Kornimate/medical-research-clean huggingface dataset:
intravitreal methotrexate and r2(rituximab & lenalidomide) regimen in newly-diagnosed primary vitreoretinal lymphoma

Conditions: Primary Intraocular Lymphoma

Summary: this is a prospective single arm phase ii study, and the purpose of this study is to evaluate the efficiency of r2 regimen (rituximab \& lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide maintenance in newly-diagnosed primary intraocular lymphoma. progression free survival (pfs) of the cohort is the primary endpoint.

all the patients will be treated with r2 regimen （rituximab 375mg/m2 iv d1, lenalidomide 25mg d1-21, 28 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses. the response will be evaluated every 3 cycles. after 3 cycles, patients who achieved complete remission (cr) or partial remission (pr) will receive 3 more cycles of r2 regimen. the patients with stable disease (sd) or progressed disease (pd) will withdraw from the trial and receive salvage regimens. after total 6 induction cycles, the investigators evaluate the efficiency again, the patients with cr or pr will go to lenalidomide maintenance for 2 years or until progression of the disease (pd), unacceptable toxicity, or patient/investigator discretion. and the patients with sd or pd will receive salvage regimen. during following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (mri) scans can be performed every 3 months up to the first 2 years, followed by doctor visit every 6 months up to 5 years or the disease relapses.

Eligibility criteria:
inclusion criteria: * newly-diagnosed primary vitreoretinal lymphoma * ecog≤2 * creatinine clearance rate (ccr) ≥ 60ml/h, according to cockcroft-gault * total bilirubin \< 2 upper limits of normal, alanine aminotransferase（alt） \< 3 upper limits of normal * sign the informed consent * women of childbearing potential must understand that the study medication could have a potential teratogenic risk. they should undergo complete contraception during the study period. * male subjects must agree to use condoms throughout study drug therapy. exclusion criteria: * primary central nervous system lymphoma involved eyes and brain * systemic b cell lymphoma involved eyes * pre-existing uncontrolled active infection * clinical evidence of grade 3 or 4 heart failure as defined by the new york heart association criteria * pregnancy or active lactation * co-existing tumors * hiv（human immunodeficiency virus） or hbv（hepatitis b virus） or hcv（hepatitis c virus） infection

Keywords: intravitreal methotrexate injection rituximab lenalidomide primary vitreoretinal lymphoma
rectrospect - a retrospective study of treatment response

Conditions: Rectal Neoplasms

Summary: biopisies from patients diagnosed with rectal cancer between 2007-2019 will be cut into 4-6 micrometer thin sections for morphology and immunostaining. every section will be numbered with a code that is connected to the patients personal identification number and the code list will be kept separately from the biopsies in a password protected file on the sahlgrenska university hospital server. patient data and outcome regarding response to treatment will be collected from patient charts and the swedish colorectal cancer registry, but all data will be numbered with the same code number and all results will be kept away from the code list. in order to achieve the stated aims, that is, to study how the molecular and cellular characteristics of the tumour and its surrounding microenvironment as well as the interaction of tumour cells and immune cells affect treatment response, several molecular and cellular techniques and assays may be applied.


Eligibility criteria:
inclusion criteria: * rectal cancer and treatment between 2007 and 2019 exclusion criteria: * no rectal cancer or no neoadjuvant treatment
human umbilical cord-mesenchymal stem cells for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(huc-msc) for rheumatoid arthritis.

human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. there have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of rheumatoid arthritis. to investigate the effects of huc-msc treatment for rheumatoid arthritis, 20 patients with rheumatoid arthritis will be enrolled and receive 4 times of huc-msc transplantation.

Eligibility criteria:
inclusion criteria: * aged 18-80 rheumatoid arthritis patient; * patients must consent in writing to participate in the study by signing and dating an informed consent document; * patients must have a diagnosis of rheumatoid arthritis according to the 2010 acr/eular criteria for at least 12 weeks duration; * stage i and ii according to x-ray. exclusion criteria: * history of neurological disease, head injury or psychiatric disorder; * pregnant women; * impaired liver function, abnormal blood coagulation, aids, hiv, combine other tumor or special condition; * progressive apoplexy; * with malignant tumors; * patients who had participated in other clinical trials within three months prior to this study.

