Kornimate/medical-research-clean huggingface dataset:
ibrutinib in combination with lenalidomide and rituximab in participants with relapsed or refractory diffuse large b-cell lymphoma

Conditions: Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma

Summary: this phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large b-cell lymphoma (dlbcl) not eligible for transplant.

phase 1b: in the dose escalation portion of the study, various cohorts with escalating doses of lenalidomide may be explored, using the 3+3+3 principle for dose determination. phase 2: this will be conducted as an international, multicenter, open-label study. eligible subjects will receive ibrutinib, lenalidomide and rituximab.

Eligibility criteria:
inclusion criteria: * pathologically confirmed relapsed/ refractory dlbcl * must have previously received first line treatment regimen * must be ineligible for high dose therapy/ stem cell transplantation * measurable disease sites on computed tomography (ct) scan (\>1.5 cm in longest dimension) * prothrombin time/international normalized ratio (pt/inr) \< 1.5 x upper limit of normal (uln) and partial thromboplastin time (ptt; activated partial thromboplastin time \[aptt\]) \<1.5 x uln * men and women ≥18 years of age * eastern cooperative oncology group (ecog) \< 2 * adequate hepatic and renal function * adequate hematologic function exclusion criteria: * medically apparent central nervous system lymphoma or leptomeningeal disease * history of allogeneic stem-cell (or other organ) transplantation * any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks * radio- or toxin-immunoconjugates within 10 weeks * concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.

Keywords: dlbcl
a study to evaluate the efficacy and safety of mabt5102a in patients with mild to moderate alzheimer's disease (abby)

Conditions: Alzheimer's Disease

Summary: this is a phase ii, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of mabt5102a in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad according to the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorder association (nincds-adrda) criteria * mini-mental state examination (mmse) score of 18-26 points at screening * geriatric depression scale (gds-15) score of \< 6 * completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders) * if receiving concurrent ad treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization. exclusion criteria: * severe or unstable medical condition that, in the opinion of the investigator or sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care * history or presence of clinically evident vascular disease potentially affecting the brain * history of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma * hospitalization within 4 weeks prior to screening * previous treatment with mabt5102a or any other therapeutic that targets abeta * treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
outcomes of steroid and oxygen therapy versus placebo therapy in non-arteritic anterior ischemic optic neuropathy

Conditions: NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Summary: patients diagnosed with naion within 14 days of onset were included. patients were randomized into 3 groups. group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. group 2 or steroid consisted of 30 patients received methylprednisolone (solu-medrol, pharmacia pharmaceutical company, belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks functional and structural outcomes were assessed at 1 and 6 months following treatment. best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.


Eligibility criteria:
inclusion criteria: * patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy exclusion criteria: * the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum c-reactive protein; * a history of previous ocular surgery; * a history of prior treatment of any type for naion; * systemic condition such as diabetes mellitus and poorly controlled hypertension
to explore the safety and efficacy of hypidone hydrochloride tablets in treatment of patients with mdd

Conditions: Major Depressive Disorder

Summary: the objective of this study is to evaluate the safety and efficacy of hypidone hydrochloride tablets in treatment of patients with major depressive disorder (mdd) by evaluating the change of madrs total score from baseline to week 6.

a total of 40 major depressive disorder (mdd) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by dsm-5 will be recruited, subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments the subjects will accept the drug treatment twice daily orally for 6 weeks, during the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment ,43±2 days after treatment to evaluate the safety and efficacy of the drug.

Eligibility criteria:
inclusion criteria: 1. outpatient, 18-65 years old, male or female 2. current major depressive disorder diagnosed by dsm-5,single episode(296.21, 296.22, 296.23),or recurrent episode(296.31, 296.32, 296.33) 3. montgomery-åsberg depression rating scale (madrs) total scores in both screening and baseline ≥ 26 4. the first item of madrs in both screening and baseline ≥ 3 5. cgi-s in both screening and baseline ≥ 4 6. able to provide written informed consent exclusion criteria: 1. patients accord with other mental disorders diagnosed by dsm-5 2. attempts to suicide, or who presently have a high risk of suicide, or the tenth item (suicidal ideation) of c-ssrs ≥ 3 3. baseline total scores compared with the screening period, the reduction rate of madrs ≥ 25% 4. subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease 5. subjects with clinically significant ecg abnormal(male qtcf ≥ 450 msec, female qtcf ≥ 470 msec ) 6. treatment with a maoi within the 2 weeks prior to the first dose of trial medication 7. practicing 2 different treatment methods of antidepressants as recommended dose of full course 8. subjects who have had a vagus nerve stimulation(vns) device implanted or who have received modified electric convulsive therapy(mect) or transcranial magnetic stimulation (tms) within 3 months of screening, received light treatment, laser treatment, acupuncture and other chinese medicine treatment, biofeedback treatment within 2 weeks of screening 9. subjects with a history of true allergic response to more than 1 class of medications 10. subjects who participated in a clinical trial within the last 30 days.
sampling biomarkers in meniscus injury to the knee

