Kornimate/medical-research-clean huggingface dataset:
effects of continuous treatment with rifaximin and probiotics on the gut microbiota of patients with ibs-d

Conditions: IBS - Irritable Bowel Syndrome; Gut Microbiota

Summary: we will use the latest rome iv criteria to recruit ibs-d patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. high-throughput sequencing combined with real-time quantitative pcr will be used to comprehensively analyze the effects of different drugs on intestinal flora. the study has important guiding significance for the treatment of patients with ibs-d.

according to the rome iv diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (ibs-d) from the multi-center (8 units in the country) will be enrolled. the ibs severity inventory (ibs-sss) and ibs quality of life scores (qol) will be used to evaluate the effect of treatments. retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with rifaximin for 2 weeks. fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (pcr) using 16 s ribosomal ribonucleic acid (rrna) gene. patients who responded to rifaximin treatment will be randomized into a (probiotics group) and b (placebo group). ibs symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.

Eligibility criteria:
inclusion criteria: * 18-75 years old; * in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome roman iv； * blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem; * no intestinal warning symptoms exclusion criteria: * suffering from severe heart, lung, liver, kidney, nervous system diseases; * suffering from mental disorders caused by schizophrenia, brain organic and physical diseases; * suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease); * history of previous abdominal surgery (excluding history of cholecystectomy or appendectomy); * pregnant or lactating women; * have undergone colonoscopy in the past month or accept other bowel preparation operations; * in the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, chinese medicine and other drugs; * have participated in other dietary treatments; * understand communication barriers, unable to communicate

Keywords: rifaximin probiotics ibs-d gut microbiota
leaders free japan

Conditions: Coronary Disease

Summary: prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in japan. all patients will receive a dcs and will be followed for 2 years.

in this study all patients will receive the a drug coated stent and will receive one month dual anti platelet therapy.

Eligibility criteria:
inclusion criteria: any indication for pci-s in patients deemed at high risk for bleeding and candidates for 1 month dapt. this includes candidates with stable angina, silent ischemia, acs (stemi and non-stemi), non-native lesions and in-stent restenosis. patients must provide written informed consent. reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or more of the following: 1. adjunctive oral anticoagulation treatment planned to continue after pci 2. age ≥ 75 years old 3. baseline hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to enrollment) 4. any prior intracerebral bleed 5. any stroke in the last 12 months 6. hospital admission for bleeding during the prior 12 months 7. non skin cancer diagnosed or treated \< 3 years 8. planned daily nsaid (other than aspirin) or steroids for \>30 days after pci 9. planned surgery that would require interruption of dapt (within next 12 months) 10. renal failure defined as: creatinine clearance \<40 ml/min 11. thrombocytopenia (plt \<100,000/mm3) 12. severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice 13. expected non-compliance to prolonged dapt for other medical reasons exclusion criteria: 1. pregnant and breastfeeding women 2. patients expected not to comply with 30 days dapt 3. patients requiring a planned staged pci procedure more than one week after the index procedure 4. procedure planned to require non-study stents, or stand-alone poba or stand-alone atherectomy 5. active bleeding at the time of inclusion 6. reference vessel diameter \ 4.0mm 7. cardiogenic shock 8. compliance with long-term single anti-platelet therapy unlikely 9. a known hypersensitivity or contraindication to aspirin, clopidogrel or other p2y12 inhibitor (if applicable), stainless steel, zinc, biolimus a9 or a sensitivity to contrast media, which cannot be adequately pre-medicated 10. pci during the previous 12 months for a lesion other than the target lesion of the index procedure 11. participation in another clinical trial (12 months after index procedure) 12. patients with a life expectancy of \< 1 year
combination therapy with two biologicals

Conditions: IBD

Summary: the efficacy and safety of dual biological therapy.

data of all patients treated with the combination of two biologicals in four finnish tertiary centres were collected and analysed. inclusion criteria were simultaneous use of two biological treatments (infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), age 16 years or over and follow-up for at least induction period after introduction of second biological therapy. the primary outcome was effectiveness, defined as remission assessed by physician after at least four months of dbt. the secondary outcome was safety defined by any adverse events or infection complications during dbt.

Eligibility criteria:
inclusion criteria: * simultaneous use of two different biological treatments for ibd. * treatment duration with combination therapy for at least for induction period. exclusion criteria: -age under 16 years.

Keywords: biological combination therapy adalimumab ustekinumab vedolizumab golimumab
follow-up the os and pfs of rituximab biosimilar hlx01 and mabthera, in untreated subjects with cd20+ dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: the main objective of this study is to observe the overall survival of rituximab biosimilar hlx01 and mabthera in combination with chop, in previously untreated subjects with cd20+ dlbcl. the secondary objective of this study is to observe the progression-free survival of rituximab biosimilar hlx01 and mabthera in combination with chop, in previously untreated subjects with cd20+ dlbcl.

