Kornimate/medical-research-clean huggingface dataset:
inhalation of ciclesonide for patients with covid-19: a randomised open treatment study (halt covid-19)

Conditions: Covid-19; Pneumonia, Viral; Sars-CoV2

Summary: randomized open label clinical trial carried out at study centers in sweden, including karolinska university hospital, s:t göran hospital, danderyd hospital and västmanlands hospital. patients with covid-19 who are hospitalized with oxygen therapy are eligible for inclusion. subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. primary outcome is duration of received supplemental oxygen therapy. key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older who have given their written consent to participate in the study. * hospitalized and treated with oxygen for a maximum of 48 hours. * verified covid-19: positive sample for sars-cov2 rna or a positive sars-cov2 antigen test from the upper respiratory tract * receives oxygen treatment. * negative pregnancy test (women of childbearing potential) * willing to exercise contraception categorized as "very effective" according to the clinical trial facilitation group during ongoing study treatment + 7 days (appendix 2). (female research participant of childbearing potential) exclusion criteria: * pregnancy, breast-feeding or planned pregnancy. * hypersensitivity to ciclesonide or to any of the excipients. * concomitant medication with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir. * treatment with\> 8 l oxygen / min or supply of \> 50% oxygen with nasal high-flow cannula * ongoing palliative care or expected survival of less than 72 hours. * expected admission to the intensive care unit within 48 hours. * active or inactive pulmonary tuberculosis. * severe liver failure (child-pugh c) * diagnosed with pulmonary arterial hypertension (pah) or fibrosis. * mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study. * participates in or has recently participated in a clinical trial in the last 30 days. previous participation in this study.

Keywords: corona virus covid-19 sars-cov2 randomized controlled trial human intervention study corticosteroids
post approval registry of corox otw, endocardial, left ventricular steroid lead, bipolar

Conditions: Congestive Heart Failure

Summary: the objective of this study is to confirm the long-term safety and reliability of the corox otw bp left ventricular (lv) pacing lead. as a condition of approval, the fda required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

this study is an fda-required, multi-center, prospective, non-randomized, data collection registry. eligible patients must have been successfully implanted with a corox otw bp, corox otw-s bp, or corox otw-l bp lv lead with a biotronik crt device and consented and enrolled between 7-180 days following implant. at least 2500 patients will be enrolled in this post-approval registry, and each patient will be followed for five years post-implant. safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention. in addition, each individual adverse event will be separately investigated. lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.

Eligibility criteria:
inclusion criteria: * successfully implanted biotronik crt system, including a corox bp lv lead, from 7-180 days prior to enrollment * able to understand the nature of the registry and give informed consent * available for follow-up visits on a regular basis at the investigational site * age greater than or equal to 18 years exclusion criteria: * enrolled in any ide clinical study * planned cardiac surgical procedures or interventional measures within the next 6 months * expected to receive a heart transplant within 1 year * life expectancy less than 1 year * presence of another life-threatening, underlying illness separate from their cardiac disorder * pregnancy * inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant

Keywords: long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients
a study of hs-20094 in chinese adults with overweight or obesity

Conditions: Overweight; Obesity

Summary: the main purpose of this study is to assess the efficacy and safety of hs-20094 in overweight and obese patients. the study will last up to approximately 52 weeks.

this is a phase ⅲ, double-blind, randomised, placebo-controlled trial to assess the efficacy of hs-20094 in chinese subjects with overweight or obesity. we enrolled adults (aged 18-65 years, both inclusive) with overweight (body-mass index \[bmi\] ≥24 kg/m2) accompanied by at least one obesity-related comorbidity or obesity (bmi ≥28 kg/m2) in china. eligible participants were randomly assigned to receive once-weekly subcutaneous hs-20094 or placebo for 48 weeks. the co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.

