Kornimate/medical-research-clean huggingface dataset:
mechanisms of the nicotine metabolism effect on tobacco dependence

Conditions: Cigarette Smoking

Summary: the purpose of the study is to learn more about tobacco dependence and nicotine metabolism in african-americans and whites, by studying to see if how fast a person metabolizes nicotine (how the body breaks down nicotine into inactive compounds) affects how dependent they are on smoking cigarettes. the investigators believe that people with a faster rate of metabolism may have more severe nicotine withdrawal symptoms and also may have a harder time trying to quit smoking.

our studies will use the nicotine metabolite ratio (nmr) (the ratio between the nicotine metabolites 3'hydroxycotinine and cotinine)as a simple and clinically feasible biomarker for the rate of nicotine metabolism. the investigators hypothesize that a faster rate of metabolism leads to faster elimination of nicotine from the body and a more rapid dissipation of brain tolerance to nicotine in the interval between cigarettes, leading in turn to (1) more severe nicotine withdrawal symptoms and (2) greater subjective reward from the cigarette smoked following deprivation. these effects would help to explain why smokers with faster rates of nicotine metabolism have a poorer response to smoking cessation therapy when compared to those with slower rates of metabolism. the investigators will explore the relationship of the nmr to the endophenotypes of withdrawal, craving and reward, with the assumption that these factors are likely intermediaries for the mechanism linking nicotine metabolism to tobacco dependence and smoking cessation rates with pharmacotherapy. our study design uses a brief (6 hour) interval of smoking abstinence followed by a "reward" cigarette to elicit the subjective responses relating to withdrawal and reward. because smoking behavior and severity of nicotine dependence vary by race and sex the investigators will also compare the relationship between nmr and withdrawal and reward in african american vs white smokers and in men vs women. secondary analyses will examine whether nicotine half-life mediates the observed effects of nmr on primary response measures.

Eligibility criteria:
inclusion criteria: * african-american or caucasian * age 18-70 years * regular smoker of 5 or more cigarettes per day * saliva cotinine of 100 ng/ml or greater exclusion criteria: * obese (bmi \> 38) or underweight (bmi \< 17) * major systemic or psychiatric condition * medications that are inducers of cyp2a6 * history of alcohol abuse * positive drug urine tox test * pregnancy or breast feeding
evaluating the impact of a virtually supervised exercise intervention and group counseling on inflammation and the microbiome of smokers at high risk for lung cancer, be fit trial

Conditions: Lung Carcinoma

Summary: this phase ii trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. this clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.

primary objectives: i. to evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the ohio state university lung cancer screening clinic (osulcsc). ii. to determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers. outline: participants are randomized to 1 of 2 groups. group i: participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (biw) in weeks 1-8 and once a week (qw) in weeks 9-12 and then continue with unsupervised exercise sessions biw in weeks 13-52. participants also attend group counseling sessions over 1 hour qw in weeks 1-8 and bi-weekly in weeks 9-12. participants also wear a fitbit throughout the trial and undergo collection of blood samples at baseline and follow up. group ii: participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. participants also wear a fitbit throughout the trial and undergo collection of blood samples at baseline and follow up. after completion of study intervention, participants are followed up at 12 weeks and 1 year.

Eligibility criteria:
inclusion criteria: * 50-77 years of age * current or former smoker with 20-pack year smoking history and within the last 15 years * fewer than 150 minutes of participation in moderate intensity physical activity each week * all participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease \[copd\]), or systemic disease that would make moderate intensity exercise participation unsafe * willing to sign an informed consent exclusion criteria: * person undergoing treatment for cancer in any form * person plans to enter smoking cessation or change status
allocating resources for cancer care in times of the sars-cov-2 outbreak. health care research

Conditions: Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa)

Summary: the focus on treatment of covid19 patients during the sars-cov-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-covid19 patients. medical care of cancer patients is a particularly sensitive area. to draw holistic conclusions, it is necessary to analyze the provision of healthcare as broadly as possible with regard to the dimensions of access, processes and outcome during the sars-cov-2 pandemic. this will be implemented exemplarily for the early detection, diagnosis and treatment of colorectal cancer (crc) and pancreatic cancer (paca) in saxony. patients with diagnosis, treatment or early detection measures for type 2 diabetes (t2d), coronary heart disease (chd) and multiple sclerosis (ms) serve as comparison groups.