1. enrollment:407 subjects. 2. the inclusion criteria of this study: subjects who have participated in phase iii clinical trials.phase iii clinical trial（nct02787239） has ended. 3. the exclusion criteria: ①subjects died; ②subjects are unwilling to participate in follow-up study; ③ the investigator judges that the subject is not suitable for participating the study. 4. duration and method of follow-up: 2-10 years (2020-2027)after the end of the phase iii trial and follow up the subjects by the phone. 5. statistical analysis method: for progression-free survival and overall survival (os), the median time and its 95% confidence intervals will be calculated by the kaplan-meier method.the log-rank test will be used for finding the difference between groups. the efficacy will be analyzed by sas9.4 , and all hypothesis tests are two-sided. the confidence level of all confidence intervals is 95%. p value less than 0.05 was regarded as statistically significant.

Eligibility criteria:
inclusion criteria: * subjects who have participated in phase iii study（nct02787239）. exclusion criteria: * ①subjects died; ②subjects are unwilling to participate in follow-up study; ③ the investigator judges that the subject is not suitable for participating the study.

Keywords: rituximab overall survival progression-free survival
effectiveness and implementation of a mindfulness intervention for depressive symptoms among adults in a fqhc

Conditions: Depressive Symptoms; Stress, Psychological; Stress, Physiological

Summary: the objective of this project is to examine the clinical effectiveness of a mindfulness intervention on reducing depressive symptoms among socio-economically disadvantaged, racial/ethnic minority adults and explore factors related to implementation in a federally qualified health center (fqhc). this research will be used to develop a generalizable model for delivery of streamlined mental health interventions in community based settings that will be broadly disseminated and scalable to other populations. black and hispanic adults are more likely than those who are white to receive depression treatment in primary care, where antidepressants are the most commonly offered treatment. however, black and hispanic adults are less likely than whites to find antidepressants acceptable. a mindfulness depression intervention provided within primary care may be more accessible and acceptable for low-income, racial/ethnic minority individuals, a severely underserved population. the investigators will conduct a randomized controlled trial to test the clinical effectiveness of a mindfulness intervention (m-body) on reducing depressive symptoms, compared to usual care, among low-income racial/ethnic minority adults in a fqhc. the m-body intervention is based on mindfulness based stress reduction and has been tailored for the fqhc setting and patient population. adults (n=254) with depressive symptoms will be recruited from a fqhc in the chicago, il area that serves majority racial/ethnic minority individuals (90%) living at or below the poverty line (74%). half of the patients will be randomized to the m-body intervention arm where they will receive 8-weeks of mindfulness training led by fqhc staff and the other half will be randomized to usual care. information on factors relevant to implementation of the intervention in the fqhc will be obtained by convening a series of workgroups and individual interviews with fqhc staff, executive leadership and community stakeholders. specific aims: 1) determine the effectiveness of m-body on reducing depressive symptoms compared to enhanced usual care for racial/ethnic minority adults in a fqhc; 2) explore potential mediators (stress related biomarkers, mindfulness) and moderators (age, personal, social, environmental stressors) of the intervention's effect; 3) conduct a broad assessment of organizational and individual agency factors related to preparation and implementation of the m-body intervention in a fqhc using a mixed methods approach.


Eligibility criteria:
inclusion criteria: * 18-65 years old * mild to severe depressive symptoms (patient health questionnaire-9, phq-9, total score ≥ 5) * english speaking exclusion criteria: * phq-9 total score \<5 * past 30-day suicidal ideation * current, regular practice of meditation (≥ 4 per week)
circulating tumor dna guided adjuvant chemotherapy for biliary tract carcinoma

Conditions: Biliary Tract Cancer

Summary: in recent years, circulating tumor dna (ctdna)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. the presence of ctdna after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. the benefit of adjuvant chemotherapy for ctdna-positive patients is not well understood.

the results of the prodige-12/accord-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (rfs) and overall survival (os). notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse rfs and os compared to those in the monitoring arm. ctdna risk stratifies patients to guide adjuvant treatment decisions this study aimed to demonstrate that a escalation strategy of ctdna guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (dfs) in patients with stage ii- iii biliary tract cancers with minimal residual disease (mrd) (ctdna positive).

Eligibility criteria:
inclusion criteria: * 1) patients with pathologically confirmed btcs according to the uicc/ajcc tnm staging system (8th edition 2017) for stage ii-iii tumours. patients eligible for radical resection of btcs. no synchronous or metastatic malignant tumour found in other organs other than the primary tumor. 2) personal status (ps) score as over 80 or eastern cooperative oncology group (ecog) score as 0 \~ 2. 3）with expected survival of more than 12 months. 4) radical operation performed. exclusion criteria: * 1) patients with positive surgical margins and residual lesions after biliary tract tumor surgery. 2) blood transfusion performed during operation or within 2 weeks before operation. 3) have a history of other malignant tumors within 5 years.

