Kornimate/medical-research-clean huggingface dataset:
hemophilia non-interventional study prior to serpinpc intervention (present-5)

Conditions: Hemophilia a; Hemophilia B

Summary: the primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (abrs) and treatment under standard-of-care (soc) therapy among participants with hemophilia a or b. participants in the study may be eligible to enroll in future planned interventional studies to be conducted by sponsor.


Eligibility criteria:
inclusion criteria: 1. male participants greater than or equal to (\>=) 12 and less than or equal to (\<=) 65 years of age 2. who are capable of providing written informed consent (adolescent assent and parental/guardian consent when appropriate) for participation after reading the information and consent form and having the opportunity to discuss the study with the investigator or their designee 3. with historically documented severe hema (defined as factor viii \[fviii\] less than (\ =6 documented acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months before enrollment or: historically documented hemb (defined as fix \ =5 bethesda units/ml\] based on medical records or laboratory reports) and an abr of \>=6 in the 6 months before enrollment 4. who are able to use a diary to document bleeding events and associated treatment exclusion criteria: 1. with known thrombophilia 2. with body weight greater than (\>)150 kilogram (kg) or body mass index \>40 3. with known current inadequate hematologic function (eg, platelet count \ 1.5\*upper limit of normal \[uln\] \[excluding gilbert syndrome\], aspartate transferase and/or alanine aminotransferase levels \>3\*uln; clinical signs or known laboratory or radiographic evidence consistent with cirrhosis of the liver) or renal function (that is, serum creatinine \>2\*uln; based on medical records or available laboratory reports) 4. with previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or stroke 5. with history of intolerance to subcutaneous injections 6. with known current uncontrolled hypertension (systolic blood pressure \>160 millimeter of mercury (mm hg); diastolic blood pressure \>100 mm hg; based on medical records) 7. with active cancer or requires therapy for cancer, except for basal cell carcinoma 8. with concurrent participation in an interventional clinical trial 9. with current or planned use of emicizumab 10. with prior, ongoing, or planned treatment with gene therapy for hemophilia 11. with history of or other evidence of recent alcohol or drug abuse as determined by the investigator or their designee (in the 12 months before enrollment) 12. with known human immunodeficiency virus (hiv) infection with cd4 count (or t-cell count) of \<200 cells/mcl within 24 weeks before enrollment 13. with current or planned treatment with anticoagulant or antiplatelet drugs 14. with any other significant conditions or comorbidities that, in the opinion of the investigator or their designee, would make the participant unsuitable for enrollment

Keywords: hemophilia prospective
an italian multicenter retrospective observational study to assess the clinical characteristics and the outcome of patients with relapsed or refractory diffuse large b-cell lymphoma treated with polatuzumab vedotin plus rituximab (± bendamustine) under named patient programme

Conditions: DLBCL - Diffuse Large B Cell Lymphoma

Summary: study designobservational, non-interventional, retrospective, multicenter study.

the study focusing on information about the effectiveness and safety of polatuzumab vedotin plus rituximab (± bendamustine) in patients who received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the npp (d.m. 7 sep 2017) programme in the period between june 2019 and feb 2020 in italy.

Eligibility criteria:
inclusion criteria: 1. patients with relapsed or refractory dlbcl who received at least 1 dose of polatuzumab vedotin under the npp (d.m. 7 sep 2017) in the period between june 2019 and feb 2020 in italy. 2. age ≥ 18 years at enrolment. 3. written informed consent (if applicable). exclusion criteria: patients with dlbcl treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context

Keywords: bendamustine rituximab polatuzumab vedotin
entecavir for chronic hepatitis b in hepatocellular carcinoma patients underwent radiofrequency ablation therapy

Conditions: Chronic Hepatitis B; Hepatocellular Carcinoma

Summary: persistent replication of hbv (47-55%) is frequently found in patients with hcc, which in turn leads to deterioration of liver reserve. moreover, a large proportion of hcc patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. it had been proved that anti-viral therapy for hepatitis c virus (hcv)-related hcc patients could reduce the rate of tumor recurrence after surgical resection. this is a prospective study to evaluate the efficacy of etv therapy in chronic hepatitis b patients after receiving rfa therapy for hcc.


Eligibility criteria:
inclusion criteria: * hcc diagnosed by pathology verification or in accordance with the guidelines of american association for the study of liver diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) , * solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter, * no extrahepatic metastasis, * no radiological evidence of invasion into major portal vein or hepatic vein branches, * good liver reserve with child-pugh class a or b, * a platelet count of more than 50,000/mm3, * serum creatinine level ≤ 2 mg/dl, * no previous treatment for hcc, * positive for serum hepatitis b surface antigen (hbsag) for more than 6 months * positive serum hbv dna using a cobas amplicor hbv monitor (roche diagnostic system, basel, switzerland). exclusion criteria: * dual or multiple infections with hepatitis c virus, hepatitis d virus, or the human immunodeficiency virus, * other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, wilson's disease, hemochromatosis, * use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study, * women who are pregnant or nursing.
a study of nivolumab in combination with ipilimumab in chinese participants with previously treated advanced or recurrent solid tumors

Conditions: Solid Tumor

Summary: the purpose of this study is to evaluate the safety and effectiveness of nivolumab in combination with ipilimumab in chinese participants with previously treated late stage cancer.


