Kornimate/medical-research-clean huggingface dataset:
menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab

Conditions: Dermatologic Complications; Malignant Neoplasm; Pain

Summary: this clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab

primary objectives: i. explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (egfr) inhibitors. secondary objectives: i. explore the adverse event profile of a menadione topical lotion to the face to prevent rash from egfr inhibitors. ii. explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients apply menadione topical lotion twice daily (bid) for 28 days. arm ii: patients apply topical placebo lotion bid for 28 days. after completion of study treatment, patients are followed up for 4 weeks.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of egfr inhibitor toxicity. * ability to reliably apply menadione topical lotion / placebo twice a day to the face. * ability to complete questionnaire(s) by themselves or with assistance. * negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only. * willing to have photographs taken to assess rash. exclusion criteria: * any active facial and/or chest rash, including adult acne, at the time of randomization. * cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest. * use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks. * any type of ongoing therapy for rash. * any of the following: * pregnant women * nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects * use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.
observational and epidemiologic study of the disease course and unmet needs in children with symptomatic moderate to severe allergic asthma

Conditions: Moderate to Severe Allergic Asthma

Summary: the study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to \< 12 years of age, managed in a real-world setting.


Eligibility criteria:
inclusion criteria: * total ige ≥30 iu (historical values obtained within 3 months of screening visit will be accepted). if historic result not available, to be obtained at screening visit. * diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit * documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific ige test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit * prescribed inhaled corticosteroid for at least 3 months prior to screening (a) and having evidence of inadequately controlled disease either with at least one from list (b) or history of asthma-related exacerbations as defined in (c). \[e.g., a and (b or c)\] a. fluticasone dpi \> 200 mcg/day or equivalent ex-valve dose ics, or if ≤ 200 mcg fluticasone dpi or equivalent plus another daily controller medication (i.e. laba, leukotriene antagonist or theophylline) b. at least one of the following in the preceding 4 weeks prior to the screening visit: * on average asthma symptoms \> 2 days/week or multiple times in a day on ≤ 2 days/week * nighttime awakenings ≥ 2 times/month due to asthma symptoms * use of sabas \> 2 times/week on average * some limitation in activity due to asthma * on spirometric evaluation, fev1 ≤ 80% of predicted, fev1/fvc ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best c. minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit exclusion criteria: * subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of visit 1 or a biologic agent within 120 days of visit 1 * subjects with a history of prior use of omalizumab * subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder) * subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis * subjects with elevated serum ige levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin e syndrome, and wiskott-aldrich syndrome other protocol-defined inclusion/exclusion criteria may apply

Keywords: allergic asthma pediatrics exacerbations perennial aeroallergens inhaled corticosteroids
effectiveness of topical olive oil in prevention and management of radiation induced oral mucositis

Conditions: Radiation Mucositis; Oral Mucositis (Ulcerative) Due to Radiation; Radiation-Induced Mucositis

Summary: this research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy.

twenty adult patients seeking radiotherapy treatment for head and neck cancer are to be selected. patients meeting the eligibility criteria are to be equally and randomly allocated in 2 different groups. group 1 will include10 patients receiving topical olive oil application, twice daily (experimental arm). group 2 will include 10 patients receiving sodium bicarbonate 5% solution, twice daily (control arm). both intervention and control groups will start the application of the agents two days before the induction of radiotherapy. evaluation will be done using world health organization (who) scale for oral mucositis to record the extent and severity of oral mucositis. pain and discomfort will be evaluated using numeric rating scale (nrs). clinical evaluation using both scales will be performed after starting radiotherapy every other week ( after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). patients scores will be recorded at similar intervals. total antioxidant capacity "tac" will be used to study the biochemical effect of topical olive oil application by evaluating the oxidative stress in the saliva. saliva samples will be collected from all patients of both groups prior to the beginning of radiotherapy, and a second sample will be collected after six weeks.

Eligibility criteria:
inclusion criteria: * patients who are aged above 25 years up to 65 years. * both genders are eligible. * patients with head and neck cancer who are planned to receive radiotherapy either as postoperative (adjuvant after surgery) or definitive therapy. * patients planned to receive radiotherapy treatment with a dose of 60-70 gy. exclusion criteria: * patients with known sensitivity to olive oil and/or any of its products * patients with gingival or oral ulceration or mucositis * smokers * vulnerable patients (pregnant women, neonates, children, prisoners, persons with physical handicaps or mental disabilities) * pregnant and lactating women. * patients with any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) * patients suffering from any physical or mental disabilities that would interfere with or be affected by the study procedure.

