Kornimate/medical-research-clean huggingface dataset:
effects of polyunsaturated fatty acids on intestinal lipid metabolism in insulin-resistant men

Conditions: Metabolic Syndrome

Summary: the overaccumulation of apolipoprotein (apo)b-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (cvd) risk. therefore, reduction of atherogenic plasma trl levels of intestinal origin appears to be crucial to improve cvd risk associated with insulin-resistance. in this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (sfas) by n-6 polyunsaturated fatty acids (pufas) reduces cvd risk in the general population. although the beneficial impact of n-6 pufas on cvd risk has been related primarily to favorable changes in plasma ldl-cholesterol levels, recent data suggest that chronic n-6 pufa consumption may also exert beneficial effects on cvd risk by reducing postprandial lipemia. the impact of substituting sfas by n-6 pufas on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal triglyceride-rich lipoproteins (trls) represent a large proportion of the atherogenic lipoproteins. the general objective of the proposed research is to investigate how dietary n-6 pufas in place of sfas modify intestinal lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. the investigators hypothesize that the intestinal secretion of apob-48-containing lipoproteins will be lower following a diet rich in n-6 pufas than after consuming a diet rich in sfas. the investigators also hypothesize that substitution of sfas by n-6 pufas will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.


Eligibility criteria:
inclusion criteria: * men aged between 18-60 years * waist circumference \> 102 cm * hdl-cholesterol \< 1.1 mmol/l * triglycerides \> 1.7 mmol/l * fasting blood glucose \> 6.1 mmol/l * normal blood pressure (\<130/85) exclusion criteria: * women * men \ 60 years * smokers (\> 1 cigarette/day) * body weight variation \> 10% during the last 6 months prior to the study baseline * subjects with a previous history of cardiovascular disease * subjects with type 2 diabetes * subjects with a monogenic dyslipidemia * subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa * subjects with endocrine or gastrointestinal disorders * history of alcohol or drug abuse within the past 2 years * subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
imaging of patients with known or suspected somatostatin receptor positive neuroendocrine tumors using cu64-dotatate

Conditions: Neuroendocrine Tumors

Summary: this is an open-label, single-dose, single-arm, single-center imaging study using dotatate peptide, labelled with the 64cu tracer.

in total, 59 subjects will be recruited in the study. the study will recruit both healthy volunteers as well as patients with confirmed or suspicious net disease by histology or conventional anatomical and functional imaging modalities including but not limited to magnetic resonance imaging (mri), and/or computed tomography (ct), and/or, f-18 fdg fluorodeoxyglucose pet (positron emission tomography)/ct and /or f-18 naf sodium fluoride bone pet/ct and/or bone scintigraphy, and/or octreoscan.

Eligibility criteria:
inclusion criteria: * confirmed or suspicion of net based on histology/ biopsy report. * confirmed or suspicion of net based on conventional imaging scans of affected area such as mri and/or contrast enhanced ct and/or an fdg pet * ct scan and/or naf pet-ct scan and/or octreoscan® performed within 8 weeks prior to study date. exclusion criteria: * pregnant, planning to be pregnant within the next two weeks * inability to provide written consent. * therapeutic use of any somatostatin analogue, including sandostatin® long-acting and lanreotide (within 28 days) and sandostatin® (within 2 days) prior to study imaging. if a subject is on sandostatin® long-acting or lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
registering genomics and imaging of tumors (regit)

Conditions: Glioma

Summary: this study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like mri and pet can predict these mutations.

this study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like mri and pet can predict these mutations. subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. subjects will complete two visits and will then undergo a follow-up period. at the baseline visit, subjects will under go a pregnancy test (if applicable), two pet-ct scans using different radioactive tracers, an mri scan, and blood draws. at the biopsy visit, the subject will undergo an mri scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. the study team will take pictures of the locations of tumor samples as they are removed during surgery. the samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. follow-up mris and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. the study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.

