Kornimate/medical-research-clean huggingface dataset:
high flow nasal cannula vs noninvasive ventilation in patients with hypoxic respiratory failure following blunt chest trauma

Conditions: Blunt Injury of Thorax

Summary: to compare high flow nasal cannula against noninvasive ventilation in patients with non-sever blunt chest trauma in improvement of oxygenation, need for intubation and mechanical ventilation within 28 days


Eligibility criteria:
inclusion criteria: * age ≥18 y, * willing and able to provide written informed consent prior to performing study procedures, * currently hospitalized and requiring medical care for non-sever blunt chest trauma (abbreviated injury severity scale ≤ 2) spo2 90% or less while breathing 10 l/min. exclusion criteria: * contraindications of noninvasive ventilation (face trauma or surgery, airway obstruction, upper gastrointestinal tract bleeding, disturbed level of consciousness), -smoker * intubation for any cause other than respiratory cause
study evaluating sirolimus (rapamune™) in solid organ transplant recipients

Conditions: Graft vs Host Disease; Kidney Transplantation

Summary: to evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (csa). to evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without csa) or who are currently enrolled in protocol 0468e1-306-us.


Eligibility criteria:
inclusion criteria: * completion of sirolimus/blinded therapy in solid organ clinical trials (with or without csa) with satisfactory compliance and an adequate safety profile. * women of childbearing potential who have a negative pregnancy test before enrollment into this study and who agree to practice either a hormonal or barrier method of birth control throughout the treatment period and for 3 months following discontinuation of sirolimus may be enrolled into the study. * signed and dated informed consent exclusion criteria: * unstable disease states, which in the opinion of the investigator would present a risk to the patient. * known hypersensitivity to macrolide antibiotics

Keywords: transplant kidney
antibody levels against 2009 influenza a h1n1 one year after vaccination with pandemrix and 2010 fluarix booster in organ transplant recipients.

Conditions: Organ Transplantation

Summary: organ transplant patients who participated in a retrospective study and received 2009 pandemrix vaccine during autumn 2009 are included in this study. the main aim is to determine the h1n1 antibody levels one year after pandemrix in comparison to healthy controls. the secondary aim is to examine the booster effect of 2010 fluarix in patients and controls.side effects to fluarix vaccine are registered.

organ transplant patients and staff members of the transplant institute who were vaccinated 2009 and received 2 doses of 2009 h1n1 influenza vaccine (pandemrix) will be asked to participate in the study. serum samples will be collected approximately one year after completed vaccination with pandemrix and analysed for haemagglutination -inhibiting antibodies against h1n1.the frequency of individuals with remaining protective titers will be examined. the same individuals will be vaccinated with fluarix containing antigen from influenza a california/7/2009(h1n1, a/perth/16/2009 (h3n2) and b/brisbane/60/2008. the booster effect will be measured one month later.

Eligibility criteria:
inclusion criteria cohort number 1: organ transplant patients who were vaccinated with pandemrix 2009 and written informed consent received cohort number 2: staff members who were vaccinated with pandemrix 2009 and written informed consent received exclusion criteria: patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to fluarix vaccination.

Keywords: 2009 h1n1 influenza vaccine, organ transplant patients, booster with fluarix
real world-clinical outcomes of tucatinib, trastuzumab, and capecitabine following trastuzumab deruxtecan (t-dxd) for the treatment of her2-positive metastatic breast cancer.

Conditions: Metastatic HER2+ Advanced Breast Cancer

Summary: a retrospective study of de-identified (to preserve patient privacy) patient information from the flatiron health database to describe 3l and 4l real-world (rw) outcomes (e.g. time to next treatment, time to discontinuation, and overal survival) of the tucatinib-trastuzumab-capecitabine triplet therapy immediately following t-dxd therapy in patients diagnosed with her2+ metastatic breast cancer (mbc) in the united states.


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. mbc diagnosis between january 1, 2017 and 6 months prior to database cutoff 2. evidence of human epidermal growth factor receptor 2 (her2) receptor positivity prior to or up to 90 days following the mbc diagnosis date 3. at least 18 years old on the mbc diagnosis date 4. treated with systemic anticancer treatment in the metastatic setting, i.e., post mbc diagnosis. 5. treated with t-dxd in the 2l or 3l setting, followed immediately by the tucatinib triplet, and at least 1 additional prior her2-targeted regimen exclusion criteria: patients meeting any of the following criteria will not be included in the study: 1. patients with evidence of other cancers prior to the mbc diagnosis date will be identified with the following international classification of diseases, 9th revision, clinical modification (icd-9-cm) and international classification of diseases, 10th revision, clinical modification (icd-10-cm) codes in all databases: 140.xx - 195.xx, 200.xx - 208.xx, c00.xx - c76.xx, c81.xx - c96.xx. (exclude - icd-9: 174.x, 175.x; icd-10: c50.xx) 2. patients treated with tucatinib or t-dxd prior to the 2l or 3l t-dxd treatment 3. patients participating in clinical trials 4. patients receiving concomitant endocrine therapy

