Kornimate/medical-research-clean huggingface dataset:
repeated high-dose inhaled corticosteroids for asthma

Conditions: Asthma

Summary: the purpose of this study is to to compare the effects of high-dose inhaled corticosteroids (ics) vs. placebo in adults with chronic stable asthma.


Eligibility criteria:
inclusion criteria: * physician diagnosis of asthma. * age ≥18 years and ≤50 years * evidence of airflow obstruction as measured by spirometry and flow-volume loop per american thoracic society guidelines. * treatment for asthma with: * daily inhaled corticosteroids and long-acting beta2-agonists, and * as-needed use of a short-acting beta2-agonist exclusion criteria: * history of \>10 pack-year tobacco use * other pulmonary or cardiac diagnosis that is actively being treated * history of adverse events or allergy to fluticasone * systemic corticosteroid therapy within 7 days of study visit * inability to obtain written informed consent

Keywords: acute asthma fluticasone inhaled corticosteroids
andecaliximab with mfolfox6 as first line treatment for advanced gastric or gastroesophageal junction adenocarcinoma

Conditions: Gastric Adenocarcinoma

Summary: the primary objective of this study is to compare the efficacy of andecaliximab (gs-5745) versus placebo in combination with modified fluorouracil (5-fu), leucovorin (lv), and oxaliplatin (oxa) (mfolfox6) as measured by overall survival.


Eligibility criteria:
key inclusion criteria: * adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that is inoperable, locally advanced or metastatic and not amenable to curative therapy * adequate hematologic, liver, coagulation and kidney function * eastern cooperative oncology group (ecog) ≤ 1 * evaluable disease per response evaluation criteria in solid tumors (recist) v 1.1 key exclusion criteria: * previous chemotherapy for locally advanced or metastatic gastric cancer. * human epidermal growth factor receptor 2 (her2)-positive gastric cancer * hiv, hepatitis b virus (hbv), or hepatitis c virus (hcv) infection * pregnant or breast feeding women * individuals with known or suspected central nervous system metastases or individuals requiring chronic daily treatment with oral corticosteroids * grade ≥ 2 peripheral neuropathy note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: gastroesophageal junction (gej) stomach cancer
contingency management for alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from investigational device exemption regulations \[21 code of federal regulations 812.2(c)

to test the feasibility/acceptability and efficacy of a minimum viable product (mvp) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).

Eligibility criteria:
inclusion criteria: participants in the pilot study will be 60 new intakes to gosnold's outpatient substance use disorder (sud) program who: * are \>18 years old; * meet dsm-5 criteria for current (past year) alcohol use disorder, at least moderate severity; * identify alcohol as the primary drug problem; * currently use alcohol (past 7 days) or have been in treatment 14 days or less and used alcohol within 7 days of treatment entry; * have and use an android or ios smartphone with acceptable * capability; * are willing to participate in home testing and use of the smartphone, * speak and read the english language adequately to understand smartphone commands and responses and * are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature. exclusion criteria: • participants must not currently be suicidal or actively psychotic, by clinician judgement.
regular antibacterial photodynamic therapy on oral hygiene in the elderly 24-hour care

Conditions: Inflamed Gums; Dryness Oral; Plaque

Summary: this study aims to determine the effectiveness of the lumoral device on oral hygiene, inflammatory load, and dryness of mouth in elderly 24-hour care residents. the second aim is to investigate the usefulness and benefits of the ammp-8 chair-side test and the lumoral device in improving the oral hygiene of elderly people. in addition, the study will investigate the usability of lumoral assessed by different care professionals to evaluate the need for oral care and plaque control procedures in elderly residents.

