Kornimate/medical-research-clean huggingface dataset:
traditional chinese medicine on gut microbiota and allergic diseases

Conditions: Allergic Rhinitis

Summary: allergic rhinitis is an importance disease in taiwan with its high incidence about 20-30% and gradually increased annually. however, symptom relapse still bothered the majority of patients though there were certain advances in western medicine. in addition, side effects of western medicine, such as lethargy, mouth dryness were noted. traditional chinese medicine, especially qi-tonifying regimen has been used and proved benefit to the allergic diseases by many researchers.this study will provide the evidences of gut microbiota changes and immune-modulatory effects of bzyqt for the treatment of allergic rhinitis.

recently studies reported that gut microbiota is related to the human immunity modulation of allergic diseases. investigators are interested to know weather qi-tonifying herbal medicine is through the changes of gut microbiota to modulate human immunity. in this study, a double-blinded, randomized, placebo control design is applied and total 60 perennial allergic rhinitis patients will be enrolled in our study. all subjects will be divided into bu-zhong-yi-qi-tang (bzyqt) and placebo control groups, 40 and 20 subjects each. subjects of bzyqt group will receive capsule of bzyqt, 4gm tid, 12gm a day, while control group will receive similar placebo capsule with same scheme. total 2 months treatment course will be done. gut microbiota will be assayed before and after 2 months treatment. additionally, various parameters for immunologic response will be checked before and after the treatment, including the total ige amount, the ratio of cd4/cd8 of t lymphocytes, the profile of cytokine such as il-10 and il-12 as well as functional change of dendritic cells and t cells. results will be analyzed statistically including gender analysis. this study will provide the evidences of gut microbiota changes and immune-modulatory effects of bzyqt for the treatment of allergic rhinitis.

Eligibility criteria:
inclusion criteria: 1. with at least one of the following clinical symptoms: itchy nose, sneeze, rhinorrhea, nasal congestion 2. diagnosed as intermittent allergic rhinitis (less than 4 days per week and for less than 4 weeks) 3. cap panel :allergy to mite 4. will to complete questionnaires and take medicine as schedule in this study 5. volunteer for study enrollment and sign inform consent exclusion criteria: 1. under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month 2. under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on 3. vasomotor type allergic rhinitis 4. history of allergy or adverse effect to chinese herbs, poor compliance of herbal medicine 5. severe organ function impairment, such as heart failure, liver failure, renal failure (egfr \<60 ml/min/1.73 m2)

Keywords: qi-tonifying regimen immune-modulation gut microbiota
upper limb biofeedback rehabilitation system (rapaelⓡ smart glove digital treatment system) training for stroke recovery

Conditions: Stroke; Cerebral Vascular Accident

Summary: this study is to investigate whether the rapaelⓡ smart glove digital treatment system improves the upper extremity function of stroke patients compared to other clinical treatment by measuring serial behavioral and neuroimaging assessments and to find out therapeutic effect or adverse effect and patient's feed back responses

80 stroke patients(subacute=40, chronic=40) were recruited and randomized to receive either occupation therapy(ot) with or without rapaelⓡ smart glove digital therapy. groups were divided as follow: group 1 (5times/4wks, total 20 sessions) conventional occupation therapy + additional occupation therapy(30min). group 2 (5times/4wks, total 20 sessions) conventional occupation therapy + rapaelⓡ smart glove digital treatment(30min). after the baseline assessment, patients are divided into two groups by drawing for simple random sampling. total four times of behavioral and neuroimaging assessments were evaluated at baseline, immediately and 2 weeks after each 10 sessions and at 4 weeks after the final session. assessment tools are as follow: 1. primary outcome. -fugl-meyer assessment, 2. motor and sensory function. mmt\&rom, motricity index(mi),action research arm test(arat), box\&block test, box\&block test, 9-hole pegboard test, jebsen-taylor hand function test, modified ashworth scale(mas), grip strength test, grasp/pinch power, visual analogue scale(vas), sensory test(two point discrimination, monofilament) 3. activity of daily living. korean version of modified barthel index (k-mbi) 4. cognition function test. korean-mini mental state examination (k-mmse) 5. depressive mood. korean-geriatric depression scale (k-gds) 6. quality of life. short form-8(sf-8) 7. neuroimaging tools. motor evoked potentials (mep), functional magnetic resonance imaging (fmri), functional near-infrared spectroscopy (fnirs).

