Kornimate/medical-research-clean huggingface dataset:
comparative study between biodentine and mineral trioxide aggregate in direct pulp capping

Conditions: Patients With Deep Carious Lesions

Summary: comparative study between biodentine and mta in direct pulp capping of deeply carious teeth.


Eligibility criteria:
inclusion criteria: 1. asymptomatic vital molars (upper or lower) 2. with complete formation of roots 3. aged 15 to 30 years. 4. accidental point pulp exposure during the process of removing dental caries. exclusion criteria: 1. if the molar not vital. 2. if the molar is symptomatic. 3. immature molar. 4. patient not in age between (15-30 years).
efficacy of an occupational time use intervention for people with serious mental illness

Conditions: Serious Mental Illness

Summary: the purpose of this study is to test the efficacy of a new occupational time use intervention designed to increase activity participation and improve meaning in the lives of people with serious mental illness living in the community.

5 assertive community treatment (act) teams from kingston (n=2), belleville (n=1), and ottawa (n=2) will be involved in a 12 week randomized controlled trial of our time use intervention. 20 subjects (4 subjects from each team) will participate in this pilot study and will be treated individually by their act team occupational therapist (1 ot per act team). this pilot test will help to determine the clinical utility and efficacy of our treatment protocol. comparison: standard act treatment with the occupational time use intervention vs. standard act treatment

Eligibility criteria:
inclusion criteria: * adults (18-65 years of age); * primary diagnosis of a severe psychiatric disorder with a psychotic feature; * team and self-perceived occupational disengagement (low activity levels); * fluent in english; * living in a community setting and receiving act treatment; * own legal guardian (thus competent to give consent to participate), and are willing to give written informed consent to participate in the study. exclusion criteria: * unstable mental health; * lack of interest in a time use intervention; * satisfied with current time use and occupations; * act team occupational therapist is subject's main case manager.

Keywords: schizophrenia psychosis occupational disengagement occupational imbalance
multimedia information and pre-operative anxiety

Conditions: Anxiety

Summary: the aim of this study is to investigate a possible reduction in pre-operative anxiety in patients undergoing major elective surgery, by providing multimedia information regarding the patient pathway to and from the operating theatre.

to determine whether multimedia information reduces the level of pre-operative anxiety in patients undergoing major elective surgery. to evaluate the efficacy of a video, showing the patient pathway to and from the operating theatre, compared with standard information, a written leaflet, about the operating room experience and environment.

Eligibility criteria:
inclusion criteria: adult patients undergoing major elective surgery, never previously undergoing surgery as an adult (\>18) and admitted to hospital at least one day before the scheduled surgery. exclusion criteria: * patients unable to give consent. * patients not able to watch the video. * patients admitted the same day of the planned surgery. * patients not at the first experience of surgery as an adult (\>18).

Keywords: pre-operative anxiety multimedia information operating theatre
a novel multiplex elisa assay for evaluating patients with gross hematuria for bladder cancer

Conditions: Bladder Cancer

Summary: to improve upon the non-invasive detection of bca by further validating a multiplex elisa assay directed at a bca-associated diagnostic signature in voided urine samples of patients with gross hematuria.

hematuria is the most common presentation of bca with 22% of patients with gross hematuria harboring bca. vuc is the most widely used urine-based assay for detecting bca; however, it fails to detect approximately 50% of low-grade or early stage bca when it is most curable. because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. we propose to improve upon the non-invasive detection of bca by further validating a multiplex elisa assay directed at a bca-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Eligibility criteria:
inclusion criteria: * age 18 years or older * have documented or reported gross hematuria within 3 month of study enrollment * willing and able to give written informed consent exclusion criteria (patients must not): * have history of bca * history of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years * have a known active urinary tract infection or urinary retention * have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dl) serum creatinine value can be up to 60 days before consent, otherwise repeat * have ureteral stents, nephrostomy tubes or bowel interposition * have recent genitourinary instrumentation (within 10 days prior to signing consent) * be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
human papilloma virus vaccination and chronic inflammatory rheumatic diseases.

