Kornimate/medical-research-clean huggingface dataset:
emricasan, an oral caspase inhibitor, in subjects with nash cirrhosis and severe portal hypertension

Conditions: Cirrhosis; Portal Hypertension; Non-alcoholic Steatohepatitis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with nash cirrhosis and severe portal hypertension (defined as hvpg ≥12 mmhg as determined by the central reader assigned to this study). upon successful screening, subjects will be randomized to receive either emricasan 50 mg bid, 25 mg bid, or 5 mg bid or matching placebo bid.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study. * cirrhosis due to nash with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.) * compensated cirrhosis or decompensated cirrhosis with no more than 1 prior significant decompensating event * severe portal hypertension defined as hvpg ≥12 mmhg * subjects who are on nsbb, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to day 1 * willingness to utilize effective contraception (for both males and females of childbearing potential) from screening to 4 weeks after the last dose of study drug exclusion criteria: * evidence of severe decompensation * severe hepatic impairment defined as a child-pugh score ≥10 * alt (alanine transaminase) \> 3 times upper limit of normal (uln) or ast (aspartate transaminase) \>5 times uln during screening * estimated creatinine clearance \<30 ml/min * prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure * known portal vein thrombosis * symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy * current use of medications that are considered inhibitors of oatp1b1 and oatp1b3 transporters * alpha-fetoprotein \>50 ng/ml * history or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) qtcf interval of \>500 msec * history of or active malignancies, other than those successfully treated with curative intent and believed to be cured * prior liver transplant * change in diabetes medications or vitamin e within 3 months of screening * uncontrolled diabetes mellitus (hba1c \>9%) within 3 months of screening * significant systemic or major illness other than liver disease * hiv infection * use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening * if female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding * previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to day 1

Keywords: cirrhosis portal hypertension non-alcoholic steatohepatitis liver cirrhosis
effect of sham anti-inflammatory diet on inflammation after spinal cord injury

Conditions: Spinal Cord Injury; Inflammation

Summary: this pilot study will evaluate the effects of a placebo anti-inflammatory diet in individuals with spinal cord injury. it is being performed to ensure that the placebo diet does not induce reductions in inflammation and also adequately conceals group allocation.

anti-inflammatory diet is a novel treatment that may be beneficial for managing chronic inflammation and neuropathic pain (np) after spinal cord injury (sci). np is a common complication following sci that significantly decreases quality of life. treatment options are limited, and current treatments can have significant side effects. those with sci have identified a need for additional treatment options, particularly those that are not medications. as pain is a subjective outcome, awareness of group allocation could influence treatment expectations and participant rated scores of neuropathic pain. it is therefore important to ensure that an adequate placebo intervention is utilized. this pilot study will assess whether the placebo diet to be used in an upcoming rct provides sufficient group allocation concealment (i.e. ensure participants are unaware of whether they are on the anti-inflammatory diet or placebo diet). this pilot study will also assess whether the placebo diet is in fact inflammation neutral (ie. induces no reductions in inflammation).

Eligibility criteria:
inclusion criteria: 1. signed informed consent obtained prior to any study-related activities 2. a spinal cord injury at least 6 months duration, nonprogressive for at least 6 months 3. dosing of other pain medications (nsaids, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry. exclusion criteria: 1. current infection of any kind. 2. presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after sci 3. currently enrolled in another clinical trial 4. any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study 5. following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study
"psychological intervention enhanced by virtual reality for the improvement of appreciation of body functionality in patients with chronic low-back-pain".

Conditions: Chronic Low-back Pain

Summary: the purpose of this study is to test whether a positive body image-based intervention is able to improve pain, disability, interference and emotional distress in people with chronic low back pain. patients will receive 4 sessions approaching 5 different clinical modules: pain psychoeducation, body awareness, pain acceptance, body appreciation and functionality and gratitude. 2 sessions will include virtual reality (vr) environments to enhance the clinical outcomes. researchers will analyse changes in the variables of interest after intervention compared to baseline.

the purpose of this intervention is to examine the effects of a positive body image-based intervention using virtual reality to improve pain, interference and emotional distress. the first session will be dedicated to psychoeducation about pain. investigators will discuss what chronic pain is, what factors influence pain, chronification, body image and a brief presentation of the modules. in the second session, a brief introduction to body awareness will be given and a vr environment will be used to carry out a body scan. in the third session, acceptance of pain will be worked on and a vr environment will be used to work on some variables related to the chronification of pain, such as paradoxical control or avoidance. in the fourth session, the modules of appreciation and gratitude will be addressed. each session will last approximately one hour. first, participants will be screened to check eligibility inclusion/exclusion criteria. second, eligible participants will complete baseline measures. the study will be conducted following the principles stated in the declaration of helsinki. the design chosen for the intervention will be a multiple baseline single case design (scd-mb). data will be analysed by visual and statistical analysis. for visual analysis, the mean and/or median will be used to report the level, trend and stability of the 'within phase' data. for "between-phase" data, "nonoverlap statistics" such as "nonoverlap of all pairs" (nap) will be used. for statistical analyses a cohen's difference of means (cohen's d) will be used to estimate the effect size at the individual level and multilevel analyses for across-case effect sizes.

