Kornimate/medical-research-clean huggingface dataset:
zanubrutinib combined with br in the first-line treatment of waldenström's macroglobulinemia

Conditions: Waldenström's Macroglobulinemia (WM)

Summary: current retrospective studies have demonstrated that achieving deep remission following treatment for waldenström's macroglobulinemia (wm) correlates with prolonged survival. while the bendamustine-rituximab (br) regimen or single-agent zanubrutinib are currently recommended as first-line therapies, neither achieves optimal deep remission. additionally, prolonged zanubrutinib monotherapy may lead to cumulative adverse effects. therefore, this study aims to evaluate the efficacy and safety of the bendamustine-rituximab-zanubrutinib combination regimen as a first-line treatment option for myd88-mutated wm patients.


Eligibility criteria:
inclusion criteria: 1. previously untreated symptomatic waldenström macroglobulinemia (wm) meeting iwwm-7 diagnostic criteria: 1. presence of monoclonal igm-type immunoglobulin in serum 2. bone marrow infiltration by plasmacytoid lymphocytes or bone marrow biopsy showing small lymphocytes/plasma cells/plasmacytoid lymphocytes (any quantity) in the intertrabecular space 3. exclusion of other non-hodgkin lymphoma subtypes 4. typical immunophenotype: cd5-/cd10-/cd19⁺/cd20⁺/cd23-/cd79b⁺ /sigm⁺/cd138- clonal b-cells. variant phenotypes may show cd5/cd10/cd23 /cd38 positivity or coexistence of clonal b-cells and plasma cells. 2. myd88 l265p mutation is detected in peripheral blood or bone marrow. 3. serum monoclonal igm ≥5 g/l. exclusion criteria: 1. co-morbidity of uncontrolled infection or autoimmune disease 2. co-morbidity of other active malignancy 3. co-morbidity of uncontrolled heart disease 4. co-morbidity of severe digestive system disorders precluding oral medication 5. seropositive for human immunodeficiency virus 6. hepatitis b virus (hbv)-dna \> 1000 copies/ml 7. seropositive for hepatitis c (except in the setting of a sustained virologic response) 8. neutrophil \ 2.5 × upper limit of normal (uln), total bilirubin \> 1.5 × uln，egfr \< 30 ml/min, or receiving renal replacement therapy.

Keywords: rituximab zanubrutinib myd88 waldenström's macroglobulinemia bendamustine
a phase 1 study of bb3008 in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of bb3008 as monotherapy in subjects with advanced solid tumors.

this first-in-human (fih) study of bb3008 will evaluate safety, tolerability, pharmacokinetics (pk) efficacy and preliminary food effect of bb3008 in subjects with advanced solid tumors. the primary objective is to determine the maximum tolerated dose (mtd) and the recommended phase ii dose (rp2d) of bb3008 as monotherapy, and to evaluate the safety and tolerability of bb3008. the secondary objectives include the assessments of pk profile, preliminary efficacy, preliminary food effect (fe) and preliminary metabolites identification of bb3008. the exploratory objectives are to explore biomarkers and c-qtcf analysis.

Eligibility criteria:
inclusion criteria: 1. fully informed of the study and voluntarily signed the informed consent form (icf), and willing to follow and have the ability to complete all trial procedures. 2. subjects with histologically or cytologically confirmed advanced solid tumors who are lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy. 3. ecog score ≤1. 4. at least one evaluable or measurable lesion as defined by recist v1.1. 5. expected survival ≥ 3 months. 6. adequate organ function. 7. female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the icf until 6 months after the last dose of study treatment. exclusion criteria: 1. history of dual-source cancer within 5 years. 2. presence of known active central nervous system (cns) and/or leptomeningeal metastases. 3. history of clinically serious cardiovascular and cerebrovascular disease within 6 months. 4. active infection (including, but not limited to hbv or hcv). 5. received radical radiotherapy within 12 weeks. 6. received live virus vaccination within 4 weeks.