Eligibility criteria:
inclusion criteria 1. subject is between 18 and 89 years of age. 2. subject has radiologically-diagnosed or suspected who grade ii-iv glioma based on physician review or conformance with published who criteria as evaluated by the pi\*. 3. subject is treatment-naïve for the above condition. 4. subject is planning to undergo surgical resection and biopsy of their brain tumor. 5. subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection. 6. subject is able to read and write in english. 7. subject is able to lay supine for up to 80 minutes. 8. subject is able to hold still during mri procedures. 9. subject or their lar has signed the consent form for participation in the study. exclusion criteria 1. subject has conditions that would preclude the completion of an mri such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy. 2. subject has serious unstable medical or mental illness. 3. subject has insufficient tissue to acquire at least two biopsy samples during resection. 4. subject has a medical contraindication to any element of the study procedures. 5. subject or their lar has not read and signed the informed consent form, or does not understand its contents. 6. subject is pregnant.\*\* 7. subject is at high risk for nsf (egfr\ 1.3) and cannot follow the weight-based dosing protocol for gadavist.\*\*\*

Keywords: glioma glioblastoma
efficacy & safety of the oral neurokinin-1 antagonist, aprepitant, in combo with ondansetron & dexamethasone in patients undergoing auto peripheral blood stem cell transplantation

Conditions: Nausea; Vomiting

Summary: the purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.


Eligibility criteria:
inclusion criteria: * male or female patients 18 years of age or older * patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria * patients with non-hodgkins lymphoma, hodgkins lymphoma or multiple myeloma or amyloidosis * written informed consent exclusion criteria: * nausea at baseline * chronic use of other antiemetic agent(s) * gastrointestinal obstruction or active peptic ulcer * radiation therapy to pelvis or abdomen within 1 week before or after study day 1 * allogeneic stem cell transplant recipient * aspartate transaminase (ast) \> 3x upper limit of normal (uln) * alanine transaminase (alt) \> 3x uln * bilirubin \> 3x uln * alkaline phosphatase \> 3x uln * creatinine \> 2 * documented hypersensitivity to any component of study regimen * pregnant or lactating women * participating in a clinical trial which involves other investigational agent(s) * patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.

Keywords: patients with non-hodgkins lymphoma or multiple myeloma
comparison of two respiratory physiotherapy treatments in postcovid-19 patients.

Conditions: COVID-19; Respiratory Distress Syndrome

Summary: to test the effectiveness of a respiratory physiotherapy treatment plan in patients who have passed covid-19, comparing two randomized groups, for the performance of different respiratory musculature training protocols. to objectify the results data obtained by means of ultrasound measurements and spirometry, observing the differences obtained at the beginning and end of the study, verifying the effectiveness of the powerbreathe® ,therosold pep® tools and the effectiveness of diaphragmatic, abdominal and expiratory exercises.


Eligibility criteria:
inclusion criteria: * patients diagnosed with covid and suffering from functional limitations in the respiratory system. * patients over 18 years of age. * patients under 65 years of age. * patientes with cognitive ability to perform spirometry. * patients with the physical capacity to perform spirometry exclusion criteria: * - patients diagnosed with covid and without functional limitations in the respiratory system. * patients under 18 years of age. * patients over 65 years of age. * patients without cognitive capacity to perform spirometry. * patients without physical capacity to perform spirometry.
spinal cord compression. icorg 05-03, v6

Conditions: Spinal Cord Compression; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. it is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression. purpose: this randomized phase iii trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.

