Kornimate/medical-research-clean huggingface dataset:
haptoglobin phenotype, vitamin e and high-density lipoprotein (hdl) function in type 1 diabetes

Conditions: Type 1 Diabetes; Heart Disease

Summary: the purpose of the study is to determine whether the function of the good cholesterol (hdl cholesterol) as well as its subfractions (via nmr spectroscopy) is altered among people with type 1 diabetes and a variation in the haptoglobin gene and to evaluate whether vitamin e supplements may improve this function.

persons with type 1 diabetes are at a much greater risk for heart disease compared to the general population. among individuals with diabetes, those with a specific variation in a genetic marker called haptoglobin (approximately 43% of persons with type 1 diabetes) are at even greater risk compared to those not carrying this genetic variation. a genetic marker or a "gene" is information inherited from parents (a blueprint) about the structure and functions of cells in the body that make up the color of our hair and eyes and may influence the way our bodies respond to certain stimuli such as an illness, or infection. in this project we are seeking to understand what some of the mechanisms may be that put persons with type 1 diabetes and this variation in the haptoglobin gene at greater risk for heart disease. specifically, we will assess whether this gene variant affects the function of the good cholesterol (hdl cholesterol) and its subfractions (via nmr spectroscopy), which is thought to help against heart disease development. we also seek to evaluate whether vitamin e supplements may improve this function. if results indicate that vitamin e is beneficial and improves the function of hdl cholesterol, the next question to be answered would be whether vitamin e would also help reduce the risk of heart disease itself in these persons. to answer the latter, a large clinical trial would have to take place. in this research project we will therefore also evaluate whether such a trial would be feasible and whether individuals with type 1 diabetes would be interested in participating in a long, 4-5 year, clinical trial.

Eligibility criteria:
inclusion criteria: * individuals with type 1 diabetes residing in the pittsburgh, pa area (members of the allegheny count or children's hospital of pittsburgh/epidemiology of diabetes complications registries) * 30 years old or older * with diabetes duration greater than 10 years or less than 10 years but with a history of heart disease exclusion criteria: * allergy to vitamin e * stroke, mi within the past 6 months * unwillingness/inability to limit antioxidant supplement use to study-provided supplements

Keywords: type 1 diabetes haptoglobin genotype hdl function heart disease feasibility of clinical trial
longitudinal assessment of cardiovascular and renal health in patients with hepatitis-c (care-hep c)

Conditions: Hepatitis C

Summary: the purpose of this study is to monitor the cardiovascular and renal health of patients who previously took bms-986094 (an investigational medication for hepatitis c) in comparison to hepatitis c infected patients who have never taken bms-986094.


Eligibility criteria:
inclusion criteria: subjects will be enrolled based on prior enrollment in the bms 986094 studies or treatment-naïve hcv subjects with no known cardiovascular abnormalities. 1. all subjects must give informed consent prior to participation in the study. 2. subject participated in the phase 1 or phase 2 trials with bms 986094 (including placebo arm) or 3. subject with known hepatitis c (control) 1. no previous exposure to bms 986094 2. treatment naive at study entry (no prior hepatitis c treatment experience at the time of enrollment, including but not limited to: standard interferon, pegylated interferon, ribavirin, boceprevir, telaprevir, or other experimental drugs for hepatitis c). exclusion criteria 1. for subjects who participated in the phase 1 or phase 2 trials with bms 986094, there are no exclusion criteria 2. for the control group of subjects without exposure to bms 986094, the following exclusion criteria, based on clinically available data, apply: 1. signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin \>2, alt or ast laboratory values ≥ 10 times the upper limit of normal, or other evidence of decompensated liver disease or hepatocellular carcinoma 2. chronic liver disease other than hcv not limited to hepatitis b virus (positive test for hbsag), hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease 3. history of liver transplantation 4. co-infection with hiv (positive test for anti-hiv ab) 5. prior history of cardiomyopathy (ejection fraction ≤ 50%) or history of heart failure 6. signs or symptoms of decompensated heart failure or 7. prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)
efficacy of probaclac in irritable bowel syndrome in children aged 8 to 18 years

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is to determine the efficacy of the administration of bifidobacterium bifidum r0071, bifidobacterium longum r0175, lactobacillus helveticus r0052, lactobacillus delb. ssp bulgaricus r9001, lactobacillus rhamnosus r0011, lactococcus lactis ssp. lactis r1058 et streptococcus thermophilus (probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo. this study is a double-blind randomized controlled study. 84 children will included. after inclusion, a 15-day period of observation precedes the randomization at day 0. patients receive probaclac or placebo for 4 weeks. at the end of the treatment period, patients are followed for a 2-week period of follow-up. 4 visits and 4 phone calls are planned during the study.