Keywords: human umbilical cord mesenchymal stem cell mesenchymal stem cell rheumatoid arthritis
the surgical education culture optimization through targeted interventions based on national comparative data - "the second trial"

Conditions: Surgical Residency; Workplace Culture; Mistreatment; Burnout

Summary: due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). our work following the first trial identified considerable variation in program-level rates of resident-reported burnout, gender discrimination, racial discrimination, sexual harassment, and verbal abuse. to investigate these issues, the second trial will include a national mixed-methods analysis of and a pragmatic cluster-randomized controlled trial to improve the resident learning environment and trainee wellness.

the prospective, pragmatic cluster-randomized controlled trial will include approximately 320 surgical training programs across the united states. participating programs will be randomized to the intervention or control arm. the intervention arm (vs. control) will receive program-specific reports about their learning environment and residents' well-being, as well as access to a wellness toolkit of ready-to-implement interventions. we will provide implementation support help facilitate and support intervention uptake throughout the trial period. to assess the individual efficacy of the reports in regards to decreasing rates of mistreatment and toxic outcomes, the reports will be given to programs approximately 2 months to 6 months prior to toolkit dissemination. prior to toolkit dissemination, programs will have the opportunity to fully review the report, form internal teams to address the issues, and mobilize necessary resources in preparation for receiving the toolkit. a comprehensive list of all activities performed after report dissemination will be kept at a program-level. toolkit dissemination to intervention programs will occur within 6 months of report dissemination. coaching webinars and in-person/virtual conferences will be held at a variety of time points during the trial. the control arm will continue to perform their normal educational (including potential wellness) activities. the investigators will compare multiple outcomes between the two study arms using data collected from an annual resident survey. extension of this work is anticipated to surgical subspecialty training programs (e.g., vascular surgery, cardiothoracic surgery). eligible subspecialty programs will be assigned as per the randomization scheme of corresponding general surgery programs at their institution. similar protocols will be in place for surgical subspecialties, with modifications to investigate specialty-specific survey items and interventions.

Eligibility criteria:
inclusion criteria: * surgery training programs in the united states exclusion criteria: * none
the effect of chinese herbal medicine as an adjuvant therapy in the treatment of traumatic anosmia

Conditions: Traumatic Anosmia

Summary: objective: to investigate the effect of chinese herbal medicine (chm) as an adjuvant therapy in the treatment of traumatic anosmia. methods: patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (pea) odor detection threshold remained -1 after treatment with steroid, zinc, and olfactory training (ot) for one month, were included in this study between september of 2018 and november of 2020. they were randomly divided into 2 groups, with patients in the chm group taking chm (tailored guizhi decoction) and performing ot, and those in the ot group receiving ot only for 6 months. after 3 months' and 6 months' treatment, the olfactory function was evaluated by both the pea threshold test and the traditional chinese version of the university of pennsylvania smell identification test (upsit-tc). magnetic resonance imaging was performed to measure the volume of olfactory bulbs after 6 months' treatment.


Eligibility criteria:
inclusion criteria: * a clear history of loss of smell after an episode of head injury * pea threshold was -1, which is assumed to be anosmic exclusion criteria: * one month later, they received birhinal and unirhinal pea threshold tests. any patient whose birhinal or unirhinal threshold was below -1 was excluded from the study.

Keywords: chinese herbal medicine guizhi decoction olfactory training phenyl ethyl alcohol threshold test traumatic anosmia university of pennsylvania smell identification test
a comparison of cbti and usual treatment for tinnitus related insomnia

Conditions: Tinnitus; Insomnia

Summary: there is evidence that cbt for insomnia (cbti) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain. this study will investigate the effectiveness of cbti as a treatment for tinnitus related insomnia. tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. six sessions of cbti will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. both groups will be offered sound enrichment at night. in order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint. all treatment/contact will be provided at the royal national throat nose \& ear hospital. participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.


Eligibility criteria:
inclusion criteria: * at least moderately distressing tinnitus (above a set minimum score on the mini tq) for at least six months and problematic insomnia (above a set minimum score on the insomnia severity index (isi) and for tinnitus related insomnia to be identified in clinical interview) as result of tinnitus, for at least three months. * patient wishes to work on improving sleep. * sufficient understanding of english and sufficient hearing ability to take part in for group discussions and to complete questionnaires. * patient has had tinnitus assessed by a doctor and an audiological specialist. * willing and able to provide written consent. able to regularly attend clinic in london, united kingdom. exclusion criteria: * • organic sleep disorders present (e.g. obstructive sleep apnoea, delayed phase sleep, etc.) assessed with a subscale of the hospital sleep unit's sleep disorder and snoring proforma. * currently pregnant, planning pregnancy or breastfeeding. * alcohol or drug dependent. * currently suffering with severe mental illness (psychosis, severe anxiety or mood disorder). * reports active risk to themselves or others. still undergoing medical investigations into sleep and / or tinnitus.