Eligibility criteria:
inclusion criteria: * mainland chinese participants with advanced or recurrent solid tumors * eastern cooperative oncology group (ecog) performance status of 0 or 1 * one prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy exclusion criteria: * cancer that has spread to the brain or central nervous system unless it has been adequately treated . in addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent) * active, known or suspected autoimmune disease or infection * positive blood screen for chronic infection of hepatitis b or hepatitis c (hcv antibody positive unless hcv rna is negative) * prior immuno-oncology therapy other protocol-defined inclusion/exclusion criteria apply
vancomycin concentration in cerebrospinal fluid during pneumococcal meningitis

Conditions: Pneumococcal Meningitis

Summary: adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. however, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. in a purely observational manner, we thought to measure blood and csf concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.

because of a considerable increase in streptococcus pneumoniae meningitis with penicillin nonsusceptible strains, it is now largely recommended to add vancomycin to the third-generation cephalosporin antibiotic regimen. it has also been recently shown that use of dexamethasone reduces mortality and unfavorable outcome in adults with pneumococcal meningitis. however, concern has arisen, that dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. we therefore thought to measure in a purely observational study, blood and csf vancomycin concentrations in adult patients with pneumococcal meningitis hospitalized in medical intensive care unit that received third-generation cephalosporin, vancomycin and dexamethasone. the aim of the study was to observe whether or not sufficient concentrations of vancomycin could be measured in the csf despite the concomitant use of dexamethasone. patients were cared for in a perfectly routine manner. there was no randomization. all patients received routine, recommended care (idsa guidelines). there was no invasive procedure. dexamethasone was administered according to the de gans study (nejm 2002). in these patients with severe meningitis, a second lumbar puncture was performed as recommended(idsa guidelines, cid 2004). at the same time, peripheral blood was taken. in both samples, vancomycin concentration was determined.

Eligibility criteria:
inclusion criteria: * adults (\> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit exclusion criteria: * allergy to one of the antibiotics used in the study

Keywords: pneumococcal meningitis intensive care unit vancomycin dexamethasone drug diffusion in cerebrospinal fluid
a blood and tissue sample collection study of patients who have inflammatory bowel disease, who have been treated with adalimumab and who developed hepatosplenic t-cell lymphoma

Conditions: Crohn's Disease; Ulcerative Colitis (UC); Hepatosplenic T-Cell Lymphoma

Summary: to collect and store blood and biopsy samples obtained from cd or uc patients exposed to adalimumab and diagnosed with hepatosplenic t-cell lymphoma (hstcl), for the purpose of identifying potential biomarkers and genetic mutations in patients who have developed hstcl.

a study to bank samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (ibd) patients to developing hepatosplenic t-cell lymphoma (hstcl).

Eligibility criteria:
inclusion criteria: * male or female who has received a single dose of humira prior to a confirmed diagnosis of hstcl. * confirmed diagnosis of cd or uc as documented by a gastroenterologist or physician who diagnosed the cd or uc. * confirmed diagnosis of hstcl as determined by a biopsy performed on a specimen taken from the patient. * patients 18 years old and older must voluntarily sign and date an irb/ec approved informed consent form. for patients younger than 18 years old, a parent or legal guardian is required to voluntarily sign and date an irb/ec approved informed consent form. pediatric patients will be included in all discussions if possible, in order to obtain their assent. exclusion criteria: * male or female who has not received at least a single dose of adalimumab prior to a confirmed diagnosis of hstcl. * unconfirmed diagnosis of hstcl, cd or uc, respectively. * the patient or the patient's hcp is unwilling to participate in this study. * the parents or legal guardians (in the case of patients younger than 18 years of age), who are unable and/or unwilling to consent to the patient's participation in this study.

Keywords: hepatosplenic t-cell lymphoma
internet-based interventions for bipolar disorder

Conditions: Bipolar Disorder

Summary: the investigators hope to learn whether access to online support and education can help people with bipolar disorder (bd) better manage their symptoms of depression.

this study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be useful. specifically, the study will examine (1) whether exposure to the moodswings 2.0 intervention results in decreased depressive symptoms as measured by the montgomery asberg rating scale for depression (madrs) and (2) whether there is an association between graduated levels of involvement (level i, 2, or 3) and resulting improvement? we expect that those participants assigned to the control condition (level 1, peer discussion board only), will have fewer positive outcomes than those in level 2 (discussion board and psychoeducation) or 3 (discussion board, psychoeducation, and interactive psychosocial tools) conditions.