for a realistic assessment, the situation will be compared with the situation before the sars-cov-2 pandemic while considering confounders and effect modifiers. the evaluation is based on pseudonymised routine statutory health insurance (shi) data of the aok plus for saxony. as data sources, shi data of the aok plus saxony for the period 2015 to 4th quarter 2020 and publicly available data on covid19 are used. the differentiation between incidence and prevalent diseases is based on a 4-year washout period, so that the health care situation can be compared between 2019 (pre-period) and 2020 (post-period). patients with confirmed diagnoses of crc and paca or early detection measures regarding crc are investigated. these will be contrasted to patients with confirmed diagnoses of t2d, chd, and ms or early detection measures regarding t2d. the differentiation of subgroups as confounders or effect modifiers is taken into account. subgroups are considered with respect to the factors age groups, gender, elixhauser comorbidities, metastasis y/n, residential regions (postal code 3 digits), characteristics of the treating institution and possibly seasonal effects. aims: analysis of the differences in the health care provision situation during the sars-cov-2 outbreak compared to the time before. research questions: 1. (how) did the situation of health care for cancer patients change due to the outbreak of sars-cov-2? which changes could be observed in the dimensions access to care, quality or guideline adherence in medical care and outcome? 2. did the focus on covid19 patients have an impact on the diagnosis or early detection of cancer in saxony? 3. are the observed effects differential with respect to the diseases, especially when comparing crc and paca with the control group regarding t2d and chd?

Eligibility criteria:
inclusion criteria: * resident of saxony, germany with health insurance coverage provided by aok plus * diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis between in 2019 or 2020 according to icd-10 exclusion criteria: * change of health insurance provider between 2015 and 2020 * born after 2014 * deceased between 2015-2018
clinical endpoint bioequivalence study of test and reference inhalation products in patients with copd with device robustness

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (fev1).


Eligibility criteria:
inclusion criteria: * male and non-pregnant female subjects (40 years of age and older). * patients with diagnosis of copd according to the gold guidelines. * post-bronchodilator fev1 \<80% of the predicted value at the screening visit. * post-bronchodilator fev1/fvc ratio ≤0.70 at the screening visit. * current or former smokers (e.g., with history of = 10 pack-years). * written informed consent. exclusion criteria: * known respiratory disorder other than copd including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease. * history of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system. * hospitalization for copd or pneumonia within 12 weeks prior to the screening visit. * treatment for copd exacerbation within 12 weeks prior to the screening visit. * viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit. * abnormal and significant ecg finding prior to the screening, during the run-in and treatment periods.

Keywords: copd
rgd-pet-ct in cancer angiogenesis

Conditions: Carcinoma, Renal Cell

Summary: the goal of this clinical research study is to look at 2 new methods of scanning and see whether they can help researchers predict which tumours will respond to drugs that attack tumour blood supply.


Eligibility criteria:
inclusion criteria: 1. patients should have advanced or metastatic rcc confirmed by histological diagnosis 2. patients considered suitable for therapy with tki for rcc according to responsible clinician 3. measurable tumour according to recist v1.1 criteria 4. standard staging ct scan performed within 28 days of first research scan 5. the patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment 6. age ≥18 years 7. adequate renal function (creatinine \<1.25xuln) 8. patient is able to tolerate and comply with scanning procedure 9. patient is not lactating or pregnant 10. absence of any psychological, familial, sociological or geographical condition which in the opinion of the investigator may potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 11. able and willing to give informed consent exclusion criteria: * not applicable

Keywords: angiogenesis pet-ct perfusion-ct
a clinical study evaluating the efficacy and tolerability of a topical facial treatment for facial rejuvenation

Conditions: Fine Lines; Wrinkles; Laxity; Skin

Summary: this single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. thirty-two (32) healthy female subjects completed the clinical study.

this single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. the efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Eligibility criteria:
inclusion criteria: * having fitzpatrick skin type i - vi * having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified griffiths scale). exclusion criteria: * breastfeeding, pregnant, or planning to become pregnant during the study. * currently having or having a history of cold sores (herpes simplex) on the face.

