Kornimate/medical-research-clean huggingface dataset:
the effect of rituximab on the humoral response to influenza vaccine

Conditions: Rheumatoid Arthritis

Summary: rituximab is a genetically engineered chimeric anti-cd20 monoclonal antibody that selectively targets cd20+ b cells and induces a transient depletion of the cd20+ mature b cell subpopulation.the objective of our study was to assess the effect of rituximab on the efficacy and safety of influenza virus vaccine in patients with rheumatoid arthritis (ra).

the study population comprised ra patients treated with conventional disease modifying drugs with or without rituximab. split-virion inactivated vaccine containing 15 mcg hemagglutinin/dose of b/shanghai/361/02 (shan), a/new caledonia a/new caledonia/ 20/99 (nc) (h1n1) and a/california/7/04 (cal) (h3n2) was used. disease activity was assessed by number of tender and swollen joints, morning stiffness duration, and evaluation of pain on the day of vaccination and 4 weeks later. cd20 positive cell levels were assessed in rituximab treated patients. hemagglutination inhibition (hi) antibodies were tested and response was defined as \>4-fold rise 4 weeks post vaccination or seroconversion in patients with a non-protective baseline level of antibodies (\<1/40). geometric mean titers (gmt) were calculated in all subjects. results: the participants were divided into 3 groups: ra (n=29, aged 64±12 years), rituximab-treated ra (n=14, aged 53±15 years) and healthy controls (n=21, aged 58±15 years). all baseline protective levels of hi antibodies and gmt were similar. four weeks after vaccination, there was a significant increase in gmt for nc and california antigens in all subjects, but not for the shanghai antigen in the rituximab group. similarly, the percentage of responders was low for shanghai and nc, but significantly lowers in rituximab treated patients for the california antigen compared with the other groups. parameters of disease activity remained unchanged. conclusion: influenza virus vaccine generated a humoral response in all ra study patients and controls. although the response was significantly lower among rituximab-treated patients,

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis * age-18-85 * treatment with rituximab and other disease modifying drugs exclusion criteria: * treatment with anti tnf alpha * allergy to eggs

Keywords: rheumatoid rituximab influenza
efficacy, safety and pharmacokinetics of qav680 versus placebo in patients with asthma

Conditions: Asthma

Summary: this study will assess the safety and efficacy of qav680 in patients with mild to moderate asthma


Eligibility criteria:
inclusion criteria: * patients with moderate persistent asthma exclusion criteria: * smokers * any significant disease or illness, other than asthma other protocol-defined inclusion/exclusion criteria may apply

Keywords: mild moderate asthma
evaluation of hospital readmission rate dependent on post-operative follow-up procedure

Conditions: Postoperative Complications

Summary: this study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. the overall aim of the study is to identify areas of improvement for discharging and following patients within 30 days of colorectal surgery.

this study will be a prospective clinical trial, in which colorectal surgery patients will be randomly assigned to a control or experimental group. patients will be consented and randomized prior to discharge.the control group will be discharged with standard of care follow-up instructions described by the ohio state university wexner medical center (osuwmc), and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. the experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but will also receive a phone call 3-days post procedure. during this phone call, the patient will be asked questions using a study-specific questionnaire that is based on the most frequent indications for readmission after colorectal surgery. based on the responses, patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the clinic within 48 hours, or go to the emergency department immediately. to determine if patients had visited an ed or been readmitted to a hospital within 30 days of colorectal surgery, both the standard of care and intervention groups will receive a phone call 30-days post-discharge. at this time we will also conduct the hospital consumer assessment of healthcare providers and systems (hcahps) survey to measure patient satisfaction.