Keywords: bb3008 hpk1 first-in-human dose escalation
internet-delivered transdiagnostic intervention for anxiety and depression

Conditions: Depression; Dysthymic Disorder; Panic Disorder; Social Phobia; Specific Phobia; Obsessive-Compulsive Disorder; Generalized Anxiety Disorder

Summary: objectives 1. to test the effectiveness and acceptability of an augmented internet-supported transdiagnostic intervention in romania. 2. to assess the cost-effectiveness of the internet version of the transdiagnostic program as compared to a standard treatment/usual care.

the effectiveness of a transdiagnostic intervention will be compared with a wait list control group using a randomized control trial (rct) design in a culture where this has not been tested before. the treatment approach is mainly emotion-focus, teaching participants how to confront and experience uncomfortable emotions, and how more adaptive coping mechanisms could be used. because internet-delivered interventions represent an effective way to disseminate evidence-based programs, investigators decided to present our intervention online.

Eligibility criteria:
inclusion criteria: * be fluent in romanian * be over 18 years * have the principal diagnostic of generalized anxiety disorder and/or obsessive-compulsive disorder and/or panic disorder and/or social anxiety disorder and/or major depression disorder and/or dysthymia (or any combination of these diagnostics) on structured clinical interview for the diagnostic and statistical manual for mental disorders (scid-i) * have access to an internet connected computer exclusion criteria: * suicidal ideation * ongoing psychological treatment for generalized anxiety disorder and/or obsessive-compulsive disorder and/or panic disorder and/or social anxiety disorder and/or major depression disorder and/or dysthymia * other primary disorder that need treatment * obstacle to participation (i.e., long travel plans) * recent change in psychiatric medication (i.e., during the last 6 weeks)

Keywords: emotional disorders internet-delivered intervention anxiety depression transdiagnostic
cognitive behavioral therapy following myocardial infarction

Conditions: Myocardial Infarction

Summary: myocardial infarction (mi) is one of the leading cause s of health loss globally, representing a large proportion of general disability. anxiety and depression occur in 20-30 percent of patients following mi and have been identified as risk factors for recurrent adverse cardiac event. the purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (c bt) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (q ol) in patients following mi.

the study will include 20 patients. the mi-specific cbt lasts for 8 weeks and is delivered face-to-face via a secure digital video solution (to minimize cancelled sessions because of the covid-19 pandemic) or at the karolinska universitetssjukhuset cardiac research unit, by licensed psychologists with expertise in cbt for cardiac disease. during treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety.

Eligibility criteria:
inclusion criteria: ( - )mi ≥ 6 months before assessment (type 1 stemi/nstemi) ( - )age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (cardiac anxiety questionnaire (caq); score ≥20) ( - ) on optimal medical treatment ( - )able to read and write in swedish. exclusion criteria: ( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.

Keywords: cbt cardiac anxiety quality of life physical activity
"carotid web incidence and radiological classification, determination of its relationship with ischemic stroke"

Conditions: Stroke; Transient Ischemic Attack; Carotid Artery Diseases

Summary: in our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; evaluating the clinical data and vascular risk factors of carotid web cases and determining their relationship with ischemic stroke and determining the measures that can be taken for future optimal treatment. we aimed to contribute to their approach.

carotid web is a thin membrane-like tissue that extends from the wall to the lumen of the carotid artery bulb, identified radiologically. it is considered that stroke may be related to altered hemodynamics, blood stasis and fibrin-based clot embolization mechanisms in the distal carotid web. radiologically, in dsa and cta, there is a thin membrane-like intraluminal filling defect extending along the posterior carotid wall in oblique-sagittal sections and a corresponding defect in axial sections. it is seen as a thin septum; there is no study on its classification in the literature. determination of the incidence of carotid web, determination of its relationship with ischemic stroke / ti̇a, facilitating distinctions such as dissection etc. by making radiological classification is important in terms of increasing awareness on this issue and early diagnosis. demonstrating the relationship between carotid webs, which are shown as a cryptogenic cause of stroke, and vascular risk factors and taking protective measures against them will be effective in preventing strokes. in our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; we aimed to evaluate the clinical data and vascular risk factors of carotid web cases, determine their relationship with ischemic stroke, and determine the precautions that can be taken to contribute to future optimal treatment approaches.

