Kornimate/medical-research-clean huggingface dataset:
the effect of wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response

Conditions: Healthy Volunteers

Summary: wheat germ is a by-product of the wheat-milling industry with high nutritional value and therefore could be used as a raw source for the preparation of food products such as bread, cookies, muffins, etc. the aim of this study is to assess the effects of ingesting wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

this is a crossover, double blinded, placebo controlled randomized trial. the study will compare the effect of consumption of wheat breads with or without wheat germ on healthy individuals, during 2 intake periods of 4 weeks each and 5 weeks washout before crossover. the study will focus on the effects of wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

Eligibility criteria:
inclusion criteria: * adult men or women * age 18 - 60 years * healthy volunteers free of chronic diseases with relevant effect on the gastrointestinal system or on visceral motility * without a diagnosis of any digestive disease including functional bowel disorders such as ibs * non-diabetic, no gastric bypass surgery * have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/l) * non-smoker * willing and able to provide written informed consent exclusion criteria: * subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries * relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening * subjects with stool frequency of ≤ 1 stool every 7 days * subjects not willing to avoid pre- and probiotics for the duration of the study * intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks * current use of medication for lowering blood cholesterol or glucose * change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibres) * pregnant subject or subject planning to become pregnant during the study; breast-feeding subject * subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study * participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results * known food intolerance or allergy * subject involved in any clinical or food study within the preceding month

Keywords: gastrointestinal discomfort wheat germ constipation glycaemic index blood cholesterol level glycaemic response cholesterol pac-sym gut microbiota
efficacy and safety of varenicline among hiv-infected patients

Conditions: HIV Infections; Tobacco Dependence

Summary: cigarette smoking is a major cause of illness among hiv-infected patients (non-aids defining malignancies (especially lung cancer), non-aids bacterial infections and cardio-vascular diseases). approximately 50% of hiv-infected patients are regular tobacco smokers. tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. however, smoking cessation interventions have never been evaluated among hiv-infected patients. this trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.

cigarette smoking is a major cause of illness among hiv-infected patients (non-aids defining malignancies (especially lung cancer), non-aids bacterial infections and cardio-vascular diseases). approximately 50% of hiv-infected patients are regular tobacco smokers. tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. however, smoking cessation interventions have never been evaluated among hiv-infected patients. this trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo. a pharmacokinetic study will be conducted to evaluate the effect of smoking cessation on the plasma concentration of antiretroviral treatment.

Eligibility criteria:
inclusion criteria: * hiv-infected patients * adults * regular smokers (at least 10 cigarettes a day during the last year) * motivated to stop smoking * followed in one of the participating clinical ward, * signed written inform consent exclusion criteria: * current co-dependency to another psychoactive substance * ongoing depressive episode * history of suicidal attempt * ongoing treatment by interferon * treatment by efavirenz for less than three months or not tolerated * previous use of varenicline * ongoing treatment by bupropion-sr or nicotinic substitute * ongoing pregnancy * ongoing breastfeeding * hypersensitivity to varenicline or to one of its excipients * drivers, air traffic controller

Keywords: tobacco dependence hiv infection varenicline
a placebo controlled safety and efficacy study of int131 besylate in type 2 diabetes, with an active comparator

Conditions: Type 2 Diabetes Mellitus

Summary: this is a 24 week study comparing the efficacy of four dose levels of int131 besylate with pioglitazone hcl in patients with type 2 diabetes. eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose * males and females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age * hba1c must be ≥7.5% and ≤10% at screening * fasting plasma glucose must be \<240 mg/dl at screening exclusion criteria: * history of type 1 diabetes * history of diabetic ketoacidosis * nyha class iii or iv cardiac status or hospitalization for congestive heart failure within 6 weeks prior to visit 1 * treatment with any non-peroxisome proliferator-activated receptor (non-ppar) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening * treatment with rosiglitazone, pioglitazone, or any ppar investigational antidiabetic agent within 6 month prior to screening * body mass index \>45 kg/m2 * fasting triglycerides \>500 mg/dl * uncontrolled hypertension (sitting systolic blood pressure \>160 mmhg and/or sitting diastolic blood pressure \>100 mmhg * presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)

Keywords: type 2 diabetes diabetes diabetes mellitus diabetes mellitus, type 2 non-tzd thiazolidinedione selective peroxisome proliferator-activated receptor gamma modulator spparm peroxisome proliferator-activated receptor gamma ppar gamma insulin sensitizer glucose control endocrinopathy hypoglycemic agent sulfonylurea metformin pioglitazone nutritional and metabolic diseases
safety and efficacy of high-intensity macrofocused ultrasound for solar lentigo in chinese population

Conditions: Solar Lentigo

Summary: this trial is a single-center, prospective study. the study proposes to recruit 20 patients with solar lentigo on both sides of the face. patients are to be treated with high-intensity focused ultrasound (mfus one, hunan peninsula medical technology co., ltd., china). oth sides of the face received treatment with identical parameters. the facial images are collected with dermoscope (dermlite dl4,3 gen inc., san juan capistrano, ca, usa), visia® (canfield company, usa) and a two-photon microscope (transcend vivoscope, china). for dermoscopy images, imagej software was then utilized to perform lab\* conversion on both the lesional area and the surrounding non-lesional areas. measurements of transepidermal water loss (tewl) values, skin elasticity and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6 and week8.


