Kornimate/medical-research-clean huggingface dataset:
host-microbiota-environment interactions

Conditions: Juvenile Idiopathic Arthritis; Diabetes type1; Inflammatory Bowel Diseases

Summary: two types of inflammatory and autoimmune diseases (excluding monogenic diseases) can be distinguished in children: those similar to adult diseases but with an early onset (type 1 diabetes, inflammatory diseases of the gastrointestinal tract, rheumatoid arthritis with anti-ccp antibodies) and those specific to children that are not described in adults (early-onset juvenile idiopathic arthritis with anti-nuclear and anterior uveitis). the familial and nosological aggregations suggest that these diseases are probably polygenically determined, and result from interactions with the environment. in a singular way, the incidence of "adult" diseases is increasing while the age of onset is getting earlier; conversely, there is no increase in early-onset juvenile idiopathic arthritis. on the other hand, the influence of early events that may alter the microbiotic environment is different for different diseases: whereas cesarean section (or early antibiotic therapy) has been shown to increase the risk of jia and t1dm, it does not seem to change the risk of ibd. we hypothesize that environmental factors, particularly those related to diet and bacterial and fungal digestive microbiota - are different between these disease categories.

exploratory pathophysiology monocentric study including an initial case-control study, followed by a cohort for cases. controls will be siblings of cases with longitudinal follow-up. stool samples will be collected simultaneously from the child with jia, t1dm or ibd (case) and his/her sibling(s) (control): * at the time of diagnosis * two months after diagnosis (for children with inflammatory disease only) * one year after diagnosis (cases and controls) tryptase level in plasma will be recorded for the child with jia, t1dm or ibd (at the time of diagnosis, 2 months and 1 year after diagnosis)

Eligibility criteria:
inclusion criteria: case: - newly diagnosed with jia, ibd or t1dm control: - brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: diet, living environment) exclusion criteria (case and control): * child with antibiotic treatment in the 4 weeks preceding the stool sample * recent digestive infectious disease (bacterial, viral, parasitic) (end of episode \< 7 days) exclusion criteria (control): children with autoimmune or inflammatory disease

Keywords: microbiota environmental factors food contaminants
photosensitivity of the skin under azathioprin in renal transplant recipients

Conditions: Skin Cancer

Summary: photosensitivity of the skin to uva and uvb will be determined

photosensitivity of the skin to uva and uvb in renal transplant recipients with and without azathioprine will be determined. azathioprine will be discontinued and photosensitivity determined after a wash-out period of three months * trial with medicinal product

Eligibility criteria:
inclusion criteria: * renal transplant recipients under azathioprin exclusion criteria: * treatment with prograf (tacrolimus)
comparison of hylastan to methylprednisolone acetate in patients with symptomatic osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: this is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (oa) of the knee.


Eligibility criteria:
inclusion criteria: * diagnosed with oa of the knee * have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications exclusion criteria: * prior or concomitant treatments that would impede measurement of safety and efficacy

Keywords: musculoskeletal osteoarthritis of the knee
vitamin d inadequacy is associated with incidence of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: emerging evidence suggests that vitamin d \[25-hydroxyvitamin d; 25(oh)d\] may play a role in the etiology of type 2 diabetes. vitamin d levels are lower in those with type 2 diabetes and impaired glucose tolerance (igt) compared with those with normal glucose tolerance (ngt). in addition, a few prospective studies have shown a significant inverse association of baseline serum 25(oh)d with incident diabetes. to date, however, the exact mechanisms through which vitamin d affects diabetes risk are not yet fully known, particularly whether vitamin d plays a role in insulin resistance (ir) and/or b-cell dysfunction, the main pathophysiological disorders underlying type 2 diabetes. so, the investigators plan to examine the prospective associations of baseline vitamin d \[25-hydroxyvitamin d; 25(oh)d\] with insulin resistance (ir), b-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes.


Eligibility criteria:
inclusion criteria: * one or more risk factors for diabetes, including: * obesity * hypertension * dislipidemia * a family history of diabetes exclusion criteria: * previous diagnosed diabetes * vitamin d supplement.