Eligibility criteria:
inclusion criteria: * being over 18 years old * having a preliminary diagnosis of cerebrovascular disease * having carotid cta and/or dsa imaging performed exclusion criteria: * being under 18 years of age * patients who cannot undergo cta and/or dsa imaging due to the risk of contrast material allergy or renal failure. * patients for whom consent for imaging cannot be obtained by the patient and their relatives and for whom cta/dsa examination is not required in terms of etiology

Keywords: carotid web ischemic stroke transient ischemic atack
classifying ectopia lentis in marfan syndrome into five grades of increasing severity

Conditions: Marfan Syndrome; Ectopia Lentis

Summary: marfan syndrome is characterized by musculoskeletal manifestations, cardiovascular disease and ocular abnormalities, particularly ectopia lentis. diagnosis depends on clinical evaluation, family history and molecular data: mutation in the fibrillin-1 gene (fbn1). ectopia lentis is the most common ocular manifestation in marfan syndrome with fbn1 mutation and is relatively specific to this disease when associated with other features. however, clinical examinations for identifying ectopia lentis have not really been codified. the purpose of this study is to describe a 5-grade classification of increasing severity for ectopia lentis based on clinical examination and to evaluate the predictive value for the early grades of ectopia lentis in order to help characterize this major clinical diagnosis criterion.


Eligibility criteria:
inclusion criteria: * mfs patient, clinical diagnosis according to revised ghent criteria, confirmed by fbn1 mutation. * relatives of mfs patients with none of the clinical features of mfs and in whom testing for the familial fbn1 mutation was negative. exclusion criteria: * patients who had surgery for ectopia lentis * patients for whom dilation was not optimal.
comparative effectiveness/implementation of tb case finding in rural south africa

Conditions: Tuberculosis

Summary: the purpose of this study is to compare three strategies for finding tb cases in a rural sub-saharan african setting: 1) screening all attendees of primary care clinics for tb; 2) conducting household contact investigations of newly diagnosed tb cases; 3) providing incentives to newly diagnosed tb cases and their contacts to promote contact screening for tb. for each intervention, investigators will measure comparative effectiveness in terms of cases identified as well as the cost-effectiveness and feasibility of implementation.


Eligibility criteria:
inclusion criteria: facility-based screening arm * age 0-99 years * informed consent provided (or assent plus parent/guardian consent) * attending any of the study 28 study clinics in the facility-based screening arm contact tracing arm- index case * age 0-99 years * informed consent provided (or assent plus parent/guardian consent) * newly diagnosed (last 2 months) with tb at any of the 28 study clinics in the contact tracing arm contact tracing arm- household contact * age 0-99 years * informed consent provided (or assent plus parent/guardian consent) * living in the same household as an enrolled index case (see above) contact tracing arm- non-household close contact * age 0-99 years * informed consent provided (or assent plus parent/guardian consent) * referred to the study as a close contact of an enrolled index case (see above) exclusion criteria (all arms): * unable to provide informed consent.
adaptive treatment for adolescent cannabis use disorders

Conditions: Mental Disorders; Addictive Behaviors; Cannabis Use Disorder

Summary: the purpose of this study is to examine an adaptive treatment approach in order to improve outcomes of youth with cannabis use disorders who are poor responders to treatment.

the study will address the current contrasts in youth response to treatment, the problem of poor response to treatment and the prevention of relapse. results from the study may support adaptive treatment as an efficacious approach for youth with cannabis use disorder who are poor responders to treatment. poor responders fall into two categories, those who failed to achieve a negative drug urinalysis during the last session of the initial met/cbt-7 treatment they attended, and those who either dropped out or were administratively discharged at any time during the initial met/cbt-7 treatment.

