Kornimate/medical-research-clean huggingface dataset:
oral supplementation of astaxanthin on skin photoaging, hydration and elasticity

Conditions: Photoaging

Summary: this study is a double-blind placebo controlled study to assess whether oral astaxanthin can improve skin hydration, skin elasticity, improve skin pigmentation, and reduce facial redness.


Eligibility criteria:
inclusion criteria: * females who are 30 to 55 years of age * half of the women will have fitzpatrick skin type 1-3 and the other half of the women will have fitzpatrick skin type 4-6 exclusion criteria: * individuals with a known allergy to astaxanthin or other carotenoids (such as zeaxanthin, lutein, lycopene). * individuals who are unwilling to discontinue carotenoid supplementation for at least 1 month prior to enrollment * individuals unwilling to restrict intake of foods like shrimp, salmon, mangos, carrots, and tomatoes during the study. * new supplementation within 4 weeks with tocopherol * individuals who are unwilling to stay consistent with a facial cleansing regimen. * those who are unwilling to discontinue topical hydroquinone, retinoid or benzoyl peroxide for 2 weeks prior to enrollment * individuals who are pregnant or breastfeeding. * individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. * current tobacco smoker or a tobacco smoking history of greater than 10 pack-years

Keywords: carotenoid astaxanthin skin hydration elasticity
reproducibility of rnfl and onh measurements in oag with heidelberg spectralis sd-oct glaucoma module premium edition

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to assess and compare the repeatability of sd-oct (spectralis™ oct, version 6.0, heidelberg engineering, germany) rnfl thickness measurements with a new software (glaucoma premium module) with the well established peripapillary rnfl thickness measurements in patients with primary open angle glaucoma.

the purpose of this study is to assess and compare the repeatability of sd-oct (spectralis™ oct, version 6.0, heidelberg engineering, germany) rnfl thickness measurements with the new software (method b) and with the previous method of measurement (method a) in patients with glaucoma. it is a prospective, not blinded, not randomised, monocentric study. inclusion of 50 patients with a diagnosis of primary open angle glaucoma (poag), that will be recruited from the ophthalmology outpatient department of the universityhospital zurich, switzerland. all patients will undergo a full ophthalmic examination including measurement of refraction, best corrected visual acuity, examination of anterior and posterior compartment and measurement of the intraocular pressure. on the same day they will have 3 oct examinations with a new method of measurement (method b).on the same day the first 10 patients will undergo also 3 oct examinations with the previous method (method a) and they will get an other 3 oct examinations with method b by a second observer. for this 10 patients the next consultation (3 months +/- 1 month) the 3 oct examinations with method b will be repeated by the first observer. primary objectives are coefficient of variations (cov) of method a and b; intra-class-correlations (icc) of method a and b.

Eligibility criteria:
inclusion criteria: * diagnosis of poag glaucoma * male and female patients aged 18 years or older, no upper limit * written informed consent * visual acuity of more or equal to 0.5 snellen * refractive error between + /- 6.00 d spheric and under or equal than 2.00 d cylindrical exclusion criteria: * history of surgery other than uncomplicated cataract surgery * disease affecting cornea, anterior compartment, lens, vitreous body * history of severe ocular disease, particularly diseases affecting the optic nerve, other than glaucoma * history of ocular trauma
study of ezatiostat (telintra tablets) for treatment of severe chronic neutropenia

Conditions: Severe Chronic Neutropenia

Summary: this is a multicenter phase 2 randomized parallel-group study to determine the effect of telintra treatment on severe chronic neutropenia. patients will be randomized to telintra or enter an observation period with an option to crossover to telintra treatment in a 1:1 allocation.


