Kornimate/medical-research-clean huggingface dataset:
reducing decannulation time: limitation of decannulation capping trials (redecap)

Conditions: Tracheostomy; Airway Management; Respiratory Therapy

Summary: multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols: 1. based on capping trials to decide decannulation, 2. based on the aspiration frequency to decide decannulation time. high-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. in patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.


Eligibility criteria:
inclusion criteria: * critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected). exclusion criteria: * patients consedered non-decannulable at time of randomization: 1. unconscious patient (motor component of gcs score \<6 points). 2. severe swallowing function (based on drink test). 3. airway patency problem (based of intolerance of occlusion test). 4. neuromuscular diseases. 5. patients with a sabadell score \>2.

Keywords: tracheostomy decannulation adult airway management
vestibular stimulation in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of parkinson's disease.

parkinson's disease (pd) is a nationwide public health problem, inflicting a complex constellation of physical and neuropsychiatric symptoms which are shown to progress with time. this research will investigate the potential of caloric vestibular stimulation (cvs), a non-invasive form of brain stimulation, as a treatment for individuals who suffer from parkinson's disease. investigators will investigate whether core cognitive and physiological deficits are responsive to stimulation by comparing participants' performance on behavioral and physiological measures after baseline and either active or placebo stimulation phases with the aim of drawing initial insights into the application of cvs within this population. the study design is based on a single-case study that recently demonstrated durable, clinically meaningful gains in the motor and nonmotor symptoms of pd.

Eligibility criteria:
inclusion criteria: * participants must be diagnosed with idiopathic parkinson's disease as defined by the uk pds brain bank criteria. * participants must report limitations to activities of daily life (adl, updrs subscale 2) * capacity to consent to the study * motivated to comply with the protocol * an understanding of english sufficient to comply with the protocol * spouse/ carer willing to support the participant throughout the study exclusion criteria: * diagnosis of induced parkinson's or essential/dystonic tremor * premorbid psychiatric history (including affective disorder, psychosis or deliberate self- harm) * previous exposure to neurostimulation * inner ear pathology
insulin detemir and waist circumference

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the weight-sparing effect of detemir and assess glycemic control and treatment satisfaction when switching from nph to detemir, to improve metabolic control.


Eligibility criteria:
inclusion criteria: * duration of type 2 diabetes for at least 12 months * bmi \<40 kg/m2 * hba1c \>7.5% * requiring basal insulin replacement and previously treated with nph insulin

Keywords: insulin therapy insulin detemir waist circumference
lymphatic drainage versus ultrasound for postpartum breast engorgement: a pilot study

Conditions: Breast Engorgement; Lactation Disorders

Summary: in this article, women were randomly assigned to the manual lymphatic drainage group, therapeutic ultrasound group, and control group, and the breast pain, swelling hardness, and milk excretion before and after each treatment were measured.

breast engorgement as the swelling and distention of breast, which is one of the most common problems of postpartum of 3-8 days. at the same time, the congested blood vessels and tissue fluid will enter the surrounding tissues, resulting in the retention of tissue fluid and blood, resulting in interstitial fluid. in cases such as interstitial edema, the flow of milk is restricted. there are many conservative treatments for relieving breast swelling. at present, there have been published studies on the application of ultrasound therapy and manual lymphatic drainage to breast problems during lactation. previous studies have shown that manual lymphatic drainage and ultrasound therapy can significantly improve the pain, temperature, and firmness of breast engorgement. manual lymphatic drainage and ultrasound therapy have been widely used in physical therapy, but there is little empirical evidence for manual lymphatic drainage on breast swelling. it is hoped that this empirical medical research method can be used to reduce the effect of breast pain caused by breast problems and improve breast milk. the purpose of this study was to examine whether manual lymphatic drainage and ultrasound therapy can improve breast pain, breast swelling, and increase the flow and volume of milk removed.