Eligibility criteria:
inclusion criteria: * 1.male or female 18 to 65 years of age at the time of consent(cutoff value included). 2. body mass index(bmi)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea. 3. weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening. exclusion criteria: * 1. diabetes mellitus 2. weight change \>5.0% after diet and exercise control for at least 12 weeks before screening 3. have used or are currently using weight loss drugs within 3 months before screening 4. history of pancreatitis 5. family or personal history of medullary thyroid carcinoma(mtc)or multiple endocrine neoplasia syndrome type 2(men-2) 6. history of moderate to severe depression, or have a history of serious mental illness 7. any lifetime history of a suicide attempt 8. have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions 9. have a history of any malignancy within the past 5 years
definition of links between non-invasives methods and intracerebral eeg with simultaneous recordings.

Conditions: Epilepsy

Summary: presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function. the current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. however, non-invasive methods have been developed in order to record brain activity with no risk for the patient. still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. to do so, it is necessary to record simultaneously electroencephalogram (eeg) and magnetoencephalogram (meg) and stereo encephalogram seeg (intracerebral). such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain. the objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements. it will be record simultaneously meg, scalp eeg and intracerebral eeg on a series of 60 patients. it will be record resting state signals, as well as stimulation protocols. the interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.


Eligibility criteria:
inclusion criteria: - patients for whom implanting intracerebral electrodes is underway exclusion criteria: * patients minors * pregnant or lactating women
steno tech explore: a study of insulin pump users with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the present study is part of an overarching study being conducted in denmark at steno diabetes center copenhagen (sdcc) and nordsjællands hospital hillerød (noh), steno tech, that aims to develop and ultimately, in a randomized controlled trial (rct), test approaches that can assist people with type 1 diabetes in obtaining optimal outcomes using csii. through a large-scale, questionnaire-based online survey enriched with data from national registers, this sub-study contributes to this overarching aim by exploring the importance of individual differences across a wide range of factors, including demographic, socioeconomic, health status, psychosocial and preference structures, for optimal use of csii in people with type 1 diabetes.

see attached protocol for a detailed description.

Eligibility criteria:
the steno tech survey repondents group: * adult (18+ years) * type 1 diabetes * insulin pump user * danish-speaking the general type 1 population group: * adult (18+ years) * type 1 diabetes

Keywords: continous subcutaneous insulin infusion clinical outcomes psychological outcomes educational aspects preferences inequality and inequity
efficacy of calcipotriol plus betamethasone gel versus calcipotriol scalp solution in scalp psoriasis

Conditions: Psoriasis of Scalp

Summary: the purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. the primary outcome is patients with clear or minimal disease after 8 weeks treatment. further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.


Eligibility criteria:
main inclusion criteria: * scalp psoriasis amenable to topical treatment * psoriasis vulgaris on trunk and/or limbs * extent of scalp psoriasis involving more than 10% of the total scalp area * disease severity on the scalp graded as moderate or worse by the investigator * consenting out-patients of 18 years or above main exclusion criteria: * puva or grenz ray therapy within 4 weeks prior to randomisation * uvb therapy within 2 weeks prior to randomisation * systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation * systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin d analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation * any topical treatment of the scalp (except for non steroid medicated shampoos and emollients) within 2 weeks prior to randomisation * topical treatment of the face, trunk and/or limbs with very potent who group iv corticosteroids within 2 weeks prior to randomisation * current diagnosis of erythrodermic, exfoliative or pustular psoriasis
randomized, parallel, comparison, double-blind efficacy & safety study of aprovel versus placebo in chinese patients with hypertensive type ii diabetic patients with microalbuminuria

Conditions: Hypertension

Summary: to evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type ⅱdiabetes mellitus.


