Kornimate/medical-research-clean huggingface dataset:
e-motivación: developing and pilot testing an app to improve latinos' screening colonoscopy rates

Conditions: Colorectal Cancer

Summary: among latinos, a fast growing and underserved population, colorectal cancer (crc) is the third leading cause of cancer death in men and in women. compared to non-latino whites, latinos are less likely to be diagnosed with localized crc and more likely to be diagnosed with advanced stage disease. of the recommended crc screening tests, a colonoscopy allows for both the detection and removal of precancerous and cancerous polyps. although screening colonoscopies can detect and prevent crc, more than half of latinos have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). the purpose of this study is to develop and begin to test an electronically-delivered motivational interviewing progressive web application (e-mi app), called motívate. the motívate app will be offered in both english and spanish to patients who self-identify as latino/a/x, after they receive a referral for a screening colonoscopy.

a pilot study will be conducted to begin to examine the efficacy of the motívate app for improving screening colonoscopy uptake among latinos. participants (n=80) will be randomly assigned, stratified for language, to one of two groups: motívate app (n=40) or general health information video (n=40). the results of the pilot study will inform power calculations for a future randomized clinical trial that will formally test the efficacy of the app. if this program of research proves the motívate app efficacious there is a strong argument to integrate the app into standard clinical care in order to reduce the overall burden of crc in the growing and vulnerable latino community.

Eligibility criteria:
inclusion criteria: * self-identified as latino/a/x; * english or spanish-speaking; * received a physician referral for a screening colonoscopy; * has access to a tablet, smartphone, or computer with working internet. exclusion criteria: * hearing or vision impaired; * aim 1 or 2 participant.

Keywords: colonoscopy early detection of cancer cancer screening tests motivational interviewing mobile health colorectal cancer
a phase 3 study of etrasimod in subjects with moderately to severely active ulcerative colitis

Conditions: Moderately to Severely Active Ulcerative Colitis

Summary: the purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. condition or disease: ulcerative colitis intervention/treatment: drug: etrasimod drug: placebo phase: phase 3


Eligibility criteria:
inclusion criteria: 1. a documented of diagnosis with uc at least 3 months prior to screening. 2. have active uc confirmed by endoscopy with ≥ 10 cm rectal involved. exclusion criteria: 1. have severe extensive colitis 2. diagnosis of crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with crohn's disease 3. diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia
sucrose breath test to determine intestinal permeability in ibs

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is a growing clinical diagnosis affecting 10-20% of the us population. while current diagnostic criteria aids in correctly diagnosing ibs, the cause of the disease still remains unclear. it has been hypothesized that patients with ibs have alterations in the intestinal lining leading to release of toxic substances into the blood, commonly referred to as leaky gut. current methods used to study leaky gut are both expensive and invasive. the investigators will test a new breath test to measure leaky gut in both ibs patients and subjects without ibs symptoms.

the sucrose breath test involves taking by mouth 20 grams of common sucrose. this amount of sucrose is about 4 packets of sugar that you would use to sweeten a beverage. if subjects meet eligibility criteria, a single breath test will be conducted on all subjects. the breath test involves collecting breath by exhaling through a straw into a special test tube. a breath sample is collected before administration of sucrose. after the baseline breath sample, a sugar solution with the 20 grams of sucrose is administered by mouth. three additional breath samples are collected at 30, 60 and 90 minutes. after 90 minutes, the protocol is finished. we will be analyzing breath carbon dioxide for different levels of heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer. our study plan is to compare the amount of carbon-13 in breath between ibs patients and subjects without the condition. up to 20 subjects per group will be studied.

Eligibility criteria:
inclusion criteria: * male or females with clinical diagnosis of irritable bowel syndrome by rome iii criteria (ibs group) or healthy control. * must be 18 years old or greater. * women of child-bearing potential must have a negative pregnancy test. exclusion criteria: * females who are lactating or pregnant. * subjects with allergy to sucrose. * subjects with other causes of abdominal pain or altered bowel habits such as ibd, celiac disease, pancreatitis or gastrointestinal bleeding. * subjects with a history of diabetes mellitus. * subjects with a recent febrile illness (5 days prior to study). * subjects that received an investigational drug or device within 30 days prior to study entry. * subjects that do not have the mental capacity to understand the protocol.

