Kornimate/medical-research-clean huggingface dataset:
the evaluation of a mask seal/mask for the treatment of obstructive sleep apnea (osa)

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.

a minimum of 15 osa participants who currently use a full face mask will be recruited for the trial. participant will be on the trial for 1 week- the participant will use the trial seal in-home for 1 week. an additional 5 participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * apnea hypopnea index (ahi)≥ 5 on diagnostic night * prescribed pap for osa * existing oro-nasal mask user exclusion criteria: * inability to give consent * patients who are in a coma or a decreased level of consciousness * anatomical or physiological conditions making automatic positive airway pressure (apap) therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency * current diagnosis of carbon dioxide (co2) retention * pregnant or may think they are pregnant
virtual pain care management (covid-19)

Conditions: Chronic Pain

Summary: the covid-19 pandemic is exacerbating the challenges faced by veterans at risk of opioid overdose including veterans prescribed moderate-to-high dose long-term opioid therapy (ltot) whose usual treatment resources and coping strategies may be inaccessible. this project combines established va care components to deploy and evaluate virtual models of care for veterans on high-risk ltot to meet the dual challenges of maintaining social distancing and delivery high quality care.


Eligibility criteria:
inclusion criteria: * eligible participants must currently receive ltot for chronic pain at 50 mg morphine equivalent daily dose exclusion criteria: exclusion criteria at baseline are: * dementia diagnosis or moderate-severe cognitive impairment * unstable or severe untreated psychiatric disorder or medical disease that requires hospitalization * documentation of suspected controlled substance diversion * inability to communicate by phone

Keywords: buprenorphine
the use of reiki for patients with advanced aids

Conditions: Acquired Immunodeficiency Syndrome; HIV Infections

Summary: this study will investigate the use of reiki, an energy-based complementary and alternative medicine (cam) intervention, as an approach to improve well-being for patients with advanced aids, and evaluate its effects on dimensions of well-being and quality of life.

this study will investigate the use of reiki, an energy-based complementary and alternative medicine (cam) intervention, as an approach to improve well being for patients with advanced aids, and evaluate its effects on dimensions of well being and quality of life. the study is a two-group comparison between participants receiving reiki plus usual medical care (treatment) and participants receiving usual medical care only (control). one hundred and forty-six patients with advanced aids will be enrolled and randomized into the two groups. patients in the intervention (reiki) group will receive a total of three one-hour reiki sessions over a period of 6 weeks. participants in both the intervention and control groups will be assessed at two times during the study period using repeated measures. we will investigate and compare changes in participants' anxiety, depression, pain, quality of life, and spiritual well being at the end of the intervention period. this is the first part of a longer-term research agenda to examine the use and effectiveness of complementary and alternative medicines for patients with advanced disease. we plan to examine one clinical context in which reiki is currently provided. it is important to design studies that respect both the context of care and the practitioner-client relationship-elements essential to an understanding of the philosophy and delivery of cam such as reiki, and at the same time endeavor to outline a systematic approach to the study of cam.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced aids, defined as: cd4 count of less than 200 during the past 12 months; * on haart for at least 6 months; * over age 18; * decisionally capable of providing informed consent. exclusion criteria: * not capable of providing informed consent because of psychiatric limitations, e.g. active psychosis.