Eligibility criteria:
inclusion criteria: * fasting plasma glucose of untreated type ii diabetes mellitus patients greater than or equal to 7.0 mmol/l, or the time between diagnosis of type ii diabetes mellitus and treatment \> 3 months * the patients of normal bp, or hypertensive patients receiving antihypertensive medication, seated systolic blood pressure (sesbp) is between 120-180mmhg and the seated diastolic blood pressure (sedbp) is between 80-110mmhg; * evidence of albuminuria defined as an aer of 20 and 500 ug/minute on a single timed overnight collection. before randomization the patient must quality with two aers of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. the two aers measurement should be in the above defined range and the variability between the two aers measurement must be \<35%. value of basal aer is calculated as the mean of the 2 measurements. the uaer measured using immunity nephelometer method (dca2000); * serum creatinine \< 150umol/l(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/l); * 18 kg/m2less than or equal to bmi less than or equal to 35kg/m2 exclusion criteria: * the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
phase ii study of artesunate ointment for the treatment of vulvar high grade squamous intraepithelial lesions (vulvar hsil, vin2/3)

Conditions: Vulvar Diseases; HPV Infection; Vulvar HSIL; Pre-Cancerous Dysplasia; HPV Disease; VIN, Usual Type; VIN 2 of Usual Type; VIN 3 of Usual Type; Vin II; Vin III; VIN Grade 2; VIN Grade 3; High Grade Intraepithelial Neoplasia

Summary: this is a phase ii double-blind, placebo-controlled study of artesunate ointment for the treatment of hpv-associated vulvar hsil (usual type vulvar intraepithelial neoplasia 2/3).

eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar hsil. both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Eligibility criteria:
inclusion criteria: * adult women age ≥ 18 years * capable of informed consent * able to collaborate with planned follow-up (transportation, compliance history, etc) * biopsy diagnosis of high-grade vulvar dysplasia (vin2, vin3, vin2/3, hsil), including both new and recurrent disease. a biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry. * positive hpv test at study entry (any genotype). * women of childbearing potential agree to use birth control during the dosing phase (through week 8). * laboratory values at screening of: * serum alanine transaminase (sgpt/alt) \< 5 x upper limit of normal (uln) * serum aspartate transaminase (sgot/ast) \< 5 x uln * serum bilirubin (total) \< 2.5 x uln * serum creatinine ≤ 1.5 x uln * weight ≥ 50kg exclusion criteria: * pregnant and nursing women * concurrent anal, vulvar, or cervical cancer * hiv-positive participants with a cd4 count \< 200 * participants infected with hiv-1 if not on a stable, suppressive antiretroviral therapy (art) regimen. * unwillingness to undergo an excisional procedure at week 18 to either remove hsil lesions, or to document histologic regression at a site where hsil was present at study entry. * currently receiving systemic chemotherapy or radiation therapy for another cancer. * concomitant use of efavirenz for hiv antiretroviral treatment * concomitant use of strong ugt inhibitors * concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-fu) for the duration of the study * concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy). * concurrent treatment with systemic corticosteroids

Keywords: topical treatment ointment non-surgical vulvar cancer prevention high-risk hpv human papillomavirus hpv vulvar hsil high grade lesions
efficacy of paroxetine in the prevention of depressive syndrome in patients with chronic hepatitis c treated by peg-interferon alfa plus ribavirin

Conditions: Chronic Hepatitis C

Summary: depression is a common side effect of interferon in the treatment of chronic hepatitis c. the aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by peg-interferon given for the treatment of chronic hepatitis c.

the aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by peg-interferon given for the treatment of chronic hepatitis c. this is a comparative study including two groups of patients randomly allocated : one with paroxetine and the other with the placebo. the rate of depression will be compared between the 2 groups

Eligibility criteria:
inclusion criteria: - chronic hepatitis c which should be treated by peg-interferon alfa and ribavirin with no contra-indication to anti-viral treatment exclusion criteria: * allergy to paroxetine * current antidepressant treatment * depression diagnosed by the mini international neuropsychiatric interview (mini, dsm iv) * history of bipolar syndrome * history of psychotic syndrome * treatment by triptan, carbamazepine, millepertuis, methadone, oral anticoagulation * renal insufficiency * hiv infection * breath feeding * contra-indication to peg-interferon and or ribavirin

Keywords: chronic hepatitis c paroxetine depression
precision medical research of non-immune fetal hydrops (nifh)-from prenatal diagnosis to intrauterine treatment

Conditions: Fetal Hydrops

Summary: based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of non-immune fetal hydrops (nifh), and then establish nifh accurate treatment strategy which is suitable for china's national conditions.