Eligibility criteria:
inclusion criteria: * 13-18 years of age at the time of intake assessment * current diagnosis of dsm-iv cannabis abuse or dependence * able to read and comprehend english at a 5th grade level * residence within 45 minutes drive from the uchc farmington treatment site * participant and a parent/legal guardian responsible for providing collateral information agree to sign an irb approved consent form * participant and a parent/legal guardian responsible for providing collateral information agree to provide locator information * the family is not planning to move from the area during the next six months exclusion criteria: * meet criteria for dependence of any other substance of abuse other than nicotine or alcohol * report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days * meet a lifetime diagnosis of schizophrenia * has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment * demonstrate an inability or unwillingness to provide locator information

Keywords: adolescents substance use disorders
an observational study of avastin (bevacizumab) in combination with chemotherapy in patients with metastatic or recurrent non-squamous non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this observational study will evaluate modality, efficacy and safety of avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. data will be collected for each patient for 18 months from initiation of avastin therapy.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) * treating physician's decision to initiate first-line avastin treatment exclusion criteria: * participation in a clinical trial evaluating anti-cancer therapies
online and narrative interventions for advanced cancer patients

Conditions: Metastatic Cancer

Summary: the investigators will test whether narrative life review and web-based social networking for middle aged adults with advanced cancer will improve: 1. existential well being (and reduce psychological distress) 2. generativity and relationship quality, thereby mediating the intervention effects the investigators will also conduct exploratory process analyses of each participant's social network.

middle aged patients with advanced cancer report more distress, and active search for meaning and personal growth than older and/or early stage patients. nonetheless, such positive growth is far from typical and interventions help. expert-guided life review reduced distress for hospice patients, but is not widely accessible-and many patients lack the energy or skill to write their own life story. online cancer information and support expert systems improve quality of life. patients are increasingly developing their own social networks, but many lack the skills to do so. moreover the effects on social networking on patient well-being have not been studied. "my living story" elicits a dignity-enhancing life story via a telephone interview (based on chochinov, jama 2002), and delivers the edited transcript on the patient's personal milivingstory social network. milivingstory links to a life review education website (called mistory) with links to high quality cancer information, support and interactive planning tools. we hypothesize that telling, revising and sharing the life story with one's selected social network will improve the patient's existential well-being and reduce their distress. furthermore, we hypothesize that these effects will be mediated by my living story's effects on improving the patient's sense of legacy (generativity) and the quality of their relationships. our exploratory observational analyses of each individual milivingstory network will contribute to an understanding of how social network configuration and communication patterns correlate with measured outcomes we will recruit and randomize 100 patients with advanced cancer. the control group will receive a personalized web portal (called miownresources) with links to high quality cancer information, social support and interactive planning tools, and a feature to add their own links. all participants will sign informed consent forms, complete a pre-test survey and post-tests at tow and four months.

Eligibility criteria:
inclusion criteria: * age 30 - 60, * stage iii or iv cancer, * able and willing to use an internet computer to complete study activities. exclusion criteria: * institutionalized, \< 6 months prognosis, * cannot read or understand english, * unable or unwilling to use an internet computer to complete study activities.

Keywords: metastatic cancer recurrent cancer distributed hematological cancer advanced cancer terminal cancer stage iii cancer stage iv cancer
study of cm310 in children subjects with moderate-to-severe atopic dermatis

Conditions: Atopic Dermatitis

Summary: this is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.


Eligibility criteria:
inclusion criteria: * with atopic dermatis. * voluntarily sign the informed consent form. exclusion criteria: * any major surgery planned during the research period. * with intestinal parasitic infection within the first 6 months of screening. * with any previous malignant tumors prior to screening. * with any circumstance that is not suitable to participate in this study.
get living: graded exposure treatment for children and adolescents with chronic pain

Conditions: Pediatric Pain; Chronic Pain, Widespread; Musculoskeletal Pain

Summary: the broad aim of this study is to implement and evaluate the efficacy of graded exposure treatment (get living) to target elevated pain-related fears in children with chronic pain at the stanford pediatric pain management clinic (ppmc). the investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. if proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.

the treatment intervention to be tested in this clinical trial is graded in-vivo exposure treatment (get living) compared to multidisciplinary pain management (mpm) in adolescents with chronic musculoskeletal pain. participants will be randomized into get living or mpm, and will be instructed to not seek new treatments for pain for the duration of the study. both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks and 3 parent-only sessions.

Eligibility criteria:
inclusion criteria: * 8 - 18 years old; male or female * musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture). * moderate to high pain-related fear ( ≥ 35 on the fopq-c) * moderate to high functional disability ( ≥ 13 on the fdi) * english language proficiency exclusion criteria: * significant cognitive impairment (e.g., brain injury) * significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)