Kornimate/medical-research-clean huggingface dataset:
study of biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.

objectives: * determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (cr), prolonged progression-free survival (pfs), and overall survival (os) in patients with previously untreated chronic lymphocytic leukemia. * determine the significance of the absence of igv_h gene mutational status as related to the ability to predict cr, pfs, and os in these patients. * correlate igv_h gene mutational status with cd38 expression, zap-70 expression, over-expression of mcl-1, bak-1, high mcl-1:bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients. * determine the prognostic significance of over-expression of mcl-1, bak-1, high mcl-1:bax ratio, p53 mutations or dysfunction, atm mutation, atm expression, and other factors that disrupt apoptosis with respect to cr, prolonged pfs, and os. * determine if clonal evolution occurs in these biological markers at partial response or disease relapse. outline: this is a multicenter study. blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. samples are analyzed by fish for interphase cytogenetics, pcr for igv_h mutational status, flow cytometry for surface expression of cd38 cells, western blot to assess mcl-1, bcl-2, bak-1, atm, zap-70, and bar expression, and sequencing for p53 and atm function.

Eligibility criteria:
disease characteristics: * diagnosis of chronic lymphocytic leukemia * previously untreated disease * registered to receive treatment on a cancer and leukemia group b protocol patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: chronic lymphocytic leukemia
tocladesine in treating patients with recurrent or progressive metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer.

objectives: * determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer. * determine the qualitative and quantitative toxicity of this drug in these patients. * assess any therapeutic activity in patients treated with this drug. outline: this is a dose-escalation, multicenter study. patients receive tocladesine iv continuously on days 1-5 and 8-12. treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, up to 14 additional patients are treated at this dose level. projected accrual: a total of 3-38 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of metastatic carcinoma of the colon or rectum * recurrent or progressive after failing prior fluorouracil and irinotecan chemotherapy, sequentially or in combination, unless unable to tolerate irinotecan * measurable disease patient characteristics: age: * 18 to 75 performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast and alt no greater than 5 times uln * pt/aptt no greater than 1.2 times uln renal: * creatinine no greater than 1.5 mg/dl * creatinine clearance at least 50 ml/min * no impaired renal function cardiovascular: * no impaired cardiac function other: * no active infection * no other malignancy within the past 5 years except basal cell or squamous cell skin cancer * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * not specified other: * no other concurrent anticancer drugs * no concurrent chronic non-steroidal anti-inflammatory agents * no concurrent chronic therapeutic anticoagulation

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer
self-compassion and bipolar disorder

Conditions: Bipolar Disorder

Summary: currently, pharmacotherapy is central in the management of bipolar disorder (bd), but does not guarantee satisfactory results for many patients. existing psychotherapies, notably cognitive-behavioral therapy (cbt), show some effectiveness, but do not target the mechanisms that maintain the disorder. indeed, people with bd present a low level of self-compassion, suffer from comorbidities (e.g. anxiety, depression), and have a high level of emotional dysregulation, which can contribute to increasing the risk of relapse and mood instability. in this context, it has been suggested that interventions targeting self-compassion could reduce bd psychopathology and strengthen emotional regulation skills. two psychological therapies targeting self-compassion could be promising in the treatment of bd: compassion-based therapy (cbt) and cognitive therapy focused on mental imagery (mtci). these approaches partly emphasize compassionate mental imagery to promote self-soothing and emotion management skills. studies on the feasibility and effectiveness of cbt and mtci in the context of bd are few in number, and do not focus on their impact on emotional regulation abilities. evaluating these therapies could lead to the development of more specific and effective interventions for people with tb.


Eligibility criteria:
inclusion criteria: * major subject (≥ 18 years old) * subject with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from january 1, 2022 to february 29, 2024. * absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed his opposition to the reuse of his data for scientific research purposes. * judicial measures: care under constraint or patient deprived of liberty due to a legal measure

Keywords: bipolar disorder self-compassion cognitive-behavioral therapy anxiety disorders depressive disorder emotional regulation mental imagery
hemodialysis adequacy using a heparin-grafted dialyzer and a citrate-enriched dialysate

Conditions: Kidney Diseases; Hemodialysis Complication; End Stage Renal Disease

Summary: after providing informed consent, patients will be randomized to either the intervention treatment ("evocit procedure") or the control treatment ("evohep procedure"). after randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. after the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. after crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.


