Kornimate/medical-research-clean huggingface dataset:
behavioral parenting skills as a novel target for improving pediatric medication adherence

Conditions: Acute Lymphoblastic Leukemia

Summary: this study observes behavioral parenting skills to see whether it could be a novel target for improving pediatric medication adherence. this study may help researchers better understand the challenges parents face when giving their young child with an illness medicine at home and learn about various factors related to medication compliance in young children

primary objectives: i. use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention. ii. use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence. outline: participants complete a survey over 15-20 minutes at baseline. family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. participants receive mems electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days.

Eligibility criteria:
inclusion: * parent of a child diagnosed within the past month with acute lymphoblastic leukemia (all) * pediatric patient's age 3 - 9. \* if present during the home visit, any other child, ages 0-18 * child on therapy that includes oral mercaptopurine (6-mp) administration * parent age 18 - na (no limit) * parent should have verbal english fluency * participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure * the following special populations may be included in this study: * pregnant women: due to the design of this behavioral research, pregnant and fetuses should incur no elevated risk from participation. children under age 18 will participate in one aspect of the study, the video recording of medication administration. \* other children (not the pediatric patient) under age 18 that are present during the time of the home visit exclusion: * pediatric patient is on therapy that does not include oral 6-mp administration * cognitively impaired adults/adults with impaired decision-making capacity * pediatric patients who are not yet adults (infants under the age of 3, children over 9 years, teenagers) * prisoners
impacts of the α-fetoprotein (afp) score in real life for patient selection for liver transplantation (lt) for hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: this is a french multicentric retrospective study on intention-to-treat comparing results of lt for hcc before and after the use of the afp score. the investigators hypothesis is a better respect of the biomedicine agency (the french national transplantation agency) criteria since the general application of this score in march 2013. the aim of this study is to determine if the tumoral characteristics at the time of lt are improved and if it modified the patients'outcome.

liver transplantation is a widely accepted treatment for hcc as it would eliminate the tumour and cure the underlying liver disease. but the success of liver transplantation depends on the tumour load; patients with extensive disease have very poor outcomes, whereas most patients with small tumours can be curred. this had to be taken into account in the context of worldwide organ shortage. that is why in 1996 mazzaferro et al. have reported milan criteria limiting access to liver transplantation for patients with a single tumor ≤ 5 cm or ≤ 3 tumors ≤ 3 cm without tumor invasion or metastasis. however, in france, these criteria were not respected in about 30% of cases, because they were considered too restrictive and unadapted, with good overall results. this led to the possibility of new criteria definition. because the value of alpha-foeto-protein was known as a good predictor of tumor aggressivity, a new score emerged in 2012, integrating blocking α-fetoprotein thresholds while allowing an increased number and size of tumors. after validation of this score, the biomedicine agency decided to use this α-fetoprotein score, to make the selection of patients allowed to be transplanted since march 2013. in this multicentric retrospective comparative study the investigators first want to assess if this new score based on imaging is also respected at the explant analysis. our secondary outcomes are to compare the amount of dropped out patients because of this score, the rate of tumoral relapse, the overall survival and the disease free survival. the investigators aim at collecting the data of 562 patients registered for liver transplantation for hepatocellular carcinoma between 2011/03/01 and 2014/03/01 in 5 centres: paul brousse (paris), montpellier, lille, lyon and grenoble.

Eligibility criteria:
inclusion criteria: * patients registered for liver transplantation because of hepatocellular carcinoma between 2011/03/01 and 2014/03/01 in 5 french hospital : paul brousse (paris), montpellier, lille lyon and grenoble exclusion criteria: * patients with a meld score superior to 20 (because this rate give them access to liver transplantation sooner than the other patients). * patients of domino's grafts * patients with non hepatocellular tumors on the explanted liver

Keywords: liver transplantation, hepatocellular carcinoma, alpha-foetoproteins, afp
registry of pregnancies conceived following exposure to ovulation stimulation medications

Conditions: Infertility

Summary: to identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.

this will be an observational cohort trial of the pregnancy of women who conceive in rmn trials, and of their resulting infants through the first 3 years of life. study specific procedures will include a patient completed log of prescribed and over the counter medications taken during a normal pregnancy, a review of their pregnancy, delivery, and neonatal records, an exam of the infant within 60 days of birth by a dysmorphologist, and yearly review of infant medical records, growth charts, and a yearly parent administered developmental questionnaire (ages and stages) for the first three years of the infant's life.

Eligibility criteria:
inclusion criteria: * positive serum hcg within the context of a rmn trial; * history of infertility meeting female subject entry criteria for a rmn trial; * informed consent. exclusion criteria: * unable to comply with the demands of the trial.

Keywords: infertility ovulation stimulation pregnancy
a safety and efficacy study of argx-119 in adult patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study aims to evaluate the safety of argx-119 in adults with als. the study will also assess the impact of argx-119 on als disease outcomes, including muscle function. the study consists of 2 periods: a treatment period when participants will receive one of three argx-119 doses or placebo and an extension period when all participants will receive the same dose of argx-119. participation in the study will last up to approximately 100 weeks.