Conditions: Systemic Lupus Erythematosus; Idiopathic Juvenile Arthritis; Human Papilloma Virus

Summary: patients with chronic inflammatory rheumatic disease (cir) are at increased risk for infections. vaccination is a powerful tool to prevent infections, even in immunocompromised patients. low-risk types of human papilloma virus (hpv) cause anogenital warts, while high risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer. hpv vaccines have been developed to prevent these conditions. human papillomavirus (hpv) infections are more prevalent in systemic lupus erythematosus (sle) patients or other auto-immune diseases when compared to the healthy population. in france, despite a vaccination available since 2007, rate of vaccination remain low. although little is known about hpv vaccination in sle, few studies in patients with autoimmune rheumatic diseases (airds) have shown that hpv vaccines are safe, and capable to induce an immunogenic response in this group of patients. to date, available data suggest that hpv vaccines can be given safely to sle patients. given the increased incidence of cervical abnormalities due to hpv in sle patients, this vaccination should be encouraged. the aim of this study was to assess the vaccination coverage rate in chronically ill girls with sle or idiopathic juvenile arthritis who require a close pediatric specialized follow-up vaccination and to understand barriers or motivations for it.


Eligibility criteria:
inclusion criteria: * young girls older than 11 years old until adult transition * follow-up for systemic lupus erythematosus (american college of rheumatology classification) or idiopathic juvenile arthritis (international league of associations for rheumatology classification) * follow-up in a childen's hospital of lyon (hopital femme mère enfant) and paris (hospital necker-enfants malades, hôpital robert debré) * with no parental opposition to participate exclusion criteria: * refusing to participate * age \< 11 years old
first-in-human dose escalation and expansion study with the sirpα-directed monoclonal antibody byon4228

Conditions: Lymphoma

Summary: this is the first-in-human study with byon4228, a humanized monoclonal antibody (mab) directed against sirpα.

this study includes a dose escalation part (part 1) in which the mtd and dose regimen for expansion (rde) will be determined, and an expansion part (part 2) to evaluate efficacy and safety in specific patient cohorts. byon4228 is a humanized igg1 mab directed against sirpα. byon4228 binds sirpα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. byon4228 blocks binding of sirpα to cd47 and inhibits signaling through the cd47-sirpα axis.

Eligibility criteria:
inclusion criteria: * part 1 (dose escalation): b-cell nhl expressing cd20 by immunohistochemistry (ihc) or flow cytometry, relapsed/refractory (r/r) to at least 2 prior lines of therapy. * part 2 (dose expansion): a. histologically confirmed diffuse large b-cell lymphoma (dlbcl) or mantle cell lymphoma (mcl) expressing cd20 by ihc or flow cytometry, r/r to frontline therapy. b. histologically confirmed marginal zone or follicular lymphoma (grade 1-3a) expressing cd20 by ihc or flow cytometry, r/r to at least 2 prior lines of therapy. * eastern cooperative oncology group (ecog) performance status ≤ 1; * adequate organ function; * laboratory measurements, blood counts (growth factor (gf) support and blood transfusions are not allowed within 2 weeks prior to this assessment): * hemoglobin ≥ 8.5 g/dl (\> 5.28 mmol/l); * absolute neutrophil count (anc) ≥ 1.0 × 10\^9/ml; * platelet counts ≥ 50 × 10\^9/ml; exclusion criteria: * having been treated with cd47 or sirpα targeting agents at any time or other anticancer therapy within 4 weeks or as defined in the protocol; * history of hypersensitivity or allergic reaction to any of the excipients of byon4228 or rituximab which led to permanent discontinuation of the treatment; * burkitt's lymphoma; * red blood cell (rbc) transfusion dependence; * patients with active graft versus host disease (gvhd) or ongoing immunosuppression for gvhd; * history of autoimmune hemolytic anemia or autoimmune thrombocytopenia; * history of active autoimmune disorders (including but not limited to: crohn's disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, grave's disease) or other conditions that compromise or impair the immune system (except for hypogammaglobulinemia); * history (within 6 months prior to start imp) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication; * currently diagnosed or suspected cns involvement; * severe active infection or other severe uncontrolled systemic disease (e.g. advanced renal disease, pulmonary, uncontrolled diabetes mellitus, severely immunocompromised state, or metabolic disease)