Eligibility criteria:
inclusion criteria: * over 20 years old * physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth * able to read and understand chinese * at least four points on the breast swelling scale exclusion criteria: * autoimmune system problems * physical and mental health problems * breast abscesses, mastitis * breast implants * cardiac pacemakers * malignant tumors

Keywords: breast engorgment breast care ultrasound therapy breast feeding manual lymphatic drainage physical therapy modalities postpartum
efficacy and safety of dietary supplementation of diamine oxidase to improve symptoms in patients with ibs

Conditions: Irritable Bowel Syndrome (IBS)

Summary: this project is a single center, randomized, controlled clinical trial evaluating the effects of dao enzyme dietary supplement on symptoms of irritable bowel syndrome. these participants are randomized to either a 4-week group with dao enzyme dietary supplement or placebo. the participants are required to fill out ibs-sss and ibs-qol questionnaires and record their ibs symptom improvement, ibs treatment drug use, compliance and adverse reactions every evening. at the same time, the patients' diet is continuously recorded for 3 days by 24-hour diet review method in visit 0, visit 1 and visit 2, respectively, to inform the patients to avoid large fluctuations in diet structure. on days 0, 14 and 28, the subjects are asked to visit the hospital offline. the staff check with the subjects in detail according to the scale and questionnaire contents, and review the general situation and questionnaire in the previous 2 weeks. on the 7th and 21st day, the staff contact the subjects online to provide guidance and remind the subjects to fill in the scale and questionnaire. in addition, oral mucosal samples, urine and feces will be collected for identifying mutations in the genetic dao enzyme coding gene, histamine detection and 16srna sequencing, respectively.


Eligibility criteria:
inclusion criteria: 1. age 18-65 years old; 2. diagnosed with ibs according to rome iv diagnostic criteria; recurrent abdominal pain occurred on an average of at least 1 day per week in the past 3 months and was associated with two or more of the following criteria: i. related to defecation; ii. associated with changes in bowel frequency; iii. correlated with fecal morphological changes. the symptoms appeared at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months. 3. voluntarily participate in the experiment and sign the informed consent. exclusion criteria: 1. patients with endoscopy examinations which suggest chronic intestinal diseases other than ibs, such as inflammatory bowel disease, celiac disease, gastric and duodenal ulcers, parasitic or bacterial intestinal infections; 2. pregnant and lactating women; 3. patients suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease, tumor; 4. alcoholism.
cyt003 in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled glucocorticosteroids

Conditions: Asthma

Summary: a phase iib study in patients to evaluate cyt003- qbg10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid. altogether 170 patients, randomized to two treatment groups will be included. key outcome measures are patient reported parameters on their asthma

a phase iib study in patients to evaluate cyt003- qbg10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid. altogether 170 patients, randomized to two treatment groups will be included. key outcome measures are patient reported parameters on their asthma at the time of primary endpoint and throughout the study.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent. 2. complete all protocol requirements. 3. between 18 to 65 years of age. 4. persistent allergic asthma patients 5. forced expiratory volume in one second (fev1) ≥60% to ≤ 90% of predicted value 6. reversibility of airway obstruction 7. patients meeting the contraception requirements 8. at baseline: patients treated with ics and insufficiently controlled 9. blood eosinophil count above a certain level exclusion criteria: 1. failure to meet at least 80% compliance of use of the patient e-diary/ peak expiratory flow (pef) meter (am3 device) at the baseline visit 2. treatment or hospitalization for asthma exacerbation within past 2 months 3. current use or use of systemic corticosteroids within past 2 months 4. current smokers. 5. ex-smokers for less than 1 year, with a tobacco smoking history of \>10 pack years 6. major surgery within 3 months prior to signing the icf or anticipated during study 7. presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. copd), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator. 8. any malignancy within the previous 5 years 9. presence of suspicious lymphadenopathy or splenomegaly on physical examination. 10. confirmed or suspected current infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv). 11. presence of active infectious disease as judged by the investigator 12. active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis. 13. pregnancy (based on positive urine test at screening visit) or lactation. 14. female planning to become pregnant during the study period. 15. patients with any history of abuse of alcohol or other recreational drugs. 16. ongoing or planned specific immunotherapy (sit) during the whole study period or sit completed within the last 3 years. 17. bmi \>40 18. use of investigational or approved biologics/immune-modulators within the last 6 months.
vitamin d and microbiota in cystic fibrosis

Conditions: Vitamin D Deficiency; Cystic Fibrosis

Summary: the objective of this study is to assess the effects of a high-dose vitamin d3 on the composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who are vitamin d deficient.

monocentric, double-blind, randomized, placebo-controlled, interventional pilot study to investigate the beneficial effects of high dose vitamin d supplementation on gut and lung microbiota in patients with cystic fibrosis who are vitamin d insufficient.

