Kornimate/medical-research-clean huggingface dataset:
education and awareness program targeting the assessment of adherence of the treatment of dyslipidemia

Conditions: Patients With Dyslipidemia

Summary: evaluate the benefit (rate of adherence to the treatment), based on the ldl-c reduction in the group that will be exposed to the program of reinforcement of orientation aimed to the patients, compared to the control group, both in previous use of rosuvastatin.


Eligibility criteria:
inclusion criteria: * subjects eligible for the treatment of dyslipidemia with statins according the current guidelines ncep atpiii and iv brazilian guidelines of dyslipidemia and atherosclerosis prevention. * patients with previous use of rosuvastatin for, at least, 15 days and, for no longer than12 months prior to the inclusion in the study. exclusion criteria: pregnancy and childbearing * history of severe hypersensitivity (including myopathy) to other hmg-coa reductase inhibitors. * subjects with indication of use of cyclosporine and other associations of other lipid lowering drugs. * subjects with underlying diseases that may influence lipid levels (i.e. uncontrolled hypothyroidism defined as a thyroid stimulating hormone (tsh) \> 1.5 times upper level of normality (uln) at visit 1, aids, transplanted subjects, etc). * history of drug and alcohol abuse. * current active liver disease or hepatic failure or elevations in alt \>3 times the uln. * elevation of cpk \> 3 times the uln. * elevation in the seric creatinine \> 2,0 mg / dl. * history of malignancy in the last 5 years, except basal cell or squamous cell carcinoma of the skin (women with a history of cervical dysplasia must be included, unless they have t3 clear consecutive papanicolaou (pap) smears , before the entry in the study). * any other known clinical condition that, in the opinion of the investigator, may compromise the subject's safety.

Keywords: prevention dyslipidemia
novel influenza a/h1n1 split- virion vaccine in healthy children aged 6 to 35 month

Conditions: Influenza; Swine-origin A/H1N1 Influenza

Summary: the purpose of this study is to generate data on immunogenicity and safety of the monovalent h1n1 vaccine in support of the development and registration.


Eligibility criteria:
inclusion criteria: * male or female aged \>= 6 months to =\<35 months at the time of the first study vaccination. born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * informed consent form has been signed and dated by the parent(s) or other legally acceptable representative subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * receipt of any vaccine in the 4 weeks preceding the first trial vaccination * planned receipt of any vaccine prior to the day 42 blood sample * receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances * thrombocytopenia contraindicating intramuscular (im) vaccination as reported by parents/legal representative * bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating im vaccination * chronic illness that in the opinion of the investigator is at a stage where it might interfere with trial conduct or completion * family members of the employees or the investigator * previous participation in a trial investigating a vaccine with the swine-origin a/h1n1 influenza strain * confirmed infection with the novel influenza a/h1n1 strain * febrile illness (temperature ≥ 38.0°c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
study of self-recognition and self/other distinction disorders in patients with psychological vulnerability

Conditions: Psychosis of Childhood Borderline; Psychotic Disorder

Summary: the main objective of this study is to establish whether there are differences in self-recognition and self/other distinction in subjects with psychological vulnerability compared to healthy volunteer controls.

this study is based on the properties of the double mirror "alter ego" which is a device that appears as a double-sided mirror surrounded by light diodes whose intensity can be varied. thanks to this variation of luminosity, this special paradigm creates morphs between two real subjects seated on both sides, resulting in different faces, each morphed to a varying extent. in this task, participants watch a double mirror in which a picture of their own face gradually transforms into the face of an unfamiliar other (self-to-other direction) or vice versa (other-to-self direction), and indicate at which point they judge the morph to look more like the target face than the starting face. the comparison of the thresholds obtained by different individuals makes it possible to establish whether there could be differences between subjects with psychological vulnerability and healthy controls and to explore hypothetical links between self/other distinction abilities and symptoms of psychological vulnerability .