Keywords: mab monoclonal antibody lymphoma non-hodgkin's lymphoma sirpα nhl cd20 cd47 sirp mcl fl mzl dlbcl
rp% measurement by fcm as a diagnostic test for itp

Conditions: Immune Thrombocytopenia

Summary: immature platelets-also termed reticulated platelets (rp)-are platelets newly released into the circulation, and have been associated with a variety of pathological bleeding events including primary immune thrombocytopenia (itp). they can be assessed by flow cytometry (fcm) after staining with thiazole orange (to) at low concentration and expressed as a fraction of the total platelet count (rp%). the diagnosis of primary itp is based on differential diagnosis and the measurement of rp% can serve as an alternative diagnostic test that are useful in daily practice. our study aimed at distinguishing primary itp from other thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced thrombocytopenia by fcm. the sensitivity and specificity of the assay as well as agreement between rp% measurement and monoclonal antibody-specific immobilization of platelet antigen (maipa) were analyzed accordingly.

the investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60\*10\^9/l from 4 medical centers in china. in brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min with 5 μl of phycoerythrin-conjugated anti-cd42b monoclonal antibody (bd pharmingen, tokyo, japan) and 1 ml of thiazole orange (retic-count; becton-dickinson, san jose, ca, usa) diluted 10 times by phosphate-buffered saline. rp% was analyzed on a flow cytometer (facscan, becton-dickinson) by measuring 10,000 events in the cd42b-positive fraction. clinical information of all participants including gender, age, platelet count and definitive diagnosis were recorded by an exclusive investigator. rp% results were revealed at the end of recruitment and after all fcm measurements were completed. the agreement between clinical diagnosis and rp% results were analyzed to identify primary itp.

Eligibility criteria:
inclusion criteria: 1. untreated adult patients of both gender between the ages of 18 and 75 years 2. each participant showed a platelet count 60\*10\^9/l, with or without bleeding manifestations 3. thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or chemotherapy-induced thrombocytopenia exclusion criteria: 1. received high-dose steroids or ivig within 3 weeks prior to the test 2. received second-line itp-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months prior to the test 3. current hiv infection, hepatitis b virus or hepatitis c virus infections 4. severe medical condition (liver and kidney function impairment). unstable cardiovascular disease or uncontrolled hypertension. 5. patients who are deemed unsuitable for the study by the investigator

Keywords: reticulated platelets immune thrombocytopenia
effect:eccentric fixation from enhanced clinical training

Conditions: Age Related Macular Degeneration (ARMD)

Summary: age-related macular degeneration (amd) is the leading cause of severe visual impairment in the uk, europe and n america. low vision patients with amd have great difficulty reading, which leads to a loss of independence and reduced quality of life. magnifiers alone do not compensate for loss of central vision in amd. it has been proposed that special low vision training can improve reading ability in patients with amd. training programmes are widely available in the us and scandinavia, but not in the uk, partly because there is a lack of evidence from randomised control trials (rct) showing that they are effective. the investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include eccentric viewing training. eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (prl), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (trl). the investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.