Keywords: radiation mucositis oral stomatitis olive oil
pilot study of lateral rotation interventions for efficacy and safety in icu care

Conditions: Pneumonia, Ventilator Associated

Summary: intensive care unit (icu) patients on respirators are at high risk for preventable pulmonary complications (ppc). turning these patients from side to side may reduce ppc, but carries the burden of decreases in blood pressure and oxygenation. the investigators hypothesize that there will be no difference in ppc or adverse events when icu patients on respirators are turned by nurses or by an automated turning bed.

the purpose of this pilot study is to test the feasibility of two turning protocols and study procedures for a multi-site randomized clinical trial to evaluate efficacy and safety of horizontal positioning interventions to reduce pulmonary complications in mechanically ventilated critically ill adult patients. the hypothesis of the randomized controlled trial (rct) is no difference in pulmonary complications between manual, 2-hourly lateral rotation to \> 45 degrees (control), and continuous automated turning to 45 degrees (experimental) groups.

Eligibility criteria:
inclusion criteria: * receiving mechanical ventilation * ability to place on study protocol within 8 hours of intubation exclusion criteria: * pulmonary mass, pneumothorax, hemothorax, pleural effusion, or other source of compression atelectasis at time of assessment for eligibility * systolic blood pressure \< 90 mmhg with vasopressor support * orthopedic injuries requiring limited or complete immobilization * head injury requiring intracranial pressure monitoring * unstable spinal injuries * rib fractures * body weight \> 350 lbs * intubation within the previous 2 weeks

Keywords: lateral rotation kinetic therapy mechanical ventilation pulmonary complications
bee venom acupuncture for the treatment of chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.


Eligibility criteria:
inclusion criteria: * nonspecific, chronic low back pain over 3 months * must have lbp of more than vas 4 exclusion criteria: * cancer, vertebral fracture, spinal infection, inflammatory spondylitis * spinal operation * radicular pain * other musculoskeletal pain * physicological or mental disorders * allergic history to bv therapy or insect bite

Keywords: chronic low back pain bee venom acupuncture
adrenoleukodystrophy national registry study

Conditions: ALD (Adrenoleukodystrophy); Adrenoleukodystrophy; Cerebral Adrenoleukodystrophy

Summary: the aim of this registry to understand the natural history and disease progression in ald and potentially develop bio-markers using the biospecimens collected using this registry.

this is a prospective, non-therapeutic protocol designed to create and maintain a registry of participants with adrenoleukodystrophy (ald) and known/presumed mutation for ald. this study also involves maintaining a prospective biorepository to collect and store buccal swab, blood, stool and urine samples as well. in this protocol, pediatric (including infants), adolescents and adult patients with confirmed or presumed ald (based on positive vlcfa testing and/or confirmed mutation) will be offered potential study participation. additionally, presumed mutation for ald (based on pedigree or confirmed mutation) will be offered potential study participation. after appropriate consent (online or in-person), subjects will be requested to provide a medical history (with authorization of release of medical records), longitudinal biospecimens, and permission to perform laboratory analyses on these samples. the overall goal is to understand the natural disease course in affected and unaffected patients (identified patients and relatives with a diagnosis of ald), as well as women with ald to assemble a resource of clinical, medical, and biological data from the participants. this study also aims to understand the outcomes of this disease, as well as possibly develop biomarkers to identify prognostic markers for disease progression, which may help develop effective interventions. the biospecimen bank and registry will provide access to samples and data for the ongoing studies as well as will provide an important resource for the future research.

Eligibility criteria:
inclusion criteria * age 0 - 100 * ald patients or family member meeting any of the following criteria: * any patient diagnosed with ald (confirmed by positive vlcfa testing and/or genetic mutation). * known or presumed mutation with ald based on pedigree or confirmed mutation in abcd1 gene * participants living in the united states and territories exclusion criteria * patients diagnosed with ald who lack the capacity to consent/assent and do not have a designated legally authorized representative or guardian. * patients who have undergone bmt or other cellular therapy . * patients not fluent in english who are unable to consent in-person at the bmt journey clinic. * patients who are illiterate * patient determined by the pi or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)

Keywords: registry, vlcfa, abcd1, x-chromosome
multidimensional system as predictor of outcomes in obstructive sleep apnea: the osa-score

Conditions: Snoring; Sleep Apnea

Summary: purpose: in a retrospective cohort the investigators will validate, the goodness of a multidimensional index to classified the severity of patients with sleep disordered breathing that has been previously developed in a prospective longitudinal cohort.

methods. in the developing study, three variables were found as predictors of mayor outcomes and were incorporated in a multidimensional index: the apnea-hypopnea index, the severity of daytime sleepiness as quantified by the epworth questionnaire and the presence of current cardiovascular disease. the index (osa-score) has a value between 0 (less risk) to 5 (more risk). for each point, a significant increment in the risk of death was found. in the retrospective validation study, a number of potential variables will be recorded, all of them also predictors of major outcomes. data will be recorded by trained personnel on-site at the respiratory sleep units around the country. the final cohort will include 1100 subjects aged \> 18 years . the observation time will be considered since the time at diagnosis to fatal event and the patient will be censored when non-invasive ventilation was started or at the recorded time if the patient is alive. the primary outcome is all-cause death.

