Kornimate/medical-research-clean huggingface dataset:
tr1801-adc in patients with tumors that express c-met

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: first-in-human, phase 1 study to assess safety, tolerability, and pharmacokinetics of tr1801-adc in patients with select solid tumors that express c-met.

first-in-human, phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of tr1801-adc in patients with select solid tumors that express c-met. this study will also assess pharmacokinetics (pk), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and pk) and c-met expression.

Eligibility criteria:
inclusion criteria: * compliance with all study procedures and visits to the clinical research site * locally advanced or metastatic disease that is not amenable to definitive therapy * histologically confirmed diagnosis of a solid tumor which expresses c-met * must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type * measurable baseline disease as defined by recist version 1.1 * ecog performance status 0-1 * body weight within 40 and 150 kg * clinical laboratory values with the limits as defined by the protocol * not pregnant or breast feeding * males and women of child-bearing potential must agree to use an effective method of contraception exclusion criteria: * any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures * treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment * brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for \<2 weeks * unresolved adverse events \>= grade 2 from prior anticancer therapies * acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study. * uncontrolled hypertension, unstable angina, or nyha class iii/iv heart failure * history of capillary leak syndrome * corticosteroid intolerance * history of anasarca * untreated or uncontrolled bacterial, viral or fungal infection * hiv infection or active infection with hepatitis b or c * significant liver disease * history of alcoholism or current alcoholism * signs of significant portal hypertension * significant kidney disease within 2 years * active or unstable gallstone disease * prior treatment with a c-met targeted agent * prior hypersensitivity reaction to treatment with another monoclonal antibody * qtcf \>=470 ms * patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment * administration of a live, attenuated vaccine within 28 days before the first dose of study treatment

Keywords: antibody-drug conjugate c-met solid tumors phase 1
safety and efficacy study of mix vaccine in pancreatic carcinoma patient

Conditions: Pancreatic Neoplasms

Summary: the purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (mv). enrolled patients will receive standard treatment according to national comprehensive cancer network (nccn) guide line with or without combining mv injection. the efficacy and side effect will be compared between the two groups.

in the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. in the control arm patients will be receiving standard therapy according to national comprehensive cancer network (nccn) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (mv). mv will be injected weekly till disease progression. blood sample will be obtained at baseline and every week before mv injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). patients will be evaluated for toxicity throughout the study. side effect, progression free survival, immunology index and general status will be recorded.

Eligibility criteria:
inclusion criteria: * 1.patients diagnosed with pancreatic carcinoma based on histology * 2.evaluable lesions on imaging study * 3.without known immunodeficiency * 4.age \>18 and \<80 years ago exclusion criteria: * 1.patients is unable or unwilling to sign informed consent * 2.any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication * 3.positive hiv and/or rpr (rapid plasma reagin) * 4.female patient who is pregnant or breast feeding * 5.patients, based on the opinion pf the investigator, should not be enrolled into this study * 6.prior anti-cancer vaccine or biological immunotherapy * 7.allergic to any known ingredient of the mv compound

Keywords: mix vaccine, pancreatic neoplasms, immunotherapy
drug-drug interaction study of dapagliflozin with voglibose in japanese type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in japanese patients with type 2 diabetes by assessment of auc and cmax of dapagliflozin


Eligibility criteria:
inclusion criteria: * already on voglibose treatment with a steady dosage for at least 8 weeks * provision of informed consent prior to any study specific procedures * diagnosed with type 2 diabetes exclusion criteria: * having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease. * the investigator(s)judged that the subject should not participate in the study according to screening test or medical history.

Keywords: type 2 diabetes mellitus japanese phase 1 safety dapagliflozin pharmacokinetics drug-drug interaction voglibose
lsd therapy for persons suffering from major depression

Conditions: Major Depressive Disorder

Summary: background: major depressive disorder is one of the most prevalent mental illnesses, leading to substantial personal distress and economical consequences. pharmacological treatment is limited and relapse is frequent. lysergic acid diethylamide (lsd) was extensively investigated in humans in the 1950s and 1960s and was shown to attenuate depressive symptoms. clinical research with lsd ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. in recent years, there has been a renewed interest in the use of hallucinogens in psychiatric research and practices, reconsidering lsd's antidepressant potential. larger, well-designed and placebo-controlled studies are warranted. this study will evaluate the potential benefits of lsd-assisted psychotherapy in patients suffering from major depressive disorder. objective: to test the efficacy of lsd in patients with major depressive disorder. design: randomised, double-blind, active-placebo-controlled trial using either two moderate to high doses of lsd (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of lsd (25 µg and 25 µg) as active-placebo control. participants: 60 patients aged \> 25 years with major depressive disorder (according to dsm-v). main outcome measures: change in depressive symptomatology (ids, bdi), anxiety (stai), and general psychopathology (scl-90) compared with active-placebo-assisted psychotherapy.