Keywords: irritable bowel syndrome breath testing carbon-13
dose escalation study with mk-2206 in patients with locally advanced or metastatic solid tumors (mk-2206-002)

Conditions: Locally Advanced Tumors; Metastatic Solid Tumors; Cancer; Neoplasms

Summary: the primary purpose of this study is to investigate the dose limiting toxicities (dlts), pharmacokinetics (pk), and pharmacodynamics (pd) of mk-2206 administered orally to participants with advanced solid tumors. the preliminary efficacy of mk-2206 will also be investigated.


Eligibility criteria:
inclusion criteria: * participant must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy * has normal organ function; is no greater than 2 on the ecog performance scale * has a negative blood or urine pregnancy test within 72 hours of receiving the first dose of study drug if participant is female * is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis exclusion criteria: * participant has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment * is currently participating or has participated in a study with an investigational compound or device within 30 days * has a primary central nervous system tumor * has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure * is a known diabetic who is taking insulin or oral antidiabetic therapy * is pregnant or breastfeeding or planning to become pregnant during the study * is hiv-positive * has known history of hepatitis b or c or active hepatitis a * is receiving treatment with oral corticosteroids
lcz696 compared to valsartan in patients with chronic heart failure and preserved left-ventricular ejection fraction

Conditions: Chronic Heart Failure

Summary: the study will assess the effects of 36 weeks of treatment with lcz696 compared to valsartan on n-terminal pro-brain natriuretic peptide (nt-probnp) in patients with chronic heart failure and preserved left-ventricular ejection fraction.


Eligibility criteria:
inclusion criteria: * patients with documented stable chronic heart failure (nyha ii-iv): * lvef ≥ 45% (local measurement, assessed by echocardiography, muga, ct scan, mri or ventricular angiography) * the ejection fraction must have been obtained within 6 months prior to randomization or after any mi or other event that would affect ejection fraction. * plasma nt-probnp \> 500 pg/ml at visit 1. * patients with documented stable chronic heart failure (nyha ii-iv). * patients receiving ace inhibitors (acei), an angiotensin receptor blockers (arb) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to visit 1. * patients must be on diuretic therapy prior to visit 1 (flexible dosing is permitted). * patients with a controlled systolic bp, defined as a target systolic bp less than 140 mm hg; participants with bp up to and including 160 mm hg are eligible for enrollment if they are on three or more medications to control bp at randomization (visit 2). * patients with at least one of the following symptoms at the time of screening (visit 1): * dyspnea on exertion * orthopnea * paroxysmal nocturnal dyspnea * peripheral edema * patients must have an egfr ≥ 30 ml/min/1.73 m2 at visit 1 (calculated by the modification of diet in renal disease formula). * patients with a potassium ≤5.2 mmol/l at visit 1. exclusion criteria: * patients with a prior lvef reading \<45%, at any time. * patients who require treatment with both an ace inhibitor and an arb. * isolated right heart failure due to pulmonary disease. * dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity. * presence of hemodynamically significant mitral and /or aortic valve disease. * presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis. * presence of hypertrophic obstructive cardiomyopathy. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic heart failure preserved ejection fraction cardiovascular disease nt-probnp biomarkers heart failure with preserved left-ventricular ejection fraction
multi-provincial cohort for hypertension (much)

Conditions: Hypertension

Summary: the purpose of this study is to construct hypertension specialized cohort using uniform standards and specifications. this study timely collected multi-dimensional clinical information through electronic medical records, mobile health, data integration, informatics and computer modern techniques, linking self-reported data and big data platforms from different sources to timely obtain the incidence and mortality data, and integrating hypertension cohort samples and the associated clinical records systematically, in order to build a 30-thousand hypertension specialized cohort with fine phenotypic data and blood/urine samples, thus far to provide support for the development of precise medicine research and related industries.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertension * over 18 years old * ti sign the informed consent exclusion criteria: * with life-threatening severe disease, such as severe tumor or aids * pregnancy or lactating women,or plan to pregnant within half a year, * with severe mental disorders * participating in clinical trials
effects of ecological rythmic-acoustic stimulation (e-ras) on motor skills in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: the use of rhythmic auditory stimulation (ras) has been proven useful in the management of gait disturbances induced by parkinson's disease (pd). typically, the stimuli used to provide ras consist of metronome or music-based sounds, which are not related with the auditory experience of walking. based on previous laboratory research, it is hypothesized that the use of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a greater impact compared to artificial sounds (i.e., metronome sounds), within a rehabilitation program. in a double-blind experiment, it was investigated the effects of 5 weeks of supervised rehabilitation integrated with ras. thirty-two individuals affected by pd (age 68.2 ± 10.5, hoehn and yahr 1,5-3) were randomly assigned to one of the two conditions (artificial vs. ecological sounds). spatio-temporal parameters of gait and clinical variables were assessed before the rehabilitation period, at its end, and after a 3-month follow-up. the results revealed that the rehabilitation program integrated with ras had positive effects on the majority of objective and subjective measures, independently of the type of sound. however, when the two groups were examined separately, the patients assigned to the ecological ras condition were the only who improved both in terms of cadence and gait speed. overall, the hypothesized greater effect of the ecological sounds compared to artificial sounds was only partially supported by data.


