Kornimate/medical-research-clean huggingface dataset:
safety study of bms-823778 in subjects with hypercholesterolemia

Conditions: Dyslipidemia

Summary: the purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on ldl cholesterol (ldl-c)


Eligibility criteria:
inclusion criteria: * hypercholesterolemia * currently taking a stable daily dose of statin therapy * serum triglyceride level \< 500mg/dl exclusion criteria: * history of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study * congestive heart failure * diabetes mellitus * active liver disease * impaired renal function * hepatitis c, b and hiv this list is not inclusive; additional information is provided in the protocol
study evaluating genotypes while using lucentis 2

Conditions: Age-Related Macular Degeneration

Summary: the purpose of the study is to investigate whether the efficacy of lucentis treatment for exudative age-related macular degeneration is associated with vegf and htra1 dna polymorphisms

age-related macular degeneration (amd) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. although geographic atrophy and neovascularization represent the advanced forms of amd, neovascular amd is the more aggressive form and accounts for almost 90% of blindness from this disease. it is characterized by choroidal neovascularization (cnv) which is the development of abnormal blood vessels underneath the retina. randomized clinical trials (marina, anchor) have conclusively demonstrated that continued intravitreal therapy with lucentis (ranibizumab) in patients with subfoveal cnv from amd leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of lucentis for the treatment of neovascular amd (see investigator brochure). this study could provide insight as to the reasons that some patients do not experience vision stabilization with lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving lucentis. this is an open-label study of 100 treatment-naïve (study eye only) amd patients treated on-label with intravitreally administered lucentis. consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. their blood will be genotyped and sequenced for various snps on vegf and htra1.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with the study assessments for the full duration of the study. * age \> 50 years. * treatment naïve (study eye only) amd patients that are determined to be candidates for ranbizumab. * visual acuity 20/32 to 20/230. exclusion criteria: * pregnancy * prior enrollment in the study * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * previous therapy in study eye for amd or other retinal disease which may be used in the treatment of amd. * any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed * any participation in another simultaneous medical investigation or trial for amd \*concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
a crossover study of the safety and tolerability of two formulations of adalimumab

Conditions: Rheumatoid Arthritis

Summary: this study will compare injection site pain levels between current humira® formulation versus a new formulation of humira in patients with rheumatoid arthritis (ra), who are either currently on a stable dose (minimum six consecutive doses) of on-label humira or biological naïve who will be prescribed on-label humira as treatment for their rheumatoid arthritis. the study is being conducted in three countries, australia (3 sites), canada (2 sites), and germany (2 sites).

61 participants were randomized, and 60 received at least one dose of the study drug. one participant, who was randomized to the new formulation of adalimumab/current formulation adalimumab arm of the study, discontinued from the study and never received study drug.

Eligibility criteria:
inclusion criteria: * male or female subject age 18 years or older, who requires humira 40 mg sc every other week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance with the local humira label. * subject must be a current, on-label user of humira who rates his/her average humira injection site related pain as at least 3 cm on a pain visual analogue scale and has had at least 6 consecutive doses of humira prior to screening, or a biologic naïve subject who requires initiation of on-label treatment with humira. * subject has diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised acr classification criteria or the acr/eular 2010 criteria, * female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least one method of birth control throughout the study and for at least 70 days after the last dose of study drug. * all female subjects of childbearing potential must have a negative test for pregnancy on a serum sample at screening and prior to study drug dosing on a urine sample obtained at visit 1. exclusion criteria: * subject has been treated with any investigational drug of a chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to visit 1. * any infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to visit 1 or oral anti-infectives within 14 days prior to visit 1. * prior exposure to natalizumab (tysabri®) or efalizumab (raptiva®). * known hypersensitivity to adalimumab or its excipients. * history of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.