the dental condition of elderly care customers is often poor. cavities and dental connective tissue disease are widespread in people over 75 and older. untreated oral infections in patients or residents living in institutional care predispose to pneumonia, among other complications. chronic oral infectious diseases, and sometimes fatal complications, are preventable with good oral hygiene. as people get older, their ability to function deteriorates, and the elderly, especially those living in round-the-clock care, have been found to have shortcomings in maintaining oral hygiene. only a small part of the population had clean teeth, and the worse the level of oral hygiene, the worse the quality of life. regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping your mouth healthy. unfortunately, this is not always the case with round-the-clock care, and new practices are needed to improve oral hygiene. the use of antibacterial photodynamic therapy (apdt) and antibacterial blue light has been studied and found to reduce the amount of plaque in the mouth. the lumoral device is a ce-marked home medical device that has been shown to be effective in reducing the development of plaque and harmful bacteria in the plaque. the performance of the device is based on the apdt method, in which the photosensitive substance in the lumorinse mouthwash attaches to the bacterial coating and is activated as an antibacterial by light. the antibacterial effect is applied directly to the plaque, reducing the impact on the normal oral flora. preliminary studies have found that the method reduces inflammatory factors in periodontitis.

Eligibility criteria:
inclusion criteria: * a 24-hour care resident; * understand and able to give consent to the study; * at least 10 functional teeth in the mouth (including implants); * able to brush teeth and follow the instruction for use lumoral treatment, based on the assessment by the nursing staff. exclusion criteria: * incapable of participating in the study based on the assessment of the nursing staff * toothless or less than 10 functional teeth in the mouth (including implants) * unwilling or unable to give consent

Keywords: lumoral lumorinse plaque anti-bacterial photodynamic therapy apdt ammp-8
inspire continuation post-approval study

Conditions: Bronchiolitis Obliterans

Summary: to evaluate long-term bos-free survival outcomes of the ocs™ lung inspire trial patients.


Eligibility criteria:
inclusion criteria: * participant in transmedics ocs lung system inspire trial exclusion criteria: * none
efficacy/safety of cilnidipine plus valsartan versus valsartan in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy


Eligibility criteria:
inclusion criteria: * essential hypertension patients whose blood pressure is not controlled before the study (sdbp≥90mmhg for drug-treated patients, sdbp≥95mmhg for drug-naive patients) exclusion criteria: * ssbp≥80mmhg after 4weeks of valsartan 160mg treatment * has a history of hypersensitivity to dihydropyridines or angiotensin ii receptor blockers
short-term exposure to lipophilic anti-proliferative drugs delivered by angiographic contrast media

Conditions: Coronary Artery Disease

Summary: this was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patients with de novo lesions in coronary arteries. thirty-two patients were included into the trial, which were divided into four treatment groups. a total of four concentration levels of paclitaxel-iopromide concentrations were investigated. in each treatment group, six patients received iopromide-paclitaxel and two patients placebo (iopromide without paclitaxel). in each patient, the doses were adjusted individually as needed.

background: non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and initial clinical trials. paclitaxel dissolved in the angiographic contrast agent iopromide was well tolerated and inhibited neointimal proliferation in a dose-dependent manner after injection into porcine coronary arteries. methods: as a first step in entering clinical development, a phase i trial was performed using 4 ascending paclitaxel dose/concentration levels: samples of up to 100 ml of the contrast agent containing 10, 50, 100 or 200 μm paclitaxel were randomly administered to 6 adult patients each assigned to bare metal stent implantation for single de novo coronary artery lesions, while 8 patients treated with plain contrast medium served as controls. safety variables and tolerability as well as angiographic parameters were assessed.

Eligibility criteria:
inclusion criteria: * male and postmenopausal female patients * aged 18 years and older * clinical evidence of stable or unstable angina, a positive functional test and a stentable de novo lesion in a native coronary artery * diameter stenosis \> 70% (visual estimate), lesion length \< 25 mm, and a vessel diameter ≥ 2.5 mm. exclusion criteria: * acute myocardial infarction * left ventricular ejection fraction of \< 30% * aorto-ostial lesion * unprotected left main lesion or a bypass graft * clear angiographic calcification in the target lesion * visible thrombus proximal to the lesion * chronic total occlusion * platelet count \ 700,000 cells/mm3 * wbc \<3,000 cells/mm3 * known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, stainless steel * sensitivity to contrast media not amenable to adequate premedication * medical illness (i.e. cancer, liver disease or congestive heart failure) associated with a life expectancy of less than two years

Keywords: stent contrast media paclitaxel stent implantation
telehealth intervention for improving distress and financial toxicity in the caregivers