Eligibility criteria:
inclusion criteria: * diagnosis of pd according to the uk brain bank criteria; * ability to walk independently; * absence of relevant hearing impairments which could prevent the correct perception of the auditory cues; * absence of significant cognitive impairment (i.e., mini-mental status examination (mmse) \> 24; frontal assessment battery (fab) \> 13); * absence of psychiatric or severe systemic illnesses; * mild-to-moderate disability assessed by means of the modified hoehn and yahr (h\&y) staging scale (1,5 ≤ h\&y ≤ 3); * no engagement in any rehabilitative program in the 3 months before the beginning of the study exclusion criteria: -

Keywords: rhythm ecological sounds auditory stimuli rhythmic auditory stimulation parkinson's disease gait gait analysis spatio-temporal parameters
subcutaneous peripheral nerve stimulation (pns) as "hybrid stimulation" after failure of spinal cord stimulation (scs) to control the back pain component in failed back surgery syndrome (fbss) patients.(cumpns study)

Conditions: Failed Back Surgery Syndrome

Summary: despite globally favourable outcomes of spinal cord stimulation (scs), a significant proportion of failed back surgery syndrome (fbss) patients do not obtain adequate coverage of low back pain. peripheral nerve stimulation (pns) has obtained the european conformity mark for the treatment of chronic refractory neuropathic pain and is now commonly used in some countries to target back pain. however, the potential value of combining scs and pns as "hybrid stimulation" remains poorly described with only isolated case reports or limited experience in various indications. the "cumpns" comparative randomized study is designed to demonstrate the potential analgesic efficacy of pns in addition to previously implanted scs, to treat the residual low back pain component pain in refractory fbss patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 80 years. * history of fbss after one or more surgical procedures on the spine, treated with scs, * failure of well conducted conservative treatment (drug or non-drug). * patients implanted with a single-column or multicolumn scs lead providing significant relief of the radicular pain component. * persistent failure on the low back pain component despite the efficacy of scs on the radicular pain component. * patients with documented residual neuropathic low back pain (dn4, sensorimotor studies, clinical examination, pain characteristics, etc.). * patients with significant residual low back pain with mean intensity on visual analogue scale (vas) ≥ 40 mm) despite conventional medical management (cmm) and scs (mean measure calculated on daily vas scores on 5 consecutive days). * positive response to transcutaneous electrical nerve stimulation (tens) trial on the back pain component. * patients understanding and accepting the study constraints. * patients covered by french national health insurance. * patients have signed the informed consent form after being provided with clear and honest information about the study. * absence of active psychosis or serious psychotic history requiring hospitalisation. * absence of active cancer. exclusion criteria: * age \ 80 years. * back pain amenable to further aetiological biomechanical surgery (discogenic pain, spinal instability, spinal deformity, etc.). * surgical, psychiatric or anaesthetic contraindication to pns lead implantation. * negative response to tens trial. * absence of signature of the informed consent form. * patients not covered by french national health insurance. * subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients member of a high-risk population. * women of childbearing age not using effective contraception.
sensing contact lens-based device for 24-hour monitoring of intraocular pressure

Conditions: Glaucoma, Open-Angle; Healthy

Summary: glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. medical therapy is aimed at lowering intraocular pressure (iop) below a clinically determined target level in order to prevent or slow glaucoma progression. iop is known to vary with the time of day as well as with daily activities. the current way of assessing nycthemeral iop fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. the procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial iop values in time. sensimed ag has developed a new contact lens (cl)-based device intended to continuously measure iop over 24 hours. the objective of this study is to investigate the use of device for 24-hour iop monitoring in healthy subjects and glaucoma patients.


