Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of single dose of 5 mg zoledronic acid in chinese patients with paget's disease of bone (pdb)

Conditions: Paget's Disease of Bone

Summary: the purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the chinese patients of paget's disease of bone (pdb).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pdb by radiological reports * serum alkaline phosphatase level (sap) at least two times the upper limit of the normal (uln) exclusion criteria: * history of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates; * history of malignancy of any organ system * severe liver or bladder disease; * calculated creatinine clearance \< 35 ml/min at baseline; * hypocalcaemia; * patients with pre-existing dental diseases or who predict to have dental surgeries during the study; * evidence of vitamin d deficiency. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: paget's disease of bone serum alkaline phosphatase
microlearning application for diabetes prevention

Conditions: PreDiabetes; Elevated Blood Sugar

Summary: the purpose of this study is to test the effectiveness of a mobile application diabetes prevention program delivered with microlearning and microcoaching.

patients with prediabetes who are interested in joining a diabetes prevention program will be randomized to either the mobile application diabetes prevention program or the traditional diabetes prevention program, which is delivered as a mixed program of in-person and virtual sessions. study participants in the mobile application version will download the health u app from the apple application store. the user will complete the daily microlearning modules and the health coach interactions within the health u application. the 12-month diabetes prevention program will follow the widely clinically-validated cdc get active to prevent t2 curriculum. for participants participating in the in-person version, they will complete the diabetes prevention program, which meets in-person and virtually approximately once every two weeks.

Eligibility criteria:
inclusion criteria: * 18 to 85 years old * high risk for type 2 diabetes (history of gestational diabetes, a1c 5.7-6.4) exclusion criteria: * pregnant * non-english speaker * not comfortable using a mobile application
perception of the covid-19 pandemic in patients with haematological or solid neoplasias

Conditions: Covid19

Summary: cancer patients are among the most vulnerable individuals, whose health-related quality of life (hrqol) may be substantially impacted by the covid19 pandemic. we want to study how the covid-19 pandemic influences the life of cancer patients and how these patients cope with the additional distress with the aim to facilitate the development of improved future interventional strategies to maintain resilience and hrqol

in december 2019, the novel human pathogenic virus "sars-cov2" from the coronavirus family was identified, causing a respiratory disease known as "covid19" (coronavirus disease 2019). covid19 manifests itself primarily with influenza-like symptoms, but in special cases it can lead to severe conditions such as ards (acute respiratory distress syndrome). compared to other pulmotropic viruses such as the influenza virus, sars-cov-2 is associated with a higher contagiousness and mortality. haematological and oncological patients are particularly vulnerable due to their advanced age, immunological restrictions in the context of the underlying disease and the treatment modalities (chemotherapy, radiation therapy, ...). to evaluate the effects of the covid19 pandemic on the perception of patients with malignant diseases, we aim to record so-called "patient-reported outcomes" (pros) from patients at the university hospital of innsbruck at the department of internal medicine v (hematology and oncology) and at the department for radiotherapy and radiation oncology. we use the validated eort qlq-c30 and a specially developed questionnaire for covid19.

Eligibility criteria:
inclusion criteria: * age \> 18 years * validated hematological or oncological disease * informed consent exclusion criteria: * age \< 18 years * insufficient discernment

Keywords: sars-cov-2 covid19 pandemic cancer patients distress hrqol
pharmacokinetics of glpg2737 in male subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of glpg2737.


Eligibility criteria:
inclusion criteria: * male subject ≥18 years of age on the day of signing the informed consent form (icf). * a confirmed clinical diagnosis of cf. * two mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene belonging to class i and/or class ii and/or class iii (documented in the subject's medical record or cf registry). * weight ≥40 kg. * exocrine pancreatic insufficiency (documented in the subject's medical record). * stable concomitant medication regimen for at least 2 weeks prior to study drug administration. * forced expiratory volume in one second (fev1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator). exclusion criteria: * history of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator. * unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration. * history of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices). * use of cftr modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
circulating tumor dna after neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: trial assessing the prognostic value of ctdna mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.

patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of ct2cn0 tumors) are preselected before the surgical procedure. they are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included). sequential plasma samples for ctdna mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. in case of relapse patients will be proposed to participate to an optional research program with a blood test for ctdna assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Eligibility criteria:
inclusion criteria : 1. age ≥ 18 years (no age limit). 2. women or men. 3. invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy): 1. locally advanced tumor known to be inoperable from the start: * ct4a, b, c, d whatever the cn * or cn2 or cn3 whatever the ct. 2. operable tumors: * ct2cn1 or ct3cn0 or ct3n1, * or ct2cn0 for which ganglionic invasion has been proven by cytology or histology. 4. lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (m0). 5. unilateral or bilateral breast cancer. multifocality is accepted. 6. patients who received 6 to 8 cycles of neoadjuvant chemotherapy. 7. preoperative radiation therapy allowed. 8. breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypt0 /is ypn0). 9. signed informed consent. 10. patients affiliated to a french social security scheme in accordance with article 1121-11 of the french code of public health. 11. possible inclusion in another interventional research (surgical, radiotherapy or drug study). exclusion criteria : 1. ct2cn0 tumor without cytological or histological lymph node involvement. 2. progression during neoadjuvant chemotherapy. 3. exclusive neoadjuvant hormone therapy. 4. complete blood transfusion within 120 days prior to 1st sampling. 5. history of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. however, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible. 6. patient unable to follow and comply with research procedures for geographical, social or psychological reasons. 7. patient deprived of liberty or subject to a legal protection measure.

