Kornimate/medical-research-clean huggingface dataset:
oral prednisolone in severe acute exacerbation of chronic obstructive pulmonary disease (copd)

Conditions: COPD Exacerbation

Summary: evaluation of systematic administration of oral prednisolone (1mg/kg/day) as an add on therapy in chronic obstructive pulmonary disease (copd) patients admitted to intensive care unit (icu) for severe exacerbation of copd. patients with pneumonia are excluded. randomization is stratified according to ventilatory support: non invasive or conventional ventilation.the major outcome is the icu mortality rate in overall population and stratified according to ventilatory mode (noninvasive ventilation (niv) versus conventional). secondary outcomes are superinfection necessitating a new antibiotic course, length of mechanical ventilation (mv) (and ventilatory free days), length of icu stay, the frequency of gastric bleeding episodes that of frequency of hyperglycemic episodes.


Eligibility criteria:
inclusion criteria: * all copd patients (according to the ats definition) experiencing acute exacerbation originating in acute respiratory failure and requiring icu admission will be included in the study. copd exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze. acute respiratory failure is defined by the presence of hypercapnia with paco2 \>45mmhg associated with ph \> 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..). exclusion criteria: * asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators, * patients with uncontrolled left heart failure, * aecopd patients with a radiologically documented pneumonia, * systemic corticotherapy within 30 days before screening, * contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..)

Keywords: copd acute respiratory failure mechanical ventilation non invasive ventilation steroids
clinical performance of a silicone hydrogel lens with use of fid 114675a

Conditions: Contact Lens Fit; Myopia

Summary: the purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (mpds).


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * history of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power acuvue® advance® sih contact lenses prior to visit 1. * wear contact lenses a minimum of 8 hours per day prior to visit 1. * vision correctable to 20/30 (snellen) or better in each eye at distance with study lenses at visit 1. * other protocol-defined inclusion criteria may apply. exclusion criteria: * need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. * use of products other than a multi-purpose solution to care for lenses at least 7 days prior to visit 1. pre-study use of rewetting drops is acceptable. * history of intolerance or known sensitivity to any component of the treatments. * use of over-the-counter (otc) or prescribed topical ocular medications within 7 days prior to visit 1. * other protocol-defined exclusion criteria may apply.

Keywords: contact lens wear contact lens solution multi-purpose disinfecting solution myopia
study of mycamine® in children with fungal infections to evaluate safety and blood levels of the drug

Conditions: Oropharyngeal Candidiasis; Candidemia; Invasive Candidiasis; Esophageal Candidiasis

Summary: children with fungal infections will be divided into two groups by weight. children weighing \ 25 kg.

this is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. subjects in group 1 and group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in group 1. subjects may only participate in one group of the study. at least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in group 1 (pk + safety). at least 36 subjects will be enrolled in group 2 (safety), with at least 12 in each of the three age ranges.

Eligibility criteria:
inclusion criteria: 1. subject is 2 to 16 years inclusive 2. subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis 3. subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables exclusion criteria: 1. subject has evidence of significant liver disease, as defined by aspartate transaminase (ast), alanine transaminase (alt), bilirubin or alkaline phosphatase \> 5 times the upper limit of normal (uln) 2. subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study 3. subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals 4. subject has received treatment with an echinocandin within one week prior to first dosing 5. subject status is unstable and subject is unlikely to complete all study required procedures

Keywords: antifungal micafungin echinocandin candidiasis
comparison between systemic exposure to ciclesonide nasal spray, ciclesonide hfa nasal aerosol and orally inhaled ciclesonide (by9010/m1-422)

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to compare the systemic des-ciclesonide exposure of omnaris™ (ciclesonide) nasal spray, ciclesonide hfa nasal aerosol, and orally inhaled ciclesonide hfa-metered-dose inhaler (mdi). the administration of the study medication will be as follows: three single doses, separated by a wash-out period. the study will provide further data on the safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * written informed consent and hipaa * body weight as indicate by a body mass index (bmi) between ≥ 18 and ≤ 28 kg/m², and a body weight \>50 kg * general good health * ability to use oral inhaler main exclusion criteria: * pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women * participation in any investigational drug trial within the 30 days before screening visit and thereafter * history or current clinically relevant allergies or idiosyncrasy to drugs or food * history of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations * any contraindication to nasally administered corticosteroids * history of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (sars)\] within the 30 days before screening visit, or development of a respiratory infection during the screening period * history or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years * non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding screening visit