Eligibility criteria:
inclusion criteria: * subjects who hemiplegic due to stroke * subjects who have more than 22 points of fugl-meyer assessment score in upper extremity * 40 subjects who have diagnosed as stroke before 3weeks to 3 months(subacute) * 40 subjects who have diagnosed as stroke more than 6 months ago(chronic) exclusion criteria: * subjects who have spasticity and upper extremity dysfunction at unaffected side * subjects who have bilateral or multiple brain lesion * subjects who have non-controllable medial or surgical disease * subjects who is less than 20 years old * subjects who have pre-existing and active major neurological or psychiatric disease * subjects who have less than 10 degrees of active wrist range of motion * subjects who can not complete outcome measurement task * subjects who have limitation of communication due to aphasia * subjects who have less than 17 points of k-mmse * subjects who is pregnant * subjects who have pain or other muscle wasting disease which may interrupt upper extremity exercise

Keywords: rapaelⓡ smart glove digital treatment system rehabilitation stroke upper limbs
osteopathy and prevention of gastrointestinal side effects in women treated for breast cancer

Conditions: Breast Cancer

Summary: adjuvant chemotherapy with the protocol 3 cure of 5-fu + epirubicine + cyclophosphamide (fec100) and 3 cure of taxotere is a standard treatment in the management of patients with breast cancer and in adjuvant situation. the efficacy of 3 fec100 and 3 taxotere protocol in adjuvant situation for women treated for breast cancer is associated with several invalidating side effects for the quality of life of patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11% will present nausea and vomiting of grade 3-4. current treatments to prevent these gastrointestinal toxicities include emend from day 1 to day 3 in association with setrons at day 1 and corticosteroids from day 1 to day 3. despite the marked improvement in gastrointestinal toxicities with preventive treatments, 83% of patients would use alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or osteopathy. osteopathy is a method of care and unconventional therapeutic approach. in france, the professional title of osteopath is recognized. it aims to prevent and treat functional disorders, especially those related to adverse effects of treatment. in oncology, this discipline may have additional support for the patient by limiting the mechanical and physical constraints of sensitive areas to the toxicity of the treatment. in the case of gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in abdominal areas to relieve symptoms. the investigators hypothesis is that osteopathy could have an interest in the management of gastrointestinal toxicities related to chemotherapy in women with breast cancer and in adjuvant treatment situation.


Eligibility criteria:
inclusion criteria: * wife * age over 18 years * operated for a breast cancer stage 1 to 3, in complete resection * plan to receive chemotherapy based on fec100 3 - 3 taxotere * nurse consultation prior to chemotherapy * planned antiemetic treatment which should include emend 125, 80, 80 at j1, j2, j3, zophren 8 mg iv 1 bulb at j1, solumedrol 80 mg iv on day 1, primperan 10 mg 3 tablets a day, from day 1 to day 3, xanax 0,25 mg 1 tablet morning 1tablet evening from d1 to d3. * distance home cgfl 0 to 50 km, 50 to 100 km, 100 to 200 kms. * having considered the information note * written, dated and signed informed consent exclusion criteria: * man * metastatic breast cancer * breast cancer surgery with incomplete excision * digestive disorders known or known digestive disease * inability to receive one of the basic elements antibiotic treatment * refusal to participate to the trial * persons deprived of liberty or under guardianship * pregnant woman or likely to be * failure to submit to medical testing for geographical reasons (distance home - cgfl more than 200 km), social or psychic * non-affiliation to a social security scheme or to the state medical aid (ame) or the universal medical coverage (cmu)
feasibility of home telemonitoring of infants with congenital heart disease awaiting surgery during the first year of life

Conditions: CHD - Congenital Heart Disease

Summary: actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. this is a vulnerable period, prone to clinical complications, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. the aim of the study is to assess the feasibility and acceptability of monitoring newborns and infants with congenital heart disease awaiting cardiac surgery using the blue-line home telemonitoring program.

today, congenital heart disease affects around 0.8% of births in france. one third of children diagnosed antenatally or postnatally with congenital heart disease will require surgical or percutaneous intervention within the first year of life. actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. this is a vulnerable period, prone to clinical complications, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. our research team at the m3c network reference center aims to develop home telemonitoring for these patients, in order to innovate and optimize their care pathway.

