Kornimate/medical-research-clean huggingface dataset:
12 weeks treatment with 3 different doses of bi 10773 in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of bi 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. in addition an open-label metformin arm will be assessed


Eligibility criteria:
inclusion criteria: * male and female patients with a diagnosis of type 2 diabetes mellitus * either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening * hba1c ≥6.5 to ≤9.0% and for treatment-naïve patients:hba1c \>7.0 to ≤10.0% * hba1c \>7.0 to ≤10.0% at visit 2 (start of run-in) for all patients * age between 18 and 80 years * bmi less than 40 kg/m2 * signed and dated informed consent prior to admission to the study in accordance with gcp and local legislation exclusion criteria: 1. myocardial infarction, stroke or tia within 6 months prior to informed consent 2. impaired hepatic function 3. renal insufficiency or impaired renal function 4. disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation 5. chronic or clinically relevant acute infections 6. current or chronic urogenital tract infection determined by medical history 7. history of clinically relevant allergy/hypersensitivity 8. treatment with glitazones, glp-1 analogues or insulin within 3 months prior to informed consent 9. treatment with anti obesity drugs 10. current treatment with systemic steroids 11. alcohol abuse 12. treatment with an investigational drug within 2 months prior to informed consent 13. known intolerance to metformin 14. dehydration 15. unstable or acute chf 16. acute or chronic acidosis 17. hereditary galactose intolerance 18. woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
lower limb tissue oxygenation using near-infrared spectroscopy during hallux valgus operation

Conditions: Lower Limb Ischemia

Summary: in acute lower limb ischemia the main goal of the treatment is to restore the blood before irreversible damage to the soft tissues of the limb. delays in identifying acute lower limb ischemia may lead to limb loss or lead to the loss of the patient. situations in which the patient is unable to express symptoms of the acute lower limb ischemia, such as during general anesthesia, in intensive care, or immediately after vascular surgery, are challenging for medical staff to identify. a reliable, easy-to-use and non-invasive monitoring method is not yet in every day use. the aim of this study is to demonstrate that near infrared spectroscopy (nirs) monitoring is such a monitoring method. tourniquet induced ischemia is often used in hallux valgus surgery because it offers a bloodless view of the anatomical structures. in our study we will measure the soft tissue perfusion (rso2) of the lower limbs during the whole operation. the sensors based on near-infrared spectroscopy will be located to the tibial surface and will record the normal state before the start of the tourniquet, during the tourniquet and also in the recovery phase. the hypothesis is that rso2 decreases linearly as a function of time from the beginning of the tourniquet induced ischemia and the recovery time depends on the duration of the tourniquet. in our study the patients will be operated under a spinal anesthesia. we also hypothesise that rso2 increases due to the induction of the spinal anesthesia. our goal is to define the percentual decline of rso2 that is significant for lower limb ischemia and also its time response to induction of ischemia.


Eligibility criteria:
inclusion criteria: * patient understands the meaning of the study and related measures. * patient gives his or her written informed consent. * a tourniquet is used. * the procedure is performed under spinal anesthesia. * body mass index under 40. exclusion criteria: * patient belongs to any of the following special groups: disabled people, minor, pregnant or breast feeding women, convicts, forensic psychiatric patients. * previous lower limb vascular surgery. * previous lower limb deep vein thrombosis. * previously performed tibial fasciotomies. * any another reason why the researcher considers that the patient is not suitable for the study.

Keywords: nirs spectroscopy lower limb ischemia adults
the effect of active exercise on maintenance haemodialysis patients

Conditions: Renal Dialysis

Summary: the goal of this clinical trial is to discuss the effects of physical activity on nutrition, inflammation, muscle metabolism, and the occurrence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. the main question it aims to answer is: can exercise improve nutritional and inflammatory status, enhance muscle strength, and reduce the incidence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. researchers will compared active exercise group to conventional treatment group to see the impact of exercise on maintenance haemodialysis patients. participants will: choose low-intensity aerobic exercise workouts such as walking (no less than 8,000 steps per day) or jogging, swimming, tai chi, etc., according to their individual conditions, for no less than 30 minutes at a time, at least 3 times per week, and the intensity of the exercise should be based on an rpe score of 12 to 16.

rpe: rating of perceived exertion. rpe scores of 12 to 16 indicate the need for increased respiratory rate and depth during exercise, the ability to engage in conversational exchanges, light sweating, and a feeling of slight fatigue without reaching a state of exhaustion.