Eligibility criteria:
inclusion criteria for patients: * aged from 15 to 25 years * subject meeting the ultra high risk criteria at caarms and / or spi-a * signature of the consent (participants and parents for minors) * subject affiliated to the social security scheme or benefiting from such a scheme inclusion criteria for healthy volunteers: * aged from 15 to 25 years * subject not familiar to the patient to whom it is matched * signature of the consent (participants and parents for minors) * subject affiliated to the social security scheme or benefiting from such a scheme exclusion criteria for both patients and healthy volunteers: * history of epilepsy and / or migraine (due to the epileptogenic potential of light stimuli) * refusal of participation of the minor even if the legal representatives want the subject to participate in the study * claustrophobia * wearing glasses * abnormal right and left visual acuity without contact lenses * distinctive signs on the face which cannot be temporarily removed * subject under legal protection (curators / guardianship) or deprived of liberty

Keywords: mental vulnerability self-recognition psychosis high-risk state self-other distinction double mirror paradigm schizophrenia
genetic study of lupus patients and their families

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to perform genetic testing in and to collect information from families affected by lupus in order to identify the genetic factors associated with systemic lupus erythematosus (sle).

little is known about the genetic factors that predispose people to developing sle. genes in patients with sle may provide clues about sle's pathogenesis. this study will compare genes from sle patients, their unaffected family members, and control participants. travel to the study site is not required. in this study, blood samples will be collected from people diagnosed with sle, their unaffected family members, and condition-matched controls. participants will be asked questions about their health and will provide a small blood sample. participants will also be asked to provide written permission for release of medical information, so that their disease status can be verified through medical record review or through consultation with their doctors. study personnel may contact participants in the future for follow-up questions and additional blood draws, if the participant agrees.

Eligibility criteria:
inclusion criteria: * diagnosis of sle or a family member of participant diagnosed with sle exclusion criteria: * pregnancy or breastfeeding

Keywords: lupus sle
study of aripiprazole in the treatment of patients with psychosis associated with dementia of the alzheimer's type

Conditions: Alzheimer Disease

Summary: the purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the alzheimer's type.


Eligibility criteria:
inclusion criteria: * institutionalized patients with alzheimer's disease

Keywords: psychosis associated with dementia of the alzheimer's type
brief bactericidal activity of anti-tuberculosis drugs

Conditions: Tuberculosis; Drug-resistant Tuberculosis; Isoniazid Resistant Tuberculosis (Disorder)

Summary: the investigators will determine the bactericidal activity of high-dose isoniazid against m. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/ml or (2) susceptible at 0.4 mcg/ml but resistant at 0.1 mcg/ml when tested in the bd mgit 960 system. further, the investigators will investigate the molecular genetic determinants of these differences in susceptibility. to achieve these objectives the investigators will carry out an innovative variation on early bactericidal activity (eba) study methodology. patients at risk for drug-resistant tb will be screened for inh resistance using approved molecular assays. in those with inh-resistant tb, the investigators will quickly perform phenotypic dsts using the direct method in the bactec mycobacterium growth indicator tube (mgit) 960 system, so results will be available within 7 days. if the dst results show the susceptibility patterns noted above, patients will receive 900 mg/d inh (600 mg if \<45kg), and assess its effect with serial quantitative sputum cultures for 6 days. if the concentration of viable bacteria decreases significantly, the investigators will interpret this to mean the drug is having an effect. if not, the drug is ineffective. after 6 days, the patients will resume treatment according to national guidelines. in case the investigators identify drugs that are effective under these conditions, the investigators will sequence known and putative genes associated with the action of these drugs for the mycobacterial isolates from these patients.