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (cs+hipec) demonstrate that they endure high depressive symptom burdens and financial distress. further, they experience symptom trajectories that differ from those of patients. in short, they require differential timing of supportive interventions. this study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.

primary objective: i. to assess the feasibility of a telehealth navigation intervention for cs+hipec caregivers. secondary objectives: i. to assess the efficacy of the intervention on financial distress and depression in intervention and standard of care caregivers. ii. to compare financial distress in intervention caregivers as compared to standard of care caregivers. iii. to compare satisfaction with care experiences in intervention caregivers as compared to standard of care caregivers. iv. to compare self-efficacy for navigating treatment-related costs in intervention caregivers as compared to standard of care participants. v. to compare self-reported community resource use among intervention and standard of care caregivers. vi. to compare the quality of life over time in intervention caregivers as compared to standard of care caregivers. vii. to compare social support over time in intervention caregivers as compared to standard of care caregivers. viii. to compare treatment satisfaction for intervention caregivers as compared to standard of care caregivers. outline: participants are randomized to 1 of 2 groups. group i: participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery. group ii: participants receive standard caregiving experience on study. after completion of study intervention, participants are followed up at 3, 6, 12, and 24 months.

Eligibility criteria:
inclusion criteria * primary caregiver of a patient scheduled to receive cs+hipec * access to a computer or smartphone and must have an email address * 18 years of age or older * the ability to understand and willingness to provide written informed consent * the ability to read and write english exclusion criteria - patient declines access to their medical record
gene polymorphism in tinea versicolor

Conditions: Recurrent Pityriasis Versicolor

Summary: blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and koh examination, for the detection of gene polymorphism in il17 a and il17 f. in addition , serum samples from patients and controls will be tested for 25(oh)2 d3


Eligibility criteria:
inclusion criteria: * - patients with recurrent pityriasis versicolor (active now) and not taking treatment for it. * patients of both genders. * age ≥18 years old. exclusion criteria: * - patients with other cutaneous diseases. * patient's having dandruff (scaly scalp) even if not symptomatizing. * pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects. * patients with autoimmune diseases. * patients with immunodeficiency diseases. * immunosuppressed patients e.g. hiv, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.
comparison of classical prosthesis and silicone prosthesis

Conditions: Traumatic Amputation

Summary: the purpose of this study is to investigate the effects of classical chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral chopart amputation.

the purpose of this study is to investigate the effects of classical chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral chopart amputation. this study will be useful for prescribing the appropriate prosthesis in patients with chopart amputation.

Eligibility criteria:
inclusion criteria: * aged between 18-65 * having a unilateral traumatic chopart amputation * to have completed prosthesis training * using prosthesis for at least 6 hours a day * being at k3-k4 activity level exclusion criteria: * bilateral lower extremity amputation * presence of wound on stump * presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

Keywords: amputation chopart satisfaction
us-ct fusion for post implant dosimetry

Conditions: Prostate Cancer

Summary: post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. ct imaging is the standard of assessment but due to contouring uncertainties, mr-ct fusion is preferred. this is not always available due to financial restrictions. this study explores the possibility of post implant us-ct fusion to improve contouring accuracy and potentially replace the use of mr-ct fusion.

25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate us images at the completion of their procedure. this will add approximately 5 minutes to the duration of their brachytherapy procedure. the us study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. the institution standard of care for quality assurance will be complied with, obtaining a ct and mri of the prostate at 30 days after the procedure. these will be co-registered and analyzed in the normal fashion. in addition, the post implant us images will also be co-registered with the ct and the resulting dosimetric parameters compared.