Eligibility criteria:
inclusion criteria: * current diagnosis of bipolar i disorder, bipolar ii disorder, or bipolar disorder nos verified with the structured clinical interview for the diagnostic and statistical manual for mental disorders (scid) mood disorder module. * age 21-65. * access to a computer with internet access. access to a printer is preferable, but not required. * able to speak and read english proficiently. * some degree of medical supervision of bipolar disorder (sees a health professional at least twice a year to discuss symptoms and treatment needs) and local access to emergency care. exclusion criteria: * current psychosis, as assessed in screening phone interview with the scid psychosis module. * acutely suicidal (defined as having a ham-d item 3, score of ≥3). * current mania, assessed using mania module of the scid mood disorders module.

Keywords: bipolar disorder bipolar online intervention internet intervention self-help
mindfulness psychoeducation program for schizophrenia

Conditions: Schizophreniform Disorders

Summary: the study is the first pilot randomised controlled trial (rct) to explore the feasibility and efficacy of mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia.

there is increasing evidence to demonstrate the safety and effectiveness of mindfulness-based psychoeducation programme (mbpp) for chinese people with schizophrenia. a single-blind, multi-site, pragmatic randomised controlled trial conducted in hong kong, mainland china, and taiwan with 300 participants consistently demonstrated significant improvement in regard to insight of illness, functioning, mental state and the length of re-hospitalisations when compared with conventional psychoeducation and treatment as usual (tau) groups (chien, 2017). the study hypothesises that: 1. participants receiving mbpp will decrease their use of rumination and expressive suppression, and increase the use of cognitive reappraisal compared to a control group after completion of the intervention. 2. participants receiving mbpp attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention. 3. these effects are expected to be maintained through 3-month follow up with regular self-practice.

Eligibility criteria:
inclusion criteria: * aged 18 years to 65 years old * diagnosis with schizophrenia-spectrum disorders according to the criteria of the diagnostic and statistical manual for mental disorders dsm-iv-tr (and the latest dsm-v) or international classification of diseases (icd-10)-classification of mental disorders * able to communicate in written and conversational chinese/cantonese * able to understand the concepts of the study and to give informed consent exclusion criteria: * comorbid organic brain disorders or substance abuse * participation in any forms of cognitive therapy * participation and/or practice of mindfulness (in the forms of tai chi, qi gong, etc.) more than twice a week during the previous three months
nerve block of the proximal interphalangeal joints pips in rheumatoid arthritis (ra) patients: a prospective pilot study

Conditions: Rheumatoid Arthritis

Summary: researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 acr/eular criteria with bilateral hand arthritis aged 18 or above. nerve block to the neural bundle of the 2nd and 3rd pips will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). the other hand will be used as a control and injected subcutaneously with saline. half ml of bupivacaine will be injected through a 27g needle at the level of the volar proximal digital crease of the 2nd and 3rd pip. the needle will be directed alternatively toward the two pedicles on both sides. pips of the 2nd and 3rd fingers in both hands will be examined eular-omeract scoring system at 0, 2 weeks, and 2 months intervals. visual analog scale (vas) for each hand will be used at the same intervals. there are no certain conditions for medications and all the patients were using sdmards.

pips of the 2nd and 3rd fingers at the control group will be injected with .5 ml of saline on each joint through a 27g needle.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis patient according to acr/eular criteria * age \>18 * bilateral hand affection exclusion criteria: * peripheral neuropathy * other chronic arthritis * patient who did mastectomy or any other hand operation
treatment of ectopic calcification / ossification with sodium thiosulfate (catsso)

Conditions: Sodium Thiosulfate; Ectopic Ossification

Summary: ectopic calcification and ossification complicate many diseases, which are rare for the most part. these calcifications (or ossifications) are generally classified according to their apparent formation mechanism. even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date. indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results. sodium thiosulfate (sts) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. more recently, sts has been reported in the treatment of renal calcification. vascular or even subcutaneous. first prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications. for several months, a magistral preparation in the form of ointment based on sts has been developed by the pharmacy of limoges university hospital in order to combine the local effect of sts while avoiding the side effects of an administration of this treatment by systemic way. the first uses of this preparation appear promising and some preliminary results have already been published. the benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the fda and the world health organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.


Eligibility criteria:
inclusion criteria: * any patient treated with sodium thiosulfate dermally provided by the pharmacy of limoges university hospital. * availability of an objective imaging evaluation to compare the volume or surface of calcifications (or ossifications) treated (on two orthogonal incidences) before and after 6 months of treatment application. * consent to participation in the study signed by the patient or by one of the holders of parental authority in the case of a minor patient. exclusion criteria: * calcification with concomitant cutaneous rupture which can allow an externalization of the calcium material by mechanical effects. * patient with calcification secondary to one of the following pathologies: * diabetes * chronic renal failure * iatrogenic origin
effects of methylprednisolone after total knee arthroplasty

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

Summary: the purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty. the hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.

in spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. we therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after knee arthroplasty.

Eligibility criteria:
inclusion criteria: * elective total knee arthroplasty * able to speak and understand danish * able to give informed consent exclusion criteria: * alcohol or medical abuse * allergies to local anesthetics or methylprednisolone * age \< 18 years * daily use of opioids or glucocorticoids * pregnancy or breastfeeding (fertile women)

Keywords: knee arthroplasty methylprednisolone post-operative pain