Eligibility criteria:
inclusion criteria: * written informed consent * inh resistance by approved molecular genetic test * phenotypic drug susceptibility test results match one of the required patterns * sputum microscopy positive for acid fast bacilli exclusion criteria: * ineligible for mdr tb treatment according to national guidelines * hiv infection with cd4 count less than 50 * pregnancy * incarceration * too sick to participate (karnofsky score \ 25/min, clinician's judgment) * hepatic enzymes \>3x normal * estimated glomerular filtration rate \<60 ml/min/1.73 m2 * unable to provide adequate sputum specimen
effects of exercise with or without blueberries on cardiovascular risk markers

Conditions: Risk Factors Cardiovascular Disease; Inflammation; Exercise; Sedentary Life

Summary: about 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being "couch potatoes". all participants are also randomized to also consume 150 g of blueberries on exercise days or not. the exercise is constituted of 5 km running 5 days a week during the 4 week period. the exercise period and the "couch" period are started and ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk factors are measured before and after this run, ie 8 times in total.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * significant disease and disabilities that hinder running

Keywords: inflammation lipids crp
mepilex border flex utilization pilot spain

Conditions: Wound

Summary: the aim of this study is to assess and describe the utilization of mepilex® border flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. the study will also allow to gain information about the opinion of the hcps and the patient's experience concerning wound management with foam dressings. this information may help to understand patient's health care optimization in terms of quality and efficiency.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * the patient has been deemed by the hcp to change dressing to mepilex® border flex. * patients with chronic wounds (wounds that have not reduced in size by more than 40% to 50% or healed within a month) treated with foam dressings, other that mepilex® border flex, according to its intended use at baseline visit for minimum 4 weeks. * patients with an expectation of wound follow-up of at least 4 weeks. * patients agree only to have the dressing changed by the hcp. * patients capable of signing the informed consent form and answer the questions being asked. exclusion criteria: * patients with any applicable contraindication or sensibilization to any of the dressing compounds * patients with pressure ulcers (pu) stage i, deep tissue injuries or terminal wounds (e.g., fungating wounds) * patients with wounds whose location and/or aetiology requires a dressing change for reasons that are unrelated to the dressing characteristics such as wounds in the sacral area. * hospice patients * patients participating in other studies interfering with this study.
a study of two approved drugs in the treatment of post-bunionectomy surgery pain (0966-234)(completed)

Conditions: Postoperative Pain

Summary: this purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

the duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Eligibility criteria:
inclusion criteria: * bunion removal exclusion criteria: * any known allergies to the study design

Keywords: bunionectomy
calypso knee system clinical study, ous

Conditions: Osteoarthritis, Knee

Summary: a study to evaluate the safety and effectiveness of the calypso knee system when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

prospective, multicenter clinical study of the calypso knee system. a total of 81 subjects were enrolled in this study. male or female subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall womac pain score ≥ 40 (scale 0-100). the calypso group was investigated under two clinical protocols, cp0001 in the usa, and cp0002 in europe. both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, clinical events committee (cec), etc. the results from the combined analysis have been reported in both nct03671213 (cp0001) and nct03838978 (cp0002).

Eligibility criteria:
inclusion criteria: 1. participants age - 25 to 65 years 2. body mass index (bmi) of \< 35, weight \< 300 lbs (136 kg) 3. knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment exclusion criteria: 1. symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee 2. knee ligament or meniscal instability 3. other bone or joint conditions such as rheumatoid arthritis, paget's disease, charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
add-on to thiazolidinedione (tzd) failures

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn if bms-512148 (dapagliflozin) can help reduce the blood sugar levels in subjects with type 2 diabetes who are not well controlled on tzd alone. the safety of this treatment will also be studied


Eligibility criteria:
inclusion criteria: * males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control * all subjects must have central laboratory pre-randomization a1c ≥ 7.0 and ≤ 10.5% * c-peptide ≥ 1.0 ng/ml (0.34 nmol/l) * body mass index ≤ 45.0 kg/m² exclusion criteria: * ast and /or alt \> 2.5 times the upper limit of normal * serum total bilirubin \> 2 mg/dl (34.2 µmol/l) * creatinine kinase \> 3.0 times the upper limit of normal * symptoms of severely uncontrolled diabetes * serum creatinine ≥ 2.0 mg/dl * calculated cr-clearance \< 50 ml/min (calculated by cockroft-gault formula) * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
first presentation of parkinson disease patients to neurologist

Conditions: Parkinson Disease

Summary: in this study information is gathered about the treatment of parkinson patients who present themselves in a neurological practice for the first time