Conditions: Cartilage Diseases

Summary: the diagnosis of clinically-significant meniscal tears of the knee remains challenging, and it is unknown why only some injuries become painful. the limitations of diagnostic magnetic resonance imaging result in arthroscopy that is not always beneficial. elucidation of biochemical pathways underlying pain in this condition may aid patient selection for surgery and provide pharmacotherapeutic targets. cytokines may be involved in pain following meniscus injury and diagnostic cytokine assay may help physicians differentiate patients that may benefit from arthroscopy from those that may not.

lavage of the operative and contralateral knee for comparison was performed under anesthesia prior to arthroscopy by the infusion of sterile saline into the knee joint followed by the immediate withdrawal into the syringe. sixteen asymptomatic control subjects also contributed knee samples. the concentrations of 17 inflammatory cytokines/chemokines were measured using a multiplexed immunoassay panel. pre-operative magnetic resonance imaging findings and cytokine assay results were compared to "gold-standard" intraoperative findings.

Eligibility criteria:
inclusion criteria: * adult patients with knee pain \< 6 months with acute onset who had failed conservative treatment and elected for arthroscopic management. indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for mcmurray's maneuver or joint line tenderness or both32, absence of severe joint space narrowing on plain radiography1 33, and the presence of grade iii signal changes on mri35 in an anatomic location consistent with the history and physical examination. exclusion criteria: * less than 18 years old. * recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis). * in addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.
evaluation of two reduced sirolimus doses in treatment of de novo coronary artery lesions (redox)

Conditions: Coronary Artery Disease

Summary: the objective of this study is to assess the performance and safety of two reduced sirolimus doses on the bx velocity balloon-expandable stent, mounted on the raptorâ rapid exchange (rx) stent delivery system (sds) in patients with de novo native coronary artery lesions.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female patient minimum 18 years of age 2. no significant (\>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff; 3. target lesion is 18mm in length (visual estimate); 4. target lesion is 3.0mm and 3.5mm in diameter (visual estimate); 5. target lesion stenosis is \>50% and \<100% (visual estimate); exclusion criteria: 1. a q-wave or non-q-wave myocardial infarction within the preceding 72 hours unless the ck and ck-mb enzymes are back to normal; 2. ejection fraction 30%; 3. stent placement of target lesion covers a side branch \>2.0mm in diameter;
18f-av-1451 and florbetapir f 18 pet (positron emission tomography) imaging in subjects at risk for chronic traumatic encephalopathy

Conditions: Chronic Traumatic Encephalopathy

Summary: this study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (cte) and examine the relationship between clinical presentation and tau deposition.


Eligibility criteria:
inclusion criteria: * male subjects consented and currently enrolled in the diagnosing and evaluating traumatic encephalopathy using clinical tests (detect) or the long-term consequences of repetitive brain injury in athletes study protocols * can tolerate up to two pet imaging sessions * have the ability to provide informed consent for study procedures exclusion criteria: * claustrophobia * current clinically significant cardiovascular disease or clinically significant abnormalities on screening ecg * history of risk factors for torsades de pointes or are taking drugs known to cause qt-prolongation * current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results * have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study pet imaging sessions
effect of using different varnishes on dentin hypersensitivity; na fluoride and nano-silver fluoride

Conditions: Dentin Hypersensitivity

Summary: 2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.

in-vivo part: each varnish will be applied separately on different teeth according to the manufacturer's instructions and the vas will be measured according to a specific timeline: t0 (baseline, before application of varnish), t1 (1 week after application), t2 (4 weeks after application) and t3 (4 weeks after application). in-situ part: dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared. it will be bonded to an orthodontic wire and bonded to upper first molar. dentinal occlusion will be measured using scanning electron microscope following the same timeline.

Eligibility criteria:
inclusion criteria: * patients consulting in one of the qasr einy, faculty of dentistry outpatient clinics. * males or females. * patient's age range 25-50 years. * patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring bpain (vas score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test). * tooth with exposed root surface, complaining from hypersensitivity (vas score; greater than or equal to 3). * patients accept the 2-months follow-up period. * provide informed consent. exclusion criteria: * • patients participating in another dental study that may alter the results of this study. * a medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders). * any chronic medical condition that requires the regular use of anti-inflammatory pain medications. * patients used or applied a desensitizing varnish within the last four weeks. * patients with dental problems; chipped teeth, defective restorations, fractured un-displaced cuspids or deep dental caries. * lack of patient's approval and compliance.
a coordination card of care relative to the medicinal treatments got out of it from hospitalization

Conditions: Treatment Related Cancer

Summary: the continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.this takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. this is clearly the case of cancer coverage. the optimization of the therapeutic suppor in town is based on pharmaceutical advice strengthening but also on the pharmaceutical analysis to check the entire treatments' prescription and eventual medicinal interactions which ensue from it.that's why it's important to have a medicinal conciliation that takes into account all the medecine taken or have to be taken by the patient. a specific support was developped by nurses , doctors and pharmacist ; it's a care coordination card that can be put easely in a pocket by the patient. the aim of the study is that this card can be also used as a communication tools by sharing the prescription done at the release of hospital by using an it link (flea datamatrix) for the patients via the use of an it link (flea datamatrix) for the patients whose pathology is complex in term of extra hospital coverage.

the aim of this strudy is to evaluate with community pharmacists the impact of a new information system on the prevalence of dispensing difficulties reported by pharmacies when hospitalized patients leave the city. this information system will be based on the care coordination card implemented by a secure computer link allowing the use of information on treatments prescribed at the end of hospitalization. patient management is not changed by this protocol. only the information of the pharmacist, which is the object of the study, is increased.