Eligibility criteria:
inclusion criteria: * for open angle glaucoma (oag) subjects, a clinical diagnosis of primary oag, including normal tension glaucoma (ntg) all known untreated iop measurements \< 22 mmhg using goldmann applanation tonometry (gat) for ntg no iop-lowering treatment; otherwise, a 4-week wash-out period prior to the recording * for healthy subjects, no structural defects, normal visual fields, iop ≤ 21 mmhg and open angles on gonioscopy * aged ≥ 18 years, either gender * body mass index ≤ 30 kg/m2 * central corneal radius (flat meridian) between 7.5 mm (45 d) and 7.9 mm (42.75 d) * central corneal thickness between 500 microns and 600 microns * difference in iop absolute value between eyes within 2.5 mmhg at screening in sitting position * same direction of iop variation (positive or negative) for the 2 eyes when moving from sitting to supine positions at screening * spherical refraction within ±6.00 diopters and cylinder refraction within ±3.00 diopters * having given written informed consent, prior to any investigational procedures exclusion criteria: * ocular pathology (other than glaucoma for glaucoma subjects) * previous glaucoma, cataract or refractive surgery * corneal or conjunctival abnormality, precluding contact lens adaptation * severe dry eye syndrome * subjects with allergy to corneal anesthetic * subjects with contraindications for silicone cl wear * subjects with contraindications for water drinking test (wdt) (eg., heart, renal problems) * subjects unable or unwilling to comply with the study procedures * participation in other interventional clinical research within the last 4 weeks
trait anxiety and defensive networks

Conditions: Healthy

Summary: to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it

individuals with high trait anxiety show stable anxiety proneness even in the absence of real threat, which could be a result of intrinsic hyper-connectivity in the defensive systems. in the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait inventory of the state-trait anxiety inventory. then two experiments using resting-state fmri technique will be conducted to first map how hubs in the defensive systems organized in high anxious individuals in a stimuli-free situation (experiment 1) and then we will examine the modulatory effect of the intranasal administration of oxytocin on functional connectivity in these independently defined defensive networks (experiment 2).

Eligibility criteria:
inclusion criteria: * healthy subjects without past or current psychiatric or neurological disorders exclusion criteria: * females should not be pregnant or during menstruation.

Keywords: brain functional connectivity changes
exercise videos - perspectives of people living with chronic pain

Conditions: Chronic Pain; Exercise

Summary: exercise videos on the internet are used by millions worldwide to provide structure and motivation. they can guide exercise execution and play a role in helping people to maintain regular exercise. on completion of the pain management programme (pmp) at the walton centre, many patients are measurably more able bodied as a result (or at least part of a result) of regular engagement in exercise. despite these positive outcomes and the patients stated intent to continue with exercise, many patients are struggling to maintain exercise in a meaningful way when re-assessed at their six month follow up appointment. patients have expressed that videos of the exercises would have motivated them to engage in sustained regular exercise in a more meaningful manner. as physiotherapists, the investigators would like to ask a sample of patients on the pmp whether they anticipate exercise videos, reflecting the exercises practised on the pmp, would be beneficial for them to support maintenance/ sustainability of pmp exercises. exercises practiced on the pmp include stretches, repeated movements in sitting, standing and lying, pilates, yoga, normalised/functional movements and patients may like these exercises included in the videos. the investigators plan to approach this using two focus groups followed by a qualitative analysis of recorded transcripts of the group discussions. data would be analysed using a thematic analysis to establish key themes related to the research questions. the information gathered will inform the value of and content / format of specifically developed exercise videos. the outcome of this project will inform the investigators of the use of exercise videos in this patient population and the value of this in encouraging people to keep up exercise over a sustained period. other centres working with patients with chronic pain may be able to learn valuable lessons from this project in informing their own exercise promotion materials for their patients.


Eligibility criteria:
inclusion criteria: * have attended a pmp at the walton centre within the last 12 months * aged 18+ * able to provide written informed consent in english exclusion criteria: * have not attended a pmp at the walton centre, or have attended \>12 months ago
user evaluation of the peristomal skin condition in ostomates using convatec moldable technology™

Conditions: Colostomy; Ileostomy; Urostomy

Summary: the primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use convatec moldable technology™ skin barriers as part of their standard protocol of care following surgery.


Eligibility criteria:
inclusion criteria: * subjects who are 18 years old and older. * subjects who agree to participate in the evaluation and who have signed the informed consent form. * subjects presenting with a stoma (ileostomy, colostomy or urostomy). * subjects for whom convatec moldable technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or sacs l1). exclusion criteria: * subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem. * subjects who are in a simultaneous clinical evaluation.