Keywords: complementary therapies alternative medicine complementary and alternative medicine subtle energy therapy reiki hiv/aids
glp-1 and microvascular function in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: some gut hormones, called incretins, stimulate insulin production in order to control sugar levels but also activate brain centres and signal to stop eating. current administration of incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the skin) injection and has been routinely available for diabetic patients for more than 4 years. it is an effective treatment for the lowering of blood glucose with an average weight loss of about 3-4kg.recent evidence, from animal studies and limited human studies, suggests that incretins based treatments may also have beneficial effects on blood vessel function. however, it is not known whether this effect is by direct action on the blood vessel independent of an improvement of latent inflammation which is typically associated with weight loss or an anti-inflammatory effect of the incretin treatment itself. the aim of this study is to determine whether the incretin-based diabetes treatment with the glp-1 (glucagon-like peptide 1) analogue liraglutide (also known as victoza), which mimics the actions of incretins, improves blood vessel function in individuals with type 2 diabetes. it will determine whether the improvement in blood vessel function is independent of the effect of weight loss and changes in inflammation. this by the study of vascular function before and after 4 months of victoza treatment in subjects with type 2 diabetes in comparison with 1) participants randomized to hypo-caloric diet to achieve a similar weight loss than with victoza and 2) participants randomized to treatment with once daily aspirin. comprehensive assessment of blood vessel function, body fat distribution and metabolic profile at baseline and at the end of the treatment phase will be combined with assessments of inflammation markers in blood and in fat tissue biopsies.


Eligibility criteria:
inclusion criteria: * type 2 diabetes and an hba1c between 7-8.5% on a stable dose of sulphonylurea and/or metformin exclusion criteria: * use of insulin * corticosteroids * contraceptives, tamoxifen * methotrexate * dpp-iv inhibitors * pregnancy * lactation * endocrine disorders * acute mi or cerebrovascular disease * raynaud's disease or connective tissue disease * current or previous history of malignancy * subjects treated with ergotamine derivatives * unstable blood pressure for the last 3 months * current treatment with warfarin * subjects on any anti-inflammatory or anti-platelet agents * history of any bleeding disorders and gi bleeds.

Keywords: glp-1 analogues microvascular inflammation fat tissue clot structure
pioglitazone hydrochloride in preventing head and neck cancer in patients with oral leukoplakia

Conditions: Head and Neck Cancer; Oral Leukoplakia

Summary: this phase ii trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. the use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.

primary objectives: i. determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia. secondary objectives: i. determine the safety and tolerability of this drug in these patients. outline: this is an open-label study. patients receive pioglitazone hydrochloride orally (po) once daily (qd) for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma. patients are followed up at 4, 8, 12, and 16 weeks.

Eligibility criteria:
criteria: * ecog 0-2 * diagnosis of oral cavity or oropharyngeal leukoplakia meeting 1 of the following criteria: * biopsy-proven hyperplasia in high-risk anatomic areas (e.g., floor of the mouth, mobile tongue, oropharynx, or in any erythroplakia lesion) * mild, moderate, or severe dysplasia at any site of the oral cavity or oropharynx within the lesion * measurable lesion that is clinically characterized by leukoplakia, erythroplakia, or erythroleukoplakia * able to be assessed by bi-directional measurements * life expectancy: more than 3 months * hemoglobin \>= lower limit of normal for males and post-menopausal females or * hemoglobin \>= 11 g/dl for premenopausal females * wbc \> 3,000/mm\^3 * hepatic: bilirubin \< 1.5 times upper limit of normal (uln); ast and alt \< 1.5 times uln * renal: bun \< 1.5 times uln; creatinine \< 1.5 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception * no contraindication to thiazolidinediones * no allergy to pioglitazone or other thiazolidinediones * no serious oral infection * no invasive carcinoma within the past 60 months except nonmelanoma skin cancer or carcinoma in situ of the cervix * no concurrent malignancy * more than 3 months since prior biologic or immunologic therapy * no concurrent insulin for diabetes * no prior radiotherapy to the oral cavity * more than 3 months since prior chemopreventative agents * more than 3 months since prior experimental therapy * more than 3 months since prior megadose vitamins or alternative therapy * no prior thiazolidinediones * no prior participation in this study * no concurrent pharmacologic treatment for diabetes * concurrent chronic use of non-steroidal anti-inflammatory drugs allowed * platelet count \> 125,000/mm\^3 * index lesion must be located in an anatomic site accessible by punch biopsy
combined access closed tympanomastoidectomy: microsurgery allied to endoscopy

