Kornimate/medical-research-clean huggingface dataset:
a phase 2 study with cc-220 in skin sarcoidosis

Conditions: Sarcoidosis

Summary: this study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral cc-220 in adult subjects with chronic cutaneous sarcoidosis.

this is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, sequential, dose-ascending, safety and tolerability study in subjects with chronic cutaneous sarcoidosis. two dose cohorts of cc-220 (cohort 1: 0.3 mg by mouth (po) every day (qd) or matching placebo and cohort 2: 0.6 mg po qd or matching placebo) will be evaluated using a sequential, dose-ascending design

Eligibility criteria:
inclusion criteria: males or females aged ≥ 18 years at the time of consent. * have chronic cutaneous sacrcoidosis (ccs) prior to consent * have active cutaneous sarcoidosis lesion(s) at screening * forced vital capacity of ≥ 45% of predicted normal value at screening. * estimated glomerular filtration rate (egfr) ≥ 60 ml/min. * females of childbearing potential must have negative pregnancy tests prior to starting study therapy and agree to either commit to true abstinence or use effective contraception. * male subjects must practice true abstinence or agree to use a condom even if he has undergone a successful vasectomy exclusion criteria: * positive tuberculosis test at screening. * history of inadequately treated tuberculosis * history of human immunodeficiency virus (hiv) and/or common variable immunodeficiency disease. * history of alcohol or drug abuse * history or current peripheral neuropathy * current uveitis or any other clinically significant ophthalmological finding * currently require therapy for precapillary pulmonary hypertension.

Keywords: chronic cutaneous sarcoidosis cutaneous sarcoidosis skin sarcoidosis sarcoidosis
real-life multicenter outcomes registry for better antithrombotic strategies in patients with af (rainbow-af)

Conditions: Atrial Fibrillation; Anticoagulant Therapy

Summary: anticoagulation therapy is the most important part of the treatment strategy for atrial fibrillation. previous studies have confirmed that both warfarin and new oral anticoagulants can effectively prevent stroke in patients with atrial fibrillation. however, the current situation of anticoagulation in atrial fibrillation is not optimistic. this project aims to explore the prevalence of inappropriate doses of anticoagulants in my country. , and the influencing factors related to such doses. by analyzing the status quo, characteristics and influencing factors, suggestions and management plans to promote rational use are put forward to provide certain guidance and help for anticoagulation therapy in patients with atrial fibrillation.

the project is carried out in 30 research centers across the country, and the research object is the prescription/medical order data of real-world atrial fibrillation patients (outpatient and inpatient), including clinical diagnosis, drug use, outpatient and emergency and inpatient records, medical records, as well as laboratory tests, demographic and other aspects of information, a total of 5000 patients were included, and it is expected to be completed within 3 years. the analysis indicators include patient population distribution, comorbid diseases, concomitant drugs, creatinine clearance rate, proportion of various drugs used, cha2ds2-vasc score and embolism risk, has-bled score, antithrombotic therapy, etc., to evaluate the influencing factors of inappropriate anticoagulation dose, and to explore the macro trend of anticoagulation therapy.

Eligibility criteria:
inclusion criteria: * patients with incident (initial diagnosis) af (atrial fibrillation) with electrocardiographic documentation or patients with prevalent (existing diagnosis) af who had initiation or transition to a noac * anticipated ability to adhere to local regularly scheduled follow-up visits exclusion criteria: * atrial flutter only * anticipated life expectancy less than 6 months * atrial fibrillation caused by reversible factors, such as hyperthyroidism, acute myocardial infarction, acute pulmonary embolism, etc. * active bleeding, such as intracranial hemorrhage, gastrointestinal bleeding, etc. * patients with deep vein thrombosis, pulmonary embolism, artificial hip/knee replacement and other anticoagulation indications * participation in a randomized trial of anticoagulation for af at the time of enrollment
vitamin d in pregnancy for prevention of early childhood asthma

Conditions: Asthma; Respiratory Tract Infections; Gastrointestinal Infection; Croup; Eczema; Allergy; Wheezing; Fractures, Bone; Development, Child; Cognition Disorders in Children; Psychiatric Diagnosis

Summary: the overall aim of the study is to develop a nutritional preventive vitamin d supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.

randomization of 2000 pregnant women to vitamin d of high-dose (3200 iu/day) vitamin d vs placebo on top of the recommended 400 iu/day. supplementation begins in gestational week 24 (22-26) until 1 week after delivery. allocation to the trial will be determined based on the pre-interventional maternal blood levels of epa+dha with a dried blood screening test. women with high levels (above 4.7% of total fatty acids) will be assigned to the vitamin d rct. maternal blood will be used for genetic, metabolomic and proteomic profiling. a 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. the primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. a follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.

