Kornimate/medical-research-clean huggingface dataset:
vitamin d, cardiovascular disease, and african americans

Conditions: Vitamin D Deficiency; Type 2 Diabetes Mellitus; Cardiovascular Disease

Summary: african-americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin d deficiency. multiple observational studies have demonstrated an increased risk of vitamin d deficiency in african americans with type 2 diabetes and correlation between cardiovascular disease and vitamin d levels; however, there is a lack of interventional trials exploring this connection. the objective of this proposal is to address the hypothesis that treatment of vitamin d deficiency in african americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.

this study will be a double blinded, randomized controlled trial of vitamin d3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in african americans with type 2 diabetes and vitamin d deficiency. outcome assessment will focus on changes in carotid intima-medial thickness (cimt - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.

Eligibility criteria:
inclusion criteria: * african americans of both genders * age 50-70 years * type 2 diabetes (a1c \< 9.0%), on stable therapy with oral medications, insulin, or a combination * 25(oh)d level \< 20 ng/ml * bp \< 140/90 mmhg; ldl \< 140 mg/dl exclusion criteria: * pregnancy * cardiovascular disease * stage 3 or worse chronic kidney disease * high urine or serum calcium or history of recurrent kidney stones * unstable medical conditions or major systemic diseases such as malignancy
clinical trial to evaluate the safety and tolerability of lagricel® ofteno multi-dose ophthalmic solution

Conditions: Dry Eye

Summary: study design: phase i clinical trial, single-center, controlled, parallel group, open, randomized. number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes). estimated duration of the study: 5 months therapeutic indication: eye lubricant use: dry eye objective:to evaluate the safety and tolerability of lagricel® ofteno multidose manufactured by laboratorios sophia on the ocular surface of clinically healthy subjects. hypothesis: h0 = lagricel® ofteno multidose ophthalmic solution has a safety and tolerability profile similar to lagricel® ofteno single dose in healthy subjects. h1 = lagricel® ofteno multidose ophthalmic solution has a different safety and tolerability profile than lagricel® ofteno single dose in healthy subjects. main inclusion criteria: clinically healthy subjects


Eligibility criteria:
inclusion criteria: * to be clinically healthy * to have the ability to voluntarily grant your signed informed consent * to have the willingness to comply with scheduled visits treatment plan and other study procedures * women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period. * to have a better corrected visual acuity of 20/30 or better in both eyes. * to have vital signs in normal parameters. * to have an intraocular pressure between ≥10 and ≤ 21 mmhg. exclusion criteria: * to be user of ophthalmic topical products of any kind. * to be user of medicines, or herbal products, by any other route of administration. * in the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period. * having participated in clinical research studies 90 days prior to inclusion in this study. * having previously participated in this same study. * to be a user of contact lenses and can not suspend their use during the study. * having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study. * to have a history of any chronic degenerative disease. * having inflammatory or infectious disease, active at the time of admission to the study. * having injuries or unresolved injuries at the time of admission to the study. * having a history of any type of eye surgery. * having undergone surgical procedures, not ophthalmological, in the last 3 months. * to be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.

Keywords: dry eye eye lubricant sodium hyaluronate
advancing community level action for improving mch/pmtct

Conditions: HIV

Summary: the goal of the acclaim (advancing community-level action for improving mch/pmtct) project is to increase community demand for, uptake of, and retention in maternal and child health (mch) and/prevention of mother-to-child transmission of hiv (pmtct) services to improve country progress toward elimination of pediatric hiv/aids.

this study will undertake a three-arm randomized trial in swaziland, uganda and zimbabwe. districts/regions (n=9) with 45 pmtct-implementing health facilities and their catchment areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. the primary study outcome is hiv exposed infants (hei) returning to the health facility within two months for early infant diagnosis (eid) of hiv. secondary study outcomes include: gestational age of women attending for first antenatal care, male partners tested for hiv, and hei receiving nevirapine prophylaxis at birth. changes in community knowledge, attitudes, practices and beliefs on mch/pmtct will be assessed through household surveys.