Keywords: her2+ mbc metastatic breast cancer tukysa tucatinib breast neoplasm human epidermal growth factor receptor 2 positive
a study to evaluate the efficacy and safety of intravenous prasinezumab in participants with early parkinson's disease

Conditions: Parkinsons Disease

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (iv) prasinezumab versus placebo in participants with early parkinson's disease (pd) who are on stable symptomatic pd medication.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd based on mds criteria with bradykinesia plus one of the other cardinal signs of pd (resting tremor, rigidity), without any other known or suspected cause of parkinsonism * on symptomatic pd medication, with stable doses for at least 3 months prior to baseline * a diagnosis of pd for at least 3 months to maximum 3 years at screening * mds-updrs part iv score of 0 at screening and prior to randomization * hoehn and yahr (h\&y) stage i or ii in off medication state at screening and prior to randomization * dopamine transporter imaging with single photon emission computed tomography (dat-spect) imaging consistent with dopamine transporter deficit, as assessed by the central reader * no anticipated changes in pd medication from baseline throughout the study duration based on clinical status during screening * willingness and ability to use a smartphone application to measure pd-related symptoms for the duration of the study * willingness and ability to wear a smartwatch to measure pd-related motor signs exclusion criteria: * medical history indicating a parkinsonian syndrome other than idiopathic pd * diagnosis of pd dementia * diagnosis of a significant neurologic disease other than pd * within the last year, unstable or clinically significant cardiovascular disease * uncontrolled hypertension * drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (nicotine is allowed, marijuana use is not allowed) * clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis * allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous irr following administration of any other monoclonal antibody * any contraindications to obtaining a brain magnetic resonance imaging (mri) * any contraindications to dat-spect imaging
biomolecular characteristics of reminder-focused positive-psychiatry

Conditions: Posttraumatic Stress Disorder

Summary: objective: posttraumatic stress disorder (ptsd) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. reminder focused positive psychiatry (rfpp) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core ptsd symptoms, decreased severity of reactivity to ptsd trauma reminders, and increased vascular function. this study evaluates the clinical and biomolecular characteristics of rfpp in adolescents with ptsd. research design/overall impact: after obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with ptsd, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at olive view ucla pediatrics clinics (\>3000 adolescents with ptsd). eligible adolescents will be randomized to 1) rfpp group intervention, or 2) an attentional control condition (group process). thirty subjects in each group will receive twice weekly telehealth intervention of either rfpp or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. vascular function, inflammatory biomarkers including crp, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of fkbp5, ddx6, b2m, lair1, rtn4, nub1, and a multi-gene conserved transcriptional response to adversity score (ctra) will be measured at baseline and 6-week. the primary and secondary endpoints are a) changes in ptsd core and reactivity to trauma reminder severity score in response to rfpp intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to rfpp, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.


Eligibility criteria:
inclusion criteria: * boy/girl with documented ptsd, * aged 11- 15 years old, * able to read/write in english exclusion criteria: * presence of intellectual disabilities, * presence of psychotic or self-injurious behavior, * presence of seizure disorder, * presence of language disorder, * presence of eye disorders, * presence of other neurodevelopmental disorders, * presence of diagnosis of substance use disorder.
oxaliplatin and 5-fluorouracil with or without docetaxel in elderly patients (>65 y) with stomach and esophagus cancer

Conditions: Gastric Cancer; Adenocarcinoma of the Esophagogastric Junction

Summary: in this trial, flot will be evaluated as therapy option for elderly patients (\>65 years) with advanced gastric cancer in comparison to the well established flo scheme. the hypothesis is that flot is more effective than flo in elderly patients with acceptable side effects.

patients with locally advanced, potentially operable or metastatic gastric cancer or adenocarcinoma of the esophagogastric junction without prior therapy in the palliative setting are treated with: * arm a: flo * arm b: flot max. 12 cycles evaluation of quality of life by standard forms at baseline and then every 2 months until progress of disease. pharmacogenetic analyses will be done to evaluate a risk profile for platin-based therapies. 140 patients will be treated (70 per arm) primary endpoint: * response rate secondary endpoints: * prospective validation of a pharmacogenetic risk profile for patients with advanced gc under first-line therapy with platin/docetaxel * evaluation of quality of life * safety and tolerability * progression free survival (pfs), time to treatment failure (ttf), overall survival (os)

Eligibility criteria:
inclusion criteria: * metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction * no prior chemotherapy in metastatic state * adequate blood and biochemistry parameters exclusion criteria: * hypersensitivity for 5-fu, leucovorin, oxaliplatin or docetaxel * khk, cardiomyopathy or cardiac insufficiency * malignancy \<5 years ago * brain metastases * severe internal disease or inadequate blood and biochemistry parameters
the elders' resilience curriculum

Conditions: Suicidal Ideation

Summary: the overall goal of this research is to better understand if and how the elders' resilience curriculum (erc), a culturally grounded, school-based upstream suicide prevention program taught by white mountain apache tribe (wmat) elders to youth, promotes connectedness, cultural strengths, and reasons for living among american indian youth.

the overall goal of this research is to better understand if and how the elders' resilience curriculum (erc), a culturally grounded, school-based upstream suicide prevention program taught by white mountain apache tribe (wmat) elders to youth, promotes connectedness, cultural strengths, and reasons for living among american indian youth. prior to this trial, the investigators collaborated with wmat research partners to gather qualitative data to identify key protective factors and core components of the erc. after identifying key protective factors and core components of the erc, the investigators developed a culturally adapted assessment battery and theoretical model to assess the erc. this study works with white mountain apache tribal community partners to collaboratively pilot test a rigorous evaluation of the erc.