Conditions: Cholesteatoma; Chronic Otitis Media

Summary: chronic otitis media is a prevalent medical condition, leading to important impact in the lives of the individuals with this condition, and a great amount of patients may need surgical intervention. the main objectives of the surgery in these cases are to restore the anatomy of the middle ear, to improve hearing and to remove the infection to avoid further complications. still, chronic otitis media with cholesteatoma presents high rates of recurrence and residual symptoms after surgery. the standard technique used for treatment of chronic otitis media is microsurgery. nonetheless, with the development of new technologies that use endoscopy, it is now possible to use endoscopic surgery to improve the visualization of the cholesteatoma and ear structures by combining both techniques. this study will evaluate the efficacy of the combined access surgery technique, which is microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with cholesteatoma. furthermore, the study aims to compare the results of the combined access technique and the standard technique by randomizing the patients in two groups: one group will receive tympanomastoidectomy by standard technique and the other group will receive combined technique.

patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be randomized into two groups. in the first group, microsurgical tympanomastoidectomy will be performed; while combined technique will be performed in the other group. the combined technique improves the visualization of the middle ear canal and the mastoid. herewith, the best visualization of the surgical site facilitates the full removal of the cholesteatoma. in addition to that, the combined technique is less invasive than the standard one, since less bone debridement is required to access the surgical site. the outcomes of the study will be evaluated through follow up medical appointments and exams. the patients will be followed by monthly medical appointments with otoscopic evaluations for diagnose of possible recurrence of the disease or residual cholesteatoma. also, audiometry exams will be performed in the third, sixth and twelfth months. image exams such as nuclear magnetic resonance may be performed at the end of this period to evaluate relapse of the disease if the otoscopic evaluation is inconclusive.

Eligibility criteria:
inclusion criteria: * patients with cholesteatoma with indication for closed tympanomastoidectomy. exclusion criteria: * patients with malformation of the temporal bone or previous surgery in the ear eligible for the study.
rct to examine the effects of scanning

Conditions: Cancer; Breast Cancer; Colorectal Cancer

Summary: the purpose of the study is to implement a randomized control trial testing effects of information scanning on cancer prevention and screening behaviors in a population sample of 50-70 year olds. participants will receive one of five versions of an e-newsletter once/month for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.


Eligibility criteria:
inclusion criteria: * us adults, male or female, between 50 and 70 years of age. exclusion criteria: * potential subjects will be excluded if they are not between the ages of 50 and 70

Keywords: exercise nutrition mammography colorectal screening
soluble vascular endothelial growth factor receptor 2 as predictor of benefit from bevacizumab beyond progression in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: a growing amount of reports has consistently evidenced that a sustained inhibition of the angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic colorectal cancer (mcrc) patients. in the last decade different biologic agents targeting angiogenesis have been approved for the treatment of mcrc, such as bevacizumab, aflibercept and regorafenib, and, more recently, solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even beyond the first progression to a bevacizumab-containing regimen. in particular, two phase iii randomized trials proved the effectiveness of prosecuting bevacizumab in second-line switching the chemotherapeutic regimen in patients already treated with bevacizumab in first-line. preliminary experiences evidenced that circulating levels of angiogenesis-related markers are significantly modulated during first-line chemotherapy plus bevacizumab. in particular, a wide variability of plasma soluble vascular endothelial growth factor receptor-2 (vegfr-2) levels is observed at the time of disease progression and retrospective data suggest that benefit from the continuation of bevacizumab may be restricted to patients with high levels of soluble vegfr-2 at the first evidence of disease progression. this study aims at prospectively validating those retrospective data.