Keywords: s-1 circulating tumor dna (ctdna)
a study of lnk01001 capsule in patients with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral lnk01001 dose a or lnk01001 dose b or matching placebo for 12 weeks.

the study was to include a 12-week double-blind treatment period. participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups. group 1:lnk01001 dose a (day 1 to week 12) group 2:lnk01001 dose b (day 1 to week 12) group 3: matching placebo (day 1 to week 12)

Eligibility criteria:
inclusion criteria: * participants between ≥ 18 and ≤75 years of age. * subjects meet hanifin and rajka criteria. * subjects meet moderate to severe ad criteria. * inadequate response to topical treatment or systemic treatment for ad within 6 months before screening. exclusion criteria: * current use of topical treatment for ad within 2 weeks before baseline visit. * prior exposure to janus kinase (jak) inhibitor. * prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit. * prior exposure to any biologic treatment including dupilumab, omalizumab within 3 months before baseline visit. * any significant clinical and laboratory abnormalities, as determined by the investigator, may affect the safety of the subjects, including but not limited to:wbc\ 1.5×uln, or total bilirubin\>1.5×uln; serum creatinine\>1.2×uln.
an open label study to evaluate g17dt compared to gemcitabine

Conditions: Pancreatic Cancer

Summary: in this study 250 µg of g17dt was administered at weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * a diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent. * a diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection. * male or female patients over 18 years of age. * laboratory values within the following ranges at screening: serum creatinine \ 9.5 g/dl white blood cell (wbc) count \> 3.5 x 109/l platelets \> 100 x 109/l total bilirubin \< 2.0 times uln aspartate transaminase (ast, sgot) \< 3 times uln * a life expectancy of at least 2 months. * a negative pregnancy test at the screening visit (females of childbearing potential only). * signed written informed consent. exclusion criteria: * history of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix). * previous cytotoxic chemotherapy (including gemcitabine). * previous radiotherapy within 30 days of baseline. * use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted. * females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study. * participation in another study involving an investigational drug within 90 days of baseline.
clinical efficacy of autologous mesenchymal bone marrow stem cells in active & progressive multiple sclerosis

Conditions: Multiple Sclerosis (MS)

Summary: the purpose of this study is to evaluate the clinical efficacy and the optimal way of administration of autologous mesenchymal bone marrow stem cells (msc) compering intravenous injection and intrathecal injection vs. placebo, in active-progressive multiple sclerosis patients.

mesenchymal stem cells (msc) induce immune-modulatory and neurotrophic effects and were shown to have an acceptable safety profile for clinical applications. we aimed to evaluate the safety and efficacy of msc transplantation in active progressive ms and investigate possible neuroprotective effects. methods: this single-center double-blind crossover trial enrolled 48 patients with progressive ms (expanded disability status scale (edss) range: 3.5-6.5, mean: 5.6+/-0.8). patients were randomised into three groups and treated intrathecally (it) or intravenously (iv) with autologous mscs (1x106/kg) or placebo. at 6-months, treatment groups were crossed over and patients re-treated with either msc or placebo. during the 2-months run-in period and the 12-months after treatment, participants were followed using edss, 25-foot timed walking, 9-hole peg test, neurocognitive tests, quantitative magnetic resonance imaging (mri), functional mri, optic coherence tomography (oct), visual evoked potentials (vep), and dynamic visual tests.

Eligibility criteria:
inclusion criteria: 1. consenting patients fulfilling the poser's clinical criteria for definite ms 2. age: 18-65, males and females 3. duration of disease: \>3 years 4. progressive form of ms: ppms, spms (with/without relapses) 5. edss score of 3.5 - 6.5 6. failure to currently available, registered - first and second line immunomodulatory treatments (at least one). 7. evidence for new activity of ms during the 3 months before the injection of msc. exclusion criteria: 1. patients who were treated with cytotoxic medications during the last 3 months prior to the inclusion. 2. patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results 3. patients with active infections 4. patients with severe cognitive decline or inability to understand and sign the informed consent 5. patients who received any cellular treatment in the past

Keywords: multiple sclerosis (ms) stem cells
effect of moisturizing creams on skin barrier function

Conditions: Atopic Eczema

Summary: this study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. the hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.


Eligibility criteria:
inclusion criteria: * dry skin barrier disorders such as atopic dermatitis or malassezia eradicated head and neck dermatitis. * rough or clinically normal skin on the volar aspect of the forearm. * either gender * age between 18 and 65 years * written informed consent exclusion criteria: * possible allergy to ingredients in the study medications. * use of any concomitant medication that may interfere with the study related activities or assessment of efficacy. * any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse). * any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results. * pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.
fear of cancer recurrence in genitourinary cancer

Conditions: Fear of Cancer Recurrence; Prostate Cancer; Renal Cell Cancer; Urothelial Carcinoma; Testicle Cancer

Summary: to perform an analysis of independent predictors of fear of cancer recurrence in patients with malignant genitourinary diseases and their impact on quality of life and survival


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer
a clinical trial comparing efficacy and safety of exubera® and humalog®

Conditions: Diabetes Mellitus, Type 1

Summary: to compare efficacy and safety of exubera® vs humalog in patients with type 1 diabetes mellitus

pfizer announced in october 2007 that it would stop marketing exubera®. at that time recruitment for study, a2171035 was placed on hold. nektar, the company from which pfizer licensed exubera®, announced on april 9, 2008 that it had stopped its search for a new marketing partner. accordingly, there will be no commercial availability of exubera®. as a result, study a2171035 was terminated on may 12, 2008. neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 exclusion criteria: * severe asthma, severe chronic obstructive pulmonary disease (copd) * smoking