Eligibility criteria:
inclusion criteria: * ages 9-14 years * enrolled in a school where the elders' resilience curriculum is delivered * participating in the elders' resilience curriculum program exclusion criteria: * parent/guardian objection to youth participation

Keywords: american indian alaska native suicide prevention
single dose study of pf-04991532 in healthy subjects

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics (pk) and preliminary food effect of pf-04991532 following single escalating oral doses in healthy adult subjects.

safety/tolerability and pk

Eligibility criteria:
inclusion criteria: * healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * self-reported history of hypoglycemia, or fasting laboratory glucose value \</=80 mg/dl at screening or day 0 of period 1, confirmed by a single repeat if deemed necessary.

Keywords: phase 1 safety and tolerability pk t2dm type 2 diabetes mellitus
circulating tumor dna and brca reversion mutation in advanced or recurrent ovarian cancer patients with germline mutation.

Conditions: Ovarian Cancer

Summary: increasing number of ovarian cancer patients are receiving parp inhibitor as maintenance or salvage therapy. predictive factors to parp inhibitor other than brca mutation or hrd status as well as specific resistance mechanism are unknown. thus, the objective of this study was to prospectively collect serial blood samples in ovarian cancer patients with germline brca mutation who receive parp inhibitor. we investigated circulating tumor dna (ctdna) before patients are started on parp inhibitor and every 3 months thereafter until progression on parp inhibitor. through assessment of the changes in ctdna mutational landscape, we aimed to investigate resistance mechanism to parp inhibitor including brca reversion mutation.


Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of epithelial ovarian cancer, 2. presence of germline or somatic brca mutation, 3. patients receiving chemotherapy after primary debulking surgery or interval debulking surgery or patients who are planned to receive chemotherapy after recurrence on first line treatment, 4. patients with platinum sensitive recurrence (recurrence after 6 months or longer after 1st line treatment) who are planned to receive parp inhibitor following response to 2nd line chemotherapy. 5. patients who recurred after 3rd or more lines of chemotherapy and are planned to receive parp inhibitor. exclusion criteria: 1. patients who refuse to participate, 2. patients having difficulty understanding the protocol due to language barrier
a prospective study of combination of peginterferon alfa-2b (40kd, y-shape) and gm-csf in chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kd, y-shape) and gm-csf in interferon-naïve chronic hepatitis b patients with hbeag positive. patients were randomized to one of the 2 groups to receive different antiviral treatment.


Eligibility criteria:
inclusion criteria: * 18yrs≤age≤65yrs. * 17≤bmi(body mass index)≤28. * hbsag positive≥6 months. * serum hbv dna≥20,000iu/ml, hbsag positive and hbeag positive at screening. * 2uln≤alt≤10uln(uln=upper limit of normal) at screening. * pregnancy test must be negative for female patients of childbearing potential. all patients take effective birth control measures during treatment and 6 months after the treatment. * agree to participate in the study and sign the informed consent. exclusion criteria: * pregnant or lactating females * interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis b treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance . * receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening. * receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening. * co-infected with active hepatitis a, hepatitis c, hepatitis d, and/or human immunodeficiency virus (hiv). * history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic liver disease, toxin exposures. * suffering from any other acute or chronic infectious disease. * mental disorder or physical disability, or family history of neurological and psychiatric disorders. * neutrophil count \<1500 cells/mm3, or platelet count \<90000 cells/mm3 at screening. * child-pugh≥b, or other evidence of liver decompensation (e.g. serum albumin\ 3 seconds prolonged, serum bilirubin\>2uln, prothrombin activity \<60%, history of liver decompensation). * serum creatinine level \>uln in screening period. * serum creatine kinase level \>2uln except for physiological factors (e.g., exercise). * afp\>100ng/l. if 50ng/l\<afp\<100ng/l at screening, retest 2 weeks later, and if afp \<50ng/l can enrolled, vs, excluded. * hepatocarcinoma or suffering from any other malignant tumor. * autoimmune disease(e.g., psoriasis, systemic lupus erythematosus). * moderate or severe hypertension, or mild hypertension without well controlled. * with not well- controlled endocrine disease (e.g., thyroid dysfunction, diabetes mellitus). * drug abusing, or alcoholism. * hbeab positive or hbsab positive at screening. * allergic to interferon, or gm-csf, or any fragment of the study drug. * other conditions which in the opinion of the investigator precluding enrollment into the study(e.g., low compliance).