Eligibility criteria:
inclusion criteria: * newborns and/or infants aged 0 to 12 months inclusive at the time of diagnosis. * with congenital heart disease as defined in the icd-11 classification. * waiting for an intervention by cardiac surgery or interventional catheterization. * free, informed consent signed by the holder(s) of parental authority. * person affiliated to or benefiting from a social security scheme. exclusion criteria: * short-term vital prognosis * clinical situation identified at the m3c rcp that contraindicates a return home * family situation identified at the m3c rcp as contra-indicating a return home * extra-cardiac co-morbidities requiring hospitalisation independent of the heart disease (e.g. severe renal failure, neurological deficit, complex immune deficiency, etc.). * limited understanding of parental authority holder(s) / caregivers (non-french speaking, hearing impaired, cognitive impairment or other) * parents unable to give informed consent. * minors with parental authority

Keywords: congenital heart disease infants vulnerability home monitoring therapeutic education digital platform
statins in patients with type 2 diabetes mellitus and previous history of acute coronary syndrome

Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Diabetes Mellitus

Summary: the purpose of this study was to compare the efficacy and safety of high dose atorvastatin (40 mg) versus high dose rosuvastatin (20 mg) in egyptian type ii diabetic patients with previous acute coronary syndrome history. this open-labeled prospective, randomized clinical trial compared once daily atorvastatin 40mg (ator®) versus once daily rosuvastatin 20mg (crestor®). the primary outcome was the 50% reduction in low-density lipoprotein cholesterol levels at 12 weeks. the secondary outcome was the achievement of low-density lipoprotein cholesterol level \< 55 mg/dl.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with type 2 diabetes. * previous history of acute coronary syndrome. * abnormal baseline lipid profile. exclusion criteria: * patients taking concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3. * patients taking concurrent interacting medications such as ciclosporin, gemfibrozil, clarithromycin and/or itraconazole. * patients with active liver disease, bile duct problems, or alt \> 3 × upper limit of normal (uln). * patients with serum creatinine \> 2 mg/dl. * patients have incidence or history of hypersensitivity reaction to any of the statin used. * women who were pregnant, breast-feeding or of child-bearing potential and not using a reliable form of contraception at the time of recruitment

Keywords: high intensity statin therapy acute coronary syndrome atorvastatin rosuvastatin diabetes mellitus
evaluating the safety of long term dosing of romiplostim (formerly amg 531) in thrombocytopenic subjects with myelodysplastic syndromes (mds)

Conditions: Hematology; MDS; Myelodysplastic Syndromes; Thrombocytopenia

Summary: this is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10\^9/l) in mds subjects. the study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. the study will further describe the time to disease progression to acute myeloid leukemia (aml) and survival.


Eligibility criteria:
inclusion criteria * subject completed a romiplostim study for the treatment of thrombocytopenia in subjects with mds * subject has an eastern cooperative oncology (ecog) performance status of 0 to 2 * subject had a platelet count ≤ 50 x 10\^9/l since the final dose of investigational product in the parent study * subject or his/her legally acceptable representative provided written informed consent before any study-specific procedures were initiated exclusion criteria * subject has been diagnosed with aml or has a blast count ≥ 10% by peripheral blood or bone marrow biopsy * subject has a prior history of leukemia * subject has a prior history of bone marrow or stem cell transplantation * subject has a prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years before randomization * subject has active or uncontrolled infections * subject has unstable angina, congestive heart failure \[new york heart association (nyha) \> class ii\], uncontrolled hypertension (diastolic \> 100 mmhg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction * subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year * subject has a history of venous thrombosis that currently requires anti-coagulation therapy * subject received interleukin (il)-11 within 4 weeks of screening * subject previously received a thrombopoietic growth factor (other than romiplostim) * subject has a known hypersensitivity to any recombinant e coli-derived product (eg, infergen®, neupogen®, somatropin, actimmune) * subject is currently enrolled in investigational device or drug study(ies), has not yet completed at least 4 weeks since ending investigational device or drug study(ies) (other than parent romiplostim study), or subject is receiving other investigational agent(s)/device(s) * subject is of child-bearing potential and is evidently pregnant (eg, positive human chorionic gonadotropin \[hcg\] test) or is breast feeding * subject is not using adequate contraceptive precautions * subject has any kind of disorder that compromises his/her ability to give written informed consent (and does not have a legally acceptable representative) or is unable to comply with study procedures

Keywords: hematology mds myelodysplastic syndromes thrombocytopenia
study of tapering and discontinuing biological dmards in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this study aims to analyses time to disease relapse of ra patients if tnf-α inhibitors are being tapered, the predictive factors that are associated with successful taper of tnf-α inhibitors. also, investigate the effects associated with dose tapering of tnf-α inhibitors.