Eligibility criteria:
inclusion criteria: * confirmed idiopathic severe chronic neutropenia * ecog performance status of 0-2 * adequate liver and renal function * adequate red blood cell and platelet counts exclusion criteria: * prior treatment of scn * non-idiopathic types of scn, ie. cyclic, congenital * history of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia * use of granulocyte colony stimulating factors (g-csf), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment * history of bone marrow transplantation or stem cell support

Keywords: hematology neutropenia scn severe chronic neutropenia idiopathic telintra ezatiostat hydrochloride ezatiostat tlk199 glutathione glutathione analog glutathione transferase glutathione transferase inhibitor glutathione transferase p1-1 inhibitor gstp1-1 inhibitor apoptosis differentiation enzyme inhibitor
pilot study of intralymphatic immunotherapy (ilit) for house dust mite, cat, and dog allergen in allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the investigators performed open-labeled pilot study which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ilit) for allergens including dermatophagoides farinae (df), dermatophagoides pteronyssinus (dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.

after informed consent, causal allergen was injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. initial dose of allergen was 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (30 au/ml for df or dp, 10 au/ml for cat hair, and 1:1/10 weight/volume for dog hair/dander, hollisterstier, new orleans, usa) in volume of 0.1ml. after the first dose, allergen concentration was escalated 3-fold at second dose, and 10-fold at third dose if there was no or mild local or systemic hypersensitivity reaction. the allergen concentration did not change at second or third dose if there was moderate local or systemic reaction. the allergen concentration was decreased by 10 or 100-fold from previous concentration if there was severe local or systemic reaction. the investigators evaluated parameters regarding allergic rhinitis within a week before the first injection and 4 months after the first injection. these parameters included rhinoconjunctivitis quality of life questionnaire (rqlq) and sino-nasal outcome test (snot-20), and visual analogue scale (vas) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life. skin prick test, intradermal test, blood sampling for serum allergen-specific ige, exhaled nitric oxide, and nasal lavage for th1, th2, and treg cytokines were also included. adverse events were recorded and graded according to muller's classification and ring and messmer's classification.

Eligibility criteria:
inclusion criteria: * allergic rhinitis to house dust mite (df, dp), cat or dog * more than 3mm reaction at skin prick test for df, dp, cat or dog or more than class 3 at serum specific ige level (unicap or mast) exclusion criteria: * uncontrolled or severe asthma according to global initiative of asthma (gina) guideline * fev1 less than 50% of predicted value if there is comorbid asthma * subject rejects the enrollment into study * low compliance * pregnancy or lactation * significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases * administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks * prior history of allergen-specific immunotherapy * allergic rhinitis caused by other perennial or seasonal allergen * vulnerable volunteer
predictive models for radiation-induced side effects in head and neck cancer based on single nucleotide polymorphisms (snp)

Conditions: Head and Neck Cancer

Summary: background of the study: swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (rise) after (chemo) radiation ((ch) rt) in head and neck cancer (hnc) patients and have a major impact on the general dimensions of quality of life (qol). in radiation0oncology, normal tissue complication probability (ntcp) models based on dose-volume parameters being used to determine the risk of acute and late rise. ntcp models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (snps), may improve model performance and thus enable more individualized radiotherapy. information of the predictive value of snps or snp signatures among patients with hnc is currently not available. objective of the study: the main objective of this project will be to test the hypothesis that snp profiles can improve the performance of predictive models for the most frequently reported late rise, i.e. dysphagia, in hnc patients after curative (ch) rt. secondary objectives will be improvement of ntcp models for hnc patients by adding snp profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated hnc symptoms and ; (9) quality of life.


Eligibility criteria:
inclusion criteria: * histological proven head and neck cancer * primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands * treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment * northern european ethnicity (ethnicity is a known confounder in snp association studies) * willing and able to comply with the study prescriptions * 18 years or older * no prior radiation (in the head and neck area) * patients must have sufficient knowledge of the dutch language to understand the meaning of the study as described in the patient information * have given written informed consent before patient registration exclusion criteria: * prior radiotherapy

Keywords: head and neck neoplasms genome-wide association study polymorphism, single nucleotide toxicity
a study to evaluate the safety, tolerability, pharmacokinetic properties and preliminary efficacy of 9mw3811 in patients with advanced solid tumors