Eligibility criteria:
inclusion criteria: * individuals with low back pain. exclusion criteria: * meeting any of the following medical conditions: * spinal tumor, infection or fracture * systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...) * fibromyalgia * cauda equina syndrome * history of spinal surgery * musculoskeletal injury of lower extremities
application of manual therapy to archers

Conditions: Healthy

Summary: the aim of this study is to: (i) characterize the effect of repeated archery shots on the emg parameters of certain selected upper limb muscles; and (ii) evaluate how manipulation of the initial two-second tension phase, in particular involving muscle stretching, affects these emg parameters after repeated shots.

emg measurements will be collected for selected muscles in the shoulder joint and forearm, at points: initially at the beginning, after the athletes have performed 50 and another 50 archery shots, and finally after undergoing manual therapy. the main phase of muscle testing will take place in the aiming phase.

Eligibility criteria:
inclusion criteria: * actively training as an archer at least twice a week for six months; * in good health, with no recent injury or illness; * over 18 years of age; * engagement in all phases of the study. exclusion criteria: * any injury or illness present at the time of the study; * recent history (within six months) of upper extremity injury (shoulder, elbow, or wrist), joint pain, lower extremity joint hypermobility, or neurological/connective tissue disease. * no training participation * no consent for study

Keywords: archery muscle fatigue recovery manipulation
7 days of td-4208 in subjects with chronic obstructive pulmonary disease

Conditions: COPD

Summary: this study will characterize the dose response of td-4208 after 7 days of dosing in subjects with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: 1. subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization). 2. subject: * has an fev1/fvc (forced expiratory volume in 1 second/forced vital capacity) \<0.7 at screening; and * has a post-bronchodilator fev1 at screening of between 30% and 80% (inclusive) of the predicted normal value. 3. subject demonstrates at screening at least a 120 ml increase in fev1 within 1 hour of receiving 500 µg of ipratropium bromide from a pari lc sprint® nebulizer. 4. females of non-childbearing potential. all male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing. 5. subject (or care giver) is able to properly prepare and administer study medication. 6. subject is willing and able to give written informed consent to participate. exclusion criteria: 1. subject has had a copd exacerbation or lung infection within 6 weeks before randomization. 2. subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (laba), or long-acting muscarinic antagonist (lama) within 4 weeks before the qualifying ipratropium bromide response test. 3. subject is taking daily maintenance inhaled/systemic corticosteroids (\>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone). 4. subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study. 5. subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. subject has a history (or family history) of congenital prolonged qtc (corrected qt interval) syndrome or has an abnormal clinically significant electrocardiogram (ecg) at screening, including qtcb (qt interval corrected for heart rate using bazett's formula) value \>450 msec (males) or \>470 msec (females); or shows evidence of clinically significant rhythm abnormality. 6. subject has a known hypersensitivity to td-4208 or similar drug class. 7. subject has a history of alcoholism or drug abuse within 2 years prior to screening.

Keywords: long acting muscarinic antagonist chronic bronchitis emphysema chronic obstructive pulmonary disease copd
fasting mimicking diet in chemotherapy of gynecologic malignancies

Conditions: Cancer, Ovarian; Chemotherapy Effect; Calorie Deficiency; Fasting, Intermittent

Summary: this study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. to expand this knowledge, the investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. these patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (fmd by l-nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). the investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

Eligibility criteria:
inclusion criteria: * women * age 35-70 years old (both inclusive) * biopsy proven gynecologic malignancy * scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining * bmi greater than or equal to 18.5 * adequate renal function (serum creatinine less than 1.5 times the upper limit of normal) * willing to adhere to a 5-day fasting mimicking diet exclusion criteria: * pregnant or nursing mothers * prisoners * patients with diabetes or history of hypoglycemia * taking daily medications that cannot be safely taken without food * history of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility. * significant medical comorbidity that would be dangerous with a fasting mimicking diet. * any known or suspected food allergies that overlap with the fmd/transitional diet by l-nutra meal kit ingredients.

Keywords: fasting mimicking diet gynecologic malignancy chemotherapy
reduction of obesity-associated intestinal inflammation by low-fat dairy yogurt

Conditions: Intestinal Barrier Function; Chronic Inflammation

Summary: the main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.