Eligibility criteria:
inclusion criteria: diagnosed of ra based on the 1987 american college of rheumatology (acr) criteria and/or 2010 acr/eular classification criteria of ra depending on the time of diagnosis age ≥ 20 years old tnf-α inhibitors was prescribed for ra patients refractory to csdmards (defined as csdmard therapy for over 6 months) during 2003/5/2 - 2017/4/30 dose reduction or discontinuation use of tnf-α inhibitors (2011/1/1-2019/4/30) exclusion criteria: tnf-α inhibitors were discontinued or tapered due to adverse events such as infection, liver transaminase elevation, malignancy and neutropenia.

Keywords: biological dmards
a study of a multi-modal sensor patch for real-time physiological monitoring and inference

Conditions: Cardiac Disease

Summary: the purpose of this research is to validate the prototype ai-flex device. researchers at mayo clinic developed a new a flexible multi-modal bio-sensing device, ai-flex, with integrated artificial intelligence (ai) capability. integration of sensing and ai analysis on the same device removes the need for data storage on the cloud for later analysis. the goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. it is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (\<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for ai analysis.


Eligibility criteria:
inclusion criteria: * subject must be referred for cardiology clinic visit. * subject must have underlying cardiac structural disease or condition to increase yield of clinically significant transmission * subject must be 18 - 85 years of age. exclusion criteria: - \ 85 years of age.

Keywords: underlying cardiac structural condition
a prospective randomized controlled study of radiotherapy and the concurrent three-week and single-week tp chemotherapy for advanced cervical squamous cell carcinoma and the correlation between hpv classification and sensitivity.

Conditions: Cervical Cancer

Summary: the main purpose for this experiments are as follows: 1. patients with stage ⅱb-ⅲb cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined tp regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. all enrolled patients will be tested for hpv subtype infection; the relationship between the sensitivity and curative effect of concurrent radiotherapy and chemotherapy will be analyzed, and at the end of the test, hpv subtypes will be tested again and changes will be analyzed to provide more clinical evidence for the reasonable comprehensive treatment and precision medical treatment of advanced cervical squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. the patient participated in this study voluntarily and all volunteers will sign the informed consent. 2. new cervical squamous cell carcinoma cases between 18 and 70 years old; 3. clinical stages: stage ⅱb-stage ⅲb; 4. ps score is less than 2 points; 5. expected survival is over 3 months; 6. blood routine: hb≥70g/l, wbc≥3.5×10\^9/l, anc≥1.5×10\^9/l, plt≥80×10\^9/l 7. serum alt and ast≤2×uln; serum creatinine≤1.5×uln; 8. women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial; 9. patients who can comply with the trial protocol (judged by the investigator). exclusion criteria: 1. active or uncontrolled serious infection; 2. liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments; 3. a history of immunodeficiency, including hiv positive or other acquired congenital immunodeficiency diseases; 4. chronic renal insufficiency and renal failure; 5. pregnant woman; 6. myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (new york heart association (nyha) classification); 7. patients receiving targeted therapy and pelvic artery embolism; 8. those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism; 9. those who have received radiotherapy for malignant pelvic tumors in the past; 10. patients with autoimmune system diseases such as systemic lupus erythematosus; 11. patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis; 12. patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent; 13. those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
exercise program on pain, physical function, and quality of life in breast cancer survivors

Conditions: Female Breast Cancer

Summary: the purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors

a randomized, double-blind, clinical trial will be conducted with 325 participants. the intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. participants\&#39; pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.

Eligibility criteria:
inclusion criteria: * women between 18 and 65 years of age, * women with oncologic treatment completed less than 3 months ago, * women without metastasis, * women without pathologies that contraindicate exercise, * women who have agreed to sign the informed consent form exclusion criteria: * not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies, * undergoing another type of therapy * pregnancy patients.

Keywords: breast cancer exercise quality of life muscle strength