Eligibility criteria:
inclusion criteria: * age greater than 18 years old * patients who underwent colorectal surgery at the ohio state university wexner medical center exclusion criteria: * patients under 18 years old * patients with limited ability to communicate * patients who do not have a telephone
hbrn: immune regulation and costimulation in natural history of chronic hepatitis b

Conditions: Hepatitis B

Summary: this is an ancillary to the niddk-sponsored hepatitis b research network (hbrn) study cohort study nct01263587. this study will examine the balance between immune regulatory and effector responses in hepatitis b-infected participants enrolled in the hbrn study (nct01263587).

aim 1: the clinical and virological status of chronic hepatitis b (hbv) infection is defined by distinct patterns of immune effector and regulatory responses: the investigators propose that one or more immune regulatory are induced during chronic hepatitis b that define the extent of immune tolerance vs. activation with associated disease activity and viremia. towards this end, the immune effector and regulatory responses relative to serum hbv dna, alanine aminotransferase (alt), hepatitis b e antigen (hbeag), hepatitis b surface antigen (hbsag) and liver histology will be examined in a cross-sectional manner in patients with chronic hbv and control groups. aim 2: clinical hepatitis flares during chronic hepatitis b reflect altered balance between immune regulatory and effector responses.

Eligibility criteria:
inclusion criteria: • providing informed consent for this ancillary study. exclusion criteria: * children under 18 years of age, participants with anemia * hgb\<10 or hct\<30, congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis or renal failure, other significant medical conditions, autoimmune disease or immunosuppression.

Keywords: immunology, hepatitis b, hbv
gluten free diet in ibs

Conditions: Gluten Sensitivity

Summary: patients with irritable bowel syndrome (ibs) often benefit from dietary changes. the effect of a gluten-free diet (gfd) on clinical symptom improvement and psychological well-being will be checked in patients with ibs. in addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.

patients with irritable bowel syndrome (ibs) often benefit from dietary changes. since it has been shown that a gluten free diet (gfd) often alleviates the clinical symptoms, an overlap between patients with ibs and non-celiac glutensensitivity is assumed. the study includes 25 healthy individuals and 150 patients with ibs taking a six week gfd. participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of ncgs. in addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.

Eligibility criteria:
inclusion criteria: * healthy controls without gastrointestinal symptoms * patients with irritable bowel syndrome (rome iv criteria) exclusion criteria: * inflammatory bowel disease (crohn's disease, ulcerative colitis) * celiac disease * wheat allergy * pregnancy

Keywords: non-celiac glutensensitivity irritable bowel syndrom
carbon dioxide laser and cryotherapy in treatment of warts

Conditions: Common Warts

Summary: viral warts are common skin conditions seen in both children and adults. human papilloma virus is responsible for verrucae. cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.

a range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved. these include: * common wart (verruca vulgaris). * flat wart (verruca plana). * filiform or digitate wart. * genital wart (venereal wart, condyloma acuminatum, verruca acuminata). * mosaic wart. * periungual wart. * plantar wart (verruca, verruca plantaris). despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. viral warts often disappear without treatment. in case of pain, discomfort and long duration they can be treated . treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery. common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. hairpin vessels were usually seen in non-wart lesions. in this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.

Eligibility criteria:
inclusion criteria: 1. patients with common warts male or females any age. 2. patient is able to read and understand english and will give written informed consent to participate. 3. patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts. 4. warts to be treated will be located only on the hands. exclusion criteria: 1. non cooperative patients. 2. patients on other lines of treatment. 3. pregnant and lactating females. 4. patients receiving topical treatment in the previous two weeks. 5. secondary infection.

Keywords: warts,laser,cryotherapy
polyp detection rate after single oral dose of methylene blue mmx modified release tablets administered to subjects undergoing outpatients colonoscopy

Conditions: Polyp and Adenoma Detection During Colonoscopy

Summary: polyp detection rate in colonoscopy following oral administration of mmx methylene blue tablets

polyp detection rate in colonoscopy following oral administration of methylene blue mmx modified release tablets in subjects undergoing colonoscopy as outpatients.

Eligibility criteria:
inclusion criteria: * patients scheduled for screening or surveillance colonoscopy. written informed consent.practising reliable contraception or sterile.ability to understand and comply with the protocol. exclusion criteria: * pregnancy or lactation known or suspected hypersensitivity gi obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.
effects of low-dose levetiracetam on clinical symptoms, cognition and hippocampal hyperactivity in schizophrenia

Conditions: Schizophrenia

Summary: levetiracetam (lev: (s)-α-ethyl-2-oxo-pyrrolidine acetamide) is an anticonvulsant/antiepileptic drug. the specific aim of this study is to assess the efficacy of low-dose lev in reducing hippocampal activity in schizophrenia. the investigators also hypothesize that lev will improve neurocognition in participants with schizophrenia.