Eligibility criteria:
* pregnant danish women before week 26 with blood levels of epa+dha above 4.7% of total fatty acids * no current vitamin d intake above the recommended 400 iu/day * no endocrine-, heart-, kidney- or auto-immune disorders

Keywords: childhood asthma infections eczema allergy development psychiatry bone development cognition growth
acute phase reactant in non-covid-19 bacterial pneumonia

Conditions: Pneumonia; Acute-Phase Reaction

Summary: this study is a cross-sectional study, was conducted at chest department of kasr al-ainy hospital, cairo university during the period between october 2020 and april 2021. the aim of the work was to evaluate levels of acute phase reactants(apr) in non-covid-19 bacterial pneumonia, and to correlate between levels of apr and the disease severity.

51 patients were included in our study, diagnosed as non-covid pneumonia inclusion criteria: 1. pcr(polymerase chain reaction) negative for covid. 2. all patients of both sexes with pneumonia . exclusion criteria: 1. non pulmonary infections. 2. post surgery patients. 3. renal patients. 4. hepatic patients. 5. cardiac patients. 6. recent pulmonary embolism. methodology in details: all patients were subjected to: 1. full history with emphasis on: * epidemiological features (age, gender). * risk factors (smoking, dm). * clinical presentation (cough, fever and duration of illness). 2. clinical examination (local chest examination). 3. laboratory investigations: venous blood samples were taken to measure apr

Eligibility criteria:
inclusion criteria: * covid-19 negative bacterial pneumonia exclusion criteria: * covid-19 positive * other non-pulmonary infections
meditative movement for copd symptoms in non-smoking flight attendants

Conditions: Pulmonary Disease; Autonomic Dysfunction; COPD

Summary: this study will explore the a qigong based exercise intervention, here referred to as meditative movement (mm), to ameliorate the symptoms associated with chronic obstructive pulmonary disease (copd) and its co-morbidities. it tests the hypothesis that mm will have a beneficial effect on copd in fa, particularly on functional ability, respiratory symptoms, affective state, inflammation, and autonomic imbalance. if the hypothesis is correct, mm could be rapidly and inexpensively taught to fa with copd and other copd patients to slow degeneration and improve quality of life.

the study has three phases. phase 1 will identify the best mm practices and their impact on a test group of affected fa. phase 2 will develop a video to apply what is learned in phase 1 to a larger group of affected fa, and will document the resulting impact on various aspects of pulmonary dysfunction and its comorbidities. phase 3 is to refine the protocols and methods developed in earlier phases. phase 1: to identify the best set of mm exercises for improving copd-related symptoms. this will be done by conducting a 12-week in-person mm program that will be held in one or more locations in the northeastern region of the us and possibly other regions of the country.these training sessions will be used to determine precisely which mm exercises are most appropriate for this group. selection will be based on professional judgment, participant feedback, and objective pre- and post-intervention measurements taken at the beginning and end of the 12-week program. phase 2: to use an rct to evaluate the effectiveness of the exercises selected in aim 1, as delivered by video only. we will design and produce an instructional dvd based on the findings in aim 1.in the rct we will test the hypothesis that targeted mm training and practice using the dvd alone will improve qol, exercise tolerance, autonomic balance and pulmonary function, and reduce fatigue, in flight attendants with a copd diagnosis. pre- and post-intervention measurements will be compared, and to outcomes from a control group of flight attendants who will be wait listed for later participation in the study. phase 3: the videos used to train subjects in phase ii will be refined and the order of introduction of training modules will be adjusted. efficacy will again be tested in newly recruited subjects. this is also a rct.

