Kornimate/medical-research-clean huggingface dataset:
management of acute bronchitis with pelargonium sidoides extract

Conditions: Acute Bronchitis

Summary: the aim of our study is to conduct a pragmatic rct meeting all required standards to evaluate the effectiveness of pelargonium sidoides extract, eps® 7630, in the management of acute bronchitis with or without covid-19 in pcp practices and walk-in clinics in french-speaking switzerland. the rct will be preceded by a pilot phase to ensure its feasibility.

the goal of this clinical trial is to evaluate the effectiveness of pelargonium sidoides extract eps® 7630, also known under the brand name kaloba®, in the management of acute bronchitis. the main questions it aims to answer are: * is pelargonium sidoides extract eps® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ? * does pelargonium sidoides extract eps® 7630 allow to reduce the prescription of antibiotics? participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (pelargonium sidoides extract eps® 7630).

Eligibility criteria:
inclusion criteria: * adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but pcp believes that acute bronchitis is the most likely diagnosis. * patients tested positive to covid-19 who meet the above-mentioned criteria will be included too. exclusion criteria: * infection requiring antibiotic treatment (ex. cystic fibrosis) * pneumonia * known hypersensitivity to pelargonium sidoides extract or excipients of the trial medication * non-infectious causes (copd, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy) * lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression) * inability to fill out the diary (no ability to read and understand french) * pregnancy or breastfeeding * immunological deficiencies * hospitalization * severe hepatic disease * patients who have already started a treatment with pelargonium sidoides eps® 7630 for this current episode (kaloba®, umckaloabo®) * important risk of bleeding (severe thrombocytopenia and anticoagulant intake) * if the patient is taking a drug among these classes of drugs: anticoagulants, immunosuppressants, chemotherapy or immunotherapy

Keywords: pelargonium sidoides
a study to evaluate the product feasibility of two new silicone hydrogel contact lenses

Conditions: Myopia

Summary: the objective of this study is to determine the clinical feasibility and to evaluate the product performance of two rd2135-01 investigational soft contact lenses (test 1 and test 2) developed by bausch + lomb. the test lenses will be compared to both bausch + lomb purevision®2 hd (high definition) soft contact lenses and ciba vision air optix aqua soft contact lenses when used among currently adapted soft contact lens wearers.


Eligibility criteria:
inclusion criteria: * have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * be correctable through spherocylindrical refraction to 32 letters (0.3 logmar) or better (distance, high contrast) in each eye. * be myopic and require lens correction from -0.50 diopters (d) to -6.00 d in each eye. * must agree to wear the study lenses on a daily wear basis for the duration of the study. * must be willing to use a lens care system on a regular basis. * if the subject requires a washout period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this washout period. exclusion criteria: * not correctable to 32 letters (0.3 logmar) in each eye with soft spherical contact lenses. * have an active ocular disease, any corneal infiltrative response or are using any ocular medications. * have worn gas permeable (gp) contact lenses within last 30 days or pmma lenses within last 3 months. * any scar or neovascularization within the central 4mm of the cornea. * any grade 2 or greater finding during the slit lamp examination, subjects with corneal infiltrates, of any grade, are not eligible. * any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * anisometropia (spherical equivalent) of greater than 2.00 d. * any systemic disease affecting ocular health. * using any systemic or topical medications that will affect ocular physiology or lens performance. * aphakic. * amblyopic. * allergic to any component in the study products. * have had any corneal surgery (ie, refractive surgery). * currently wear monovision correction, multifocal, or toric contact lenses. * ocular astigmatism greater than 1.00 d in either eye.
understanding hallucinations (part i)

Conditions: Hallucinations; No Hallucinations

Summary: psychotic symptoms (hallucinations and delusions) are present in several psychiatric and neurological disorders as well as in the general population. effective treatment strategies for these symptoms in all patients are lacking and treatment-response can presently not be predicted. to date, the exact pathophysiological mechanism of these symptoms remains unknown. by investigating (subtypes) of hallucinations and delusions in all populations, a common pathway may be found, leading to more effective treatment options. alternatively, different subtypes may be associated with different pathophysiological mechanisms.


Eligibility criteria:
inclusion criteria: * age \> 18 years * mentally competent * in case of delirium: family member able to give informed consent * individuals with hallucinations will have to experience at least one episode of hallucinations over the last month. * individuals without hallucinations: no current hallucinations and a history of maximum 1 episode of hallucinations with a maximum duration of 1 week, at least two years ago. exclusion criteria: * age \<18) * participants that cannot read, speak or understand dutch * for all included diagnostic groups except delirium: mentally incompetent individuals who are not capable to provide informed consent, as determined by their treating physician.
a study of izalontamab brengitecan versus chemotherapy in participants with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer ineligible for anti-pd(l)1 drugs (izabright-breast01)