Eligibility criteria:
inclusion criteria: * localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost exclusion criteria: * unable to undergo mri

Keywords: prostate cancer brachytherapy quality assurance
non-interventional study to evaluate the change in symptoms scores and treatment response after 4 weeks of proton-pump inhibitors (ppi) treatment

Conditions: Gastroesophageal Reflux

Summary: the primary objective of the study is to describe the change in gerdq sum scores, after a 4-week period of systematic treatment with ppis(using gerdq questionnaire). the secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (gerdq questionnaire)


Eligibility criteria:
inclusion criteria: * provision of informed consent * patients known or newly diagnosed with gerd or patients with typical symptoms of gerd- heartburn, regurgitation (in the last case, gerdq sum score should be ≥8, in the absence of ppi treatment) exclusion criteria: * any symptoms at visit 1 suggesting a need for further investigation, judged by the investigator (alarm symptoms).the alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia. * previous participation in the present study

Keywords: gerdq questionnaire
muscle energy technique and foam roller self myofascial release in two-wheeler riders with chronic low back pain

Conditions: Chronic Low-back Pain

Summary: pain in the lower back is a major concern in today's era due to prolonged sitting in two-wheeler riders, mainly due to hamstring tightness. it also creates physical disability and impairment in activities of daily living. this study aimed to compare the efficacy of muscle energy technique (met) and self-myofascial release (smfr) using the foam roller on hamstring flexibility, dynamic balance, and physical disability amongst two-wheeler riders with chronic low back pain. participants were randomized into two intervention groups, met and smfr, using the envelope method, with each group having 20 participants. hamstring flexibility and range of motion for knee extension and the lower back were assessed using the active knee extension test and sit and reach test, the dynamic balance was assessed by the star excursion balance test (sebt) and physical disability by roland-morris disability questionnaire, (rmdq). measurements were taken at baseline and after 4-week of intervention. the level of significance value was set at 95% (p \<0.05).

the present study proved that both smfr using the foam roller and met are effective in improving hamstring muscle flexibility, dynamic balance, and physical disability in two-wheeler riders with chronic low back pain. thus, either of the two techniques can be used for treating bikers with tight hamstrings causing chronic low back pain. compared to met, smfr using foam rollers was found to be more effective in enhancing hamstring flexibility, improving balance, and decreasing disability levels on the rmdq after 4 weeks. this study will be aware of the necessity of hamstring stretching and balance training among two-wheeler riders for a prolonged duration on a daily basis and take the initiative to improve their hamstring flexibility and balance.

Eligibility criteria:
inclusion criteria: * two-wheeler riders of either gender between the ages of 20 and 40 years, * who had ridden at least two hours per day for the previous two years, * had musculoskeletal pain in the back for the previous three months, and * had a 15-20-degree loss of knee extension when hips were held in 90-degree flexion. exclusion criteria: * pregnant women, * those with a recent spine or lower limb fracture, recent surgery, * a previous hamstring injury, * lumbar and lower limb neurological deficits, or limb length disparity.

Keywords: hamstring flexibility muscle energy technique self-myofascial release foam roller dynamic balance physical disability sit and reach test active knee extension
percutaneous laser ablation in benign thyroid nodules.long term results

Conditions: Thyroid Nodule

Summary: thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. the incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. the majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. long-term levothyroxine treatment has, however, several well-known side effects and limitations. during the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (pla) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects. aim of the study: 1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy; 2. to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up; 3. to demonstrate reproducibility of results within different environments and under different operators; 4. to validate eventual presence of major or minor side effects. to this aim we shall randomized 200 patients either for pla (100 pts) or standard follow-up. patients will be recruited, treated and followed in 4 italian centers (ospedale regina apostolorum - roma, arcispedale s. maria nuova - reggio emilia, ospedale s. maria della misericordia - perugia, ospedale di cisanello - pisa) by physicians with experience in pla.the scientific coordinator of this multicentre study is dr. claudio maurizio pacella.


Eligibility criteria:
inclusion criteria: * the presence of a single nodule or dominating nodule; * a solid or mixed echo-structure with less than 20% fluid volume; * a lesion volume between 5 and 18 ml (greatest diameter \> 3.0 cm and \<= 4 cm); * thyroid hormone and tsh serum levels within the normalcy value; * 2 cytologically negative examinations for suspected neoplasia (british thyroid association, second class thy)within the last six months; * calcitonin values within the normalacy value; * anticoagulant treatment suspension and antiaggregation treatment suspended for at least 72 hours. exclusion criteria: * hyperfunctioning lesion (99mtc scintigraph); * autoimmune thyreopathy or elevation of autoantibodies; * active anticoagulant treatment or antiaggregation treatment.