Eligibility criteria:
inclusion criteria: * premenopausal women * bmi from 18.5-27 and 30-40 kg/m2 * resting blood pressure \<140/90 mmhg * not taking medication to control hypertension * stable body weight for the previous 2 months * willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling * willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study exclusion criteria: * previous diagnoses of cardiovascular disease (cvd), diabetes, or arthritis (except for osteo-arthritis) * currently being treated for cancer (i.e., chemotherapy, radiation therapy) * prescribed estrogen replacement therapy * practicing weight-loss, vegetarian, kosher, or vegan diets * currently taking dietary supplements * exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week) * actively using antibiotics * taking anti-inflammatory drugs * have allergies to soy, egg or milk * perimenopausal or menopausal symptoms

Keywords: yogurt intestine inflammation obese
single ascending dose study of sra-444 in healthy subjects

Conditions: Alzheimer Disease

Summary: this is a first-in-humans study of sra-444. this study will provide an initial assessment of the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of sra-444 (sr formulation) after administration of ascending single oral doses to healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy men or women of nonchildbearing potential aged 18 to 50 years, * body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. exclusion criteria: * family history of sudden death and/or qt prolongation. * an automatic ecg corrected qt (qtc) interval reading at screening \>450 ms and \>470 ms for male and female subjects, respectively. * sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. resting supine blood pressure at screening \<110 mm hg (systolic) and/or \<60 mm hg (diastolic).
nationwide utilization of danish government electronic letter system for increasing influenza vaccine uptake

Conditions: Influenza; Behavior and Behavior Mechanisms

Summary: in randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. however, the real-world effectiveness of influenza vaccination is limited by its uptake. this study will investigate investigate whether digital behavioral nudges delivered via the official, mandatory danish electronic letter system can increase influenza vaccine uptake among eligible influenza vaccination candidates.

the study is a prospective, randomized, open-label implementation trial. the study population will consist of persons identified as eligible for free-of-charge influenza vaccination in the danish health system aged 18 years and above. subjects will be identified through danish nationwide health registries using codes from the international classification of diseases, 10th revision (icd-10) and the anatomical therapeutic chemical (atc) classification system. individuals will be randomized to 1 of 10 arms (1 control arm and 9 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. the interventions will be delivered through the official, mandatory danish electronic letter system. all subject data will be retrieved from the danish nationwide registries with the exception of information on intervention allocation. endpoints will be retrieved at prespecified dates using prespecified search algorithms. the study will be performed in collaboration with the danish health data authority and statens serum institut.

Eligibility criteria:
inclusion criteria: 1. age \>=65 years at january 15, 2023 (eligible for free influenza vaccination in the official danish vaccination program) 2. access to the official, mandatory danish electronic mailbox system exclusion criteria: 1) persons living in nursing homes

Keywords: influenza vaccination nudging behavioral science
motivational interviewing

Conditions: Essential Hypertension

Summary: the purpose of this project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors.

the objective of this randomized control trial is to evaluate, among 190 african-american patients with poorly controlled hypertension followed in a community-based primary care practice, whether motivational interviewing is more effective than usual care (routine counseling) in achieving adherence to prescribed blood pressure medications at 12 months. the project aims to: 1) determine whether patients who receive motivational interview counseling have greater reduction in both systolic and diastolic blood pressure than those in the control group at 12 months. clinic blood pressure readings will be assessed at baseline and at every three months thereafter for one year and 2) assess the effect of self-efficacy and intrinsic motivation as potential mediators of motivational interview on adherence. self-efficacy and intrinsic motivation will be assessed at baseline and every three months thereafter for one year.

Eligibility criteria:
inclusion criteria: the target population consisted of hypertensive african american patients who fulfilled the following eligibility criteria: * self-identification as african american * age 18 years or older * diagnosis of hypertension utilizing icd-9 codes 401-401.9 (the code for essential hypertension) * taking at least one antihypertensive medication * uncontrolled hypertension of a clinic blood pressure reading \>140/90 mm hg or 130/80 mm hg (for those with kidney disease or diabetes) on two successive clinic visits prior to screening (defined per jnc vi criteria) * fluent in english language exclusion criteria: participants were excluded if they: * had a diagnosis of cognitive impairment or serious medical condition as determined by their primary physician * were unable to give informed consent * refused to participate

Keywords: hypertension african americans adherence motivational interviewing
in vivo evaluation of perineal mechanical properties during childbirth

Conditions: Perineum; Rupture; Perineum; Tear; Perineal Tear

Summary: the objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

the objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

Eligibility criteria:
inclusion criteria: * pregnant and volunteer women \>18 years old * primiparous * with a singleton pregnancy * no objection from the subject and the spouse to participate in the study exclusion criteria: * history of prior delivery or c-section * history of perineal troubles * bmi \> à 35 mg/m² * history of chronic muscular disease or connective tissue pathology * psychiatric pathology requiring hospitalization * patients who do not understand the french language * legal incapacity or limited legal capacity * patients unlikely to cooperate

Keywords: perineal tear hyperelasticity