Eligibility criteria:
inclusion criteria: * children 8 to 18 years * irritable bowel syndrome according to rome iii criteria exclusion criteria: * not able to collaborate * known digestive malformation * history of digestive surgery (except hernia repair and appendectomy) * history of known digestive disease (crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease) * symptoms suggestive of organic disease (such as rectal bleeding, weight loss * history of chronic extra-digestive disease * acute gastroenteritis in th e4 weeks prior to inclusion * central catheter, artificial cardiac valve, endocardiac prothesis * current antidepressant treatment * patients taking a treatment for irritable bowel syndrome unable to cease their current treatment * patient taking regularly probiotics and natural products

Keywords: irritable bowel syndrome children pediatrics probiotics
multisensory environment room in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Autism

Summary: to investigate the effect of multisensory environment room on behavior in children with autism spectrum disorder age 3-5 years old. the children will be randomized into 2 groups: the experimental and the control group. the control group will be educated about the autistic and hoe program training. the intervention group will got the same educational program as the control group plus training in multisensory room environment once a week for 10 weeks. the outcome measurement was done as the before intervention, at the 5th and 10th week.

this project is a pilot study.

Eligibility criteria:
inclusion criteria: * the children who was diagnosed with autism according to dsm-5 * age 3-5 years old * has the severity mild-to-moderate and severe according to childhood autism rating scale, 2nd edition exclusion criteria: * the guardians deny to enroll into the study. * blindness, deafness * got the treatment of r-tms less than 1 year
exploring nitrous oxide effects for post traumatic stress disorder (ptsd)

Conditions: Post Traumatic Stress Disorder

Summary: the purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (ptsd)

post traumatic stress disorder (ptsd) is a disabling mental health disorder that impacts the lives of individuals. this study aims to understand nitrous oxide's effects in ptsd.

Eligibility criteria:
inclusion criteria: * age 18-80 * veterans of the united states uniformed services * primary diagnosis of ptsd * sufficient severity of ptsd symptoms * fluency in english * capacity to provide informed consent exclusion criteria: * psychiatric or medical conditions that make participation unsafe * pregnant or nursing females * allergy to nitrous oxide

Keywords: ptsd
prostatectomies using einstein vision® 3d

Conditions: Prostate Carcinoma

Summary: the aim of the study is collecting clinical data on the learning curve of different surgeons using the einsteinvision® 3d visualization system in laparoscopic radical prostatectomies.


Eligibility criteria:
inclusion criteria: * patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using einsteinvision® * written informed consent * age ≥ 18 years exclusion criteria: * previous turp (= transurethral resection of the prostate) * previous operations on the sigmoid colon or rectum (e.g. because of carcinoma, perforation, diverticulum) * bmi \> 35 kg/m² * participation in another clinical study * representation by a legal guardian or under involuntary commitment

Keywords: prostatectomy laparoscopy 3d visualization learning curve anastomosis
real world evidence of the effectiveness of paritaprevir/r - ombitasvir, ± dasabuvir, ± ribavirin and patient support program in patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (abbvie regimen) ± ribavirin (rbv) for the treatment of chronic hepatitis c (chc) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. this observational study is the first effectiveness research examining the abbvie regimen ± rbv, used according to local label, under real world conditions in the netherlands in a clinical practice patient population.


Eligibility criteria:
inclusion criteria: * treatment-naïve or -experienced adult male or female participants with confirmed chc, genotype 1 or 4, receiving combination therapy with the interferon-free abbvie regimen ± rbv according to standard of care and in line with the current local label. * if rbv is co-administered with the abbvie regimen, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy). * participants must voluntarily sign and date informed consent prior to inclusion into the study exclusion criteria: * patients participating or intending to participate in a concurrent interventional therapeutic trial. * unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient. * unable to complete the questionnaires due to language incompetence. * unable to voluntarily sign and date the informed consent.

