Kornimate/medical-research-clean huggingface dataset:
echinacea safety study

Conditions: Infections

Summary: extracts produced from echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. the aim of this clinical study is to assess clinical safety and efficacy of a treatment with echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during october and november 2009 and will be treated with either echinacea or placebo over a period of 4 months. throughout the study period adverse events (aes) and adverse drug reactions (aes with at least a possible causal relation to the treatment) will be recorded. common cold related symptoms will be recorded in a daily diary.


Eligibility criteria:
inclusion criteria: * on average more than 2 cold episodes per year * age above 18 years * good physical condition * signed informed consent exclusion criteria: * women without appropriate and effective contraception * participation in a clinical trial 30 days prior to this trial * pregnant or breast feeding women * subjects with pre-existing cold symptoms for more than 24h at inclusion * concurrent participation in another clinical trial * intake of antimicrobial and/or antiviral medications at inclusion * alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day) * psychiatric disorders which may influence the results of the trial, * epilepsy, suicide attempts * planned surgical intervention during the trial. * serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia, * collagen disorders and multiple sclerosis * known aids, hiv-infections and autoimmune diseases * known diabetes mellitus (type 1) * corticosteroid-treated asthma * atopic and allergic subjects (under medicinal treatment) * known allergy to plants of the composite family (asteraceae)

Keywords: safety of echinacea in comparison to placebo
safety and immunogenicity of 2 commercially available influenza vaccines in children

Conditions: Influenza

Summary: this is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

a phase ii, observer-blind, randomized, parallel groups, multicenter, exploratory clinical study to evaluate the immunogenicity and safety of one and two 0.25 ml intramuscular doses of a commercially available influenza vaccine versus two 0.25 ml intramuscular doses of a commercially available influenza vaccine in healthy children

Eligibility criteria:
inclusion criteria: * 6 months to \< 36 months of age exclusion criteria: * any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) * other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period. * known or suspected impairment/alteration of immune function * history of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

Keywords: influenza children vaccine influenza disease
to evaluate the clinical study of cud005 injection in patients with cirrhosis

Conditions: Cirrhosis, Liver

Summary: the study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of cud005 injection in patients with cirrhosis

the study was designed according to the 3+3 principle, with a total of 3 dose levels and dose escalation. low-dose group: 5.0×107 cells/time; medium-dose group: 1.5×108 cells/time; high-dose group: 5.0×108 cells/time. subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose. according to the enrollment restriction design, a total of a minimum of 9 subjects are expected to be enrolled, and the final sample size depends on the number of dlt, the number of dose groups ascended before dlt is observed, and the mtd is determined.

Eligibility criteria:
inclusion criteria: 1. bmi≤30 kg/m2 2. the results of liver histopathological examination were consistent with the ishak stage of liver fibrosis ≥3 points； 3. consent to liver histopathological examination before and after cell therapy (the subject is exempted from liver histopathological examination during the screening period, if he has been performed liver histopathological examination within 2 months before signing the informed consent)； 4. subjects were able to communicate well with the investigator, cooperate with follow-up work, and understand and comply with the requirements of the study. exclusion criteria: 1. subjects who were allergic to cell therapy, steroids, and related drugs used in the study； 2. have malignant tumors, history of organ transplantation or tissue regeneration therapy, active, known or suspected autoimmune diseases, idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, active pneumonia, heart disease that is not well controlled, hypertension, etc; 3. subjects with stage iii or iv hepatic encephalopathy within 3 months before apheresis or currently diagnosed； 4. virology shows anti-hcv antibodies, hiv-positive, or syphilis antibodies during the screening period； 5. subjects were hbv surface antigen positive and hbv-dna titer was ≥ 20 iu/ml during the screening period； 6. subjects with clinically symptomatic ascites or pleural effusions requiring puncture drainage. or who had received thoracic and ascites drainage within 2 weeks prior to treatment, had may only show a small amount of ascites or pleural effusions on imaging, except in those without clinical symptoms； 7. according to the judgment of the investigator, the subjects had other factors that may cause the study to be terminated halfway, such as other serious concomitant diseases (such as severe diabetes, mental illness, drug use, etc.), serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.

Keywords: cirrhosis cell therapy pbmc safety tolerability mtd dlt dose escalation
follicular revival in treatment-resistant alopecia areata: evaluating use of micro-needling

Conditions: Alopecia Areata

Summary: the investigators propose to study the efficacy of micro-needling via the sol nova device in generating hair growth in patients with alopecia areta (aa) who are either non-responsive or only partially responsive to combination oral jak inhibitor plus oral minoxidil therapy.

this will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with aa refractory to combination jak inhibitor and oral minoxidil treatment. ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of jak inhibitor plus oral minoxidil treatment will be enrolled. subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. procedures and visits are not standard of care but conducted for research. each visit will last about an hour. approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. the remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. during the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. remaining 10 minutes on visits 2 and 8 will be used for biopsy.