Eligibility criteria:
inclusion criteria: * mhd more than 3 months, 3 times per week, 3-4h each time; * urea clearance index (kt/v) \>1.2; * stable condition, no serious infection, tumour and cardiovascular disease; * willing to join the study and sign the informed consent form. exclusion criteria: * combined with serious heart and lung disease: such as repeated heart failure, severe arrhythmia, unstable angina pectoris, severe pericardial effusion, severe heart valve disease, hypertrophic cardiomyopathy, aortic coarctation, severe emphysema, pulmonary heart disease, severe pulmonary hypertension (average pressure of the pulmonary artery \> 55mmhg), etc.; * combined with chronic joints, muscles, or vascular disease can not be or is not suitable for regular exercise, such as cerebrovascular disease; combined chronic joint, muscle or vascular disease can not or are not suitable for regular exercise, such as cerebrovascular disease sequelae, serious lower limb joint damage, severe myopathy, deep vein thrombosis, etc.; * unwilling to cooperate with the movement of people

Keywords: exercise inflammation nutrition muscular atrophy
spiriva observational study measuring saint george's respiratory questionnaire (sgrq) in routine medical practice in central & eastern european region

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this observational study is to collect and evaluate data on health related quality of life (hrqol) of spiriva delivered by handihaler, using disease specific sgrq in the national samples of central \& central european patients with varying severities of chronic obstructive pulmonary disease (copd) in the real life setting over the 6 months.

study design: an open-label, uncontrolled and single arm post-marketing surveillance study

Eligibility criteria:
inclusion criteria: * 40 years and older male and female ambulatory outpatients. * clinical diagnosis of chronic obstructive lung disease (copd) (global initiative for chronic obstructive lung disease (gold) guidelines: forced expiratory volume in one second (fev1)/ forced vital capacity (fvc) \< 0.7 and fev1 \< 80% predicted). * stable patient, without exacerbation for at least one month to the study. exclusion criteria: * uncooperative patients as judged by the physician. * patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study. * patients with any conditions excluded as per country specific package insert. * patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.
d-solve cohorts (cohort a and b)

Conditions: HDV; HDV Infection; Chronic Liver Disease

Summary: hepatitis d is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death. hepatitis d is caused by coinfection hepatitis d is caused by co-infection with hepatitis b virus (hbv) and hepatitis d virus (hdv). this multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined hdv-infected patients, followed by mechanistic studies to determine the functional role of distinct molecules. patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life and save direct and indirect costs caused by hdv infection.

the d-solve consortium ("understanding the individual host response against hepatitis d virus to develop a personalized approach for the management of hepatitis d"), aims for an unbiased screening of a large multicenter cohort of well-defined hdv-infected patients to better understand individual factors determining the outcome of infection and to identify subjects benefitting from currently available treatments. the d-solve cohorts will be collected retrospectively as well as prospectively with clinical and virological data and biomaterial for the biomarker analysis. the aim of the cohorts is as following: cohort a: to define the demographic, clinical, virological, and immunological features of a large cross-sectional cohort of 750 untreated and treated hdv patients at 4 eu centers. to compare these features among patients with different origin, gender, disease severity and treatment. to collect biological material to generate translational studies, aimed to better understand pathogenesis, natural history and treatment response. cohort b: to identify histological and immunological features that are associated with fibrosis progression and clinical complications in patients with chronic hdv infection. the d-solve consortium has received funding from the horizon 2020 eu horizon call "personalised medicine and infectious diseases: understanding the individual host response to viruses (e.g. sars-cov-2)" of the european union (grant agreement no 101057917). the consortium is coordinated by hannover medical school (mhh) and the centre for individualised infection medicine (ciim). other partners are: * helmholtz-zentrum für infektionsforschung (hzi), germany * institut national de la santé et de la recherche médicale (inserm) * karolinska institutet (ki), sweden * karolinska university hospital / region stockholm (kuh), sweden * policlinico of milan (pfm), italy * national institute for infectious diseases "prof dr matei balș" (inbimb), romania * helmholtz-zentrum für informationssicherheit (cispa), germany the cohorts and the biomarker screening are part of the eu-funded d-solve consortium.