Conditions: Advanced Malignant Solid Tumor

Summary: this is a single ascending dose study of 9mw3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9mw3811 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. male or female participants between 18 and 75 years of age, inclusive. 2. histologically or cytologically confirmed advanced malignant solid tumors, for which standard therapy does not exist or has proven ineffective or intolerable. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. life expectancy of ≥ 3 months. 5. participants must have measurable disease according to recist (version 1.1). 6. adequate organ functions. 7. sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy. exclusion criteria: 1. participants with cancerous meningitis and/or central nervous system metastases with clinical symptoms. 2. history of other active malignant tumor within 3 years prior to screening. 3. suffering from poorly controlled body cavity effusion. 4. suffering from active autoimmune disease. 5. history of chronic obstructive pulmonary disease (copd), pulmonary fibrosis, or other respiratory diseases that require hospitalization within 4 weeks prior to the first dose of study drug. 6. history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug. 7. history of other severe or uncontrolled systemic disease, i.e. poorly controlled diabetes. 8. previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 9. major surgery within 28 days prior to the first dose of study drug. 10. participants with one or more clinically significant positive test results of hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody, treponema pallidum antibody or human immunodeficiency virus (hiv) antibody. 11. participants who have received treatment with biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy within 2 weeks prior to the first dose of study drug; radical radiotherapy received within 3 weeks or palliative radiotherapy received within 2 weeks prior to the first dose of study drug; received treatment with chemotherapy within 3 weeks prior to the first dose of study drug (6 weeks for nitrosourea or mitomycin); received treatment with oral fluorouracil or small molecule targeted drugs within 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is shorter); received treatment with anti-tumor traditional chinese medicine within 1 week prior to the first dose of study drug; participated in other clinical trials within 4 weeks prior to the first dose of study drug. 12. participants who have received systemic treatment with immunosuppressants within 2 weeks prior to the first dose of study drug.
communication and education for the new cpap experience

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (pap) adherence) in patients newly diagnosed with obstructive sleep apnea (osa).

continuous positive airway pressure (cpap) therapy is an effective treatment for obstructive sleep apnea (osa), but adherence is poor. cpap adherence interventions to date have been met with limited success. intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. significant others (so) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (pap) therapy and are frequently described as the greatest source of social support for patients with chronic illness. beginning the intervention before pap initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. the aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between pap adherence and patients' and partners' sleep quality and daytime functioning. patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.

Eligibility criteria:
inclusion criteria: patient: * age is 21 years of age and older * have spouse or partner * polysomnographically (psg) diagnosed osa (ahi ≥ 5) * choice of continuous positive airway pressure (cpap) as preferred treatment partner: * age is 18 years of age and older * have spouse or partner who has been diagnosed with osa and has chosen cpap as preferred treatment exclusion criteria: patient: * ahi \< 5 on the diagnostic psg * have a spouse or partner with osa diagnosis and on osa treatment * past treatment for osa * diagnosis of a sleep disorder other than osa that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia) * diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma) * history of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner: * have been diagnosed with osa and using cpap

Keywords: continuous positive airway pressure patient compliance intervention studies spouses
impact of negative pressure ventilation in patients hospitalized with acute hypercapnic respiratory failure

Conditions: Acute Hypercapnic Respiratory Failure

Summary: the study aims to find if using a biphasic cuirass ventilation is as effective as using a non invasive positive pressure ventilation in patients admitted with acute hypercapnic respiratory failure.

patients presenting via emergency room or inpatients who are noted to be in acute hypercapnic respiratory failure will be approached for consent and if they are agreeable will be randomized to the standard of care arm which would be the use of bilevel positive pressure ventilation via face mask vs the intervention arm which would use the biphasic cuirass ventilation. patients will be monitored and treated in the medical icu and will be regularly clinically assessed as per usual standard of care. the study investigators will obtain periodic arterial/venous blood gas sampling to assess for improvement or lack thereof in patients carbon dioxide levels. if patients' condition doesn't improve or deteriorates their primary treating physician will have full authority to withdraw such patients from study and or change the modality of the patient's treatment. this is a pilot study, and the investigators are aiming to compare the success rate of biphasic cuirass ventilation when compared to non-invasive positive pressure ventilation.