Keywords: breast cancer neoadjuvant chemotherapy circulating tumor dna
pain-related evoked potentials in unilateral peripheral nerve injuries

Conditions: Peripheral Nerve Injuries

Summary: the study examines pain-related evoked potentials (prep) in patients with peripheral nerve injuries. since previous studies found altered latencies and amplitudes of prep in generalized polyneuropathies, e. g. hiv-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.


Eligibility criteria:
inclusion criteria: * peripheral nerve injury exclusion criteria: * polyneuropathy * contralateral peripheral nerve injury * severe psychiatric disorders * disorders affecting central nervous system
barrier enhancement for eczema prevention

Conditions: Eczema

Summary: the primary objective is to determine whether advising parents to apply emollient (moisturiser) to their child's skin for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only.


Eligibility criteria:
inclusion criteria: * child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma * child up to 21 days old * consenting adult has the ability to understand english exclusion criteria: * preterm birth (defined as birth prior to 37 weeks gestation) * sibling (including twin) previously randomized to this trial. if multiple births, the first child will be randomized into the trial. * child has a severe widespread skin condition that would make the detection and/or assessment or eczema difficult * child has a serious health issue, which, at parent or investigator discretion, would make it difficult for the family to take part in the trial * any condition that would make the use of emollient inadvisable or not possible
atibar - efficacy and safety of two doses of allert in patients allergic to birch pollen

Conditions: Allergic Rhinitis

Summary: a multicentre, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of allert, a combination of contiguous overlapping peptides derived from bet v 1, in adults with birch pollen allergic rhinitis/rhinoconjunctivitis


Eligibility criteria:
inclusion criteria: * adult subjects 18 to 65 yrs old, male or female * moderate to severe allergic rhinitis/rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons * positive skin prick test (spt) to birch pollen extract * positive specific ige cap to bet v1. exclusion criteria: * persistent non-controlled asthma (forced expiratory volume, fev1 \< 85% of predicted), * previous specific immunotherapy (sit) to tree pollens, * previous sit to any allergen within 5 years, * previous history of severe anaphylactic reaction, * perennial allergic rhinitis/rhinoconjunctivitis, * other disorder possibly influencing the trial outcomes, * pregnancy, * any severely debilitating disease, * primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).
a study to compare the effects of insulin peglispro and glargine on insulin sensitivity and meal time insulin requirements in type 2 diabetics

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. the study has two treatment periods, each of which will last about four weeks. one drug (insulin peglispro or insulin glargine) will be administered in each period. participants will receive both drugs during the study. participants may remain on stable dose metformin, as prescribed by their personal physician.


Eligibility criteria:
inclusion criteria: * stable glycated hemoglobin (hba1c) less than (\<) 10.0 percent (%) * stable dose of either 0.2 to 1.5 units per kilogram per day (u/kg/day) basal insulin or a total daily insulin dose l\<2.0 units per kilogram (u/kg) * c-peptide \<0.3 nanomole per liter (nmol/l) * stable body during the last 2 months exclusion criteria: * corrected qt interval (qtc) prolongation greater than (\>) 500 milliseconds (ms) or have any other abnormality in the 12 lead * abnormal blood pressure * a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from type 1 diabetes mellitus (t1dm)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data * currently treated with oral antidiabetic drugs (oads) (excluding metformin and dipeptidyl peptidase-4 (dpp4) inhibitors), or glucagon-like peptide-1 (glp-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect pg or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization * fasting triglycerides (tgs) \>400 milligrams per deciliter (mg/dl) (4.52 millimoles per liter (mmol/l)) * have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization * currently receive insulin by pump or insulin degludec * poorly controlled diabetes or known to have poor awareness of hypoglycemia * history of gastroparesis or gastrointestinal malabsorption * require treatment with any drug other than insulin to treat diabetes * previous history of proliferative retinopathy * excessive consumers of xanthines
chest wall influence on respiratory system mechanics in morbidly obese patients

Conditions: Obesity; Intra-Abdominal Hypertension

Summary: the goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure. the effects of increasing and decreasing positive end-expiratory pressure (peep) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation. patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. then, patients will be evaluated again during weaning from the ventilator to assess the influence of peep in assisted ventilation prior to extubation.

the goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. investigators want to describe how extreme obesity and intra-abdominal hypertension (iah) affect normal respiratory system behavior. the effects of increasing and decreasing positive end-expiratory pressure (peep) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation. investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of peep. patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. patients will then again be evaluated during weaning from the ventilator to assess the influence of peep in assisted ventilation prior to extubation. investigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. improper mechanical ventilation leads to lung damage. high ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. all of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. adequate peep and transpulmonary pressure are fundamental in preventing this vicious cycle.