lev is typically administered in twice-daily doses of 500-1500 mg for the treatment of epilepsy; these doses are generally well tolerated (patsalos, 2000). most relevant to the proposed study, lev (125 mg twice-daily, two week administration) has been shown to reduce hippocampal hyperactivity and improves cognition in patients with mild cognitive impairment (mci). the proposed study will administer 125 mg of immediate release lev twice-daily for two weeks. this dose was chosen to potentially maximize efficacy while minimizing side effects. the proposed dose is substantially lower than the most common dose used clinically for epilepsy treatment of 3000 mg/day.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * good general health * normal vital signs (blood pressure, pulse, cardiac, pulmonary, abdominal, neurological exam) * normal renal function (as assessed by a metabolic panel at screening if results current within three months are not already available) exclusion criteria: 1. substance abuse 2. significant neurological disorders 3. significant head trauma/injury 4. left-handedness 5. pregnancy 6. mri-specific exclusion criteria (e.g., claustrophobia, weight \> 450lbs, metal in the body)
appendectomy and colorectal cancer

Conditions: Colorectal Cancer; Appendicitis

Summary: colorectal cancer (crc) is one of the most common cancer worldwide. initiation and progression of crc involve complex interactions among genetic, epigenetic and environmental factors. given that hereditary and familial crc only accounts for 2% to 5% of cases, environmental factors are the key triggers of crc. emerging evidence has indicated that gut microbes are an important environmental factor promoting crc development. gut dysbiosis has been shown to promote colorectal carcinogenesis in mice. several individual bacterial species, such as the enterotoxigenic bacteroides fragilis (etbf), fusobacterium nucleatum and peptostreptococcus anaerobius, could exert carcinogenic effects by inducing direct dna damage, oxidative damage and activating oncogenic signaling pathways. recent studies have shown that the appendix plays an important role in maintaining homeostasis and biodiversity of gut microbiome by providing an ideal ecological niche for commensal bacteria and production of immunoglobulin a. considering the key role of microorganisms in gastrointestinal pathophysiology, absence of appendix may result in disruption of microbiome homeostasis, which could potentially influence the risk of developing crc. in terms of epidemiological evidence, the association of appendectomy with the risk of crc development has been controversial, and to date no consensus has been attained. although gut microorganisms could be a crucial pivot between appendectomy and risk of subsequent crc development, the direct contribution of appendectomy and the underlying mechanisms are still largely unexplored. in this study, we aim to study 1. the association between appendectomy and colorectal cancer, and 2. the role of appendectomy in crc risk through causing gut microbial dysbiosis.


Eligibility criteria:
inclusion criteria: * individuals underwent appendectomy from january 2000 to december 2020 exclusion criteria: 1. patients with the age ≤18 years at enrollment; 2. patients with any malignant diseases or inflammatory bowel disease history before enrollment; 3. patients with hereditary syndromes of colorectal adenomas or polyps (familial adenomatous polyposis, lynch syndrome, etc.); 4. patients that underwent appendectomy for appendiceal neoplasms.
dose escalation study of jnj-54767414 (daratumumab) in chinese participants with relapsed or refractory multiple myeloma who failed at least 2 prior lines of systemic therapy

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the tolerability, safety and the pharmacokinetic (pk) profile of daratumumab in chinese participants with relapsed or refractory multiple myeloma (rrmm) who failed at least 2 prior lines of systemic therapy (part 1 and part 2); and to evaluate the tolerability and safety of daratumumab in chinese participants whose prior therapy included a proteasome inhibitor (pi) and an immunomodulatory drug (imid) and who have demonstrated disease progression on the last therapy (part 3).