Eligibility criteria:
inclusion criteria: - parkinson disease patients presenting to neurologist for first time exclusion criteria: - hypersensitivity to the active substance or to any of the excipients
efficacy and safety study of 4975 to manage pain of bunionectomy

Conditions: Pain

Summary: the primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. placebo in the management of acute postoperative pain in patients undergoing bunionectomy. secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.

this is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the us. a dose of 4975 will be evaluated against placebo in patients undergoing bunionectomy. upon enrollment, patients will be randomized in a 1:1 ratio to receive either 4975 or placebo. after the surgery, patients will be admitted to the clinical study site, where trained study personnel will monitor them for up to 48 hours. while at the clinical study site, patients will undergo safety and efficacy assessments. after discharge, patients will report pain severity daily through day 14 via an interactive voice response system (ivrs). also, safety and patient-reported outcome assessments will be performed at the day 14 (week 2) and day 28 (week 4) clinic visits.

Eligibility criteria:
inclusion criteria: * male or female aged 18 years and older. * planning to undergo unilateral transpositional first metatarsal osteotomy for correction of hallux valgus deformity (referred to as bunionectomy in this protocol). exclusion criteria: * use of certain medications or having a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments. * diabetes mellitus with a known hba1c \> 9.5 or a history of prolonged uncontrolled diabetes. * participated in another clinical trial or used an investigational product within 30 days prior to the planned bunionectomy surgery, or is scheduled to receive an investigational product other than 4975 while participating in the study. * previously participated in a clinical study with 4975.

Keywords: foot bunion bunionectomy hallux valgus deformity surgery for transpositional first metatarsal osteotomy - bunionectomy
mobile health cognitive stimulation in heroin users

Conditions: Substance Use Disorder

Summary: heroin use has been related to brain dysfunction particularly in the prefrontal cortex. these effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. to assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.


Eligibility criteria:
inclusion criteria: * only patients that scored higher than the cutoff values for their age on the mini mental examination test and with no clinical scores on the symptoms checklist revised will be included in the study. exclusion criteria: * patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. patients will be also screened for minimal computer literacy.

Keywords: opioid abuse disorder cognitive therapy executive function mobile health rehabilitation
association between genetic variant scores and warfarin effect

Conditions: Atrial Fibrillation; Deep Vein Thrombosis; Intracardiac Thrombus; Pulmonary Embolism; Venous Thromboembolic Disease

Summary: study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (inr), inr ≥ 4, bleeding event, ischemic stroke, death) in participants taking warfarin for atrial fibrillation, deep vein thrombosis (dvt), pulmonary embolism (pe), and/or intracardiac thrombosis.

it is anticipated that next generation genomic sequencing will identify rare genetic variants in ethnically diverse populations, which otherwise would not have been detected using commercially available warfarin tests. furthermore, retrospective review of clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (inr), inr ≥ 4, major bleeding event, ischemic stroke) of study participants will determine the clinical utility of genetic variant risk scores. study outcomes will provide guidance on future directions for optimizing dosing algorithms for warfarin that combine pharmacogenetic principles with clinical dosing.

Eligibility criteria:
inclusion criteria: 1. non-valvular atrial fibrillation 2. deep venous thrombosis (dvt) and/or pulmonary embolism (pe) with no hypercoagulable condition 3. non-valvular atrial fibrillation and dvt/pe (with no hypercoagulable condition) 4. intracardiac thrombosis (i.e. apical thrombosis, atrial thrombosis, auricular thrombosis, mural thrombosis, and/or ventricular thrombosis) 5. age 18-99 years 6. signed informed consent exclusion criteria: 1. presence of a mechanical heart valve 2. failure to provide signed informed consent 3. known diseases that affects coagulation test results such as vitamin k deficiency, disseminated intravascular coagulopathy, von willebrand disease, hemophilia, liver failure, etc.

Keywords: warfarin coumadin pharmacogenomics pharmacogenetics adverse drug reactions bleeding/hemorrhaging