Eligibility criteria:
inclusion criteria: * male or female of ≥ 18 years of age * progressive disease during or after first-line chemotherapy plus bevacizumab, including fluoropyrimidine alone (5-fluorouracil or capecitabine), fluoropyrimidine in combination with oxaliplatin (xelox or folfox regimen) or irinotecan (folfiri regimen) or with oxaliplatin and irinotecan (folfoxiri regimen); * no more than 3 months from the last administration of bevacizumab and evidence of progressive disease are allowed; * measurable disease according to recist 1.1. * indication to second-line treatment with a bevacizumab-containing second-line regimen (second-line xelox, folfox, folfiri and folfoxiri plus bevacizumab are allowed); * neutrophils 1.5 x 109/l, platelets 100 x 109/l, hgb \>9 g/dl * total bilirubin 1.5 time the upper-normal limits (unl) of the institutional normal values and asat (sgot) and/or alat (sgpt) 2.5 x unl, or 5 x unl in case of liver metastases, alkaline phosphatase 2.5 x unl, 5 x unl in case of liver metastases * creatinine clearance \>50 ml/min or serum creatinine 1.5 x unl * urine dipstick of proteinuria \<2+. patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate \<1 g of protein/24 hr * will and ability to comply with the protocol * written informed consent to study procedures. exclusion criteria: * patient unable to give consent * absolute contraindications to the use of bevacizumab.
desvenlafaxine for treatment of hot flashes in women with breast cancer taking tamoxifen

Conditions: Hot Flashes; Breast Neoplasms

Summary: this study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. the purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.


Eligibility criteria:
inclusion criteria: i. women age 18 years and older with localized breast cancer. histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (dcis), lobular carcinoma in situ (lcis), or invasive adenocarcinoma of the breast stages i-iii a. ii. current daily tamoxifen use (≥ 6 days/week). any planned surgery, adjuvant chemotherapy or radiation must have been completed. iii. history of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. participants must have had bothersome hot flushes for at least one month prior to enrollment. exclusion criteria: i. women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression. iv. presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.

Keywords: hot flashes breast neoplasms tamoxifen desvenlafaxine succinate
parkinsonics: a controlled study of group singing in parkinson disease

Conditions: Parkinson Disease

Summary: the overall objective of this study is to observe the effect of group vocal performance training and performance experience on patients' reported symptoms and quality of life. the effectiveness of pd medications varies significantly in different patients depending on their symptoms. by using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in pd patients. "parkinsonics: a controlled study of group singing for quality of life and voice outcomes in parkinson disease" (pd) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic pd (progressing toward a group performance) and once weekly discussion/support group meetings.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd based on uk parkinson's disease society brain bank clinical diagnostic criteria for pd (hughes et al. 1992). exclusion criteria: * patients unable to consent to the study. * patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting. * patients with active psychiatric disturbances (agitation, active hallucinations).
evaluation of inflammation and pain post injection of ranibizumab vs aflibercept in patients with dme

Conditions: Diabetic Macular Edema

Summary: this study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with dme. the investigators will be evaluating patients (1-7 days) post injections for: 1. intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. pain (as measured on a standardized pain scale).

this is an open-label, phase ii study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with diabetic macular edema. treatment naïve and experienced patients will be enrolled. treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. patients will be randomized to receive either lucentis 0.3 mg or eylea 2.0 mg, and followed for a week. a non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. pain will also be recorded at these visits using a standardized pain scale. consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. a standard intravitreal injection protocol will be followed. patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. a non-injecting physician will evaluate the patients for anterior chamber and vitreous inflammation; this physician will be blinded about the specific treatment. anterior chamber inflammation is described as any cell or flare in the anterior chamber. these will be evaluated using standardization of uveitis nomenculature (sun) working group classifications. pain score will be evaluated using a numerical rating scale.

Eligibility criteria:
inclusion criteria: * subjects will be eligible if the following criteria are met: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 21 years * exam and oct confirming diabetic macular edema * visual acuity of 20/400 or better * no history of post injection pain or inflammation in the past exclusion criteria: * subjects who meet any of the following criteria will be excluded from this study * history of endophthalmitis in either eye * current inflammation in either eye * uncontrolled or symptomatic dry eye syndrome * intravitreal injection less than 3 months ago * history of anterior or posterior uveitis * history of post injection pain with prior treatments * recent thromboembolic event (\<3 months) * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception.