Kornimate/medical-research-clean huggingface dataset:
phase 1b study evaluating opomd in relapsed or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: a study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma.

a multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma. the study will be conducted in two parts. part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.

Eligibility criteria:
inclusion criteria * participant must have a pathologically documented, definitively diagnosed, multiple myeloma relapse, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalidomide. * participant must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines). * measurable disease (assessed within 28 days prior to day 1). * eastern cooperative oncology group (ecog) performance status of \<= 2. * other inclusion criteria may apply exclusion criteria * currently receiving treatment in another investigational device or drug study, or less than 28 days or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s). * previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1; received immunosuppressive therapy within the last 3 months prior to study day 1; having signs or symptoms of acute or chronic graft-versus-host disease. * autologous stem cell transplant \< 90 days prior to study day 1. * multiple myeloma with igm subtype. * poem syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). * plasma cell leukemia (\> 2.0 x10\^9/l circulating plasma cells by standard differential). * waldenstrom's macroglobulinemia. * other exclusion criteria may apply

Keywords: multiple myeloma
endothelial dysfunction in covid-19

Conditions: Covid19; Hypoxemic Respiratory Failure

Summary: sars-cov-2 targets endothelial cells via the angiotensin-converting enzyme 2 receptor. the specific impact of the resulting endothelial injury is currently unknown but may contribute to the pro-coagulant state classically described during covid-19 disease and commonly associated with an exacerbated activation of the renin-angiotensin-aldosterone system.

we prospectively compared clinical and biological parameters in icu- and non-icu-admitted covid-19 patients, icu-admitted patients with septic shock unrelated to covid-19 and matched control subjects. primary hemostasis and coagulation parameters and endothelial biomarkers are measured. activation of the renin-angiotensin-aldosterone system is monitored through measurements of plasma renin, angiotensin ii, aldosterone, and serum soluble angiotensin-converting enzyme 2. vascular oxidative status is assessed by measuring plasma lipids peroxides. neutrophilic polymorphonuclear activation is assessed by measuring plasma levels of triggering receptor expressed on myeloid cells-1. vascular nitric oxide bioavailability is measured by quantification of the concentration of heme-nitrosylated hemoglobin (hbno) in venous erythrocytes using electron paramagnetic resonance spectroscopy. structural abnormalities of vascular endothelial cells were analyzed by transmission electron- and scanning electron microscopy.

Eligibility criteria:
inclusion criteria: * positive result on a reverse-transcriptase-polymerase chain reaction testing performed on nasopharyngeal swab at hospital admission exclusion criteria: * icu admission more than five days after admission on a general ward, * concomitant bacterial infection * older than 75 years * cirrhosis

Keywords: endothelial dysfunction covid19
vital pulp therapy (vpt) using calcium enriched mixture (cem) to treat irreversible pulpitis

Conditions: Irreversible Pulpitis

Summary: to compare the effect of different vpt methods using calcium enriched mixture (cem) cement for management of human dental pulp with irreversible pulpitis.

the purpose of this randomized clinical trial is to demonstrate the effect of four methods of vital pulp therapy (vpt) using a new endodontic bio-material \[calcium enriched mixture (cem) cement\] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.

Eligibility criteria:
inclusion criteria: 1. carious permanent vital mature molar tooth with closed apex (with preoperative x-ray) 2. positive response to ept or cold test 3. patients willing to participate in study 4. healthy subjects; absence of any systematic disorder 5. age ≥ 10 years old 6. both gender 7. written informed consent exclusion criteria: 1. moderate or severe periodontitis; pockets \>3mm 2. none restorable tooth 3. internal or external root resorption 4. root canal calcification 5. non vital pulps 6. analgesic taken within the last 8h 7. active systemic disease 8. pregnancy or nursing 9. history of opioid addiction/abuse 10. temporary residency

Keywords: vital pulp therapy pulp cap pulpotomy calcium enriched mixture cem cement endodontic
diagnosis of active tuberculosis by elispot

Conditions: Tuberculosis

Summary: recent studies revealed that the ex vivo enzyme-linked immunospot (elispot) assay for gamma interferon is a specific method for contact tracing of mycobacterium tuberculosis infection. however, its use in endemic area and bacillus calmette-guérin (bcg)-vaccinated hosts has not been proved. we hypothesize that the tb-elispot assay can be a rapid and accurate diagnostic tool for active tuberculosis in clinical suspects in taiwan.


Eligibility criteria:
inclusion criteria: * patients who present with fever or respiratory symptoms (cough, dyspnea, or hemoptysis) lasting for ≥ 2 weeks and have compatible radiographic findings were considered clinical suspects of tb. exclusion criteria: -

Keywords: tuberculosis, tb-elispot, active tuberculosis latent infection interferon
treatment of idiopathic pulmonary fibrosis with long acting octreotide

Conditions: Idiopathic Pulmonary Fibrosis

Summary: octreotide is a somatostatin analog with a long half-life in vivo. octreotide has interesting anti-inflammatory and anti-fibrotic properties in vitro and in vivo. somatostatin receptors are increased and octreotide uptake is increased in the lung in patients with idiopathic pulmonary fibrosis. our hypothesis is that octreotide may slow the degradation of lung function in patients with ipf. in this proof of concept study, patients with ipf will receive an intramuscular injection of slow release octreotide (sandostatin lp, 30 mg)every 4 weeks for 48 weeks. lung function (fvc, dlco), hrct scores for fibrosis and ground glass, 6 minute walking test,quality of life and survival will be monitored.


Eligibility criteria:
inclusion criteria: * confident diagnosis of ipf according to ats/ers criteria exclusion criteria: * known intolerance to somatostatin or octreotide * another disease with predicted survival \< 12 months * pregnancy or lactation * previous treatment with somatostatin or somatostatin analogs * patient on a waiting list for transplantation * antifibrotic treatment or prednisone \> 10 mg/day within the last 6 weeks * symptomatic biliary lithiasis * blood coagulation disorders that prevent intra-muscular injections * hiv infection * hepatitis b or c active infection
effect of the vojta therapy in patients multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis is the most common disabling neurological disease in young adults. inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. clinically, ms manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction. the main subtypes of ms are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. clinically, rrms presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. approximately 40-50% of these patients progress to spms, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. ppms is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.

from the field of physiotherapy, one of the main tools for the treatment of ms is physical exercise. numerous studies show that exercising is safe and beneficial in people with ms, as long as it is done correctly and supervised by health professionals. physical exercise is considered an important part of symptomatic and supportive treatment for people with ms, since it induces improvement of physiological functions affected by lack of physical activity and helps to manage some symptoms, such as spasticity, fatigue and lack of balance there are therapies within physiotherapy that help treat ms such as the vojta method and the bobath method.

Eligibility criteria:
inclusion criteria: * persons with ms who have signed the informed consent. * persons of both sexes. * ages between 20 and 65 years. * subjects of both sexes diagnosed with multiple sclerosis on the edss (expanded disability status scale). exclusion criteria: * persons with multiple sclerosis with edss scale score equal to or greater than 7.0. * occurrence of a flare during the period of the patient's participation in the study. * pregnant women. * oncology patients. * non-acceptance and non-signing of informed consent. * refusal to participate in the study. * patients with severe cognitive impairment that does not allow them to understand the development of the study. * patients with cardiovascular instability. * patients who do not complete at least 75% of the scheduled sessions. patients who do not present any of the contraindications contemplated for vojta therapy.

Keywords: vojta therapy bobath therapy
types of fixation in arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tear

Summary: the study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. the two different techniques are either the single row fixation or the double row fixation.

primary research question; what is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the western ontario rotator cuff index (worc)at one year post op?

Eligibility criteria:
inclusion criteria: * patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff. * imaging and intra-operative findings confirming a full thickness tear of the rotator cuff. exclusion criteria: * characteristics of the cuff tear that render the cuff irrepairable. * significant shoulder comorbidities * previous surgery on affected shoulder * patients with active workers compensation claims * active joint or systemic infection * significant muscle paralysis * rotatorcuff tear arthropathy * charcots arthropathy * major medical illness * unable to speak or read english * psychiatric illness that precludes informed consent

Keywords: full thickness rotator cuff tear
dasatinib or nilotinib followed by imatinib in patients with newly diagnosed, chronic phase chronic myeloid leukemia

Conditions: Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia; Leukemia

Summary: this phase ii trial studies how well dasatinib, nilotinib, and imatinib mesylate works in treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature blood cells) (chronic phase). dasatinib, nilotinib, and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

primary objective: i. to assess incidence of major molecular response (mmr) at 12 months. secondary objectives: i. to assess progression free survival (pfs) at 12 and 24 months. ii. to assess accelerated phase (ap) or blast phase (bp) transformation-free survival at 12 and 24 months. iii. to assess incidence of deep mrs (≥ mr⁴) at 12 months and 24 months. iv. to assess safety. v. to assess patient reported outcomes (pro). tertiary objectives: i. to assess prognostic significance of detecting aberrant myeloid or lymphoid markers on diagnostic bone marrow. ii. to assess ability to enroll subjects who maintain deep molecular remissions in tyrosine kinase inhibitors (tkis) discontinuation trials. outline: patients receive dasatinib orally (po) once a day (qd) or nilotinib po twice a day (bid) at the discretion of the treating hematologist. patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (bcr-abl1) transcript levels may switch to imatinib mesylate po qd. after completion of study treatment, patients are followed up at 2 weeks and then up to 60 months.