Eligibility criteria:
inclusion criteria: * admission diagnosis of hypercapnic respiratory failure * ph between 7.20-7.35 in an abg sample or ph between 7.16-.31 in a venous sample. exclusion criteria: * age \<21 * pregnant * inmate/prisoner * contraindication for cuirass ventilator (open chest wound, flail chest, prior thoracic surgery) * chest wall defect, neuromuscular disease or diaphragmatic paralysis. * bmi \>50
comparing cardiac output measurements using a wearable, wireless, non-invasive ppg-based device to a swan ganz catheter

Conditions: Cardiac Output, Low; Cardiac Output, High; Congestive Heart Failure

Summary: invasive pulmonary capillary wedge pressure measurements using a swan-ganz catheter (sgc) is considered the gold standard for cardiac output (co) monitoring. in this prospective study, we will compare co measurements between a ppg-based wearable monitor and a sgc in ambulatory chf patients.


Eligibility criteria:
inclusion criteria: * patients with chf exclusion criteria: * pregnant women * pediatric patients * inability to sign an informed consent form

Keywords: non-invasive monitoring cardiac output
serum neuroglobin and hif-1α in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke. hypoxia inducible factor (hif)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral infarction in humans and experimental animals.the investigators sought to examine the changes in serum neuroglobin and hif-1α concentrations in patients with acute ischemic stroke during the initial 96-h period after stroke and assessed the relation between them and the relation of them to prognosis of such patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute ischemic stroke * admission within 12 hours exclusion criteria: * lacunar infarction * cerebral hemorrhagic infarction * epilepsy or epileptic persons * history of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases * contraindications to antiplatelet treatments * serial blood samples could not be obtained

Keywords: neuroglobin hif-α acute ischemic stroke prognosis
prehabilitation feasibility among older adults undergoing transplantation

Conditions: Multiple Myeloma

Summary: this is a pilot feasibility trial among older adults (≥60y) scheduled to undergo autologous stem cell transplantation at uab. participants will be randomized into either a prehabilitation program or an attention control group before their transplant. the primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.

this is a pilot randomized trial of older adults 60y and above planned to undergo autologous stem cell transplant for multiple myeloma. eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma * scheduled for asct at uab within 10 weeks of study enrollment * age at asct ≥60y exclusion criteria: * at high risk for impending pathologic fracture using mirels score

Keywords: autologous stem cell transplant
triple-therapy in patients with hcv genotype 3 who previously failed treatment

Conditions: Hepatitis C

Summary: the purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with peginterferon α-2b + ribavirin + boceprevir (prb) in patients with hcv genotype 3 who previously failed peginterferon α + ribavirin (non-responders or relapsers).

i) obtain preliminary information on the association between important baseline and on-treatment factors and svr in this patient population. variables to be examined may include gender, age, advanced fibrosis or cirrhosis (f3 or f4 estimated by fibroscan), baseline viral load, rvr, wk 8 viral load, end-of-treatment viral response. ii) evaluate adverse events. iii) evaluate viral resistance.

Eligibility criteria:
inclusion criteria: * subjects will be eligible for the study if they meet the following inclusion criteria: 1. 18 years of age or older 2. infected with hcv genotype 3 (mixed genotypes are not permitted) 3. have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin 4. detectable serum hcv-rna 5. no significant co-morbid conditions 6. liver biopsy is not necessary 7. cirrhotic patients will be eligible to participate if child-pugh class a (maximum 15% of subjects) exclusion criteria: * subjects will be excluded from participation in this study if the following conditions are present: 1. significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma. 2. active substance abuse within the past 12 months 3. co-infection with hepatitis b or hiv 4. decompensated cirrhosis (child-pugh class b or c) 5. significant cytopenia - any of the following: platelets \<80 x 109/l, neutropenia \<1.2 x 103/l, hb \<120 g/l for men or 110 g/l for women 6. lack of informed consent 7. previous null-responders (\<2 log10 decrease at week 12 with previous pr therapy)

Keywords: boceprevir hepatitis c genotype 3