Eligibility criteria:
inclusion criteria: * presenting to the cystic fibrosis clinic for routine follow up of cystic fibrosis * serum 25(oh)d concentrations obtained within 2 months of enrollment * able to tolerate oral medications exclusion criteria: * inability to obtain or declined informed consent from the subject and/or legally authorized representative * pregnancy or plans to become pregnant in the next 3 months * history of disorders associated with hypercalcemia including parathyroid disease * current hypercalcemia (albumin-corrected serum calcium \>10.8 mg/dl or ionized calcium \>5.2 mg/dl) * history of nephrolithiasis with active symptoms within the past two years * chronic kidney disease worse than stage iii (\<60 ml/min) * current significant hepatic dysfunction total bilirubin \> 2.5 mg/dl with direct bilirubin \> 1.0 mg/dl * current use of cytotoxic or immunosuppressive drugs * history of aids * history of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana) * too ill to participate in study based on investigator's or study team's opinion * current enrollment in another intervention trial * in addition we amended our study with three additional criteria 11) systemic antibiotic use in the last 4 weeks, 12) use of probiotics and, 13) inflammatory bowel disease, four months after the start of the study and after 12 subjects were randomized, as we considered that these factors may also influence our study endpoints. of the 12 subjects who were randomized, only 4 would have been excluded.

Keywords: clinical endocrinology immunology inflammation microbiology respiratory disorders vitamins
tamoxifen treatment in patients with motor neuron disease

Conditions: Amyotrophic Lateral Sclerosis; ALS Functional Ration Scale; TAR-DNA-binding Protein-43; Tamoxifen; mTOR

Summary: the aim of this study is to survey the effect of tamoxifen in motor neuron disease (mnd) patients, amyotrophic lateral sclerosis (als) with regular riluzole usage. tdp-43 is related to als. increased the ubiquitinated or phosphorylated tdp-43 can cause animal model of als, and tdp43 can be degraded either by proteasome or autophagy pathway system. autophagy pathway can be activated by mtor inhibition, resulting in ameliorating tdp-43 accumulation and rescue in motor function in animal model. tamoxifen had shown ability of enhance both proteasome and autophagy pathway, therefore the investigators assume that tamoxifen probably can ameliorate tdp-43 accumulation and inclusion body formation in als.

the investigators will assess the alsfr-s in als patients at start, 1, 3, 6 and 12 months and correlate the score to the neurological outcome of the patients with and without tamoxifen treatment at dose of 40mg daily for one year. the study will be able to prove the investigators hypothesis: tamoxifen, a protease and autophagy enhancer, has synergic effect with riluzole in als patients to slowing the progression of neurological dysfunction, and respiratory insufficiency.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosed and confirmed als patients, with regular follow up and oral form riluzole at national taiwan university or shuang- ho hospital for more than 6 months. 2. age ≧20 years old exclusion criteria: 1. patients who had already ventilator dependent, not regular followed up for more than 6 months or against medical advice, refuse to follow up at neurology department will be excluded in this study. 2. patients with now or previous usage of tamoxifen 3. patients with any contraindications of tamoxifen usage 4. patients with other internal medicine illiness

Keywords: amyotrophic lateral sclerosis als functional ration scale tar-dna-binding protein-43 tamoxifen mtor
safety and efficacy study of a biologic to treat systemic lupus erythematosus

Conditions: Lupus

Summary: study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. patients who qualify will be randomized to either active bms-931699 or placebo for initially, up to 24 weeks. patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving bms-931699 as part of a long-term extension (lte). disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

1. subjects completing day 169 (24 weeks) on study medication may be eligible to enter an optional lte period 2. the lte period will remain blinded but will no longer have a placebo arm: * subjects will remain on their originally assigned treatment arm unless they were on placebo * subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at day 169 (24 weeks)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * male or female aged between 18 to 70 (included) * diagnosed with active systemic lupus erythematosus by a doctor * disease must be in patient's joints or on the skin at a minimum * taking other medications is allowed but some are excluded exclusion criteria: * diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis * diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
tympanoseal clinical study

Conditions: Tympanic Membrane Perforation

Summary: the purpose of this investigational study is to assess the ability of tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

this study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.