Eligibility criteria:
inclusion criteria: 1. adults between 18 and 70 years old, regardless of gender; 2. comply the clinical diagnostic criteria for solar lentigo on both sides of the face; 3. patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form; exclusion criteria: 1. women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period; 2. those who are allergic to medical condensation gel; 3. those with photosensitive diseases, immune deficiencies, or those who are taking immunosuppressants; 4. those with scar physique; 5. those with inflammatory or infectious skin diseases; 6. those who have systemically used retinoic acid in the last six months or topically applied retinoic acid drugs in the last three months, or have a history of sun exposure in the four weeks prior to treatment; 7. those who have undergone high-intensity focused ultrasound treatment within the last six months;
effect of intermittent fasting on fat mass

Conditions: Obesity

Summary: this study is aimed to assess the different effect on fat mass between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (if) among obese male student aged 18-25. female students are excluded because if they do any restriction intake during their menstruation period which is a lot of blood lost, it will be a risk for them. this study is designed as non-blinding randomized control trial. subject who adhere with less than 85 percent fasting (14 out of 16) will be dropped out from this study. total sample in this study is 62 students which are 31 students for each group.

5:2 intermittent fasting (if) is eating pattern in which no or few calories are consumed for 13 hours (for 5 am to 6 pm) done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, without any requirement of water restriction. subjects will be distributed to each group by using randomization block of four. this study will use 8 forms consist of; informed consent, subject selection form, re-anthropometric measurement form, questionnaire, semi quantitative food frequency questionnaire (sq-ffq), international physical activity questionnaire (ipaq), food record book, and control and evaluation form. while the tolls are consist of food photograph book (to help in filling the food record book), body height scale, and bio-electrical impedance analysis (bia) seca medical body composition analyzer (mbca) 515/514 (to measure body composition).

Eligibility criteria:
inclusion criteria: * obese male student age 18-25 * do not have experience on amputation * willingness to participate in the whole study by signing informed consent exclusion criteria: * hypertrophy muscle students identified from body composition measurement * in a certain diet at the moment * consuming lipid-lowering drug at the moment * doing regular fasting (2 days a week) for 2 months before the study begin * suffer from chronic illness (confirmed by disease history form * using electronic implants, for example pacemaker or pane * using prostheses (artificial body part)

Keywords: obese intermittent fasting fat mass body fat reduction
study immunogenicity and safety of 13-valent pneumococcal conjugate vaccine

Conditions: Pneumococcal Infections

Summary: this study will assess the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine compared with 23-valent pneumococcal polysaccharide vaccine. all participants should be naïve of pneumococcal vaccine.


Eligibility criteria:
inclusion criteria: * healthy male and female adults over 50 years of age at screening. * the subject who understand the requirements of the study and voluntarily consent to participate in the study. * the subject willing to use birth control measures for the entire study duration and negative urine hcg(human chorionic gonadotrophin) test at screening for women presumed to be of reproductive potential. exclusion criteria: * known hypersensitivity to any components of the pneumococcal vaccine * any confirmed or suspected immunosuppressive or immunodeficient conditions including leukemia, multiple myeloma, lympoma, hodgkin's disease, etc. * history of autoimmune disease including multiple sclerosis(ms), lupus, polymyositis, dermatomyositis, hashmoto's thyroiditis, sjogren's syndrome, rheumatoid arthritis * functional or anatomic asplenia * coagulation disorder contraindicating im(intramuscular) vaccination * use of any immunosuppressive therapies within the preceding 3 months including anti-cancer chemotherapies or radiation therapies and medication such as cyclophosphamide, 6-mercaptourine, azathioprine, methotrexate, steroids, cyclosporine a, rapamycin, leflunomide, tnf-α antagonist (for corticosteroids, this will mean prednisone, or equivalent dose of ≥ 15mg/day. inhaled and topical steroids are allowed.) * serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, impaired immune function. * any licensed vaccine(not including diphtheria toxoid) administered within the 1 month prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine(not including diphtheria toxoid) within 1 month following receipt of study vaccine. * subject has received diphtheria toxoid within 6 months prior to receipt of study vaccine or planned to receive diphtheria toxoid during full period of the study.
unilateral approach for bilateral decompression of lumbar canal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: the purpose of this study was to compare standard open laminectomy with ulbd approach in regard to efficiency, safety, and clinical outcome.

lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord. minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ulbd) have been reported to achieve this goal . the objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes. the object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ulbd) to a standard "open" laminectomy for lss.