Keywords: allergic rhinitis
intraosseous with intra-articular injection of platelet rich plasma in treatment of knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (oa) given a combination of intraosseous with intra-articular injection of platelet rich plasma (prp), intra-articular injection of prp and a single application of hyaluronic acid (ha).

methods eighty-six patients from january 2015 to june 2015 with grade ii to grade iii knee osteoarthritis according to the kellgren-lawrence classification were randomly divided into 3 groups to receive either prp or ha. group a received intra-articular injection of prp 2 ml combination with medial tibial plateau and medial femoral condyle injection of prp 2 ml (once more 2 weeks later). group b were treated with 2 ml of prp intra-articular injection every 14 days for a total of two injections. group c received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. all patients were evaluated by the visual analogue scale (vas) and the western ontario and mcmaster universities (womac) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.

Eligibility criteria:
inclusion criteria: * unilateral symptomatic knee with pain for at least 1 month or swelling. * radiographic findings of knee degeneration (kellgren-lawrence score of ii - iii). * age 40-73 years. * body mass index (bmi) 18-32.5). * knee stability without a severe trauma history. exclusion criteria: * bilateral knee osteoarthritis indicative of treatment for both knees. * kellgren-lawrence score greater than iii. * bmi \>32. * age \>73 years. * systemic autoimmune rheumatic diseases and blood disorders. * active immunosuppressive or anticoagulant therapy. * intra-articular injection to the knee within the previous 1 year or previous joint infection. * use of corticosteroids for 3 weeks before the procedure. * use of nonsteroidal anti-inflammatory drugs (nsaids) in the 3 weeks before treatment.
psychotraumatology in somatic medicine

Conditions: Trauma, Psychological; Somatic

Summary: psychotraumatology is clinically highly relevant, especially in the medical-somatic disciplines. despite progress in recent decades, the clinical care is still inadequate - with unfavorable health effects for affected patients. there are avoidable burdens for involved clinicians and the health care system as a whole, also in terms of costs. with this background, our long-term project combines different research levels. besides clarifying the clinical phenomenon, it aims to examine 1) the influence of traumatization on the physician-patient interaction as well as 2) the current psychological stress of the patients. furthermore, 3) moderating factors on the side of the physicians, such as professional experience on the physician-patient interaction will be examined.


Eligibility criteria:
inclusion criteria: * at least 18 years old * female patients of the preventive consultation of the gynecological clinic of the cantonal hospital st.gallen exclusion criteria: * severe mental disorder (e.g. dissociative disorder) * insufficient knowledge of german
group psychodrama for skin picking

Conditions: Excoriation of Skin

Summary: this study aims to evaluate the effectiveness of psychodrama group therapy (pgt) compared with supportive group therapy (sgt) for excoriation disorder (ed). patients will be randomly allocated for either pgt or sgt. the skin picking scale revised (sps-r) will be the primary outcome and emotional regulation measured by the difficulties in emotion regulation scale (ders) will be evaluated as a potential intermediator. the clinical global impression scale (cgi); beck depression scale (bdi); beck anxiety scale (bai), and the social adjustment scale (eas) will assess secondary outcomes.