Keywords: vitamin d diabetes pancreas beta cell function insulin resistance deficiency of vitamin d3
effects of concurrent training on physical fitness and body composition in obese individuals

Conditions: Obesity

Summary: ample evidence demonstrates the beneficial role of physical activity combined with a structured dietary plan to counteract obesity. international guidelines as the world health organization states that to improve fitness levels at least 150 min a week of physical activity at moderate intensity, combined with resistance training composed of 8-12 repetitions with an intensity of 60-70%1rm for each muscle group, are recommended. in this regard, a minimum dosage of 60-90 min of physical activity composed by aerobic exercises in alternation with resistance training protocols, allow a sequential development of cardiorespiratory fitness and muscular strength parameters avoiding potential interference effects. interference may occur when strength and endurance stimuli both target opposite peripheral adaptations (e.g., hypertrophy vs. muscle capillarization) and this phenomenon seems to be particularly clear during adolescence. nevertheless, the incorporation of different training stimuli within the same training session is called concurrent training. this training mode, thanks to the activation of two different metabolic pathways (e.g., aerobic and anaerobic), has a variety, beneficial effects in terms of muscle mass and strength development, body composition profile regulation and neuromotor function improvement. concurrent training seems to be effective not only in normal-weight subjects, but also in obese individuals, reporting positive adaptations on physical fitness and health status compared with a single-mode (i.e., aerobic or strength training). therefore, the aim of this study is to detect the effects of a 10-week-concurrent training protocol compared with a single training modality on physical fitness, body composition and circadian rhythms in adult outpatients with obesity.


Eligibility criteria:
inclusion criteria: * physical activity frequency minor of 2 days/week * bmi major of 30 kg/m2 * informed consent signature exclusion criteria: * age over 65 years * knee or hip pain (visual analogue scale score \>7 arbitrary units * a history of hip, knee or foot replacement or osteoarthrosis * cardiac infarction * neurological impairments or any other clinical condition that affects the practice of physical activity

Keywords: physical activity obesity treatment body composition
clinical trial using humanized cart directed against bcma (ari0002h) in patients with relapsed/refractory multiple myeloma to proteasome inhibitors, immunomodulators and anti-cd38 antibody.

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: to assess the safety and efficacy of cartbcma ari0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-cd38 monoclonal antibody.


Eligibility criteria:
inclusion criteria: * patients between the age of 18 and 75 years with diagnosis of multiple myeloma * disease measurable by monoclonal component in serum and/or urine or by free light chains in serum according to the eligibility criteria for clinical trials of the international myeloma working group * previous two or more lines of treatment. patients must have received at least a proteasome inhibitor (such as bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide or pomalidomide) and an anti-cd38 monoclonal antibody (such as daratumumab) * refractory to the last line of treatment * ecog functional status ranging from 0 to 2 * life expectancy over 3 months * patients who, after being informed, give their consent by signing the informed consent document. exclusion criteria: * previous allogeneic transplant in the prior 6 months to inclusion or gvhd that requires active systemic immunosuppressive treatment * absolute lymphocyte count \<0.1x10\^9/ l * previous neoplasia, except if patients have been in complete remission \> 3 years, except for cutaneous carcinoma (non-melanoma) * active infection that requires treatment * active infection by hiv, hbv or hcv. * uncontrolled medical disease * severe organic condition that meets any of the following criteria: ef \ 3 times normal value (except gilbert syndrome) * previous diagnosis of symptomatic al amyloidosis * pregnant or lactating women. women of childbearing age should have a negative pregnancy test in the screening phase * women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who cannot or do not wish to use highly effective contraceptive methods from the beginning until the end of the study. * men who cannot or do not wish to use highly effective contraceptive methods from the beginning to the end of the study. * contraindication to receive conditioning chemotherapy
anti-scarring efficacy and safety of intradermal juvista (avotermin) in healthy males

Conditions: Cicatrix

Summary: this study was undertaken to investigate safety and scar-improvement activity of different applications of juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. the study addressed two issues: whether juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.