objectives: primary * to compare the response in patients with malignant spinal cord compression treated with single fraction (10 gy) radiotherapy vs standard multiple fraction (20 gy) radiotherapy. * to compare the toxicity of these treatment regimens in these patients. secondary * examine the safety, practicability, and efficacy of treatment with a single 10 gy fraction of radiotherapy in these patients. * analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients. * perform an economic impact analysis comparing the two treatment arms. outline: this is a multicenter study. patients are stratified according to participating center. patients are randomized to 1 of 2 treatment arms. * arm i (control): patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 gy). * arm ii: patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 gy). patients complete the eortc qlq-c30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter. after completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed malignancy, excluding the following: * leukemia * myeloma * germ cell tumor * primary tumor of the spine or vertebral column * diagnosis of malignant spinal cord compression confirmed by mri of the entire spine * deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment * no single bone metastasis with controlled primary site patient characteristics: * karnofsky performance status 30-100% * no medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation prior concurrent therapy: * no prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance

Keywords: spinal cord compression unspecified adult solid tumor, protocol specific
brief alcohol intervention for hiv-infected men who have sex with men (msm) in a primary care setting

Conditions: Hazardous Drinking; HIV

Summary: this is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking hiv-infected men who have sex with men compared to hiv care as usual. the study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better hiv-related outcomes.

this study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (msm), who receive their hiv primary care at fenway health in boston, are randomly assigned to treatment as usual (tau) or tau plus a brief intervention to reduce alcohol use (tau-bi). tau-bi will be based in motivational interviewing and include personalized feedback tailored to an hiv-infected msm population. follow-ups will occur at 3, 6, and 12 months. the first primary aim of the study is to test the hypothesis that tau-bi, compared to tau, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. the second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to hiv medication regimens; (2) less engagement in high-risk sexual behavior that could result in hiv transmission; (3) lower plasma hiv rna levels (viral load) (cd4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week * have a confirmed diagnosis of hiv/aids * be a male who has had sex (oral or anal) with a male partner in the past 3 months. exclusion criteria: * current intravenous drug use * currently psychotic, suicidal, or manic * are currently being treated or have been treated in the past 3 months for an hiv-related opportunistic infection * currently receiving treatment for an alcohol or drug problem
avonex 15 year long term follow-up study

Conditions: Multiple Sclerosis

Summary: the avonex fifteen-year long-term follow-up of patients with relapsing multiple sclerosis: assessment of drug utilization, early treatment, and clinical outcomes (assurance), was a single-time-point evaluation of patients conducted 15 years after the pivotal mscrg study, evaluated the impact of im ifnβ-1a treatment on long-term disability and quality of life outcomes in patients who completed 2 years in a previous multiple sclerosis collaborative research group (mscrg) study.

the primary objective of this study is to determine the impact of early versus delayed initiation of treatment on the long-term physical status of patients with relapsing forms of ms measured by the self-reported edss. primary endpoints for this study were as follows: 1. changes in edss score from baseline for original avonex® pivotal trial 2. percentage of patients with edss scores less than or equal to 4 3. percentage of patients with edss scores less than or equal to 6 4. percentage of patients with edss scores less than or equal to 7 secondary endpoints were: 1. percentage of patients alive 2. percentage of patients living independently 3. sf 36 quality of life status 4. self-reported vas of independence with self-care

Eligibility criteria:
inclusion criteria: 1. patients having completed at least 2 years of treatment (avonex® or placebo) in the original avonex® pivotal trial. 2. subjects (or their caregivers) must be willing to complete a multi-page questionnaire. 3. signed written informed consent form exclusion criteria: 1. unwillingness or inability to comply with the requirements of this protocol. 2. any other reasons that, in the opinion of the investigator, the subject is determined to be unsuitable for enrollment into this study

Keywords: avonex pivotal trial avonex avonex long term follow-up avonex outcomes
international collaborative gaucher group (icgg) gaucher disease registry & pregnancy sub-registry

Conditions: Gaucher Disease; Cerebroside Lipidosis Syndrome; Glucocerebrosidase Deficiency Disease; Glucosylceramide Beta-Glucosidase Deficiency Disease

Summary: the icgg gaucher registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with gaucher disease, irrespective of treatment status. no experimental intervention is involved; patients in the registry undergo clinical assessments and receive care as determined by the patient's treating physician. the objectives of the registry are: * to enhance understanding of the variability, progression, identification, and natural history of gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * to assist the gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * to characterize the gaucher disease population. * to evaluate the long-term effectiveness of imiglucerase and of eliglustat. gaucher pregnancy sub-registry: the primary objective of this sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. no experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.if a patient consents to this sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.