Eligibility criteria:
inclusion criteria: * patients treated with hemodialysis or hemodiafiltration since at least three months. * hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly. * ≥ 18 years of age. * patients able and agree to provide signed informed consent. exclusion criteria: * contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by swartz and port1. * planned surgery during study period, including scheduled living-donor kidney transplantation during study period. * hypercoagulable state defined as known malignancy, known apc resistance/fv leiden, known prothrombin gene mutation, known protein c or protein s deficiency, known antithrombin deficiency. * mean qb of \<300ml/min during one of the last 3 dialysis sessions before inclusion. * 1 or more results of spkt/vurea \< 1,35 during the last three months prior to study inclusion. * need for 2 or more supplementary dialysis sessions on top of the regular 3x4 hours weekly hemodialysis regimen during the last month before inclusion. * vascular access dysfunction defined as 1. use of urokinase the 2 months before study inclusion, including to restore catheter permeability. 2. non-tunneled hemodialysis catheter use. 3. known av access outflow tract stenosis. 4. planned vascular access intervention. 5. planned vascular access conversion. * known allergy against heparin grafted an69stmembranes. * use of ace-inhibitor * use of vitamin k antagonist * use of novel oral anticoagulant therapy. * any medical condition, which puts the patient at risk of premature study termination in the opinion of the investigator. * planned conversion of dialysis modality during study period or planned absence/leave (including pregnancy or planned pregnancy). * symptomatic hypocalcemia. * hb \< 8g/dl at screening. * hct \> 45% at screening. * perdialytic total parenteral nutrition therapy

Keywords: dialysis adequacy clotting
longitudinal mindfulness intervention to decrease burnout in medical residents

Conditions: Burnout

Summary: this was a single-site rct to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (pgy-1) internal medicine (im) and pediatrics residents. the primary outcome was maslach burnout inventory mbi) scores at baseline and 12 month follow-up. secondary outcomes were feasibility and perceived benefit of the intervention.


Eligibility criteria:
inclusion criteria: * washington university (wusm) first year residents in internal medicine and pediatrics exclusion criteria: * none

Keywords: burnout medical residents
bf2.649 in patients with osa, still complaining of eds and refusing to be treated by cpap.

Conditions: Obstructive Sleep Apnea; Excessive Daytime Sleepiness

Summary: multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. this double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

the first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of bf2.649 by verifying whether the results of bf2.649 are superior to those of placebo. the aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the bf2.649 efficacy.

Eligibility criteria:
inclusion criteria: * patients with osa still complaining eds,refusing ncpap * ess score ≥ 12 exclusion criteria: * patients suffering from insomnia without osa * co-existing narcolepsy * patient with sleep debt not due to osa * acute or chronic severe disease

Keywords: multicenter randomized double-blind efficacy and safety study bf2.649 versus placebo patients suffering from obstructive sleep apnea complaining from excessive daytime sleepiness refusing nasal continuous positive airway pressure
a double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of briquilimab in participants with allergic asthma

Conditions: Allergic Asthma

Summary: study jsp-cp-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. a single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.


Eligibility criteria:
inclusion criteria: * men and women 18 to 65 years of age; stable, allergic asthma; history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (fev1) at baseline at least 70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form; positive methacholine challenge at baseline (concentration of methacholine causing 20% decrease in fev1 \[pc20\] pc20 ≤ 16 mg/ml or pd20 equivalent to ≤400µg); and positive skin-prick test and positive allergen-induced early and late airway bronchoconstriction to common aeroallergens. exclusion criteria: * worsening of asthma or respiratory infection in the preceding 6 weeks; lung disease other than allergic asthma; prior treatment with a c-kit inhibiting therapy; anaphylaxis to any parenterally administered biologics; use of asthma medications (note: intermittent doses of short-acting β2-agonist are allowed once weekly for relief of symptoms but prophylactic use for exercise is allowed as-needed); pregnant or lactating women; and women actively seeking pregnancy or who are not using adequate contraception.

Keywords: asthma allergy chronic disease lung function exacerbation bronchial diseases respiratory tract diseases lung diseases, obstructive lung diseases respiratory hypersensitivity hypersensitivity, immediate hypersensitivity immune system diseases
prime: pilot study evaluating percutaneous vaccination of bcg for bladder cancer

Conditions: Bladder Cancer

Summary: approximately 25 subjects will be enrolled and receive a standard who adult potency bcg immunization (1cc/50mg live mycobacilli) in the deltoid. following a wait period after bcg vaccination, patients will then receive standard strength bcg intravesical therapy once a week for a total of 6 weeks. the bcg is instilled and held in the bladder for approximately 2 hours. while the bcg is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. patients will undergo a cystoscopy every 3 months following most recent turbt. study duration last approximately 6 months.

approximately 25 subjects will receive a standard who adult potency bcg immunization (1cc/50mg live mycobacilli) in the deltoid. following a wait period after bcg vaccination, patients will then receive standard strength bcg intravesical therapy once a week for a total of 6 weeks. the bcg is instilled and held in the bladder for approximately 2 hours. while the bcg is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. patients will undergo a cystoscopy every 3 months following most recent turbt. study duration last approximately 6 months.