excoriation disorder (ed) is a diagnostic characterized by recurrent picking at one´s own skin, resulting in skin lesions, despite repeated attempts to stop the behavior that causes clinically significant distress or impairment in important areas of functioning. the skin picking behavior is better accounted by physiological effects of a substance or better explained by symptoms of another mental disorder. objective: this study aims to evaluate the effectiveness of psychodrama group therapy (pgt) compared with supportive group therapy (sgt). justification: the scientific studies on treatment for ed are scarce and all associated with behavioral therapy methods, which do not adequately consider underlying factors of ed, such as emotional dysregulation. there are also not reports of group treatment for ed. method: patients who meet criteria for ed according to dsm-5 will be selected . patients in need of treatment for psychiatric comorbidities (such as anxiety and depression) will wait at least 4 weeks until pharmacological prescription is stable. the subjects will be randomly allocated to either pgt or sgt. the skin picking scale revised (sps-r) will be the primary outcome and emotional regulation measured by the difficulties in emotion regulation scale (ders) will be evaluated as a potential intermediator. the clinical global impression scale (cgi); beck depression scale (bdi); beck anxiety scale (bai), and the social adjustment scale (eas) will assess secondary outcomes. hypotheses: 1. the pgt is more effective than sgt for the ed patient regarding the reduction of skin excoriation behavior. 2. pgt is more effective than sgt for the ed patient regarding the improvement of the symptoms of anxiety, depression and trichotillomania (when present). 3. the therapeutic effects of pgt is intermediated by emotional regulation.

Eligibility criteria:
inclusion criteria: * skin picking diagnosis exclusion criteria: * illiteracy * other acute psychiatric diagnosis in need of inpatient treatment * mental retardation * prader-willi syndrome or other medical condition causing recurrent excoriation behavior or intense itching
the effect of leukocyte and platelet-rich fibrin with antimicrobial photodynamic therapy in aggressive periodontitis

Conditions: L-PRF; Photodynamic Therapy; Aggressive Periodontitis

Summary: antimicrobial photodynamic therapy (apdt) is associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. leukocyte and platelet-rich fibrin (l-prf) has been used extensively in the treatment of intrabony defects and achieved excellent results. it acts as an immune regulation node with inflammation control abilities, including a slow continuous release of growth factors which stimulates periodontal regeneration. the aim of this study is to evaluate the adjunctive effects of apdt with and without l-prf in aggressive periodontitis patients.


Eligibility criteria:
inclusion criteria: * systemically healthy * non- smoker, * not received any periodontal treatment within the last 6 months, * no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months exclusion criteria: * any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment, * any medical condition that required antibiotic prophylaxis before the treatment, * smoking, * pregnancy and lactation, * ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period, * any physical limitations or restrictions that might preclude normal oral hygiene procedures.
digital dialectical behavioural therapy (d-dbt) for youth at clinical high risk (chr) for psychosis

Conditions: Clinical High Risk for Psychosis (CHR)

Summary: this study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-dbt) intervention for youth at clinical high risk (chr) for psychosis. the study aims to assess the acceptability of the intervention to the chr population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. participants will be randomized to receive either the d-dbt intervention or treatment as usual over eight weeks.

this study evaluates the feasibility, acceptability, and preliminary efficacy of digital dialectical behavior therapy (d-dbt) for youth at clinical high risk (chr) for psychosis. given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital dbt approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in chr populations and may contribute to distress and progression of disease. participants will be randomized to receive either d-dbt or treatment-as-usual (tau). the intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. primary outcomes include measuring feasibility, acceptability, and usability. secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. results will inform future adaptations, larger trials, and clinical applications.

Eligibility criteria:
inclusion criteria: 1. be 16-29 years old. 2. being competent and willing to consent to study participation. 3. meets chr criteria for a psychosis risk syndrome based on the structured interview for psychosis risk syndromes (sips) within the past 3 years. exclusion criteria: 1. diagnostic and statistical manual of mental disorders (dsm-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features) 2. diagnosis of intellectual disability 3. severe developmental disorder 4. acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care). 5. receiving any additional psychotherapy interventions or structured digital mental health support during the study period.