Eligibility criteria:
inclusion criteria: * anti-hdv positive * ≥18 years old * sex: m/f/d * informed consent for prospective procedures exclusion criteria: * anti-hdv negative

Keywords: hdv hepatitis delta chronic liver disease patient cohort biomarker
trigger finger treatment

Conditions: Trigger Finger; Trigger Digit; Stenosing Tenosynovitis

Summary: trigger finger is a common disorder of the hand which causes pain at the a1 pulley, inflammation, stiffness and/or snapping during movement. this observational study compared all of the possible treatments and combinations of treatments for trigger finger at the a1 pulley, including surgery, cortisone injections and hand therapy.

trigger finger is a common disorder of the hand which causes pain at the a1 pulley, inflammation, stiffness or snapping during movement. this can be very debilitating. current treatment includes local steroid injection, oral nsaids, resting orthoses, physical or occupational therapy and surgical intervention. the aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger. there were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, modality hand therapy alone (ongoing visits) or with corticosteroid injections.

Eligibility criteria:
inclusion criteria: * trigger finger in digit 2-5 exclusion criteria: * if prior treatment for trigger finger, or trigger thumb

Keywords: treatment outcome hand therapy physical therapy occupational therapy
rates of middle meatus synechiae formation post ess

Conditions: Sinusitis

Summary: the study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ess) compared to spacer without drug.

the study is designed to evaluate basic device usability and confirm safety and effectiveness of the restora steroid eluting spacer compared to a silastic spacer. at the completion of their procedure, patients undergoing ess will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without drug placed on the other side. patients will return for standard post-op visits. between post-op day 6 and 8, both spacers will be removed. patients will again be seen on post-op day 35 and 90 to evaluate the surgical sites with respect to healing, scarring, infection, degree of inflammation, polyp formation, and the need for secondary intervention. data from the two sides will be compared to determine if there is a benefit derived from the spacer with steroid vs the one without.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years 2. diagnosis of chronic rhinosinusitis (crs), per current guidelines 3. patients who need to undergo primary bilateral complete endoscopic sinus surgery 4. subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments 5. subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment exclusion criteria 1. subject is pregnant or breast feeding 2. patients with sino-nasal tumors 3. patients solely undergoing nasal septal reconstruction 4. patients with previous history of endoscopic sinus surgery 5. cystic fibrosis or syndromic patients 6. patients with autoimmune diseases 7. patients who have taken oral steroids less than 30 days prior to surgery 8. patients with a history or diagnosis of glaucoma or ocular hypertension 9. any other circumstance or condition that in the investigator's opinion causes the subject to be an inappropriate candidate for participating in this study
exploring biomarkers of the carcinogenesis of intraductal papillary mucinous neoplasm (ipmn) of the pancreas

Conditions: Intraductal Papillary Mucinous Neoplasm

Summary: this is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of ipmn.

this prospective study was designed to explore biomarkers for detecting early carcinogenesis of ipmn. this study intends to prospectively and continuously enroll ipmn patients, and regularly collect biological samples including blood, urine, feces and saliva. we aimed to detect biomarkers which can predict the carcinogenesis of ipmn by multi-omics. the primary endpoint is the predictive accuracy of biomarkers for ipmn malignant transformation. the probability of ipmn malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as ipmn; * without other malignant tumor; * agree to sign informed consent. exclusion criteria: * with mental disorders which can affect cognition and cooperation; * with serious blood diseases or taking drugs that can affect peripheral blood

Keywords: intraductal papillary mucinous neoplasm biomarkers prospective cohort
changes in cerebral glucose metabolism after electroconvulsive therapy (ect)

Conditions: Major Depressive Disorder

Summary: there exist already a few studies that have measured changes of brain metabolism pre and post electroconvulsive therapy (ect) by positron emission tomography (pet) but these were all performed in a small number of patients and used different methodologies. it is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 schmidt,e.z. 2008}}. in patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by pet occur after treatment with ect and (b) whether these correlate with the clinical amelioration of symptoms. to pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18f-fluoro-deoxyglucose (18f-fdg) pet at baseline and at the end of treatment. patients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 berlim,m.t. 2007}} - in whom ect had been intended on clinical grounds were consecutively asked for participation in this study. patients had to be between 18 and 80 years old and to be physically healthy.