Eligibility criteria:
inclusion criteria: the patient must: * be 18 years of age or older * be able to give informed consent * have newly diagnosed or recurrent multi-focal ta, large ta, high grade ta, cis or t1 bladder cancer * determined by treating urologist to be a good candidate for bcg induction therapy * have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent exclusion criteria: the patient cannot: * be less than18 years of age * unable to give informed consent * have a history of muscle invasive bladder cancer * be self-reported to be immune-compromised (hiv, chronic immunomodulators, chronic corticosteroids) * have a history of tuberculosis and/or received bcg percutaneous vaccination * pregnant or planning to become pregnant.
apc-111 once a day (qd) for 7 days vs. penicillin taken four times a day (qid) for 10 days in patients with strep throat

Conditions: Pharyngitis; Tonsillitis

Summary: the purpose of the this study is to evaluate the safety of efficacy of apc-111 775 mg mp tablet once daily dosing for 7 days for treating patients with strep throat. the evaluation will look to confirm if apc-111 eliminates the bacterial infection (streptococcus pyogenes).


Eligibility criteria:
inclusion criteria: * give informed consent, assent and patient authorization * age 12 and over * a clinical diagnosis of acute pharyngitis or tonsillitis * a positive rapid strep test * can swallow the oral study dosage forms * females must have a negative urine pregnancy test and be using acceptable birth control if sexually active exclusion criteria: * chronic or recurrent odynophagia * need for hospitalization or iv antimicrobial therapy * pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials * known carrier of s. pyogenes * allergies to penicillin or other beta-lactam antibiotics * any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study * seizure disorder * pregnant or nursing * expectation of additional systemic antibacterials would be required for another condition * current drug or alcohol abuse * any experimental drug or device within the last 30 days * prior systemic antibiotic therapy within the last 30 days * hospitalization within the last month which included antibacterial therapy * the presence of clinically significant hematologic conditions, etc * probenecid treatment

Keywords: pharyngitis tonsillitis
accuracy of pulse oximeter with profound hypoxia

Conditions: Hypoxia

Summary: clinical evaluation of the accuracy of spo2 measurements with the anne limb sensor compared to blood gas analysis in healthy, adult subjects. hypoxia is induced in patients to different and stable levels of sao2 over the range of 70-100%.


Eligibility criteria:
inclusion criteria: * the subject is male or female, between the ages of 18 and 55 years. * the subject is in good general health with no evidence of any medical problems * the subject is fluent in both written and spoken english * the subject has provided informed consent and is willing to comply with the study procedures. exclusion criteria: * known history of heart disease, lung disease, kidney or liver disease * diagnosis of asthma, sleep apnea, or use of cpap * subject has diabetes * subject has a clotting disorder * the subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation * the subject has any other serious systemic illness * th subject is a current smoker * any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly * the subject has a history of fainting or vasovagal response * the subject has a history of sensitivity to local anesthesia * the subject has a diagnosis of raynaud's disease * the subject has unacceptable collateral circulation based on exam by the investigator (allen's test) * the subject is pregnant, lactating, or trying to get pregnant * the subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures * the subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study
the effects of well-being interventions on affect, attention, sleep, social stress and pain regulation

Conditions: Health; Mental Health

Summary: this study is focused on the brain mechanisms and peripheral biological correlates of two different forms of meditation--mindfulness-based and compassion/loving-kindness. project 1 is focused on the impact of compassion/loving-kindness meditation on emotional reactivity and emotion regulation. project 2 is focused on the neural and behavioral correlates of mindfulness meditation and attention and pain regulation. in addition, project 2 will examine the relations between changes in oscillatory rhythms during meditation and attention and pain processing. project 3 will examine the impact of meditation on spontaneous brain activity during sleep. this project will also examine the impact of intensive meditation on regional changes in slow wave activity during subsequent sleep. each of these projects will be conducted on the same participants so that interrelations among the various measures collected in the different projects can be examined. we believe that this study will dramatically advance the understanding of the mechanisms by which meditation produces changes in behavioral and biological processes.


Eligibility criteria:
inclusion criteria: * mri safe exclusion criteria: * not available for scheduled visits or applicable interventions * current medical conditions that may affect outcome measures, including chronic inflammatory diseases, asthma, serious mental health diagnoses, chronic pain conditions, a personal history of seizures * regularly taking medications that may affect outcome measures, including pain medications, corticosteroids, immuno-suppressants, prescription sleep medications, psychotropic medications * alcohol or non-prescription drug problems * night-shift worker * diagnosed sleep disorder or habits, such as late bedtime, that would prevent enough sleep in the laboratory * previous training related to one of the two active interventions for meditation naive participants * unwillingness or inability to engage in intervention activities as determined by participant or their primary care physician * currently pregnant or planning on becoming pregnant in the next year * currently nursing * current iud