Eligibility criteria:
inclusion criteria: * diagnosis of age-related macular degeneration * visual acuity 6/12 to 3/60 inclusive in the better eye * dense central scotoma confirmed by microperimetry exclusion criteria: * patients who are not fluent in english or are cognitively impaired * patients with serious hearing impairment * patients who are hospital inpatients, who are living in nursing homes or are otherwise non-independent * ocular co-morbidity (other than mild cataract) in the better eye * recent low vision assessment or eccentric viewing training
effect of meal composition and timing modification on glucose metabolism, body temperature and sleep

Conditions: PreDiabetes; Type 2 Diabetes; Healthy

Summary: the purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.

pilot data points to an effect of the time between waking up and first meal is important in blood glucose management through the rest of the day. the investigators are interested in understanding the effect of caloric distribution through the day, specifically consuming more later in the day versus earlier in the day. the investigators want to test the hypothesis that consolidating the meals during a shorter span in the day (time restricted eating) can ameliorate blood sugars and sleep parameters in the studied population. the researchers would also like to compare dynamic range of meal-induced sympathetic responses (e.g. temperature and heart rate changes) between different metabolic health conditions (e.g. insulin sensitive vs insulin resistant vs diabetes) while controlling for dietary intake. previous research studies suggest that people with different metabolic health conditions would have different meal-induced sympathetic responses. based on this, the primary goal of the study is to characterize metabolic health based on non-invasive wearable sensor data that measure these responses.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older; * not be pregnant, if female; * be generally healthy (with no apparent symptoms at the time of enrollment) * patients with prediabetes or diet- controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate. * be willing to provide written informed consent for all study procedures. exclusion criteria: * major organ disease * pregnant/lactating * diabetes medications except for metformin * malabsorptive disorders like celiac sprue * heavy alcohol use * use of weight loss medications or specific diets * weight change \>2 kg in the last month * history of bariatric surgery * any medical condition that physicians believe would interfere with study participation or evaluation of results * mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
a study of bevacizumab in combination with first- or second-line therapy in subjects with treated brain metastases due to non-squamous nsclc (passport)

Conditions: Non-Small Cell Lung Cancer; Brain Neoplasms

Summary: this was an open-label, multicenter, single-arm, phase ii trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (nsclc) with previously treated central nervous system (cns) metastases. a total of 115 patients enrolled in the study.


Eligibility criteria:
inclusion criteria: * signed informed consent * histologically or cytologically confirmed nsclc except for squamous cell carcinoma * treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (mri or ct) during the screening period * appropriateness for first- or second-line systemic therapy for advanced nsclc * eastern cooperative oncology group (ecog) performance status of 0 or 1 * age ≥ 18 years * for women of childbearing potential and sexually active males, use of an accepted and effective method of contraception (e.g., hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study exclusion criteria: * brain biopsy/neurosurgical procedure performed within 3 months prior to day 1 * progressive neurologic symptoms * active malignancy other than lung cancer * current, recent, or planned participation in an experimental drug study * prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms * gross hemoptysis within 3 months prior to day 1 * inadequately controlled hypertension * unstable angina or new york heart association grade ii or greater congestive heart failure (chf) * abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 * myocardial infarction within 6 months prior to day 1 * stroke within 6 months prior to day 1 * active symptomatic peripheral vascular disease within 6 months prior to day 1 * history of significant vascular disease * evidence of bleeding diathesis or coagulopathy * known hypersensitivity to any components of bevacizumab * inadequate organ function * serious non-healing wound, ulcer, or bone fracture * urine protein/creatinine (upc) ratio of ≥ 1.0 * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1, or anticipation of need for major surgical procedure during the course of the study * pregnancy or lactation * known evidence of disseminated intravascular coagulation (dic) * active infection or fever \> 38.5°c within 3 days prior to day 1 * any other medical condition (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Keywords: brain cancer brain metastases avastin nsclc lung cancer passport
eplerenone versus spironolactone as treatment of ascites due to liver cirrhosis; a study of efficacy and side effects

Conditions: Ascites; Cirrhosis

Summary: this study compares spironolactone, a non-selective aldosterone antagonist, with eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. the investigators hypothesis is that eplerenone is as effective as spironolactone as treatment of ascites with less side effects such as painful gynecomastia.


Eligibility criteria:
inclusion criteria: male ascites cirrhosis - exclusion criteria: prior treatment with aldosterone antagonist uncontrolled heart disease or diabetes current malignancy current medication interacting with aldosterone antagonists