Eligibility criteria:
inclusion criteria: * occupation as a flight attendant for at least 5 years * no history of significant tobacco use * occupational controls exclusion criteria: * inability to give consent * history of tobacco habituation

Keywords: copd qigong ans meditative movement flight attendants secondhand smoke nicotine blood pressure 6 minute walk test
the effect of combined speech and music-therapy on the speech characteristics of people with parkinson's disease (pd)

Conditions: Speech Disorders; Voice Disorders; Parkinson Disease

Summary: speech and voice disorders are observed in almost 90% of patients with pd during their course of illness. reduced voice pitch inflections or monotone speech, reduced vocal loudness, prosody disorders, the imprecise articulation of the consonants, hoarseness, and breathy voice is also observed in patients with pd; these symptoms often lead to reduced speech intelligibility. the aim of this study will to investigate the possible changes in the voice and speech features in people with pd after a combined speech and music therapy using telerehabilitation.

the investigators of this study propose to conduct a pilot randomized, controlled trial in patients with pd to assess the potential effectiveness of a telerehabilitation intervention that encourage a higher level of speech performance. the investigators hypothesize that patients in the combined treatment group will have more and better improve in the study outcome measures after treatment and 3 month follow up, as compared with patients in speech therapy group and music therapy group.

Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease (ipd) * patients who are in stages 1-3 according to hoehn \& yahr test * native language is persian * the patient or family complains about the person's speech condition * adequate vision and hearing * no history of stroke, head injury, brain surgery, laryngeal diseases such as vocal cord nodules * no other neurological disorders other than ipd * do not use treatment other than medication (such as deep brain stimulation surgery (dbs) * informed consent exclusion criteria: * if a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment * lack of cooperation
serum levels of apelin, chemerin and adiponectin adipokines in irritable bowel syndrome and healthy subjects

Conditions: Irritable Bowel Syndrome

Summary: in this observational case-control study investigators aimed to assess the serum levels of adipokines such as apelin, chemerin and adiponectin in patients with irritable bowel syndrome (ibs), and compare it with healthy controls. furthermore, investigators evaluated the possible correlation of these adipokines with ibs-qol, ibsss, gi symptoms and other clinical and psychological disorders.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 18, and 80 years. * ibs patients diagnosed according to the rome iii diagnostic criteria for functional gi disorders. exclusion criteria: * any evidence of abdominal surgery or radiation * celiac disease, or other primary gi illnesses * gi infection obscuring ibs symptoms, * using total parenteral nutrition therapy in the last 6 months * pregnancy and lactation * alcohol consumption * concurrent chronic diseases such as diabetes, renal failure * diagnosed and/or treated malignancy in the past 5 years * anti-inflammatory drugs usage * intake of vitamin d, omega-3, vitamin e, and calcium supplements * being on a special diet or medication regimen during the last 6 months
car19 donor lymphocytes for relapsed cd19+ malignancies following allogeneic transplantation

Conditions: CD19+ Malignancies: Relapse Post-allogeneic Transplant

Summary: eligible patients will receive escalating doses of 4g7-card t-cells paralleling clinical standard of care with unmanipulated donor lymphocytes. there are 3 intra-patient dose levels planned. patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4g7-card t-cell infusion. thereafter patients will be followed up annually for years 2 and 3.

patients will receive escalating doses of 4g7-card t-cells (after pre-conditioning with fludarabine and cyclophosphamide), paralleling clinical standard of care with unmanipulated donor lymphocytes. intra-patient dose escalation will proceed at intervals of not less than 8 weeks, dependent on development of toxicity or evidence of efficacy and confirmation by the trial management group. three dose cohorts levels are planned, and dosing will be according to total cd3+ t- cell dose as this correlates with toxicity in the unmanipualated donor lymphocyte setting: * dose level 1: 1x10\^6 cd3+ t-cells/kg (starting dose for all patients) * dose level 2: 3x10\^6 cd3+ t-cells/kg * dose level 3: 1x10\^7 cd3+ t-cells/kg the inter-patient dosing for the first 3 patients was at least 28 days, following tmg confirmation. patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4g7-card t-cell infusion. during the long term follow up phase of the study (years 2-3 post-final 4g7-card t-cell infusion) patients will be followed-up annually for overall survival, disease status and safety. all patients will enter long term follow up until 3 years post-final 4g7-card t-cell infusion.