Eligibility criteria:
inclusion criteria: * diagnosis of aa * salt score ≥90% * no or minimal scalp hair regrowth after ≥three months of oral jak inhibitor plus oral minoxidil treatment exclusion criteria: * known concomitant androgenetic or other form of alopecia (in addition to aa) * patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation * anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
ambrisentan for treatment of portopulmonary hypertension

Conditions: Portopulmonary Hypertension

Summary: portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension and is present in approximately 5% of cirrhotic patients. treatment options include prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan. this study investigates the safety and efficacy of ambrisentan in portopulmonary hypertension.

patients with clinically significant poph (resting mean pulmonary arterial pressure \>25 mm hg, pulmonary vascular resistance \>400 dynes\*s\*cm-5) will be offered treatment with ambrisentan. patients will be followed clinically and hemodynamically up to 12 months after start of treatment.

Eligibility criteria:
inclusion criteria: * adult patients with portal hypertension, age \>18 years * cirrhosis of any etiology; child-pugh class a and b * noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis) * informed consent exclusion criteria: * presence of other causes for pulmonary arterial hypertension * history of pulmonary embolism or myocardial infarction within 6 months before study start * child-pugh class c * presence of hepatocellular carcinoma * liver transplantation * hiv infection * severe obstructive or restrictive pulmonary disease (predicted fev1 or vc \<65%, respectively) * severe dilated cardiomyopathy (ef \<50%) * latent left-heart insufficiency * pregnancy and lactation * esophageal variceal hemorrhage within the last 6 months * refractory ascites * hepatorenal syndrome * persistent hepatic encephalopathy \> grade 1 * bilirubin \>3.0 mg/dl * ast and/or alt \>3x uln * creatinine \>2.0 mg/dl * known hypersensitivity to ambrisentan
activating seniors to improve chronic disease care

Conditions: Healthy

Summary: chronic diseases are the primary cause of morbidity and mortality for older americans. active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. some studies have found that older individuals are less interested in participating in clinical decision-making, but other studies find that exposing patients to decision aids (ptdas) increases their desire to take an active role in making decisions with their physicians. the present study targets hard-to-reach seniors by showing decision aids focused on chronic disease management in senior centers. decision aids will be made available in two senior centers through a lending library and by conducting group screenings of the decision aids followed by moderated discussion of the content with participants. a randomized encouragement design will be used to test the effectiveness of a modest financial incentive on increasing seniors' participation in group screenings. the investigators will evaluate the effects of the intervention on seniors' decision-making role preferences, attitudes, perceived social norms and self efficacy for asking questions of their physician, health-related quality of life, physical activity, and changes in prescribed treatment regimens and self-care.


Eligibility criteria:
inclusion criteria: * at least 55 years old. * able to ambulate * able to complete self-administered surveys * able to speak and read english exclusion criteria: * not willing to provide consent

Keywords: decision aids seniors chronic disease management advance directives
genomic/epigenomic biomarkers of deregulation of immune system in inflammatory bowel diseases

Conditions: Crohn Disease

Summary: the purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of crohn's disease in transcriptome (measurement of gene expression through number of mrna copies transcribed for each gene) and in methylome. secondary objectives are to compare expression and methylation profiles according to: * treatment response * morphological (endoscopic and/or radiological) and clinical post-operating recurrence.

this aim of this study is to search for new biomarkers predictive of post-operating recurrence. at present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data. predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.

Eligibility criteria:
inclusion criteria: * patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies...), radiological (entero-mri), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data * patient undergoing ileocolic resection * patient affiliated to french social security exclusion criteria: * patient refusing sampling * patient with undetermined colitis * patient with non-confirmed diagnosis of inflammatory bowel disease * patient with inflammatory bowel disease not undergoing ileocolic resection

Keywords: genomics epigenomics recurrence
the effectiveness of an online support group in enhancing recovery identity and health-related quality of life

Conditions: Ovarian Cancer

Summary: background ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. a research gap exists on the impact of online support groups (sps) on identity synthesis and health-related quality of life (hrqol) for these patients. objective to assess the feasibility and efficacy of an online sg in influencing recovery identity and hrqol in middle-aged and older ovarian cancer patients (mdocp). method a four-week randomized controlled trial, followed by a three-month evaluation, was conducted, employing a mobile online sg and an offline sg both grounded in the social identity model of identity change. recovery identity, hrqol, and participant engagement were utilized to evaluate the feasibility and efficacy of interventions.