Keywords: chronic hepatitis c paritaprevir/r - ombitasvir, ± dasabuvir sustained virological response observational study chronic hepatitis c genotype 1 chronic hepatitis c genotype 4
perception of cure among patients with metastatic cancer

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Metastatic Malignant Solid Neoplasm

Summary: this study collects information about perception of cure among patients with cancer that has spread to other places in the body (metastatic). this study aims to determine patients' perception (knowledge) before starting immunotherapy and if differences exist in understanding of treatment to stimulate or restore the ability of the body's immune (defense) system to fight infection and disease (immunotherapy) based on social and economic factors or on race/ethnicity.

primary objective: i. to assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy. secondary objectives: i. to determine if expectations of cure are associated with quality of life and distress. ii. to determine if patients' perceptions differ by gender, age, and ethnicity. outline: patients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. patients' medical records are reviewed.

Eligibility criteria:
eligibility criteria: 1. patients must be aged 18 and over 2. patients sufficiently fluent in english 3. patients must have a cytologically or pathologically verified diagnosis of cancer 4. patients must have measurable metastatic disease 5. patients must be initiating immunotherapy 6. patients must be undergoing evaluation and treatment at city of hope cancer center
de-111 against timolol ophthalmic solution 0.5%

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: de-111 ophthalmic solution will be evaluated for superiority in comparison with timolol ophthalmic solution 0.5%, in iop(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. safety will be compared and evaluated as well.


Eligibility criteria:
inclusion criteria: * diagnosed with primary open angle glaucoma or ocular hypertension * provided signed, written informed consent * 20 years of age and older * if a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception * presence of any abnormality or significant illness that could be expected to interfere with the study

Keywords: primary open angle glaucoma or ocular hypertension
a study in healthy male subjects to investigate whether administration of rifampicin can affect the fate of clazosentan in the body of clazosentan

Conditions: Healthy Subjects

Summary: a study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan


Eligibility criteria:
inclusion criteria: * signed informed consent in a language understandable to the subject prior to any study-mandated procedure. * healthy male subjects aged between 18 and 65 years (inclusive) at screening. * body mass index (bmi) of 18.0 to 30.0 kg/m2 (inclusive) at screening. * systolic blood pressure (sbp) 100-145 mmhg, diastolic blood pressure (dbp) 50-90 mmhg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on day -1 of the first period. * healthy on the basis of physical examination, cardiovascular assessments and laboratory tests. study-specific criteria - acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate. exclusion criteria: * previous exposure to clazosentan. * previous exposure to rifampicin within 3 months prior to screening. * known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients. * known hypersensitivity or allergy to natural rubber latex. * participation in a clinical study involving study treatment administration within 3 months prior to screening or in more than 4 clinical studies within 1 year prior to screening. * history or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. * positive results for hepatitis b surface antigen or hepatitis c virus antibody at screening. * positive results from the hiv serology at screening. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
effectiveness and clinical application of moleculight bacterial fluorescence imaging in wound debridement

Conditions: Infection, Surgical Site

Summary: moleculight is a device that utilizes a special light which, when used on wounds, helps identify the regions which pathogenic bacterial counts are the highest. the device applies 405nm violet light which is harmless to the human tissue. when specific components in bacteria catches up the light, a photoluminescent reaction is triggered and the fluorescence light is caught by the camera on this device in real time. when treating an infected wound which requires debridement and/or reconstruction, traditionally surgeons rely on many clinical clues to judge the severity and region of infection. however, these clues, such as lab data, vital signs, bacterial culture growth, or infection symptoms/signs, are usually indirect and also require several days to be fully interpretated. the advantage of moleculight is its simple, direct, real-time, and flexible application, which is very important and valuable when treating an infected wound. we aim to add this device to our routines and see if the treatment course for these wounds can be more rapid and effective, and also utilize the countless potential of immediate bacterial identification in numerous aspects of our work.