Keywords: tinnitus insomnia cognitive behaviour therapy
green tea in breast cancer patients

Conditions: Incident Breast Cancer

Summary: prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have not been well studied. of special interest are lifestyle factors that can be modified by women after diagnosis to increase disease-free survival. green tea is rich in polyphenols consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (egcg). the investigators hypothesize that there will be a reduction in proliferation and/or an increase in apoptosis in association with short-term egcg treatment.


Eligibility criteria:
inclusion criteria: * postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy * non-current (not with past 6 months) user of menopausal hormones * mammographic abnormality consistent with any type of incident breast cancer necessitating a diagnostic biopsy (birad iv(b), (c) or v) will be sufficient to draw baseline lft and complete screening questionnaire. unless the biopsy confirms incident breast cancer, such subjects will not be included in further research interventions and they will not serve as egcg treated or control subjects. * diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the egcg or control treatment groups. * non-green tea drinker (less than monthly) - this criteria does not apply to black tea or herbal tea * provided written informed consent exclusion criteria: * green tea drinker (once per month or more) * history of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer. * known allergy to tea * abnormal liver enzymes (plus or minus 10% of the normal ranges).

Keywords: postmenopausal women suspicious for breast ca
clinical effects of two new chlorhexidine digluconate formulations: 0.12% and 0.03%.

Conditions: Dental Plaque; Side Effects

Summary: in the current study we tested the hypothesis that new 0.05% cetylpyridinium chloride (cpc) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (chx): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% chx mouthrinse (perio-aid treatment without alcohol. dentaid, spain), 2) reduce the side effects caused by the marketed 0.12% chx formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.


Eligibility criteria:
inclusion criteria: * 18-30 years * good overall health without medical history or medications that could interfere with the study conduct. * minimum of 6 teeth per quadrant. * absence of probing depths ≥4mm. exclusion criteria: * allergy to chx or to cpc. * continuous use of chx or of any other oral antiseptic in the months prior to the study. * any adverse medical background or long-term medications that could affect gingival conditions. * having taken antibiotics in the previous three months. * moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(van der weijden et al. 1994). * pregnancy or breastfeeding. * smokers of more than 5 cigarettes per day. * orthodontic appliances. * fixed or removable prostheses. * systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression). * severe dental crowding.

Keywords: chlorhexidine digluconate gingivitis cetylpyridinium chloride mouthrinse dental plaque de novo in vivo
the pharmacology/aging clinic

Conditions: HIV Infection

Summary: the treatment of hiv and the tests performed for hiv care have changed over the last 20 years. however, improvement of management of hiv-infected subjects is still warranted, especially as the hiv-infected population is aging. therefore, this study will involve the collection and analysis of clinical information obtained from subjects who are over 50 years of age. for example, patients' risk of heart disease will be measured and monitored by looking at blood tests and clinical data (such as blood pressure). this will allow researchers to understand if the current way of assessing the risk of future heart disease is the best one available for hiv-infected individuals. no genetic research will be done.

patients will be asked to read the information contained in this leaflet. no extra visits will occur; all samples will be collected at their routine visits to the pharmacology clinic. all blood samples and results will be managed by the routine clinical laboratory at chelsea and westminster hospital, with the exception of the assessment of the hscrp. the latter is a marker of inflammation that is measured to be able to add more information when cardiovascular risk is assessed. the blood sample for this test is sent to a laboratory in london called the doctors laboratory (tdl). all shipped samples are anonymous and patient names will not be disclosed outside the hospital. the clinical visits will be scheduled approximately once within one year. however, extra visits may be clinically necessary if a clinical condition requires proper follow-up. furthermore, clinical details will be marked to show patients have agreed to their use for this research study.