Eligibility criteria:
inclusion criteria: * clinically healthy, male subjects aged 18 to 45 years (inclusive) * body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using quetelet's index exclusion criteria: * subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied. * subjects with tattoos or previous scars within 3cm of the area to be incised during the trial. * afro-caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring. * subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease. * subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial. * subjects with a history of clinically significant allergies. * subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination. * subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics. * subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not. * subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness. * subjects smoking more than 20 cigarettes a day. * subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer \[285ml\], 25ml of spirits, or 1 glass of wine). * subjects showing evidence of drug abuse. * subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis b surface antigen (hbsag) or hepatitis c antibody. * subjects previously testing positive for hiv antibodies, or who admit to belonging to a high-risk group. * subjects with pre-existing clinically significant neurological conditions. * subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.

Keywords: cicatrix, scarring, tgf-beta3, avotermin, juvista
acupuncture treatment for chronic sciatica: the neuroimaging pain-network study

Conditions: Therapy, Acupuncture; MRI, Functional

Summary: sciatica is a common pain disorder in the neurological clinic that typically present as low back or gluteal pain and may radiate to one leg with motor or sensory complaint. sciatica has drawn more attention worldwide as a public health issue for its pain disability, high prevalence and significant medical and economic burden. a meta-analysis of sciatica treatment revealed discectomy, epidural injections, non-opioid analgesics, and acupuncture might relieve pain. however, the central effect of acupuncture-induced analgesia and its functional connectivities in various brain region remain unclear. besides, the number of acupoints selection and its correlation in functional connectivity also need to be discussed. this clinical trial would collect the sciatica subjects assign by intent to treat, divided to acupuncture and non-acupuncture herbal control group. the treatment of acupuncture assigns randomized as high dose and low dose acupuncture group. the acupuncture will perform two times a week for four weeks. the primary outcomes are visual analog scale for pain and sciatica bothersomeness index; the secondary outcomes are roland's disability questionnaire for sciatica, whoqol, and traditional chinese medical constitutional scale. the functional magnetic resonance imaging scan would apply at the baseline and after four weeks' treatment. this study aims to explore the model of dmn in sciatica patients; it's central effect in different stimulation modality and to investigate the mechanism of the long-lasting, sustained impact in different acupuncture dosage.


Eligibility criteria:
inclusion criteria: 1. 35 - 70 y/o. 2. low back or gluteal pain radiating into one leg. 3. pain duration of at least two weeks. exclusion criteria: 1. known or suspected severe spinal pathology (for example, cauda equina syndrome, or spinal fracture). 2. pregnant or breastfeeding women. 3. scheduled or being considered for spinal surgery or interventional procedures for sciatica during the 8-week treatment period. 4. administration of sedative or analgesics within 24 h before the fmri scan. 5. comorbidities include systemic malignancy, bleeding tendency, rheumatic arthritis and other known autoimmune diseases. 6. focal neurologic deficits with progressive or disabling symptoms 7. history of received acupuncture treatment in the past one month. 8. any contraindication related to acupuncture and mri. 9. visual analog scale \< 3. 10. low back pain without sciatica.

Keywords: acupuncture, sciatica, default mode network
neoadjuvant tisleizumab(bgb-a317) for dmmr/msi-h non-late stage crc patients before surgery

Conditions: DMMR Colorectal Cancer; Anti PD-1; Immunotherapy

Summary: according to the cancer statistics in 2020, colorectal cancer (crc) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the crc-related death occurs in china. among all the crc, stage i-iii account for 75%. for the standard management for non-late stage(stage i-iii) crc patients, surgery including the primary site and local lymph nodes dissection has been the most important one. but for the high-risk stage ii and locally-advanced stage iii crc, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. for the past decades, immunotherapy like anti-pd-1 and anti-ctla4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage crc. and pembrolizumab and nivolumab has been proved for dmmr/msi-h late-stage-crc by fda. combination of ipilimumab and nivolumab has achieved great success among the early-stage-crc in niche study. the investigators here to carry out a phase ii clinical trial to explore the safety and effect of single anti-pd-1 (tisleizumab-bgb-a317 ) neoadjuvant treatment for non-late stage crc patients.