Keywords: on label humira users rheumatoid arthritis pain
patient participation beliefs and post-traumatic stress disorder (ptsd)

Conditions: Post-Traumatic Stress Disorder; Brain Injuries, Traumatic

Summary: this is an exploratory qualitative interview study being conducted with a primary objective of examining perceptions held by active military and veterans regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in post-traumatic stress disorder (ptsd) or traumatic brain injury (tbi) clinical trials. active duty military and/or veterans aged 18 years and older who consent to participate (n = 50), or have recently declined participation (n = 50), in an intrust affiliated outpatient clinical trial for deployment-related ptsd or tbi will be recruited. participants who consent to participate in an intrust clinical trial (group 1) will be interviewed once at the beginning the of the clinical trial, and again following participation in the trial. participants who decline participation in an intrust affiliated outpatient clinical trial (group 2) will be interviewed once. for participants in both groups, study participation will initiate within 1 month of referral to study. total duration of study participation is based on the specific clinical trial that the participant is recruitment from; the longest trial is estimated to be 24 weeks or less. semi-structured qualitative individual interviews will be conducted to carry out a thematic analysis of the data exploring familial, social and institution-level constructs which may influence the subjective experience of the research treatment process.


Eligibility criteria:
inclusion criteria: 1. age between 18 and over 2. active duty and/or veteran 3. referred to participate in intrust-affiliated outpatient clinical trials for ptsd or tbi 4. ability to provide written informed consent

Keywords: qualitative research health knowledge, attitudes, practice refusal to participate
high intensity interval versus continuous moderate intensity training: maximizing the benefits of exercise in overweight adolescents

Conditions: Metabolism; Physical Fitness

Summary: 6-week, single site, two parallel arm, randomized, controlled trial comparing the effectiveness of a high intensity interval training (hiit) versus a continuous moderate intensity training (mit) program on cardiovascular and metabolic health outcomes in overweight adolescent males. hiit training may be a potent time-efficient strategy to induce similar metabolic and cardiovascular adaptations typically associated with mit.


Eligibility criteria:
inclusion criteria: * ages 17-22 * men * bmi (25.0 - 35.0 kg/m2) * interested in improving health and fitness exclusion criteria: * weight loss or gain of \>10% of body weight in the past 6 months for any reason. * currently taking medication that suppresses or stimulates appetite. * history of prior surgical procedure for weight control or liposuction. * current smoker. any major disease, including: * active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer). * active or chronic infections, including self-reported hiv positivity and active tuberculosis. * diagnosed heart conditions. * uncontrolled hypertension: systolic blood pressure 160 mm hg or diastolic blood pressure 95 mm hg on treatment. * gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy). * asthma. * diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dl), or use of any anti-diabetic medications. * conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes. * currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months). * any active use of illegal or illicit drugs. * excessive alcohol intake defined as an average consumption of 3 or more alcohol containing beverages daily. * unwilling to limit alcohol intake to ≤2 drink per day (one drink = 4 oz. wine, 12 oz. beer, or ½ shot of liquor). * current exerciser (\>30 min organized exercise per week). * indication of unsuitability of current health for exercise protocol (parq). * any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Keywords: high intensity interval training aerobic exercise insulin sensitivity obesity cardiovascular fitness
effect and feasibility of non-linear periodized resistance training in people with copd

Conditions: Pulmonary Disease; Chronic Obstructive

Summary: this study aims at improving the knowledge about resistance training for people with copd. resistance training is an important part of pulmonary rehabilitation when the goal is to improve muscular endurance and strength. the study will evaluate the effects and the feasibility of two resistance training programs for people with copd using a parallel group design. one program will include a larger day-to-day variation (i.e. non-linear periodization) and the progression will be guided by ratings of dyspnea, muscle fatigue, and exertion. the other program will follow the established guidelines for resistance training for people with copd. the programs will be evaluated for effects regarding muscular endurance, strength, intramuscular adaptions, functional preformance, dyspnea, and health related quality of life. the programs will also be evaluated for feasibility regarding the duration of training sessions, attendance rates, adverse events, and participant satisfaction. the hypothesis is that the non-linear periodization group will have superior effects and that feasibility aspects will be similar between groups.