Eligibility criteria:
inclusion criteria: * the participant is at least 18 and ≤80 years of age * the participant is diagnosed with familial or sporadic als according to gold coast criteria * the participant has a treatment research initiative to cure als (tricals) risk profile of ≥ -6.0 to \< -2.0 * slow vital capacity (svc) of ≥ 60% of the predicted value according to global lung function initiative 2012 exclusion criteria: * use of noninvasive ventilation more than 10 hours a day or use of a tracheostomy for ventilatory support * any history of or current exposure to any gene or cell therapies (off-label use or investigational) for als * pregnant or lactating state or intention to become pregnant during the study
effectiveness of isometric vs. eccentric exercise in chronic achilles tendinopathy

Conditions: Tendinopathy

Summary: this is a prospective single blinded randomised controlled trial with a 12-week intervention period and a half-year follow-up period. the main purpose is to determine the effects of isometric exercise on mechanical, morphological and functional tendon properties versus eccentric exercise in chronic achilles tendinopathy.

this research project was funded by means of the "bundesinstitut für sportwissenschaft" based on a resolution of the german federal parliament.

Eligibility criteria:
inclusion criteria: * chronic (3 months or more) condition of unilateral achilles tendinopathy confirmed by a medical doctor based on ultrasound * age 18-60 * male * visa-a score of at least 80 exclusion criteria: * bilateral tendinopathy * any systemic or inflammatory diseases (i. e. diabetes, arthritis) * surgery on lower extremities in the past * corticoid injections in the last 12 months

Keywords: achilles tendon isometric muscle training competitive sports strength training eccentric exercise isometric exercise chronic condition regeneration tendon tendon properties tendinopathy tendinosis intervention training load high performance sports
feasibility of performing peripheral pulmonary lesion biopsy using robotic bronchoscopy-guided cryoprobe

Conditions: Bronchi--Diseases; Lung Diseases, Obstructive; Lesions Mass

Summary: this research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the ion robotic bronchoscope to collect biopsy tissue.


Eligibility criteria:
inclusion criteria: - patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy. lesion criteria: - pulmonary nodules of 8-50mm in largest dimension. exclusion criteria: * patients with known bleeding diathesis; platelet count \< 50,000. * current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable). * inability or unwillingness to give informed consent. * pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment. * pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmhg. * individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent. * international normalized ratio (inr) \< 1.5. * do not resuscitate (dnr) status; do not intubate (dni) status.
the combination of terbutaline and danazol as the treatment of steroid-resistant/relapse immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: single-arm, open-label, single center study to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid resistant/relapsed itp.

immune thrombocytopenia (itp) is a severe bleeding disorder. approximately 2/3 of patients achieve remission from first-line therapies. however, the underlying mechanism of corticosteroid-resistant or relapsed itp is not well understood; thus, treatment remains a great challenge. β2-ar agonist terbutaline modulates t cell differentiation and effector cell function. a single center prospective study was performed in non-splenectomized itp patients who were either resistant to a standard dose of corticosteroids or had relapsed. patients were assigned to terbutaline plus danazol group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study, in order to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid-resistant/relapsed itp.

Eligibility criteria:
inclusion criteria: * itp confirmed by excluding other supervened causes of thrombocytopenia; * platelet count of less than 30×10\^9/l at enrollment; * patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; * subject has signed and dated written informed consent. * fertile patients must use effective contraception during treatment and observational period * negative pregnancy test. exclusion criteria: * secondary immune thrombocytopenia (e.g., patients with hiv, hcv, helicobacter pylori infection or patients with systemic lupus erythematosus) * congestive heart failure * severe arrhythmia * nursing or pregnant women * aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria * creatinine or serum bilirubin levels each 1•5 times or more than the normal range * active or previous malignancy * unable to do blood routine test for the sake of time, distance, economic issues or other reasons. * diagnosis with any of the following diseases: chronic hypertension, hyperthyroidism, diabetes, or seizure disorder.
gathering records to evaluate antiretroviral treatment-zambia (great )

Conditions: HIV

Summary: to achieve global goals for the treatment of hiv, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (dsd). a handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. for most countries, however, there is little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support. ambit a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of hiv treatment delivery in the future. the project will collect and analyze a wide range of existing data sets pertinent to dsd. this protocol is for an analysis of existing medical record data collected by the ministry of health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. outcomes to be reported include coverage/uptake of dsd, patients' outcomes, and distribution of each model. there will be no study interaction with individual patients, providers, caregivers, or others for this analysis.