Eligibility criteria:
inclusion criteria: * clinical indication for ect * treatment refractory depressive episode * age 18-85 y exclusion criteria: * addiction as a first diagnosis * dementia

Keywords: depression fdg-pet electroconvulsive therapy glucose metabolism
a novel combined therapy for refractory vernal keratoconjunctivitis

Conditions: Vernal Keratoconjunctivitis

Summary: to evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate 0.5%/tobramycin 0.3% (le/t) in vernal keratoconjunctivitis (vkc) patients resistant to conventional treatment. this prospective 6-mouth period study aims to include 20 severe vkc patients who were not responding to conventional treatments. all the patients will be treated with 0.1% tacrolimus suspension two times daily, le/t eye drops four times daily for 1 month. additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four times daily will be used. after the first month, le/t will be stopped, with other treatments continued for the last 5 months. visual acuity and intraocular pressure (iop) will be measured at enrollment and 1, 2, 3 and 6 months after treatment. besides, 6 subjective symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. the primary endpoints are the change in symptoms and objective signs. treatment failure will be recorded if extra corticosteroids were required.


Eligibility criteria:
inclusion criteria: * vernal keratoconjunctivitis patients resistant to conventional treatments exclusion criteria: * patients diagnosed with other coexisting eye disease; with a confirmed or possible pregnancy; younger than 5 years old; had presence of systemic diseases other than coexisting allergic rhinitis, asthma, and atopic dermatitis; reported hypersensitivity to tacrolimus

Keywords: refractory vernal keratoconjunctivitis 0.1% tacrolimus loteprednol etabonate 0.5%/tobramycin 0.3%
modulation of circulating levels of the ketone body 3-hydroxybutyrate in patients with type 2 diabetes and heart failure with preserved ejection fraction: cardiovascular effects.

Conditions: Heart Failure With Preserved Ejection Fraction; Diabetes Mellitus, Type 2; Ketonemia

Summary: heart failure (hf) is among the most common causes of death in patients with type 2 diabetes (t2d). ketones, 3-hydroxybutyrate (3-ohb), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. however, this have never been investigated in patients with heart failure with preserved ejection fraction (hfpef). in this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with hfpef and t2d.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * lvef \> 40 % * a clinical diagnosis of hfpef and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction * age ≥ 18 years old, * one of the following criteria (a-d) should be fulfilled: 1. echocardiographic signs of diastolic dysfunction e/e' \> 8 2. septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s 3. left atrium volume index ≥34 ml/m2 and/or left atrial diameter \> 4 cm 4. nt-probnp \> 125 pg/ml. exclusion criteria: * insulin treatment, inability to give informed consent
potential allergens in wine: double-blind placebo-controlled trial

Conditions: Food Allergy; Anaphylaxis

Summary: this study is designed to identify whether wines which are produced using the common potential food allergens such as proteins derived from fish, milk or egg are likely to contain sufficient food allergens to cause allergic reactions in susceptible individuals.

recent international legislation requires labelling of wines made using potentially allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated milk where "there is detectable residual processing aid". however it is not clear whether the final wine contains concentrations of residual added food proteins that can provoke allergic reactions. comparison:this study is a double blind, placebo-controlled trial to determine whether adults known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following consumption of australian commercial wines fined with food allergens.

Eligibility criteria:
inclusion criteria: individuals with ige-mediated food allergy to milk, fish, egg or nuts otherwise no major medical problems able to drink wine - exclusion criteria: major asthma or cardiac disease unwilling or unable to participate -

Keywords: food allergy wine milk allergy egg allergy nut allergy fish allergy