Eligibility criteria:
inclusion criteria: * major depressive disorder according to diagnostic and statistical manual of mental disorders (dsm-v) * \> 25 years * sufficient understanding of the german language exclusion criteria: * \< 25 years * concomitant diagnosis of past or present psychotic disorder * concomitant diagnosis of past or present bipolar disorder * first degree relative with a psychotic disorder * unable or unwilling to discontinue antidepressant medication * pregnancy or breastfeeding * known hypersensitivity to lsd * somatic disorders including central nervous system (cns) involvement * known or suspected non-compliance, drug or alcohol abuse * metal implants * weight \< 42 kg * suicide risk or very likely to require psychiatric hospitalisation
trauma-focused cognitive-behavioural therapy(tf-cbt) for children: a study of process and outcome.

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of this study is to determine whether trauma focused cognitive behavioral therapy (tf-cbt)is more effective in the treatment of traumatized youth than treatment as usual(tau).

children experiencing traumas, such as sexual abuse, physical abuse, domestic violence, serious accidents, or natural disasters, may develop severe health problems. this study will examine the short and long-term effects of trauma-focused cognitive-behavioural therapy on children exposed to serious trauma, and moderating factors of treatment outcome. the study will use a random control design, and will be implemented in regular clinical practice in norway. more knowledge within this field is important for practitioners as well as policy makers in planning interventions and therapy for children and their caregivers.

Eligibility criteria:
inclusion criteria: * children between the age of 10-18 * referred to a guidance clinic * who have experienced trauma * present with ptsd reactions * participants and the primary caretaker must be able to speak norwegian. exclusion criteria: * severe psychosis * severe mental retardation. * the youth must not have had severe conduct disorders previous to the trauma experience

Keywords: tf-cbt effectiveness study trauma therapy
a study to evaluate safety and efficacy of ttp054 for 12 weeks in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the safety and effect of ttp054 versus placebo on glucose control in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * on a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (oad) agent * hba1c: metformin only: 7.0 - 11.0%; metformin + acceptable oad agent: 6.5 - 9.5% exclusion criteria: * history or evidence of significant diabetic complications * history of heart attack, stroke or congestive heart failure * severe, uncontrolled hypertension * frequent hypoglycemia * women of child-bearing potential
elucidating age-related comorbidity patterns in down syndrome (ds)

Conditions: Down Syndrome

Summary: this study is a non-drug, multicenter, prospective cohort study. it will be conducted in 300 volunteers from 12 to 45 years of age (inclusive) with a diagnosis of down syndrome from 3 countries (france, spain, united kingdom (uk)). the basic hypotheses of the study are the following: 1. diseases (and comorbidity) arise from one or more biological networks perturbed by the genetic disorder (trisomy 21) through interaction with environmental risks factors and epigenetic changes. 2. health comorbidity patterns in ds individuals (particularly of obesity and related conditions) will likely vary by age and sex. 3. obesity comorbidity patterns will relate to variation in factors including lifestyle, stress-response, severity of intellectual disability (id) and variation in cognitive domains such as executive functioning. 4. stress responses, as measured with cortisol concentrations, will differentiate individuals with ds who are obese and those who are not. extremes in phenotype (obese vs. non-obese) will be related to differences in the metabolomic, transcriptomic, and microbiome concentrations.

the study will be conducted in n= 300 volunteers with ds from 3 countries (france, spain, uk); equal numbers in 3 age groups (12 - 18 years; 19 - 34 years; 35 - 45 years). the total number of volunteers expected to be included in each country is n = 100. from the initial cross-sectional cohort, individuals will be selected on the basis of obesity status and invited to participate in a nested case-control study (n = 30 for normal weight ds individuals and n = 30 ds individuals with extreme phenotype). in adults, normal weight is defined as bmi 18.5 to 24.9 and significant obesity as bmi \> 35 kg/m2. in children under age 18, the research team will use the international obesity task force (iotf) curves which are international norms) with iotf \> 30 for obese and iotf 18.5 - 25 for the normal weight group. the research team will monitor allocation using monthly ecrf recruitment reports for central allocation of recruits to ensure balance between age, sex and bmi between the "cases" and the "controls".