Eligibility criteria:
inclusion criteria: * ≥ 15 years old * patients accessing care for hiv within the data collection period * in any hiv transmission risk group exclusion criteria: * none

Keywords: hiv zambia differentiated service delivery antiretroviral therapy
a clinical pharmacology study of jns010 (paliperidone palmitate) in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.

this is a multicenter (study conducted at multiple sites), open label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel-group (each group of participants will be treated at the same time) study. approximately, 60 participants will be enrolled in the study. this study will consist of a screening phase (maximum 14 days), an observation phase (92 days), and a follow-up phase (98 days). participants will be randomly assigned to treatment group a, b, or c. during the observation phase, participants will receive injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in the deltoid muscle or gluteal muscle as applicable on days 1, 8, 36, and 64 alternating between sides (left/right). safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, injection site reaction, drug-induced extrapyramidal symptoms scale, and visual analog scale which will be evaluated throughout the study. the total study duration for each participant will be approximately 190 days.

Eligibility criteria:
inclusion criteria:- participants had to have the capability to provide informed consent in writing to participate in the study * participants with a diagnosis of schizophrenia in accordance with the diagnostic criteria for diagnostic and statistical manual of mental disorders -iv-tr (dsm-iv-tr) * participants whose psychiatric symptom is considered stable by the investigator/subinvestigator at the time of giving informed consent * participants with a positive and negative syndrome scale (panss) score of less than or equal to 4 (moderate) in the following 9 items at screening: delusion, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility, uncooperativeness, poor impulse control * participants with an experience of taking a risperidone formulation or a paliperidone formulation by 8 days before the initial day (day 1) of the study treatment exclusion criteria:- dsm-iv-tr diagnosis other than schizophrenia * dsm-iv-tr diagnosis of substance-related disorders within 180 days before the date of screening * at a risk of suicide or other-injurious behavior as considered by the investigator/subinvestigator , and participants with a history of suicide attempts * concurrent condition of parkinson's disease (except for drug-induced extrapyramidal syndrome) - concurrent condition or history of symptomatic cerebrovascular accident

Keywords: schizophrenia jns010 paliperidone palmitate clinical pharmacology
the effect of two different doses of noradrenaline on hypotension caused by spinal anesthesia for cesarean section

Conditions: Cesarean Section; Hypotension; Norepinephrine

Summary: to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. usually, this hypotension is treated with phenylephrine or ephedrine. norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity. although the use of norepinephrine for this purpose has shown promising results. however, no sufficient data are available with regard to its optimum dose. the objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Eligibility criteria:
inclusion criteria: * pregnant women scheduled for cesarean section under spinal anesthesia * gestational age of at least 37 weeks exclusion criteria: * patient refusal * contraindications of spinal anesthesia * allergy to the study drug * height\<150 cm, weight \< 60 kg, body mass index (bmi) ≥40 kg/m2. * patients with cardiac morbidities * hypertensive disorders of pregnancy. * prepartum hemorrhage

Keywords: norepinephrine spinal anesthesia hypotension cesarean section
poly-omic predictors of symptom duration and recovery for adolescent concussion

Conditions: Concussion, Mild

Summary: the purpose of this study is to identify changes in salivary micro ribonucleic acid (mirna) levels that are predictive of symptom duration and character following mild traumatic brain injury (mtbi) in children.

the objective of this multi-center study is to refine and validate a saliva rna assessment for adolescent concussion, yielding a non-invasive test that predicts duration and character of symptoms, and helps guide clinical decisions. to accomplish this goal, the study will enroll 750 adolescents with mtbi. saliva rna levels and symptoms will be assessed at \<48 hours, 7 days, and 30 days post-injury. aim 1 will assess the ability of saliva rna dynamics (δ from \<48 hours to day 7) to predict ppcs 30 days after mtbi (defined by persistence of ≥3 symptoms on day 30, compared with pre-injury state on the post-concussion symptom inventory; pcsi). rna accuracy will be compared to a validated clinical prediction tool (5p tool). aim 2 will assess the ability of saliva rna dynamics (δ from \<48 hours to day 30) to identify recovered participants on day 30. rna accuracy will be compared to change in composite score on a standardized reaction time test (from \<48hrs to day 30). completion of these aims will yield an objective biologic test that can be used for prognosis at the time of mtbi, and to aid clinical decisions regarding return-to-learn or return-to-play.

Eligibility criteria:
inclusion criteria: * presence of mtbi: defined by criteria from the berlin consensus statement and who. assessment for mtbi status be performed by a licensed clinician per the 2018 cdc guidelines. * age at enrollment: 13-18 years of age (inclusive). exclusion criteria: * \> 48 hours after initial mtbi * glasgow coma scale score of 13 or less * previous moderate-to-severe tbi requiring overnight hospitalization * unresolved symptoms from previous concussion, or any concussion within the last 3 months * abbreviated injury scale (ais) score \> 3 (to reduce confounding from poly-trauma) * psychiatric illness requiring previous hospitalization; * neurological condition (e.g. epilepsy, hydrocephalus) or abnormality on neuroimaging (if performed) * intellectual disability that prevents ability to provide informed assent * pregnancy * active substance use/dependence * previous neurosurgery * non-fluency in english * upper respiratory infection * periodontal infection * injury to the oropharynx * previously enrolled in the same study * inability to complete follow-up assessments