Eligibility criteria:
inclusion criteria: * 18 years or older * requiring intubation and mechanical ventilation * bmi≥40 kg/m2 or iap≥12 mmhg exclusion criteria: * known presence esophageal varices * recent esophageal trauma or surgery * severe thrombocytopenia (ptl≤10,000/mm3) * severe coagulopathy (inr≥2) * presence of pneumothorax * pregnancy * patients with diagnosed moderate to severe ards or with poor oxygenation index (pao2/fio2 \< 200 mmhg)

Keywords: respiratory mechanics esophageal pressure functional residual capacity positive end-expiratory pressure
implementing music therapy for video-assisted thoracoscopic surgery patients: a quality improvement initiative

Conditions: Pain Assessment; VATS; Music Therapy

Summary: the purpose of this project is to introduce and implement music therapy as an evidence-based pain management protocol focused on reducing postoperative pain levels among video-assisted thoracoscopic surgery (vats) patients in the post-anesthesia care unit (pacu) of the project site. the clinical question guiding this initiative is: in adult patients undergoing a vats procedure, does the implementation of music therapy lead to lower postoperative pain scores in the pacu compared to no intervention within an 8-week timeframe? the investigator will ask eligible patients their immediate pain scores upon arrival into the pacu and then start music of patient's choice via over-the-ear headphones. pain scores will be rechecked 30 minutes after implementation of music therapy. the standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.

the clinical question guiding this initiative is: in adult patients undergoing a vats procedure, does the implementation of music therapy lead to lower postoperative pain scores in the pacu compared to no intervention within an 8-week timeframe? the investigator will ask eligible patients their immediate pain scores upon arrival into the pacu and then start music of patient's choice via over-the-ear headphones. pain scores will be rechecked 30 minutes after implementation of music therapy. the standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and older with lung mass diagnosis undergoing vats exclusion criteria: * individuals with dementia, neurocognitive disorders, or chronic pain conditions.
biomarker effects of alz-801 in apoe4 carriers with early alzheimer's disease

Conditions: Early Alzheimer's Disease

Summary: the study will investigate the effects of oral alz-801, in subjects with early ad who have the apoe4/4 or apoe3/4 genotype, on the biomarkers of core ad pathology. the objectives of this study include determining the efficacy and safety/tolerability of alz-801. in addition, the study will evaluate the extended pk profile over 8 hours in 16 subjects after 65 weeks of treatment.


Eligibility criteria:
inclusion criteria 1. age between 50 and 80 years, inclusive. 2. early alzheimer's disease (ad): a diagnosis of probable ad dementia or mild cognitive impairment (mci) due to ad in accordance with the national institute on aging-alzheimer's association (nia-aa) working group criteria \[albert et al, 2011; mckhann et al, 2011\]. 3. one of the following apolipoprotein e (apoe) genotypes - either apoe4/4 (homozygous) or apoe3/4 (heterozygous). 4. mmse score 22 to 30 inclusive; clinical dementia rating (cdr)-global score of 0.5 or 1.0, and cdr memory box score of ≥ 0.5. 5. documented confirmation of ad diagnosis by either positive amyloid positron emission tomography (pet) or positive csf ad signature. subjects without documented positive ad biomarker status must have a positive csf biomarker result from a sample provided at screening. 6. stable doses of acetylcholinesterase for the duration of the study are allowed. exclusion criteria 1. brain mri at screening indicative of significant abnormality 2. diagnosis of neurodegenerative disorder other than ad 3. current diagnosis of major depressive disorder (mdd) 4. concomitant treatment with memantine.
adipose-derived mesenchymal stem cells in acute respiratory distress syndrome

Conditions: ARDS

Summary: currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ards). mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. the main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ards.


Eligibility criteria:
inclusion criteria: 1. ards diagnosed using berlin definition 2. eligible patients were at least 18 years of age had acute onset of ards. 3. bilateral opacities in chest radiography 4. no cardiac failure 5. pao2/fio2 ratio \< 200 exclusion criteria: 1. 72 hours after all inclusion criteria met 2. pre-existing severe diseases of any major organs 3. pregnancy 4. pulmonary hypertension 5. malignant diseases 6. hiv infections.

Keywords: ards mesenchymal stem cells safety cytokines