1. etiological study of non-immune fetal hydrops(nifh): 1. etiological study of nifh in mid-pregnancy period; 2. etiological study of nifh and hygroma colli in first trimester; 3. value assessment of technology for exome sequencing in diagnosis of nifh; 2. the accuracy of nifh intrauterine intervention and its effect assessment: 1. perinatal outcomes of nifh ; 2. the effect of intrauterine treatments.

Eligibility criteria:
inclusion criteria: * cases corresponding to diagnosis standards * willing to accept the regular follow-up exclusion criteria: * immune hydrops fetalis * multiple pregnancy, except for twin-to-twin transfusion syndrome iv
efficacy and safety of bi 201335 (faldaprevir) in combination with pegylated interferon-alpha and ribavirin in treatment-experienced genotype 1 hepatitis c infected patients (startverso 3)

Conditions: Hepatitis C, Chronic

Summary: the aim of this trial is to evaluate the efficacy and the safety of bi 201335 given for 12 or 24 weeks in combination with pegifn/rbv given for 48 weeks as compared to pegifn/rbv alone in chronic gt-1 hepatitis c virus infected patients who failed a prior pegifn/rbv treatment.


Eligibility criteria:
inclusion criteria: 1. chronic hepatitis c genotype 1 infection, diagnosed at least 6 months prior to screening 2. confirmed prior virological failure with an approved dose of pegifn/rbv 3. age 18 to 70 years, 4. hcv rna (ribonucleic acid) = 1,000 iu/ml at screening, exclusion criteria: 1. hcv infection of mixed genotype; hepatitis b virus (hbv) or human immunodeficiency virus (hiv) co-infection 2. evidence of acute or chronic liver disease due to causes other than chronic hcv infection, 3. decompensated liver disease, or history of decompensated liver disease, 4. body weight \ 125 kg, 5. clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder 6. pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study 7. laboratory parameters disorders (thalassemia major, sickle cell anemia or g6pd deficit) 8. hemoglobin \< 12 g/dl for women and \< 13 g/dl for men 9. patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic hcv infection including and not restricted to protease or polymerase inhibitors,
systolic pressure index in assessing the risk of cardiovascular events

Conditions: Cardio-vascular Events

Summary: to investigate whether the presence of a systolic pressure index (\ 1.4) is a marker of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac and vascular surgery.


Eligibility criteria:
inclusion criteria: * age\> 40 years * surgery set : * visceral surgery: gastrectomy or colectomy, abdomino-perineal amputation, pancreatic surgery, liver surgery, esophageal surgery * in urological surgery: nephrectomy, total prostatectomy, cystectomy * in thoracic surgery: pneumonectomy, lobectomy * in orthopedic surgery: total hip replacement and total knee prosthesis exclusion criteria: * pathology making it impossible to measure systolic pressure index * life expectancy less than 6 months * emergency surgery
subjective well being of schizophrenic patients in greece

Conditions: Schizophrenia

Summary: non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with schizophrenia under antipsychotic medication. moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * diagnosis of schizophrenia according to dsm-iv * the patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit exclusion criteria: -

Keywords: schizophrenia antipsychotics social functioning subjective well being patients suffering from schizophrenia
interest of the cone-beam computed tomography in the imagery of the middle ear

Conditions: Ear Diseases

Summary: cone beam computed tomography (cbct), is a recent medical imaging technique where the x-rays are divergent, forming a cone. as a result, this technique is less irradiating that the scanner. the purpose of this exploratory study is to compare the performance of the scanner and the cone beam in the detection of anatomical structures of the ear.


Eligibility criteria:
inclusion criteria: * adult patient * indication of a ct scan of the ear * written and signed informed consent by the patient to participate in the study exclusion criteria: * pregnancy * breast feeding * patient under a legal protection procedure * lack of affiliation to a social security system