resemble healthy controls in terms of outcome measures whereas their counterpart, latent tb patients harboring living bacteria, will not.

Eligibility criteria:
ltbi (2 groups) inclusion criteria: * latent tuberculosis: interferon gamma (ifn-γ) \>0.70 iu/ml in the quantiferon-tb plus assay * age 15-25 years or high likelihood of recent tb transmission * informed consent exclusion criteria: * active tuberculosis * chronic illness * immunosuppressive treatment * pregnancy (including 6 months post-partum) * previous treatment for either active or latent tb infection controls inclusion criteria: * age 15-25 years * informed consent exclusion criteria: * latent- or active tuberculosis * chronic illness * immunosuppressive treatment * pregnancy (including 6 months post-partum) * previous treatment for either active or latent tb infection active tb inclusion criteria: * diagnosed with active tb * informed consent exclusion criteria: age \< 15 years