Eligibility criteria:
inclusion criteria: part 1 and 2: * chinese participant who must be at least 20 years of age * documented multiple myeloma (mm) with measurable disease according to protocol-defined criteria * relapsed or refractory multiple myeloma after receiving at least 2 prior lines of therapy * eastern cooperative oncology group performance status score of 0, 1, or 2 * adequate recovery from prior therapy part 3: * chinese participants who must be at least 18 years of age * received both a proteasome inhibitor (pi) (greater than or equal to \[\>=\] 2 cycles or 2 months of treatment) and an immunomodulatory drug (imid) (\>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months) * documented evidence of progressive disease (pd) based on investigator's determination of response as defined by the international myeloma working group (imwg) criteria on or after their last regimen exclusion criteria: part 1 and 2: * received daratumumab or other anti-cd38 therapies previously * previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks * exhibiting clinical signs of meningeal involvement of multiple myeloma * known chronic obstructive pulmonary disease, known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification * known clinically significant cardiac disease * known to be seropositive for human immunodeficiency virus, hepatitis b or known to have a history of hepatitis c * has plasma cell leukemia, waldenstrom's macroglobulinemia, poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis * abnormal laboratory values according to protocol-defined parameters at screening part 3: - received anti-myeloma treatment within 2 weeks before cycle 1, day 1
the trauma intramuscular tranexamic acid clinical trial

Conditions: Traumatic Haemorrhage

Summary: intramuscular injection of tranexamic acid (txa) would increase its use in situations where administration of intravenous drugs is difficult. the investigators aim to assess the population pharmacokinetics of intramuscular txa in trauma patients. primary endpoint: serum txa concentrations over time. secondary endpoints: local reactions at injection sites and adverse events

a prospective, open-label, multicentre, pharmacokinetic study conducted in the uk hospital. potential eligible patients will have received a 1 gram iv dose of txa at the scene of the injury or on arrival in hospital and a second dose is clinically indicated.

Eligibility criteria:
inclusion criteria: * adult (appear to be at least 16 years old) trauma patients who have received 1 gram of intravenous txa for the management of haemorrhage in whom a second dose is clinically indicated are eligible. exclusion criteria: * none

Keywords: tranexamic acid pharmacokinetic intramuscular
systemic light exposure in preventing frailty in older patients with prostate cancer on hormonal therapy

Conditions: Prostate Carcinoma

Summary: this pilot trial studies how well systemic light exposure works in preventing frailty in older patients with prostate cancer on hormonal therapy. hormone therapy causes many symptoms of frailty in older men including fatigue, slower time to walk a specified distance, reduced activity levels, loss of lean muscle, and muscle weakness. it is not yet known if systemic light exposure may reduce frailty in older prostate cancer patients.

primary objectives: i. determine if bright white light (bwl), compared to dim white light (dwl), significantly prevents frailty development in older prostate cancer (pc) patients following prostate anti-androgen therapy initiation. ii. determine if bwl, compared to dwl, significantly increases functional performance and physical activity levels, yields significant reductions in fatigue, lowers body mass index (bmi), and reduces weakness in older pc patients following prostate anti-androgen therapy initiation. exploratory objective: i. examine the feasibility of collecting and storing clinically-usable bio-measures for future analysis in patients at baseline and if available at 6 months, including blood samples (inflammatory markers), and salivary swabs (genetics, genomics, cortisol circadian rhythms). outline: patients are randomized to 1 of 2 arms. arm i (bwl): patients wear an actiwatch for 5 days at baseline, 3 months and 6 months. beginning 1-4 weeks after first anti-androgen therapy, patients undergo bwl treatment using luminette glasses for 30 minutes every morning for 3-6 months. arm ii (dwl): patients wear an actiwatch for 5 days at baseline, 3 months and 6 months. beginning 1-4 weeks after first anti-androgen therapy, patients undergo dwl treatment using luminette glasses for 30 minutes every morning for 3-6 months.

Eligibility criteria:
inclusion criteria: * prostate cancer (pc) patients who are starting androgen deprivation therapy (adt), abiraterone, or enzalutamide with plans to continue for at least six months with minimal evidence of disease burden in accordance with current standards of care. * a life expectancy of 6 months or longer. * all subjects must have the ability to understand and the willingness to sign a written or electronic informed consent. exclusion criteria: * significant pre-existing frailty precluding completion of baseline assessments. * other active malignancies * previous use of radiation therapy within the year prior to consent. * widely metastatic disease. * confounding serious medical illnesses which causes frailty. * severe sleep disorders. * eye diseases which limit the ability of light to be processed. * severe psychological impairment. * current employment in night shift work. * previous use of light therapy to alleviate fatigue or depressive symptoms. * secondary cancer diagnosis within the past 5 years. * plans to travel across meridians during treatment. * uncontrolled illness including ongoing or active infection in disease status patients.