Keywords: digital therapy dialectical behavioural therapy emotional dysregulation mental health intervention digital mental health clinical high risk for psychosis
the role of the seven sweeps in the prevention of the prostate cancer among those with a positive family history

Conditions: Prostate Cancer; Prostatic Neoplasms; Prostatic Hyperplasia

Summary: the seven sweeps is a recommended act performed by men after urinating in order to be confident that no urine is left in the urethra, and its not compulsory to perform. it is performed by the following way: after urinating, the anus is first purified if it has become impure; then, the middle finger of the left hand is slid three times from the anus up to the scrotum; then, the thumb is placed on the penis and the forefinger is placed under the penis, and the thumb and forefinger are pulled three times along the penis up to the point of circumcision; finally, the end of the penis is pressed three times.

the investigators have investigated 350 people who have been doing this habit for at least 20 years of their life and they have a family history of prostatic cancer to check the effect of this procedure on the prevention of the cancer. the investigators have excluded 135 participants of them because they have not full-filled the criteria of inclusion. so 215 of them have been included and investigated using psa and prostate ultrasound.

Eligibility criteria:
inclusion criteria: * family history of prostate cancer, more than 40 years of age, is doing the seven sweeps habit for at least 20 years, has not any urinary problems or chronic diseases. exclusion criteria: * no family history of prostate cancer, less than 40 years of age of more than 70 years old, has a urinary problem or chronic diseases.

Keywords: prostate cancer prostate hyperplasia the seven sweeps
to assess the pharmacokinetics and safety and tolerability of efanesoctocog alfa (bivv001)in adults with type 2n and 3 von willebrand disease (vwd)

Conditions: Von Willebrand's Disease (VWD)

Summary: primary objective: -to characterize the pharmacokinetics (pk) of bivv001 after a single intravenous (iv) administration, as assessed by factor viii (fviii) activity determined by the one-stage activated partial thromboplastin time (appt) clotting assay, as well as, bivv001 capture chromogenic coatest fviii activity assay secondary objective: -to assess the safety and tolerability of a single iv dose of bivv001 in adult patients with type 2n and 3 vwd

duration of each part of the study for one participant: total study duration: up to 57 days. * screening: up to 28 days. * up to 29 days of safety observation following the iv bivv001 dose administration (this period includes pk sampling up to the first 10 days following administration).

Eligibility criteria:
inclusion criteria : -- male and/or female participant, between 18 and 65 years of age, inclusive at the time of informed consent. * the participant has been diagnosed with hereditary type 3 vwd or type 2n vwd as documented in historical medical records or a documented genotype known to produce vwd type 3 or 2n vwd. * type 3 vwd participants are included if they have a medical history of at least 25 exposure days to vwf and factor viii-containing coagulation factor concentrates * type 2n vwd participants are included if the use of ddavp is deemed insufficient or contraindicated, as assessed by the investigator, or if they have required prior use of vwf- and fviii- containing coagulation factor concentrates. exclusion criteria: * hereditary or acquired coagulation disorder other than vwd (including qualitative and quantitative platelet disorders, and thrombocytopenia \< 100,000 cells/ul at screening) * the participant has a fviii activity levels \>20 iu/dl, at screening * history or presence of a vwf inhibitor or clinical suspicion of a vwf inhibitor * history of a positive fviii inhibitor test, defined as ≥0.6 bu/ml (by nijmegen modified bethesda assay) or a clinical suspicion of a fviii inhibitor * positive fviii inhibitor test, defined as ≥0.6 bu/ml, at screening * history of hypersensitivity or anaphylaxis associated with any fviii- or vwf- containing product * the participant has received or anticipates receiving systemic immunosuppressive or immunomodulatory treatment within 12 weeks prior to baseline. * the participant requires the use of acetylsalicylic acid, non-nsaid anti-platelets, and nsaids above the maximum dose product * patients currently on a prophylaxis regimen for the treatment of vwd that, in the investigator's opinion, would preclude participation in the study due to the possible increased risk of bleeding associated with the requirement to withhold prophylaxis during the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study of the bioequivalence of the 20% and 30% etoricoxib tablet formulations (0663-070)

Conditions: Pain

Summary: this study will establish the bioequivalence of the 20%, milled, roller compaction final market image (fmi) etoricoxib tablets and 30% unmilled, roller compaction (umc) etoricoxib tablets.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject agrees to follow the study guidelines exclusion criteria: * subject is a smoker * subject has a history of adverse reactions caused by nsaids or allergies/intolerance to nsaids * subject is in a situation or has a condition/disease which may interfere with optimal participation in the study