Eligibility criteria:
inclusion criteria: * must be a member of the community surveyed exclusion criteria: * under 18 years of age

Keywords: hiv aids pmtct
observational study of viral biomarkers and micrornas in tumors orofarynx and occult tumors positive for papilloma virus

Conditions: Squamous Cell Carcinoma of the Oropharynx; Carcinomas of Unknown Primary Site; High-risk Human Papillomavirus Infection; Liquid Biopsy; Lymph Node Metastasis; Occult Tumor of the Head and Neck Area

Summary: based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of hpv-dna, certain mirnas, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in hpv-related opsccs but also in hpv+ occult t. accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (pet-ct and mri), already in use in clinical practice, for monitoring disease progression in this specific subgroup. finally, by using the collected material to generate organoids and patient derived xenograft (pdx), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.


Eligibility criteria:
inclusion criteria: * squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with tors or rt or rt/ct * age \> 18 years * ecog performance status \<_ 2 * ability to follow study procedures and complete questionnaires * signature of informed consent exclusion criteria: * presence of distant metastases at the time of diagnosis * previous cancer of the head and neck district * second tumor in therapy or follow-up for less than 5 years

Keywords: oropharyngeal tumor occult cancer hpv infection head-neck area
evaluation of the efficacy of rosuvastatin in daily practice (target)

Conditions: Hypercholesterolemia; Coronary Heart Disease

Summary: in this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident chd and ldl-c ≥ 3.2 mmol/l. this was done in a large observational study (target) representing daily practice. primary end points analysis was the percentage of patients reaching the target of ldl-c \< 3.2 mmol/l. secondary outcomes were the changes of ldl-c, hdl-c, tc, triglycerides (tg) and tc/hdl-c-ratio from baseline.


Eligibility criteria:
inclusion criteria: * high-risk patients with and without evident chd who had ldl-c \> 3.2 mmol/l and were treated at that moment with hmg-coa-reductase inhibitor apart from rosuvastatin. * patients were aged \>18 years and \<70 years (men) and \< 75 years (women). exclusion criteria: * treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg * patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin

Keywords: cholesterol coronary heart disease rosuvastatin ldl-c goal hypercholesterolemia
head positions to open the airway iv

Conditions: Cardiac or Respiratory Arrest, Anaesthesia

Summary: after routine induction of general anaesthesia peak airway pressure (= p max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory co2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years * elective operations in general anaesthesia * patient´s written informed consent * american society of anesthesiology scale i-iii exclusion criteria: * non fasting patient * body mass index \> 35 kg/m2 * anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine * malformations of the head or upper airway * history of perforation of stomach or esophagus * anamnestic hiatus hernia or reflux * acute respiratory infection or obstructive airway disease

Keywords: anesthesia, cardiac arrest, resuscitation, ventilation
postprandial blood cell transcriptome of normal weight and obese subjects to 3 caloric doses of a high-fat meal

Conditions: Obesity; Nutritional Intervention

Summary: the study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.


Eligibility criteria:
inclusion criteria for normal weight subjects: * age 25-50 * 20\ 25 * waist circumference \<94cm inclusion criteria for obese subjects: * age 25-50 * 30\ 40 * waist circumference \>102cm exclusion criteria for both groups: * physiological or psychological diseases * allergies to food or intolerance to high-fat meal * vegetarians, vegans * chronic intake of drugs * smokers * diabetes mellitus type i and ii * debiliating kidney disease * debiliating liver disease * clinically established coronary heart diseases * ingestion of vitamins or dietary supplements during the course of the study
optimisation of cardiac resynchronisation therapy by non-invasive cardiac output - the choice2 study

Conditions: Heart Failure; Cardiac Resynchronisation Pacemakers

Summary: an evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.