Conditions: Breast Neoplasms

Summary: the purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against egfr and her3 with a topoisomerase inhibitor payload versus treatment of physician's choice (tpc) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (tnbc) or estrogen receptor (er)-low, human epidermal growth factor receptor 2 (her2)-negative bc patients who are not candidates for anti-pd(l)1 therapy and endocrine therapies.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic tnbc (er \< 1%, pgr \< 1%, her2 ihc 0, 1+, or 2+ with fish negative for her2 gene amplification) or er-low, her2-negative bc (er and / or pgr 1% to 10%, her2 ihc 0, 1+, or 2+ with fish negative for her2 gene amplification) per asco/cap criteria, based on the most recently analyzed biopsy or other pathology specimen. * patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent. * patients with tnbc must be considered ineligible for 1l chemotherapy combination treatment with an anti-pd-1 or an anti-pd-l1 due to either one of the following criteria:. * investigator-determined ineligibility based on pd-l1 negative disease determined and documented prior to trial screening as part of soc. * has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-pd(l)1. * has a severe auto-immune disease or other contraindication. * patients with er-low, her2-negative bc must be ineligible, in the opinion of the investigator, for endocrine therapy-based treatments. * no previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting). * measurable disease by ct or mri as per recist v1.1. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: triple-negative breast cancer antibody-drug conjugate
spinal cord stimulation for low back pain

Conditions: Chronic Pain

Summary: the purpose of this study is to assess the acute and chronic effectiveness of the advanced bionics precision(tm) spinal cord stimulation system in subjects with failed back surgery syndrome and associated low back axial pain. subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.


Eligibility criteria:
inclusion criteria: 1. eligible for spinal cord stimulation as labeled in the fda approval for the precision(r) spinal cord stimulator by advanced bionics; 2. age ≥18 years; 3. have pain of neuropathic origin; 4. have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures. exclusion criteria: 1. enrollment in any research that would conflict with study requirements.

Keywords: back pain low back pain chronic pain spinal cord stimulation
fistura® procedure for the treatment of complex anal fistulas

Conditions: Complex Anal Fistulas

Summary: this study aims to evaluate the healing rate of complex fistulas using radiofrequency (fistura® procedure), in a prospective, interventional, monocenter, single-arm design.


Eligibility criteria:
inclusion criteria: 1. patients with complex fistulas complex fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas, fistulas involving multiple tracts (according to the ascrs) and fistulas with a curved tract or a tract presenting diverticula, for which: suppuration is described by the patient and/or visible by an opening in the anal margin or by anoscopy clinical symptoms led to an mri demonstrating the path fistula path demonstrated in the acute phase during drainage of an abscess 2. patient ≥ 18 years at study entry 3. patients with a previously drained fistula, without diverticula \> 10 mm, without t2 hyperintensity (assessed by mri). drainage is achieved by placing a seton, usually from 10 weeks to 12 months prior to the procedure 4. patient and investigator signed and dated the informed consent form prior to the procedure exclusion criteria: 1. patient \< 18 years at study entry 2. patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual longo anterior treatment staples) 3. patient has a known contraindication to mri 4. simple fistulas defined as inter-sphincteric or trans-sphincteric, involving less than 30% of the total height of the sphincter apparatus (attested by mri, ascrs classification) 5. patient has a fistula associated with radiation and inflammatory bowel disease 6. patient is unable/unwilling to provide informed consent 7. patient is unable to comply with the protocol or proposed follow-up visits and questionnaires 8. patient is currently participating in another clinical study 9. patient is pregnant
vascular events in surgery patients cohort evaluation - cardiac surgery

Conditions: Vascular Death; Myocardial Infarction; Stroke; Cardiac Surgery

Summary: worldwide over 2 million adults (\>30,000 canadians) undergo heart surgery annually. although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. there is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications. this study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. this study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. this information will facilitate further studies of timely interventions. in summary, the vision cardiac surgery study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patients who have undergone cardiac surgery. this includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement. exclusion criteria: 1. previously enrolled in the vision cardiac surgery study. 2. patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.

Keywords: cardiac surgery troponin vascular events myocardial injury observational cohort study public health
a safety, tolerability, pharmacokinetics, and pharmacodynamics study of jnj-28431754 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of jnj-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of jnj-28431754 compared to placebo in patients with type 2 diabetes mellitus.