Eligibility criteria:
inclusion criteria: * adults patients (\> 18 years) exclusion criteria: * under 18 years old * unable to complete sleep study

Keywords: snoring sleep apnea sleep study cardiovascular outcomes
helicobacter pylori eradication with berberine quadruple therapy versus bismuth-containing quadruple therapy

Conditions: Gastritis; Peptic Ulcer; Dyspepsia

Summary: this study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in h. pylori eradication. it is hypothesized that berberine-containing quadruple therapy is non-inferior to bismuth-containing quadruple therapy. patients with confirmed h. pylori positive status will be randomized to one of the treatments described above. at week 2 and 6 follow-up visits, a urea breath test(ubt) will be performed to confirm eradication.

the study will include three phases: screening, treatment and follow-up. screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. endoscopy and urea breath test will be performed in addition to the baseline routine evaluations. treatment: subjects are randomly assigned to treatment and will be treated for 14 days. a randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 12 and 14. follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. eradication of h. pylori will be confirmed through urea breath test(ubt).

Eligibility criteria:
inclusion criteria: 1. age between 18\~70,both gender. 2. patients with upper gastrointestinal symptoms and with documented h.pylori infection. 3. patients are willing to receive eradication treatment. 4. women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. exclusion criteria: 1. patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with h. pylori. 2. contraindications to study drugs. 3. substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 4. constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening) 5. pregnant or lactating women. 6. underwent upper gastrointestinal surgery. 7. patients with barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. 8. evidence of bleeding or iron eficiency anemia. 9. a history of malignancy. 10. drug or alcohol abuse history in the past 1 year. 11. systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. enrolled in other clinical trials in the past 3 months.

Keywords: helicobacter pylori berberine-containing quadruple therapy bismuth-containing quadruple therapy
validation of an early warning score based triage system in the emergency department

Conditions: Critical Illness

Summary: at bispebjerg hospital we have introduced an early warning score based triage system , called bispebjerg early warning score (bews), in order to identify critically ill patient on arrival at the emergency department. the purpose of this study is to validate our triage system.


Eligibility criteria:
inclusion criteria: * "red" patient * seen in our emergency department between 1. april 2009 and 30. september 2009 exclusion criteria: * none
an observational study to learn more about the use of darolutamide as a part of a combination therapy in belgian men with metastatic hormone-sensitive prostate cancer in routine medical care

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Summary: this is an observational study in which only observations from routine clinical practices will be made. participants will not receive any advice on treatment or any changes to healthcare as a part of the study. in this study, medical records data of belgian men with metastatic hormone sensitive prostate cancer (mhspc) who had received or are receiving treatment with darolutamide in combination with androgen deprivation therapy (adt) and docetaxel will be studied. mhspc is a cancer of the prostate gland, a male reproductive gland found below the bladder. metastatic means that the cancer has spread to other parts of the body. hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (adt). adt lowers the level of androgens, male hormones, and slows down the growth of cancer cells. however, in some cases, adt alone is not sufficient for the treatment of mhspc and doctors recommend a combination of treatments. the study drug darolutamide, in combination with adt and docetaxel is an approved treatment for mhspc. darolutamide aims to work by blocking the androgens signals to slow the growth of the cancer cells. docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. the main purpose of this study is to learn more about the real-world use of darolutamide in combination with adt and docetaxel in belgian men with mhspc. to do this, researchers will study the following information about participants who are already prescribed this combination treatment by their treating doctors in real-word condition: * participants' cancer characteristics before starting the treatment, and * participants' treatment history the data will be collected between july 2024 to september 2024, from eligible participants' medical records. study doctors will only look at the medical records of adult men with mhspc in belgium. in this study, only available data from routine care will be collected. no visits or tests are required as part of this study.


Eligibility criteria:
inclusion criteria: * patients diagnosed with mhspc * patients treated with darolutamide (nubeqa, bay1841788) in combination with adt and docetaxel according to local reimbursement * initiation of treatment with darolutamide (nubeqa, bay1841788) in this indication between the index date (should be before 15mar2024) and start of data collection. exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice * contraindications according to the local reimbursement