Eligibility criteria:
inclusion criteria: 1. age 16-70 years 2. confirmed diagnosis of cd19+ malignancy relapsing following allogeneic transplantation 3. agreement to have a pregnancy test, use adequate contraception for 12 months post-final 4g7-card t-cell infusion 4. karnofsky performance status \>60 5. written informed consent exclusion criteria: 1. women who are pregnant or lactating 2. prior history of ischaemic heart disease, dysrhythmias, abnormal ecg (lbbb), multi gated acquisition scan (muga) left ventricular ejection fraction (lvef\<40%) (if performed) 3. known involvement of the central nervous system or cerebral vascular accident within prior 3 months 4. patients receiving corticosteroids at a dose of \> 10mg prednisolone per day (or equivalent) 5. active graft versus host disease requiring immunosuppression 6. use of rituximab within the last 2 months prior to atimp infusion 7. known allergy to albumin or dimethyl sulfoxide (dmso) 8. patients who have experienced significant neurotoxicity following blinatumomab treatment

Keywords: cd19+ allogeneic transplant relapse
lifetime incidence and socio-economic implications of mental illness

Conditions: Mental Illness

Summary: the purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the danish population and to estimate the influence on socio-economic functioning.

the purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the danish population in total and according to gender and to estimate the influence on socio-economic functioning. the investigaters hypothesised that the lifetime incidence of any mental disorder is substantially higher than hitherto believed.

Eligibility criteria:
inclusion criteria: * the study was based on a randomly selected 1,500,000 sample of all persons who were registered in statistics denmark on the 1st of january 1995. exclusion criteria: * none

Keywords: mental illness
comparison of epiduo associated with lymecycline versus epiduo vehicle associated with lymecycline in acne vulgaris

Conditions: Acne Vulgaris

Summary: randomized, controlled, multi-center, double-blind, parallel-group comparison study in subjects with moderate to severe acne vulgaris on the face. the purpose of this study is to demonstrate the efficacy of adapalene 0.1% / benzoyl peroxide (bpo) 2.5% gel associated with lymecycline 300mg capsules compared to adapalene 0.1% /benzoyl peroxide 2.5% vehicle gel associated with lymecycline 300mg capsules, in the treatment of moderate to severe acne vulgaris. the safety of the two treatment regimens will also be evaluated.


Eligibility criteria:
inclusion criteria: 1. male or female subjects of any race, aged 12 to 35 years inclusive, 2. subjects with moderate to severe facial acne vulgaris (investigator's global assessment score of 3 or 4), exclusion criteria: 1. subjects with more than 3 nodules or cysts on the face 2. subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. subjects with a wash-out period for topical treatment on the face less than: corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), zinc containing drugs (1 week), phototherapy devices for acne and cosmetic procedures (1 week) 4. subjects with a wash-out period for systemic treatment less than:acne therapy containing zinc (4 weeks), corticosteroids, antibiotics (4 weeks), other acne treatments (6 months), ciproterone acetate / chlormadinone acetate (6 months), spironolactone / drospirenone (3 months) 5. subjects with impaired hepatic (alt/ast \> 3xuln and bilirubin \> 1.5xuln) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample, 6. subjects with known intolerance to lactose,

Keywords: acne vulgaris
impact of oral probiotic blend on pregnancy outcome

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: the aim of this study is, to investigate the effect of oral intake of lactobacillus rhamnosus gg (atcc 53103), lactobacillus crispatus lbv88, lactobacillus rhamnosus lbv96, lactobacillus jensenii lbv116 lactobacillus gasseri lbv150 on outcomes of pregnancy and microbiota and their interrelation.

pregnant women aged \> 18 years in the \< 14th week of pregnancy willing to consume the study product once daily starting the day after v1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study. after enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo. the study population will be recruited in a screening examination ( g1 ) by gynaecologists from kiel area. primary target parameter of the study : homa-ira value in week 24-28 (v2), which is based on glucose and insulin measures during the second oral glucose tolerance test (ogtt) secondary target parameters : homa-ir value in week 36-40 , alteration (v2 - v1) δ homa-ir, alteration (v2 - v1) δ quicki

Eligibility criteria:
inclusion criteria: * pregnant women aged \> 18 years in the \< 14 week of pregnancy * willing to consume the study product during pregnancy ( v1 to delivery) * willingness to abstain from probiotic food and supplements containing probiotics * written informed consent exclusion criteria: any of the following is regarded as a criterion for exclusion from enrollment in the study: 1. subjects currently enrolled in another clinical study 2. subjects having finished another clinical study within the last 4 weeks before inclusion 3. diabetes mellitus 4. acute metabolic disorder interfering with glucose metabolism 5. known cancer \< 5y ago 6. any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota 7. anus praeter 8. hypersensitivity, allergy or idiosyncratic reaction to any component of the test product 9. any disease or condition which might significantly compromise the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system 10. history of active hepatitis b and c 11. history of hiv infection 12. regular medical treatment including otc, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.) 13. major cognitive or psychiatric disorders 14. present drug abuse or alcoholism, reformed alcoholic legal incapacity