Eligibility criteria:
inclusion criteria: * older than 44 years old * diagnosis of ovarian cancer * expected survival time of greater than four months * fluent in using smartphones and the wechat mini program * normal cognitive function * capability to participate in follow-up surveys. exclusion criteria: * were currently participating in or had previously participated in other mental treatment groups * had been diagnosed with any other type of cancer.
combining saxagliptin and acarbose to improve postprandial glycaemia in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the proposed study is designed to evaluate (i) the effects of saxagliptin, with or without acarbose, on gastric emptying, postprandial glycaemia, and plasma intact glp-1, insulin, c-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin) * body mass index (bmi) 20 - 40 kg/m2 * age 18 - 70 years * males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion) * glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9% * haemoglobin above the lower limit of the normal range (i.e. \>135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. \>10mcg/l) exclusion criteria: * use of any medication that may influence gastrointestinal motor function, body weight or appetite * evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis * history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy) * other significant illness, including epilepsy, cardiovascular or respiratory disease * autonomic nerve damage (as assessed by standardised cardiovascular reflex tests \[36\]) * impaired renal or liver function (as assessed by calculated creatinine clearance \ 2 times upper limit of normal range)) * allergy to vildagliptin or any other 'gliptin' * donation of blood within the previous 3 months * participation in any other research studies within the previous 3 months * females who are pre-menopausal * inability to give informed consent * vegetarians
safety study of flavocoxid in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: objective of this study is to evaluate safety and tolerability of flavocoxid administered at the daily oral dose of 500 or 1000 mg/die for one year in dmd patients, alone or in association with steroids (deflazacort on alternate days) started at least one year before. the investigators will also perform a multidimensional clinical evaluation covering functional and muscle strength and quality of life (qol)assessments.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of dmd, confirmed by muscle biopsy and molecular analysis by mpla; * range of age between 4 -16 years; * unaided ambulation for at least 75 meters, unassisted during the screening 6mwt. other personal assistance or use of assistive devices for ambulation (eg, short leg braces, long leg braces or walkers) is not permitted. * follow-up of at least 1 year before baseline with the selected motor outcome measures; * patients able to perform evaluation tests; * patient legally authorized representative (lar) able to understand and give the informed consent; * absence of contra-indications to the use of flavocoxid (see below); * written informed consent signed by lar. exclusion criteria: * treatment with other drugs analogue, similar or interacting with flavocoxid or immunosuppressive therapy (other than corticosteroids) within 3 months prior to start of study treatment; * exposure to another investigational drug or supplements within 2 months prior to start of study treatment; * presence of cognitive impairment that could influence the performance of the evaluation tests; * history of major surgical procedure within 30 days prior to start of study treatment; * expectation of major surgical procedure (eg, scoliosis surgery) during the 12-month treatment period of the study; * ongoing participation in any other therapeutic clinical study; * expectation of recruitment in the forthcoming exon-51 trial; * requirement for daytime ventilator assistance; * presence of liver-diseases or assumption of any hepatotoxic agent; * screening laboratory values out of the laboratory ranges if clinically meaningful; * prior or ongoing medical condition (eg, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ecg findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.

Keywords: flavocoxid duchenne muscular dystrophy pilot study
post market clinical follow-up of crt-dx therapy with lumax 640/740 hf-t

Conditions: Atrial Fibrillation; Heart Failure

Summary: the study is designed to collect data of the performance and confirm the safety of the dx (diagnostic extension) functionality in the lumax 640/470 hf-t in patients with permanent atrial fibrillation and crt-d indication according to current esc guidelines. the dx functionality is a feature, which can be activated in the lumax 640/740 hf-t when connected to the linoxsmart s dx right ventricular lead. the combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.


Eligibility criteria:
inclusion criteria: * crt-d indication according to current esc guidelines (nyha iii/iv; qrs≥120ms; lvef≤35%; expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of av nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise) * permanent atrial fibrillation * patients planned to be implanted with biotronik lumax 640/740 hf-t * patients planned to be implanted with biotronik linoxsmart s dx right ventricular lead (or successors) * patient eligible for programming of dx functionality according to the physicians' decision * patient is willing and able to comply with the cip and provided written informed consent * patient accepts home monitoring® concept and has sufficient gsm/gprs coverage exclusion criteria: * patients with any contraindication to crt-d therapy * patients listed for heart transplantation * life expectancy less than 12 months * pregnant or breast-feeding women * patients under the age of 18 * patients with limited contractual capability * participation in any other clinical study

Keywords: dx functionality atrial fibrillation crt-d indication
the gore viabahn endoprosthesis for the treatment of venous occlusions and stenoses

Conditions: Venous Thrombosis

Summary: to study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. the use of the device for the treatment of peripheral arterial disease is approved by the fda, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years old * patient has clinical manifestations (i.e. symptoms and/or signs) of chronic dvt of an extremity. the venous clinical severity score (vcss) will be used to determine if the patient is currently suffering from chronic dvt, with a vcss score of 4 or greater necessary for inclusion. * imaging confirmation of venous occlusion or stenosis (\>50%) involving the femoral, and/or popliteal veins * obstructed vessel caliber can accommodate a 7fr system, from insertion site to target segment * patient is able to read and answer a questionnaire in english exclusion criteria: * history of life-threatening reaction to contrast material * unwilling or unable to provide informed consent, or return for required follow-up evaluations * participating in another investigational study that has not completed follow-up testing * cannot receive outpatient anticoagulation such as lmwh and/or vitamin k antagonists (vkas) * absolute contraindication to contrast media or renal insufficiency (baseline creatinine \>2.0 mg/dl). * either a history or presence of heparin-induced thrombocytopenia antibodies

Keywords: post thrombotic syndrome venous stasis venous occlusions venous stenosis