Eligibility criteria:
inclusion criteria: 1. male or female patients over 2 years of age at enrollment 2. documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane. 3. written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study exclusion criteria: 1. active otorrhea or otitis media 2. otorrhea or otitis media within 4 weeks prior to the operation 3. history of cholesteatoma 4. perforations on the edge of the tympanic membrane 5. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data 6. subject is taking systemic/oral corticosteroids 7. subject will require the continued use of any type of topical otic medication to the ear(s) with tympanoseal
effects of multimodal therapy versus myofascial release techniques in patient with upper cross syndrome

Conditions: Upper Extremity Dysfunction

Summary: upper cross syndrome (ucs) is a frequent condition which is most commonly encountered in the musculoskeletal disorders showing a characteristics pattern of muscular imbalance and dysfunction in the joints of the neck and shoulder region. upper cross syndrome remains a prevalent and debilitating condition, despite optimal approaches aimed at reducing pain and improving function.

this study investigates the additional benefits of multimodal therapy and myofascial release technique in individuals with upper cross syndrome. rooted .the researcher employs a randomized controlled trial methodology. participants are divided into two groups: one receiving multimodal therapy, and the other receiving myofascial release techniques. outcomes are assessed over a 6-week period, focusing on pain levels, posture and functional disability by goniometer, numeric pain rating scale (nprs), neck disability index (ndi) scores and reedco posture assessment scale.

Eligibility criteria:
inclusion criteria: * diagnosed by physician with sign and symptoms includes muscle in neck, chest and shoulder become overactive or underactive creating the x shape. * office worker. * aged 20 to 40 years. * male and females. exclusion criteria: * recent trauma or surgery to the neck or shoulder region. * cancer or metastasis in the neck or shoulder region. * infection or abscess in the neck or shoulder region. * neurological conditions.
cortisol control of human inflammatory responses to endotoxin

Conditions: Sepsis

Summary: the purpose of the research is to study a common and dangerous medical condition called 'septic shock' that often occurs in critically ill patients. in order to learn about septic shock in humans, we will administer a substance called 'endotoxin' to participants in this study. endotoxin causes a temporary period of inflammation in the human body, a brief 'virtual' infection. this is an established method for the investigation of inflammation properties. we are interested in how the natural hormone, cortisol, can affect the human response to endotoxin. we know that when cortisol is given at the same time as endotoxin it can decrease the inflammation that occurs due to endotoxin. in this study we will test whether or not cortisol, when given the day before the endotoxin, will work to change the inflammation that occurs due to endotoxin. in order to test this, two-thirds of the study participants will receive cortisol on the day before they receive the endotoxin and one-third of the study participants will receive a placebo (no medication) before the endotoxin.


Eligibility criteria:
inclusion criteria: * 18 \< age \< 55 * weight \> 50 kg * the participant is healthy, without known or suspected medical illness following routine history and physical examination and is expected to easily tolerate the clinical effects of endotoxin. * the participant does not take any regularly scheduled medication other than thyroid replacement therapy, birth control pills, or estrogenic hormone replacement therapy. exclusion criteria: * history of chronic disease of any kind such as diabetes, heart disease, cancer, hiv infection, hypertension, asthma, etc. * history of chronic medication use other than hormone therapy as above * history of recent acute illness within 30 days prior to study * inability to provide informed consent * history of recent exposure to drugs known to alter immune function including steroids or recent infection (\< 3 months) * pregnancy * history of known risk factors for hiv infection (recent multiple partners, sexually transmitted disease and unprotected sex; intravenous drug use; blood transfusion before 1985)

Keywords: systemic sepsis