Eligibility criteria:
inclusion criteria: * males and females aged 12 to 45 years * with established genetic diagnosis of down syndrome (full trisomy 21; based on karyotype results - not exclusion if not available but will need to confirm karyotype if not done previously) * availability of parent/caregiver to accompany the subject to clinical visits and to be willing to give written informed consent, when necessary exclusion criteria: * confirmed mosaic trisomy 21, partial trisomy 21, or translocation * comorbid conditions - participation is allowed as long as the condition(s) are considered stable and it do not interfere with the participation of the study * subjects with evidence of dementia or meeting clinical diagnoses for dementia * participation in a medication treatment trial in the last 3 months prior to the study

Keywords: down syndrome trisomy 21 obesity comorbidities
self-supporting nasopharyngeal airway (ssnpa) treating upper airway obstruction in hypotonia

Conditions: Obstructive Sleep Apnea; Hypertonia, Muscle; Nasal Airway Obstruction; Tolerance; Trisomy 21; Down Syndrome

Summary: the researchers are investigating if the self-supporting nasopharyngeal airway (ssnpa) device can be used in the treatment of obstructive sleep apnea in children with hypotonic upper airway obstruction (huao).


Eligibility criteria:
inclusion criteria: * children with hypotonic upper airway obstruction (huao): this includes those who newly diagnosed with obstructive sleep apnea (osa). these children will undergo overnight polysomnography to determine the presence of osa (apnea-hypopnea index \[ahi\]\>10 or ahi\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \[spo2\] nadir \<=75%). * all subjects require the presence of at least one symptom of osa (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors) * post adenotonsillectomy or those with contraindications to tonsillectomy. * tonsil size 2+ or smaller. * parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate. exclusion criteria: * ahi ≤10 on polysomnogram (psg) without hypoxemia or ahi\<5 with hypoxemia. * any medical reason why self-supporting nasopharyngeal airway (ssnpa) therapy may not be suitable * active coronavirus (covid) 19 infections * end-tidal carbon dioxide (etco2) or transcutaneous carbon dioxide (tco2) values \>60 mmhg for \>10% of sleep time on psg * psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssnpa highly unlikely or make local follow-up at 8 weeks unfeasible. some psychiatric conditions may be provoked or exacerbated by osa, and those most commonly implicated - attention deficit/hyperactivity disorder, conduct disorder, and oppositional defiant disorder - will not be exclusions. however, more pervasive conditions such as severe autism will be excluded. * presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia) * moderate/severe tracheobronchomalacia * need for anticoagulative therapy * bleeding disorder * restrictive thoracic disorders

Keywords: sleep apnea syndromes sleep apnea, obstructive hypertonia, muscle apnea respiration disorders respiratory tract diseases sleep disorders, intrinsic dyssomnias sleep wake disorders nervous system diseases neuromuscular manifestations neurologic manifestations
pediatric sonics: pediatric study of neuropsychology and imaging in cns demyelinating syndromes.

Conditions: Multiple Sclerosis, Relapsing-Remitting; Neuromyelitis Optica; Acute Disseminated Encephalomyelitis; Transverse Myelitis

Summary: central nervous system (cns) demyelinating conditions include multiple sclerosis (ms), acute disseminated encephalomyelitis (adem), neuromyelitis optica spectrum disorder (nmosd), optic neuritis (on) and transverse myelitis (tm). the symptoms of these conditions are quite variable from patient to patient, but can include motor, sensory, visual, gait and cognitive changes. conventional mri can be used to look for new anatomic changes, but fails to measure underlying biochemical changes in brain tissue. the purposes of this study are to identify the biologic and anatomic correlations between cognitive profiles and disease activity using mri imaging techniques.

pediatric patients (age 12 to 21 inclusive) with a diagnosis of multiple sclerosis, adem, anti-mog mediated demyelinating disease as well as healthy controls will be recruited to undergo clinical testing. the study visits will include neuropsychological testing, optical coherence tomography (oct) and mri on both the 3t and 7t magnet. subjects will be asked to undergo two study visits separated by 12 months to 18 months. each study visit will have the same neuropsychological, oct, and research mri examinations.