Eligibility criteria:
inclusion criteria: 1. the ability to understand and sign a written informed consent form 2. hiv-infected patients attending the pharmacology/aging clinic (hiv/gum directorate, chelsea and westminster hospital nhs foundation trust) exclusion criteria: none
a clinical follow-up study on the efficacy of thumbtack needle for postoperative sleep and recovery treatment

Conditions: Postoperative Complications; Postoperative Pain; Acupuncture

Summary: to understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting postoperative recovery


Eligibility criteria:
inclusion criteria: 1. patients undergoing breast cancer surgery with general anesthesia in the hospital; 2. american society of anesthesiologists (asa) classification i-ii; 3. women aged 18-55 years; 4. no history of chronic insomnia; 5. individuals who have not taken sedative-hypnotic drugs within the past month. exclusion criteria: 1. those who do not meet the aforementioned inclusion criteria; 2. a history of severe heart, brain, lung, or kidney diseases (such as acute coronary syndrome (acs), severe heart failure classified as nyha class iii or iv, severe arrhythmias, severe valvular disease; acute aortic disease, and severe peripheral vascular disease, etc.), or poor physical condition (including reduced exercise tolerance, multi-organ dysfunction, malnutrition, etc.); 3. a history of sleep disorders and psychiatric history; 4. inability to receive thumb-tack needle treatment.
impact of monoclonal antibody treatment on post-acute covid-19 syndrome

Conditions: Post-acute COVID-19 (PACS), or "long COVID" Syndrome

Summary: use the intermountain real-world mab-treatment registry and control group to prospectively evaluate pacs symptoms at least 60 days after initial covid-19 diagnosis.

it is now recognized that many patients who develop symptomatic covid-19 infection continue to suffer from a variety of symptoms that persist well after the acute syndrome. this has been called post-acute covid-19 (pacs), or "long covid" syndrome. in a meta-analysis of studies of hospitalized patients, 70% of patients reported pacs symptoms 60 days after diagnosis. patients with non-severe covid-19 appear to have lower rates of pacs symptoms, although a recent study suggested that at 4 months follow-up, 28% of patients still reported at least one symptom. pacs is associated with significant morbidity, decreased quality of life, mental and behavioral health impact and healthcare cost. neither the pathophysiology nor risk factors for pacs are well-understood and further research is needed to characterize this syndrome. some studies have suggested that age, female gender, obesity, comorbid burden, symptoms at diagnosis and hospitalization during acute covid-19 increase risk for pacs. because of the significant overall impact of pacs, there is significant interest in identifying therapies to prevent this condition. early neutralizing therapy with anti-sars-cov-2 monoclonal antibodies (mabs) addresses the initial phase of disease and has now been shown to be effective at decreasing viral load and preventing progression to severe disease, hospitalization and death. understanding how mab therapy may impact pacs symptoms is important to determining usage and value of these products and an important contribution to our understanding of how to prevent pacs. study design: prospective electronic survey using matched case-control design objective: use the intermountain real-world mab-treatment registry and control group to prospectively evaluate pacs symptoms at least 60 days after initial covid-19 diagnosis. aim 1: determine whether ambulatory patients who received monoclonal antibody infusion for early symptomatic covid-19 have fewer persistent symptoms of post-acute covid-19 ("long covid") syndrome at least 60 days after initial diagnosis. hypothesis: mab therapy is associated with significantly less post-acute covid-19 (pacs) symptoms at 120 days post diagnosis aim 2: explore predictors associated with pacs symptoms in high risk patients hypothesis: hospitalization, age, obesity, number of comorbidities and symptoms at diagnosis predict pacs

Eligibility criteria:
inclusion criteria: * age ≥18 * positive antigen or polymerase chain reaction test for sars-cov-2 * symptomatic covid-19 * between day 60 and day 90 from date of positive test * not hospitalized or hypoxemic by day 7 of symptoms (aim 1 only) exclusion criteria: * unwilling to participate * not able to understand the english language survey questions * prisoners * inadequate cognitive capacity to provide consent and complete the survey
evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of ub-221 in healthy volunteers

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of ub-221 in healthy volunteers.

this is a phase i, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of ub-221 in healthy volunteers.

Eligibility criteria:
inclusion criteria: * subjects with age between 20 to 65 years old (inclusive). * subjects who are able and willing to provide the informed consent. * male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above. * researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities exclusion criteria: • the investigator considered that the subjects were not suitable to participate in this study.