Eligibility criteria:
inclusion criteria: * cardiac resynchronization device in situ for heart failure exclusion criteria: * unable to cope with mouthpiece * estimated life expectancy \< 6 months

Keywords: heart failure pacemakers
improving attention skills of children with autism

Conditions: Autism

Summary: toddlers with autism have poor joint attention skills. joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. improved joint attention skills may lead to better verbal ability as the child ages. this study teaches caregivers how to help their toddlers with autism develop joint attention skills.

young children with autism show impairment in joint attention. the impairment affects their ability to sustain a shared interest in social interaction and to use specific joint attention skills, such as pointing and showing. the importance of joint attention is underscored by data suggesting these skills are important to later language skills. targeting joint attention deficits in developmentally young children using familiar caregivers may result in better child language outcomes. this study will teach caregivers how to initiate and maintain episodes of joint engagement with their children. participants will be randomized to either the intervention group or to a wait list control group. each caregiver and child in the intervention group will participate in 24 1-hour sessions, 3 times a week for 8 weeks. in these sessions, caregivers will be taught 10 different modules for teaching joint attention skills to their children. outcome measures will include language and joint attention skills in the child and caregiver adherence to the intervention protocols. children and caregivers will be assessed at baseline, during the course of the 8-week intervention, and 10 weeks after the end of the intervention. participants assigned to the wait list group will begin the intervention at week 12.

Eligibility criteria:
inclusion criteria * diagnosis of autism based on autism diagnostic interview-revised (adi-r) and autism diagnostic observation schedule (ados) criteria exclusion criteria * seizures * medical or psychiatric diagnoses other than autism that potentially contribute to developmental delay (e.g., genetic syndromes)

Keywords: joint attention developmental delay caregiver interaction
parkinson and the males body composition

Conditions: Neurodegenerative Disease

Summary: the main aim of the present study was to ascertain the type of relationship (dependency or independency) among some of the cardinal motor symptoms of the parkinson´s disease (pd) and the body composition (bc) variables of a group of the male pd´s patients, using the bioelectrical impedance analysis.


Eligibility criteria:
inclusion criteria: (i) males with diagnosis of idiopathic pd and rated 1-3 on the hoehn and yahr scale. (ii) no type of dementia as assessed by the mini-mental state examination. (iii) between 50 and 69 years old (a specific range of ages of the illness´s onset). (iv) between one and five years diagnosed with the illness. (v) able to stand for two min without assistance. (vi) able to walk teen m without assistance. exclusion criteria: (i) do not meet the eligibility criteria. (ii) suffer a neurological disease other than parkinson´s disease.

Keywords: movement disorders components of the human body
the effect of acupuncture protocol involving in weizhong (bl4) and huantiao (gb30) points in treating ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to evaluate the effect of acupuncture protocol involving in weizhong (bl4) and huantiao (gb30) points in treating ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * eligible adult (≥18 years of age) patients * had a diagnosis of as for at least 3 months defined as definite by the 1984 modified new york criteria * eligible patients also had a bath ankylosing spondylitis disease activity index (basdai) of ≥4 (0-10 cm scale) * a visual analogue scale (vas) score for total back pain of ≥4 (0-10 cm scale) exclusion criteria: * had received prior acupuncture therapy * with complete ankylosis of the spine, defined as the presence of bridging syndesmophytes at all intervertebral levels of the cervical and lumbar spine on lateral view spinal radiographs
a study of pertuzumab in participants with prostate cancer

Conditions: Prostate Cancer

Summary: this study will evaluate the efficacy and safety of intravenous (iv) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. participants will be enrolled in two stages, the first (cohort a) at a lower 420-mg dose and the second (cohort b) at a higher 1050-mg dose based upon observations in cohort a. up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.


Eligibility criteria:
inclusion criteria: * adults greater than (\>) 18 years of age * histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal * prostate-specific antigen (psa) values at least 20 ng/ml among those with asymptomatic or mildly symptomatic disease * karnofsky performance status (kps) at least 80 percent (%) * castrate testosterone less than (\<) 50 ng/dl * life expectancy at least 12 weeks * left ventricular ejection fraction (lvef) at least 50% * adequate hematologic, hepatic, and renal function exclusion criteria: * prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer * systemic corticosteroids within 1 month prior to screening * bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug * prior cumulative doxorubicin dose of \> 360 mg/m\^2 or equivalent * central nervous system (cns) or pulmonary metastases * other malignancies, except adequately treated basal or squamous cell skin cancer * significant cardiovascular disease * active/uncontrolled concurrent illness or infection * major surgery or traumatic injury within 4 weeks of study drug
a training of the rhythmic skills with a serious game to improve gait and cognitive abilities in parkinson's disease