Eligibility criteria:
inclusion criteria: * all patient admitted in onco-thoracic service * handled by an anticancer agent * having frequented the same city pharmacy for at least 3 months exclusion criteria: * hospitalization above 21 days * refusing participation * palliative care * misunderstanding of french language * frequenting several pharmacy
stroke and mi in users of estrogen/progestogen

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Cerebrovascular Accident; Myocardial Infarction; Postmenopause

Summary: to estimate the relative risks of acute myocardial infarction (mi) and of stroke in postmenopausal users of estrogen/progestogen (e/p) combinations and to estimate the relative risks of mi and of stroke in users of estrogen alone.

background: post-menopausal hormone use is becoming increasingly widespread based on evidence of the benefits of estrogen use for bone and the heart. however, because estrogen alone substantially increases the risk of endometrial cancer, estrogen users who have not undergone a hysterectomy are frequently also placed on a progestogen (e/p), a strategy that reduces the likelihood of endometrial cancer when compared with use of estrogen alone. in 1991, there were almost no data on the risk of cardiovascular disease in post-menopausal women who used e/p combinations. design narrative: the study had a case-control design, cases were women hospitalized with mi or stroke in any of nine participating northern california kaiser permanente hospitals in a 36 month period. for each case, one control, matched by year of birth, was selected at random from among members of the kaiser permanente health plan who were expected to use the same nine hospitals for their medical care. information about use of estrogen, e/p combinations, past use of oral contraceptives, menopause, hysterectomy and oophorectomy, demographics, general health status, preventive health care, and cardiovascular risk factors were collected in interviews done of the subjects or, for fatal cases, a surrogate. information about then current use of estrogen and e/p combinations were also gathered by reviewing medical records. the investigators used conditional logistic regression analysis to estimate the relative risks of mi and of stroke in users of e/p combinations, taking into account prior oophorectomy and other potential confounders. they also estimated the risks of acute mi and of stroke in users of estrogen alone, accounting for prior oophorectomy and potential confounders. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
retrospective and prospective cohort of patients entering the multidisciplinary management of post-covid syndromes

Conditions: Post-Covid Syndrome

Summary: sars-cov2 pneumonia has been a global public health emergency since 2020. the prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in france) since the emergence of the virus. a substantial proportion of patients with sars-cov2 infection present persistent symptoms long after the acute infection. this is independent of the degree of severity of the sars-cov2 infection. these symptoms can affect the quality of life and impede the return to work. while the majority of symptoms progress favourably with outpatient care, some persist and/or are particularly severe, justifying expert and multidisciplinary care. this investigation aim to create a clinical database of patients with complex and/or severe post-covid and study blood markers what could predict the disease and orientate new ways of treatment.


Eligibility criteria:
inclusion criteria: all patients who have joined the epsilon care pathway since its opening in february 2022, i.e.: * patients with post-covid syndrome referred to the epsilon sector from the city medicine: * patient with documented sars-cov2 pneumonia * with persistent and severe symptoms beyond 4 weeks or complex or disabling symptoms beyond 3 months * patient over 18 years old. post-hospital sector: * patient with documented sars-cov2 pneumonia * hospitalized for oxygen therapy (at least 48h) * not having a referring pulmonologist * not institutionalized * with a life expectancy of more than 6 months. exclusion criteria: * patient refusing that this data to be used for research purposes (objection form). * patient with untreated comorbidities
an investigational immuno-therapy trial of nivolumab, or nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy, compared to platinum doublet chemotherapy in patients with stage iv non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.


Eligibility criteria:
inclusion criteria: * subjects with histologically confirmed stage iv or recurrent nsclc squamous or non-squamous histology, with no prior systemic anticancer therapy * subjects must have programmed death-ligand 1 (pd -l1) immunohistochemical (ihc) testing, with results, performed by the central lab during the screening period * eastern cooperative oncology group (ecog) performance status of ≤ 1 * measurable disease by ct or mri per response evaluation criteria in solid tumors version 1.1 (recist 1.1) criteria exclusion criteria: * subjects with untreated central nervous system (cns) metastases are excluded * subjects with an active, known or suspected autoimmune disease are excluded * any positive test for hepatitis b virus or hepatitis c virus or human immunodeficiency virus (hiv) indicating acute or chronic infection other protocol defined inclusion/exclusion criteria apply