Eligibility criteria:
inclusion criteria: * fev1/fvc ratio \< 70% postbronchodilator * fev1 \<80% of the predicted normal value postbronchodilator exclusion criteria: * clinical evidence of asthma, cardiovascular diseases, and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation * other contraindications to exercise * currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months * experienced a copd exacerbation and/or change in medication dosage/frequency in the past 6 weeks

Keywords: muscle dysfunction
trial to investigate the efficacy, tolerability and safety of fesoterodine sustained release in subjects with overactive bladder syndrome

Conditions: Overactive Bladder

Summary: this phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (sr) (fesoterodine; spm 907) in adult male and female subjects with overactive bladder syndrome. the trial is a randomized, double-blind placebo controlled multicenter trial. the trial consisted of a 2 week run-in period, 12 week double-blind treatment period and 2 week safety follow-up period. subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind treatment period. two primary efficacy variables will be assessed for submission in the united states: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. for the submissions in the european union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. all continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. the following safety variables were observed and assessed: adverse events, change in residual urinary volume (ml), change in laboratory parameters, change in vital signs, change in electrocardiogram (ecg), change in physical examination and change in urological/urogynecological examination.


Eligibility criteria:
inclusion criteria: * overactive bladder syndrome exclusion criteria: * less than 8 micturitions in 24 hours
simvastatin for treating erectile dysfunction

Conditions: Erectile Dysfunction; Vascular Disease Detected; C Reactive Protein

Summary: this is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.it is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.


Eligibility criteria:
inclusion criteria: * erectile dysfunction * elevated c reactive protein * able to adhere the protocol exclusion criteria: * diabetes mellitus * cardiac disease * cerebral vascular disease * hypogonadism * any contraindication to simvastatin

Keywords: simvastatin endothelial dysfunction erectile dysfunction
real-life outcomes of multiple sclerosis treatment with rebif

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether rebif has an impact on employment status, quality of life and cognition.

with this study the investigator plans to evaluate the impact of rebif on the real-life outcomes (rlo) of multiple sclerosis (ms) patients followed at the clinic within the last two years, and with a follow-up of up to 18 years. the investigator will evaluate the employment outcomes with a questionnaire designed to document eventual changes in the employment status and other variables in the work conditions of the study participants. furthermore, to evaluate the quality of life (qol),eligible patients will be asked to complete the multiple sclerosis quality of life (msqol)-54 instrument, contains 52 items distributed into 12 scales, and two single items. this ms-specific qol assessment tool uses the short form health survey (sf-36) as its generic core measure and includes 18 additional items under the following categories: health distress, sexual function, satisfaction with sexual function (one item), overall quality of life, cognitive function, energy, pain, and social function. a sub-group of patients will be selected to come to the clinic to undergo the cognitive portion of the study, using the well-known and validated battery of tests named minimal assessment of cognitive function in ms (macfims battery). socio-demographic data on education level, marital and family life will also be collected. all questionnaires (including the msqol-54) will be available by means of an online survey.

Eligibility criteria:
inclusion criteria: * patients with cis or definite ms (rrms or spms); * patients seen at our clinic within the last 2 years; * patients untreated, or treated with either low dose or high dose rebif for at least two years; * patients between 18 to 60 years old at time of treatment initiation; * edss ≤ 5.5 at treatment initiation; * patients able to read and write in french. exclusion criteria: * patients diagnosed with primary progressive ms; * patients treated with other dmd, other than rebif; * co-existence of other diseases that could influence outcomes.

Keywords: multiple sclerosis patient-reported outcomes employment status quality of life cognition rebif
irisin expression and gene polymorphism in type ii diabetic patients with and without cad

Conditions: Irisin Gene Polymorphism in Type II Diabetic Patients

Summary: this is an observertional study aimed at study the association between the level of irisin expression and (fibronectin type iii domain containing 5 (fdnc5) gene polymorphism and the presence and severity of coronary artery disease in patients with type ii dm.