Eligibility criteria:
inclusion criteria: 1. diagnosis of multiple sclerosis , adem, anti-mog antibody associated cns demyelination 2. age 12 to 21 inclusive at time of enrollment 3. ability of parent or legal guardian to provide informed consent if participant is under 18. 4. ability of patients age 12-17 to give assent 5. completion of the signed hippa authorization form by a parent or legal guardian or by participants (18 years of age). exclusion criteria: 1. known history of traumatic brain injury that required medical care 2. non-english speaking (based on standardized neuropsychological testing and questionnaires) 3. claustrophobic, the presence of metallic braces, implants or medical devices that are unsafe at 3t or 7t and/or interfere with the mri/mrs signals

Keywords: multiple sclerosis nmo anti-mog acute disseminated encephalolmyelitis
identifying and managing alcohol-related health problems in general practice

Conditions: Alcohol-Related Disorders; Alcohol Problem; Alcohol Drug Interaction; Alcohol Use Disorder

Summary: the overall purpose of the proposed research is to increase patients' and general practitioners' (gps') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. to achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.

alcohol use is a major health problem, and there is a strong need for improved identification of and interventions for alcohol-related health problems. these constitute somatic and neuropsychiatric health problems, caused, precipitated, or complicated by alcohol use. the investigators will especially recruit patients in late adulthood (60+), as this group may experience more barriers with digital interventions, and will have more health problems potentially affected by alcohol. the investigators have developed the identification strategy and the interventions in close collaboration with key stakeholders: patients and health care professionals. the aim is to test the feasibility of interventions for hazardous (a quantity or pattern placing patients at risk for adverse health events) and harmful alcohol consumption (consumption resulting in adverse events), with two distinct components, namely pragmatic case finding and a digital self-administered intervention (called endre) for use between consultations. the study will focus mainly on aspects related to acceptability, demand, implementation and practicality. the results from this feasibility study may give valuable knowledge on how this treatment approach should be adapted and implemented, and will indicate whether a full-scale rct is warranted. this study is testing the feasibility of interventions intended to facilitate change for both patients (reduced alcohol consumption) and for physicians (improved addressing of alcohol and improved intervention delivery).

Eligibility criteria:
inclusion criteria: * registered patient with participating clinic, accepting that alcohol may be relevant for his/her health problem and wanting to participate exclusion criteria: * none, except age

Keywords: general practice feasibility implementation
comparison between urocortin 2 and brain type natriuretic peptide

Conditions: Urocortin 2

Summary: 1. evaluation of the role of serum urocortin 2 levels in acute decompensated hf patients and their association with clinical and echocardiographic findings. 2. assessment of the clinical utility of urocortin 2 in monitoring ahf patients. 3. comparison between urocortin 2 and bnp as a biomarker in ahf patients

heart failure (hf) is a clinical syndrome with symptoms and/or signs caused by a structural and/ or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. (1) .the pathophysiology of hf is a complex interplay of genetic and multiple molecular mechanisms (from inﬂammation to hormonal pathways) performing in the composite network of the cardiovascular system environment. (2). monitoring of biomarkers in hf can be used to make an initial diagnosis, to aid in prognostic stratification, and to identify a patient's response to therapeutic intervention. (3). natriuretic peptide (np) concentrations are quantitative plasma biomarkers for the presence and severity of haemo-dynamic cardiac stress and heart failure. (4). that facilitate renal filtration and sodium excretion whilst suppressing the vasoconstrictor sodium, retaining renin angiotensin aldosterone system and exerting a tonic anti-trophic effect. (5). but the natriuretic peptide levels are significantly affected by weight, the nt- probnp in obese subjects is much lower than normal weight subjects. (6). other factors that affect bnp levels including gender, age and renal disease

Eligibility criteria:
inclusion criteria: * adult patients with acute decompensated heart failure. exclusion criteria: * acute coronary syndrome or stroke in the past 3 months. * severe chronic kidney disease. * severe valve disease.