Conditions: Parkinson Disease

Summary: this project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in parkinson's disease. timing rehabilitation will be done by the means of a serious game. serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. overall, we propose to test a low-cost tool for rehabilitation.

auditory rythmic cueing is a method consisting in presenting a regular auditory stimulus (metronom or music) when someone is walking. it is known to improve gait in pathologies such as parkinson's disease. it has also an effect on general timing abilities (e.g. tapping the beat of the music). this project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in parkinson's disease. timing rehabilitation will be done by the means of a serious game. serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. overal, we propose to test a low-cost tool for rehabilitation.

Eligibility criteria:
inclusion criteria: * age \< 18 * good understanding of the nature, the goal and the methodology of the study * signing of the informed consent * being insured with a social security * diagnostic of idiopathic parkinson's disease following the queen square brain bank (hughes, 1992) * hoehn et yahr between 2 and 3 * mild to moderate walk and speech deficits (item mds-updrs) * stable therapy one month before inclusion for all the duration of the study exclusion criteria: * atypic parkinson syndrom (oculomotor troubles, early falls, hallucinations, moca\<20, early dysautonomy) * dystonia ou dyskinesia preventing from using a tablet (item mds-updrs4.2 \>2) * unable to move without help (walking stick, walker, wheelchair) (item mds-updrs 2.12 \>2) * adult protected by law * deprivation of liberty * high propability of non compliance to the protocol * pregnant women, nursing women * moderate to severe auditory trouble * severe walk fluctuations item mds-updrs 4.4 \>2) * pacemaker or neurosensorial device or heart defebrillator * cochlear implants * ferromagnetic external bodies claose to the brain * metallic prothesis * agitated, non cooperative patient * claustrophobic patient * neuro-surgical shunt valves * dental appliance
innovative biotechnological production of antioxidant products

Conditions: Oxidative Stress; Inflammation; Body Weight; Homocystine; Metabolic Disorder

Summary: several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. the safety and biological activity of a standardised supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified escherichia coli strains and equal amounts (8.33 μl) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical study were studied. the supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks.

the study was designed to evaluate the safety and biological activity of the supplement antiox-plus: one capsule/day, 15 minutes before their main meal which contained 10 mg of ht, synthesised using genetically modified escherichia coli strains and equal amounts (8.33 μl) of essential oils from origanum vulgare, sage officinalis and crithmum maritimum. the volunteers will consume the supplement for 8 weeks. a follow-up analysis will be performed one month after the end of the supplementation period (12 weeks from the initiation of the study). during this time, the participants will consume a placebo. the volunteers are instructed to maintain their normal dietary habits. the following measurements will be taken: a) dietary assessment at the beginning of the study (week 0), b) body composition analysis at the beginning (week 0) and the end of the study (week 8), c) biochemical and laboratory analysis of plasma samples at week 0, 8 and 12. the volunteers will record their food intake for 3 days (including one day of the weekend) and will fulfil a food frequency questionnaire. analysis of their data will be done by a certified nutritionist. nutritional assessment will be performed using the evexis dietary software. the tanita dual frequency body composition monitor "innerscan" will be employed to measure weight, muscle mass, muscle quality score, heart rate, body fat (%), physique rating, visceral fat, metabolic age, basal metabolic rate, bone mass, body water (%) and body mass index (bmi) in the morning. physical activity will be assessed by the greek version of the short international physical activity questionnaire (ipaq-short).

Eligibility criteria:
inclusion criteria: * age between 25 and 65 years * the absence of any chronic health conditions * adequate understanding of the study exclusion criteria: * the presence of any chronic health conditions (diabetes, hypertension, dyslipidemia) * intake of nutritional supplements over the past 60 days * heavy smokers (≥25 cigarettes/day) * high alcohol use (men \>14 drinks/week, women \>7 drinks/week)