Eligibility criteria:
inclusion criteria: 1. age:40-80 years 2. sex:both sexes 3. symptomatic lss with radiculopathy , neurogenic claudication , or urinary dysfunction. 4. radiologically confirmed lss , caused by degenerative changes 5. canal stenosis at a maximum of 2 levels exclusion criteria: 1. were to undergo a concomitant fusion or instrumentation placement; 2. had had previous lumbar surgeries at the same level; 3. had spondylolisthesis of any grade or degenerative scoliosis; 4. had evidence of instability on dynamic radiographs.
costs, effectiveness, qalys, and efficiency of bioabsorbable devices in daily clinical practice

Conditions: Coronary Stenosis Treated With Implant of Bioresorbable Devices

Summary: a multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (qalys) gained by patients with ischemic heart disease revascularized with absorb in standard clinical practice in spain. a before-after comparative analysis will be performed, so that each patient will act as his/her own control.

economical evaluation study of the efficiency of absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with absorb based on the criteria established according to standard clinical practice. a comparison group without absorb cannot be used for ethical reasons. thus, each patient will act as his/her own control, and a before-after comparison will be done. this is therefore a prospective, observational cohort study with concurrent data collection. primary objective: * to assess utility (qalys gained) in patients implanted absorb in standard clinical practice conditions. secondary objectives: * to assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with absorb implantation. * to assess costs (direct and indirect) derived from coronary revascularization with absorb implantation. * to assess efficiency in terms of cost/utility (cost per qaly gained) and cost/effectiveness (cost per mace -major cardiac adverse events- free patient).

Eligibility criteria:
inclusion criteria: * age ranging from 18 and 95 years. * both sexes. * coronary revascularization with absorb for any of the following lesions: de novo, restenosis, segment st elevation myocardial infarction (stemi), chronic total occlusion (cto), trunk, venous graft, or bifurcations. * informed consent signed before participation in the study is started. exclusion criteria: * pregnant or nursing woman.. * cardiogenic shock. * refusal to participate in the study.

Keywords: coronary artery disease angioplasty bioresorbable coronary device qaly (quality-adjusted life years)
a quantitative study to assess the construct validity of the prescription opioid misuse and abuse questionnaire

Conditions: Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Summary: the purposes of this study are to evaluate the validity and reproducibility of the pomaq to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.

the food and drug administration (fda) has requested, as part of a post-marketing requirement (pmr) for new drug application (nda) holders of extended release/long-acting (er/la) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. this measure will be used to assess misuse and abuse in pmr study 2065-1a and pmr study 2065-4b. to date, no tool currently exists to address the needs of the pmr except for the self-report misuse, abuse and diversion of prescription (rx) opioids questionnaire (sr-mad) which has undergone several rounds of content validation but requires further validation. the sr-mad has been substantially modified to meet the needs of pmr studies 2065-1a and 2065-4b and has been renamed the prescription opioid misuse and abuse questionnaire (pomaq). the pomaq will undergo content validation via qualitative interviews (protocol 2065-2a \[qualitative\]) prior to use in this validation study (protocol 2065-2a \[quantitative\]). this quantitative study will seek to further develop and validate the pomaq following the general tenants according to the food and drug administration (fda) guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims (fda 2009) which emphasizes the importance of conducting sound psychometric evaluation of patient-reported instruments through quantitative research methods. however, it should be noted that the pomaq is not a typical pro measure capturing a specific latent construct and the specified analytic approach to the pomaq reflects this difference in theoretical frameworks.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. diagnosed chronic pain (≥ 3 months) condition which requires long-term treatment with opioids; 3. willingness to provide written informed consent; and 4. able to participate in and complete an internet-based survey and a telephone interview in english. exclusion criteria: 1. cognitive or other impairment based on the principal investigator's judgment that would interfere with the ability of a participant to complete the validation study 2. terminal illness with life expectancy \<6 months.
molecular quantification of insulin mrna

Conditions: Type 1 Diabetes Mellitus

Summary: the objectives of this study are to: 1. quantitate the level of insulin mrna in the while cell fraction of whole blood in selected groups of subjects, 2. determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects, 3. determine the identity of the white cell responsible for expression of insulin mrna and 4. determine protein expression of mrna of insulin/proinsulin and selected genes of white cell activation.

indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. currently there are no reliable indicators readily available. insulin mrna in the white cell fraction of blood has been detected or elevated under several circumstances including: 1. normal animals 2. after islet cell transplantation 3. hyperglycemic induced expression and 4. during induction of diabetes with streptozotocin the investigators propose that quantitative measurement of insulin mrna may be an accurate, innovative and minimally invasive indicator of beta cell destruction.

Eligibility criteria:
inclusion criteria: 1. male or female subjects ages 1 to 17 years of age 2. subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity 3. subjects with new onset type 1 diabetes 4. non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes 5. unrelated nondiabetic controls with no family history of type 1 diabetes 6. of sufficient size to donate 10ml of blood exclusion criteria: none if subjects meet above inclusion criteria

Keywords: type 1 diabetes mellitus insulin mrna