Eligibility criteria:
inclusion criteria: * newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (cp-cml) (by world health organization \[who\] definition) (hydroxyurea permitted up to 7 days prior to enrollment) * clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications * able to give written informed consent and comply with all study visits and procedures exclusion criteria: * chronic myeloid leukemia (cml) in ap or bp * unable to receive tki for insurance reasons (uninsurable) * refuse or unable to perform telephone or video conferences with research coordinator * subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with tki * any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject
evaluation of exercise tolerance and cardiac output in patients with heart failure after intervention of rehabilitation program

Conditions: Heart Failure With or Without CRT-P/D

Summary: home-based rehabilitation programs have not been widely few been studied and the training effects are not unclear. this study evaluates the beneﬁcial effects of home-based cardiac rehabilitation on quality of medical care in patients with chronic heart failure.

cardiopulmonary rehabilitation programs are safe and effective for improving functional capacity, quality of life, as well as for reducing in the re-admission rate and all-cause mortality of patients with heart failure.clinical trials that have established the benefits of hospital-based cardiac rehabilitation for patients with chronic heart failure. home-based cardiac rehabilitation could be more accessible and acceptable compared with hospital-based cardiac rehabilitation.

Eligibility criteria:
inclusion criteria: * heart failure patients with nyha i, ii, iii, and lvef\<50%. exclusion criteria: * heart failure patients with nyha i, ii, iii, and lvef\<50%. but excluded pregnancy, disability.

Keywords: home-based cardiac rehabilitation quality of medical care heart failure
colombia daise feasibility exercise

Conditions: Stroke, Acute Ischemic

Summary: this study is to assess initial safety and performance data of the daise thrombectomy device for removal of thrombus during an acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified rankin score 0-2. * diagnosis of acute ischemic stroke with study enrollment time \< 8 hours from onset of symptoms. * disabling stroke defined as a baseline nihss \> 6. * confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, m1. * signed informed consent from patient or legal representative. exclusion criteria: * computed tomography (ct) or magnetic resonance imaging (mri) evidence of recent/ fresh hemorrhage on presentation. * clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. * rapidly improving neurological deficits based on the investigator's clinical judgement. * pregnancy; if a woman is of child-bearing potential and urine or serum beta hcg test is positive. * severe contrast allergy or absolute contraindication to iodinated contrast. * difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy. * evidence of dissection in the carotid or target artery for treatment. * presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure. * renal failure (serum creatinine level ≥ 3 mg/dl or on dialysis). * severe, sustained hypertension resistant to treatment (sbp \>185 mmhg or dbp\>110 mmhg). * use of warfarin anticoagulation with international normalized ratio (inr) \>3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. * use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (ptt) \> 2.0 times the normal prior to procedure. * cerebral vasculitis or evidence of active systemic infection. * suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis. * clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation). * a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
a study to investigate the safety and efficacy of abt-122 given with methotrexate in subjects with active rheumatoid arthritis who have an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: this study is a phase 2 randomized, double-blind, double-dummy, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of abt 122 in subjects with active rheumatoid arthritis (ra) who are inadequately responding to methotrexate (mtx) treatment.


Eligibility criteria:
inclusion criteria: 1. adult male or female, 18 years of age or older. 2. diagnosis of ra based on the 2010 american college of rheumatology (acr)/european league against rheumatism (eular) criteria (as defined in the definition of terms). 3. rheumatoid arthritis (ra) diagnosis at least 3 months from the date of first screening. 4. have active ra defined by minimum disease activity criteria: * ≥ 6 swollen joints (based on 66 joint counts) at screening and baseline visits. * ≥ 6 tender joints (based on 68 joint counts) at screening and baseline visits. * hscrp\> uln or positive for both rheumatoid factor (rf) and anti-cyclic citrullinated peptide (anti-ccp) antibody levels at screening. 5. inadequate response to methotrexate (mtx) treatment defined as oral or parenteral treatment ≥ 3 months with an unchanged mode of application and stable prescribed mtx dose for at least 4 weeks prior to baseline of ≥ 10mg/week and \< the upper limit of the applicable approved local label. subject can also be on stable doses of sulfasalazine and/or hydroxychloroquine, so long as they are also on methotrexate. exclusion criteria: 1. subject has previous exposure to humira, other tumor necrosis factor (tnf) inhibitors or other biological dmards. 2. current treatment with traditional oral disease modifying antirheumatic drugs (dmards) (except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to mtx). oral dmards must be washed out 5 times the mean terminal elimination half-life of a drug apart from mtx prior to day 1. • subject could have been exposed to prior janus kinase (jak) inhibitors so long as they have been off therapy for 5 half-lives. 3. stable prescribed dose of oral prednisone or prednisone equivalent \> 10 mg/day within the 30 days of first dose of study drug. 4. intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of first dose of study drug. inhaled corticosteroids for stable medical conditions are allowed. 5. laboratory values of the following at the screening visit: * confirmed hemoglobin \< 9 g/dl for males and \< 8.5 g/dl for females, * absolute neutrophil count (anc) \< 1500 mm\^3, * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 1.5 × the upper limit of normal (uln) or bilirubin ≥ 3 mg/dl, * serum creatinine \> 1.5 × the uln, * platelets \< 100,000 cells/\[mm3\] (10\^9/l), * clinically significant abnormal screening laboratory results as evaluated by the investigator.

Keywords: efficacy methotrexate safety