Eligibility criteria:
inclusion criteria: * this study will include type ii diabetic patients aged between 18 and 45 years old exclusion criteria: 1. recent acute myocardial infarction. 2. patients with heart failure 3. active infection 4. end stage renal failure (gfr \< 30 ml/min) or on dialysis 5. liver cell failure 6. athletes or having heavy muscular exercise in the previous 3 days
senseye's obci diagnostic tool for ptsd

Conditions: PTSD

Summary: this pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the senseye obci diagnostic tool to assess the presence and severity of ptsd symptoms and monitor response to trauma-informed interventions. a total of 68 adults will be included in the study with a follow-up time point of 9 weeks post-initial intervention.

this pilot study will investigate the feasibility, acceptability, repeatability, accuracy, and efficacy of operator-independent senseye ocular brain-computer interface (obci) diagnostic tool to assess the presence and severity of ptsd symptoms and monitor response to trauma-informed interventions. after informed consent, 68 adults - 34 with ptsd and 17 adults with significant trauma exposure but no ptsd, and 17 healthy adults without known major psychiatric disorders, aged 18-65 years old, will be recruited and undergo obci diagnostic tool, comparing against gold standards tools- the caps-5, ucla ptsd reaction index for dsm-5 (ptsd-ri). fifteen participants will undergo repeatability and reproducibility assessments. adults with ptsd will receive a standard of care trauma-informed interventions for eight weeks, and their biopsychosocial characteristics, senseye obci, neuropsychiatric measures will be measured at baseline and week 9. using senseye's machine learning algorithm, senseye obci will use a facecam recorder during a series of visual tasks, pupil light reflex, and heart rate measurement throughout.

Eligibility criteria:
inclusion criteria: 1. male/female diagnosed with ptsd (only for ptsd group) 2. aged 18- 65 years old 3. able to read/write in english exclusion criteria: 1. presence of intellectual disabilities 2. psychotic or self-injurious behavior 3. seizure disorder 4. major depression 5. traumatic brain injury (tbi) 6. language disorder 7. eye disorders 8. other neurodevelopmental disorders 9. history of lifetime psychosis 10. mania 11. current suicidality 12. diagnosis of a substance use disorder 13. impaired functioning to the degree that requires immediate initiation of psychotropic medication.
nutritional intervention with moderately high-protein, low-glycemic load products in type-2 diabetes patients

Conditions: Type-2 Diabetes; Overweight

Summary: the main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2 diabetes patients following a chronologically scheduled pattern.

type 2 diabetes prevalence in adults has grown in the last years in many societies, accompanying the high incidence of obesity-related and other cardiovascular risk factors. indeed, obesity is the most relevant overnutrition disease worldwide, being more dramatic than a self-esteem problem or an aesthetic issue, since it is associated to different metabolic disorders such as coronary diseases, hypertension, certain tumors, dislipidemia, biliary disorders, immunodeficiencies and insulin resistance. different studies have shown the efficacy of low-fat diets on weight reduction, which has been associated to an improvement in overweight-related chronic pathological conditions. additionally, a moderate increase of protein content (up to 30% of total caloric intake) in the diet and the inclusion of low-glycemic index products have been shown as a good tool for weight loss and maintenance. recent studies have also shown the benefits of partial nutritional interventions, mainly on modifying breakfast intake, on anthropometrical and cardiovascular risk factors in overweight patients. the study has been designed as a longitudinal nutritional intervention with two consecutive 4-week periods: from week 0 to 4, volunteers will follow their habitual diet. the second period (week 4 to 8), the volunteers' habitual breakfast, mid-morning and afternoon snacks will be substituted by 40-30-30 products, without changing any other parameter of their habitual diet or lifestyle.

Eligibility criteria:
inclusion criteria: * clinically diagnosed of type-2 diabetes * under dietary treatment or with metformin * body mass index (bmi) between 22 and 35 kg/m2 exclusion criteria: * bmi under 22 or over 35 kg/m2 * to follow a pharmacological treatment with other drugs but metformin * to be already insulin-dependent * to have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study). * to suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc) * to have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.

Keywords: chrononutrition moderately high protein glycemic index type-2 diabetes overweight obesity weight management