Eligibility criteria:
inclusion criteria: icgg gaucher registry * all patients with a confirmed diagnosis of gaucher disease are eligible for inclusion in the registry. confirmed diagnosis is defined as a documented β-glucocerebrosidase deficiency and/or mutation in the β-glucocerebrosidase gene. * for all patients, appropriate patient authorization will be obtained. gaucher pregnancy sub-registry: * be enrolled in the icgg gaucher registry. * be pregnant, or have been pregnant with appropriate medical documentation available. * provide a signed informed consent and authorization form(s) to participate in the sub-registry prior to any sub-registry-related data collection being performed. exclusion criteria: - no exclusion criteria for participation in the icgg gaucher registry and sub-registry.

Keywords: gaucher disease glucocerebrosidase deficiency disease
a personalized voice restoration device for patients with laryngectomy

Conditions: Dysphonia; Aphonia

Summary: the investigators will conduct a pilot experiment for a novel and personalized method for voice restoration using machine learning applied to surface emg (semg) signal from articulatory muscles of the face and the neck allowing recognition of silent speech. the investigators predict that the use novel personalized method for voice restoration will be feasible and successful for patients.

this is a prospective pilot study evaluating the feasibility of a personalized voice restoration device and patients' experience with it. study participation will include a one-time visit where subjects will read passages and phrases. acoustic and signal data will be captured. machine learning will be applied to the data to classify words. subjects will also participate in a qualitative interview about their experience with voice restoration devices.

Eligibility criteria:
inclusion criteria: group a: healthy volunteers 1. adult subjects, 18 or older 2. without any voice impairments group b: subjects with aphonia or dysphonia 1. adult subjects, 18 or older 2. documentation of severe dysphonia and/or aphonia, or a grbas score \> 0 (grbas is a scale that can be used to assess voice quality of subjects who do not have a recorded history of dysphonia or aphonia. the grbas scale evaluates for grade, roughness, breathiness, asthenia, and strain). exclusion criteria: - group a: healthy volunteers 1. voice impairment group b: subjects with aphonia or dysphonia 1. subjects whose face muscles are entirely paralyzed
pilot study of tens for ocular pain

Conditions: Eye Pain

Summary: approximately 20% of veterans have a diagnosis of dry eye (de) syndrome which is often accompanied by ocular pain that significantly impacts activities of daily living. currently very few treatments are available for chronic ocular pain, likely because the mechanisms underlying this type of pain have only recently begun to be studied. new treatments that target the neuropathic mechanisms contributing to this type of pain are needed. the proposed research provides a crucial step in addressing the lack of treatments for neuropathic ocular pain by validating the methodology needed to support a randomized controlled trial of transcutaneous electrical nerve stimulation (tens). tens is a non-pharmacologic, non-addictive, non-invasive treatment that has been shown to be effective in other chronic pain conditions. the present pilot study aims to address the need for preliminary support of safety and efficacy of tens for ocular pain, t to advance the study of new treatments for the long-term relief of chronic ocular pain and its impact on health.


Eligibility criteria:
inclusion criteria: * male or female * all races and ethnicities * at least 18 years of age * persistent eye pain for at least 6 months * average eye pain intensity of 4 or more on a 0-10 numerical rating scale * on a stable medication regimen for at least the past 3 months * naïve to tens use for orofacial conditions * eye pain having neuropathic-like characteristics exclusion criteria: * presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.) * contraindication to tens (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy) * patients with confirmed signs of tear dysfunction * current participation in another study with an investigational drug or device within one month prior to screening

Keywords: eye pain dry eye neuropathic pain transcutaneous electrical nerve stimulation