Eligibility criteria:
inclusion criteria: * patients with wounds that present obvious symptoms or/and signs of infection, and chronic wounds that have failed to heal or improve for 14 days (chronic wounds are often complicated or caused by wound infection) * patients that are scheduled for surgical treatment for the wound * patients that are older than (including) 20 years and younger than (including) 85 years. * wounds with a size larger than 1x1 cm2 exclusion criteria: * wounds that heal within 14 days. * patient is unable to continue further surgical treatment due to any reason * the wound site is amputated * patient refuses further surgical treatment * the patient has an active malignancy currently under treatment * patient is immunocompromised or currently under systemic steroid treatment * the wound had been treated by radiation * the patient refuses to participate in this study
evaluating the effects of cannabis use and circulating cannabinoids on tumor infiltrating lymphocytes in malignant melanoma

Conditions: Melanoma

Summary: the goal of this proposal is to determine how cannabinoid use affects the tumor immune microenvironment (tme) of melanoma by correlating tils with reported cannabinoid use and circulating plasma cannabinoids. the central hypothesis is that cannabinoid use decreases tils in melanoma in a dose-dependent fashion. this is important because cannabinoid-driven tme changes in melanoma may alter patient outcomes mediated by tils and response to standard of care ici treatments.

specific aim 1.assess how systemic cannabinoids remodel tumor infiltrating lymphocytes (tils) within the melanoma tumor microenvironment. we hypothesize that decreased grade of tils and exhaustive differentiation of t cells in melanoma are associated with lower cannabinoid receptor (cb1/cb2) expression and higher levels of systemic exogenous cannabinoids. aim 1a.) correlate plasma levels of cannabinoids with til grade. aim 1b.) correlate plasma levels of cannabinoids with til t cell immunohistochemical markers of exhaustion. aim 1c.) correlate plasma levels of cannabinoids to til cb1/cb2 expression. specific aim 2. determine the relationship between peripheral t cell activation and circulating cannabinoid levels in patients with melanoma. we hypothesize that the phenotypic activation of peripheral t cells is inversely associated with increased plasma levels of systemic exogenous cannabinoids. aim 2a.) immunophenotype peripheral t cells from patients with melanoma. aim 2b.) correlate plasma levels of cannabinoids with peripheral t cell phenotypic activation.

Eligibility criteria:
inclusion criteria: * biopsy proven melanoma, any stage * biopsy obtained within 4 weeks of anticipated enrollment * patients \>21 years old * report no cannabis use in the last year or chronic cannabis use (at least weekly use for 3 months or more) exclusion criteria: * patients unwilling or unable to provide informed consent
cpap in-home assessment australia

Conditions: Obstructive Sleep Apnea

Summary: the study is to evaluate the product reliability, therapy effectiveness and user feedback of a continuous positive airway pressure (cpap) device in-home for up to 6 months.

existing and naïve cpap users will be recruited into a 6 month in-home study participants will attend 5 study visits at day 0, 7, 30, 60 and 180. outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Eligibility criteria:
inclusion criteria: * aged 18 and over. * diagnosed with osa by a practicing physician and prescribed positive airway pressure (pap) therapy. exclusion criteria: * persons contraindicated for continuous positive airway pressure (cpap) therapy. * persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea). * persons with obesity hypoventilation syndrome or congestive heart failure. * persons that require supplemental oxygen with their cpap device. * persons with implanted electronic medical devices (e.g. cardiac pacemakers). * persons who are pregnant or think they might be pregnant. * persons whose primary language is other than english. * persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process. * persons highly dependent on medical care. * people with cognitive impairment, an intellectual disability or a mental illness
remedē system therapy study

Conditions: Central Sleep Apnea

Summary: the purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē system in a real-world setting.

this is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē system. approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the united states and europe. a sub-study involving the watchpat device will be performed in a subset of sites.

Eligibility criteria:
1. moderate to severe central sleep apnea (ahi ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. it is strongly recommended that a patient have a diagnostic psg within 12 months of the expected implant date documenting moderate to severe csa. 2. age 18 years or older 3. signed institutional review board (irb)/independent ethics committee (iec) approved informed consent 4. in the opinion of the investigator, subject is willing and able to comply with the protocol. 5. not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. each instance should be brought to the attention of the sponsor to determine eligibility. 6. in the opinion of the investigator, life expectancy exceeds one year. 7. the subject is not pregnant or planning to become pregnant.