Eligibility criteria:
inclusion criteria: * able to provide consents and agree to follow the trial requirement and assessment; * age \>=18 * ecog score: 0 or1 * biopsy pathological diagnosis as msi-h/dmmr( both ihc and pcr method required) * measurable and assessible primary tumor sites according to recist 1.1 * able to provide 22ml peripheral blood for assessment for ctdna * with all organ function sufficient * no bowel obstruction or fistula * no previous chemotherapy, radiotherapy and immunotherapy accepted history * distant metastasis excluded before surgery by ct scan * contraception required for women for the whole enrollment time until 3 months after last dose of immunotherapy exclusion criteria: * self-autoimmune diseases history such as sle * people who using the immune suppressor * severe allergy to other mono-clone antibody * cerebral metastasis which hasn't be managed yet * hypertension(sbp\>140mmhg，dbp\>90mmhg) * uncontrolled diabetes(fbg\>10mmol/l) * accepted anti-pd-1 or anti-pd-l1 immunotherapy in the past * uncontrolled heart diseases such as nyha ii heart failure, unstable angina , cardiac infarction in 1 year and arrhythmia * systemic inflammation which needs whole body treatment * urine routine: protein \>=++ or 24hr urine protein\>=1g * innate or acquired immune deficiency like hiv and hbv * enrolled in other clinical trial already * confirmed as metastasis before the surgery * other malignancies has been diagnosed before * tuberculosis * pregnancy

Keywords: crc
appropriate medication use in dutch terminal care

Conditions: Palliative Care; Terminal Care; Medication Therapy Management; Clinical Decision Support System (CDSS); Quality of Life

Summary: the amuse trial is a multicentre stepped-wedge cluster randomized controlled trial where medication optimization of patients with a life expectancy of less than three months is investigated by using cdss-optimed (a personalized medication advice to attending physicians of patients in the last phase of life) the investigators will include 250 patients, in 7 different study sites across the netherlands. the primary outcome is an assessment of the quality of life of patients, two weeks after baseline assessment.

rationale: patients in the last phase of life often use many medications that are continued until shortly before they die. this is partly inevitable, because these patients often experience multiple distressing symptoms. however, for a considerable number of medications currently often used at the end of life, the benefit is debatable, e.g. because they are aimed at the long-term prevention of illness. primary objective: to examine whether the use of cdss-optimed, a personalized medication advice to attending physicians of patients in the last phase of life, contributes to patients' quality of life. main study endpoints: the primary endpoint is patients' quality of life two weeks after baseline assessment, as measured by the eortc qlq-c15-pal questionnaire (scale 0 to 100). potential risks and benefits associated with participation: the intervention in this trial supports physicians in using available evidence and knowledge when deprescribing medication for patients in the last phase of life. the intervention does not involve experimental treatment or medication. the investigators expect no other risks than known side effects of (stopping) medications. the investigators are aware that the trial population concerns vulnerable people who may experience fluctuating symptoms and levels of suffering across their disease trajectory. the investigators acknowledge the risk of overburdening participants. if patients feel burdened by participating in the study, they are encouraged to indicate that.

Eligibility criteria:
inclusion criteria: * patient is 18 years or older and provides informed consent to participate. * the patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician. * the patient is competent to decide about trial participation * the patient has a life expectancy of at least two weeks and at most three months, as estimated by an attending physician. exclusion criteria: * the patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).
the effects of air pollution on respiratory diseases in children

Conditions: Respiratory Disease

Summary: the investigators expect to reveal the association between air pollution and childhood respiratory diseases through a multi-center observational study, and summarize the relationship between air pollution and childhood respiratory diseases.

the investigators will collect the data of outpatient and emergency children in beijing children's hospital and other participating hospitals due to respiratory diseases from 2010 to 2021, , collect clinical data and basic information, obtain air pollution data and meteorological monitoring data and perform data processing and statistical analysis,，then analyzes the impact of air pollution on children's respiratory diseases.

Eligibility criteria:
inclusion criteria: * all children participating in this clinical study must meet all of the following criteria: 1. age: 0-18 years old, male and female 2. consultation for respiratory diseases 3. visit time is between 2010-2021 4. provide complete personally identifiable information and medical information exclusion criteria: * all children with any of the following conditions must be excluded from this study: 1. children who visit hospital don't for respiratory diseases 2. children participating in this clinical study don't provide complete personally identifiable information and medical information 3. visit time is not between 2010-2021.

Keywords: respiratory diseases children air pollution