this is a randomized (study drug assigned by chance), double-blind (neither physician, patient nor the sponsor knows the assigned treatment), placebo-controlled, single and multiple (14 days) ascending dose, parallel group study in 3 study centers (united states, germany and south korea). five cohorts (groups) of patients with type 2 diabetes mellitus (t2dm) will be studied. one dose level will be evaluated in each cohort. sixteen (16) patients will be randomly assigned to receive jnj-28431754 and four (4) patients to receive matching placebo within each cohort. the planned doses are 30, 100, 300 and 600 mg per day. twice-daily dosing may also be evaluated in one or more of the cohorts. an additional cohort of asian patients will also be evaluated at a dose level, which was previously tested in a prior cohort and considered to be well tolerated. blood and urine samples will be collected from patients during the study for pharmacokinetic and pharmacodynamic assessments. the safety and tolerability of jnj-28431754 will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * patients must have been diagnosed with type 2 diabetes for at least one year before screening * patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications * males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months) * body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2 exclusion criteria: * history of type 1, brittle diabetes or secondary forms of diabetes * history of repeated severe hypoglycemic episodes * history of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis * history of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the investigator to be clinically significant

Keywords: diabetes mellitus, type 2 jnj-28431754 canagliflozin sodium glucose co-transporter (sglt2 inhibitor) pharmacokinetics pharmacodynamics
comparison of ultrasound-determined and intraoperative #enzian-classification in patients with deep endometriosis

Conditions: Endometriosis

Summary: the enzian classification, which was developed in order to describe deep endometriotic (de) lesions, is determined intraoperatively by the surgeon. transvaginal ultrasound (tvs) examination is considered as the first-line imaging technique for endometriosis. the aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #enzian compartments by a preoperative ultrasound examination to the definitive intraoperative enzian classification using the latest revision of the enzian classification (#enzian).

endometriosis is a common disease with endometriotic lesions being found in the ovaries, peritoneum, or as deep endometriosis (de) involving different pelvic organs and structures. in order to describe de lesions, the enzian classification was developed. in the last revision of this enzian classification, the so-called #enzian, presence and severity grades of ovarian and peritoneal endometriosis as well as adhesions involving tubes and ovaries are also described in addition to de lesions. the enzian classification is determined intraoperatively by the surgeon. transvaginal ultrasound (tvs) examination is considered to be the first-line imaging technique for this disease. therefore, the aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #enzian compartments by a preoperative ultrasound examination (in the form of an us-#enzian classification) to the definitive intraoperative enzian classification (op-#enzian) using the latest revision of the enzian classification (#enzian).

Eligibility criteria:
inclusion criteria: * all women who are scheduled for a radical surgical treatment of deep endometriosis (de) and who undergo preoperative evaluation by transvaginal sonography (tvs) exclusion criteria: * diagnosed or suspected malignancy * previous colorectal surgery or previous surgery for de including full thickness bowel resection, vaginal resection or excision of a de lesion involving the urinary bladder * virgo intacta women

Keywords: endometriosis deep endometriosis (de) transvaginal sonography (tvs) enzian classification #enzian classification
factors influencing patient satisfaction in an egyptian sample after orthodontic treatment of different malocclusions

Conditions: Patient Satisfaction

Summary: previously, patient satisfaction with orthodontic treatment has been reported at a broad range of 34% to 95% but these values mostly represent satisfaction for tooth alignment or simple satisfaction with treatment results. in keeping with the increased focus on patient satisfaction, many other factors were put into consideration in our study which contributes to the level of total satisfaction as host factors, concerns regarding the treatment, treatment motivation and discomfort during or after treatment. there are also a lack of studies conducted for orthodontic treatment satisfaction using previously validated questionnaires as well as correlation between patient's treatment satisfaction and abo grading hasn't been sufficiently discussed in the literature, this study aims to address that gap. it would be also beneficial to investigate the frequency of different malocclusions presented in a sample of postorthodontic patients as it will give an insight about the distribution of the different malocclusion treated within the clinic and the degree of success in treating such malocclusions.

research procedure in brief: the following will be done for each participant: collection of patients telephone numbers: through the orthodontic department patient's database ensuring complete confidentiality. telephoning the patients for follow ups after orthodontic treatment and asking them to fill in a questionnaire during their visit for explaining our aim for the study. personal data chart: including name, age, date of birth, mobile number and address. examination of pretreatment records of the patients included in the sample to detect the type of malocclusion presented initially. orthodontic treatment satisfaction questionnaire: the questionnaire is reviewed by faculty experts to determine whether the items in the questionnaire truly represent the items to be measured. the translated questionnaire's face validation is led by the expert faculty members who are specialists in both english and arabic guaranteeing clarity, intelligibility and comprehensiveness of items. this is significant in light of the fact that while performing any questionnaire in another setting, not all of the items may be compatible to egyptian culture and lifestyles. in addition, a portion of items may not be applicable to specific age groups. abo grading system study models will be selected from the orthodontic department database. the post-treatment models will be assessed using the mgs of the american board of orthodontics.

Eligibility criteria:
inclusion criteria: * male and female patients with different malocclusions who received and completed their fixed orthodontic treatment. * age: 16 years old or above. * patients who have completed their orthodontic treatment between november 2020 and november 2021. exclusion criteria: * patients who refuse to participate in the study. * patients below 16 years old. * illiterate patients. * patients who finished their treatment before november 2020 and after november 2021