Keywords: topical treatment skin rejuvenation anti-aging
early dehiscence markers in ovarian cancer surgery

Conditions: Ovarian Neoplasms Malignant; Anastomotic Leak

Summary: edmocs trial pretends to evaluate if c-reactive protein (crp) and procalcitonin (pct) can predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer surgery requiring intestinal resection. these markers have already been positively tested in colorectal cancer surgery, but not yet in ovarian surgery. patients undergoing intestinal resection in ovarian cancer surgery will be included. c-reactive protein and pct will be measured pre-operatively, and on the second, fourth and sixth postoperative day. thirty-day readmissions, re-operations and mortality will be recorded.


Eligibility criteria:
inclusion criteria: * ovarian cancer stage iii-iv * intestinal resection needed exclusion criteria: * infection diagnosed at time of surgery. * urgent surgery
study to determine the effects and safety of a weight loss compound on overweight, otherwise healthy, volunteers

Conditions: Obesity

Summary: the purpose of this study is to determine whether cp-866,087 is effective in the weight loss of overweight patients.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 30 to 40 kg/m2 and total body weight of \>110 lbs. * otherwise healthy exclusion criteria: * women must be of non-childbearing potential. * significant current or history of medical illness.

Keywords: obesity, weight loss
a study of the immunogenicity, tolerability, and safety of a new formulation of rotateq™ in infants (v260-035)

Conditions: Rotavirus Gastroenteritis

Summary: a study to compare safety, tolerability, and immunogenicity of a new formulation of rotateq™ with the existing formulation in infants. the primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.


Eligibility criteria:
inclusion criteria: * parent or legal guardian agrees to have infant participate by giving written informed consent exclusion criteria: * history of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery * history of intussusception * known or suspected impairment of immunological function, including severe combined immunodeficiency (scid) * prior administration of any rotavirus vaccine * clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (gerd) * receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. participant using non-systemic corticosteroids will be eligible for vaccination. * residing in a household with an immunocompromised person * prior receipt of a blood transfusion or blood products, including immunoglobulins * participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study * receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
supplementing intracytoplasmic sperm injection handling medium with cytochalasin d ( icsi-cd)

Conditions: Infertility

Summary: vienna consensus has identified 10% damage rate after icsi as a competency value. despite the highest quality embryologists doing icsi, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. cytochalasin d serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. using cytochalasin d during icsi could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.


Eligibility criteria:
inclusion criteria: * icsi indicated participants exclusion criteria: -
the vis opti-k low vision aid device provides vision improvement.

Conditions: Hyperopia; Presbyopia

Summary: the vis opti-k low vision aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).


Eligibility criteria:
inclusion criteria subjects who meet all of the following criteria are candidates for this study: 1. male or female 2. any race 3. patient is at least 40 years old. 4. patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated. 5. patient has manifest refraction, spherical equivalent (mrse) between -0.50 d to 2.50 d, with no more than 1.0 d of refractive cylinder, in eye(s) to be treated. 6. patient has uncorrected distance visual acuity (udva) of 20/100 or better (i.e., logmar ≤ 0.70) in both eyes. 7. patient has best corrected distance visual acuity (cdva) of 20/20 or better (i.e., logmar ≤ 0.00) in both eyes. 8. patient has uncorrected near visual acuity (unva) between 20/50 (logmar 0.40) and better than 20/100 (logmar \&lt; 0.70) in eye(s) to be treated. 9. patient has best corrected near visual acuity (cnva) of at least 20/20 (logmar ≤ 0.00) in eye(s) to be treated. 10. patient requires reading adds of +1.0 to +3.0 d in eye(s) to be treated. 11. patient is not a contact lens (cl) wearer. 12. patient has normal corneal topography. 13. patient is willing and able to comply with all examinations. 14. patient must be competent to sign an informed consent form before study entry. exclusion criteria subjects who meet any of the following criteria are to be excluded from this study: 1. corneal disease or corneal disorder in either eye. 2. any active ocular surface disease of any severity. 3. increased iop (above 20 mm hg), glaucoma or history of glaucoma. 4. previous corneal surgery in the eye to be treated. 5. conjunctivochalasis 6. nystagnus 7. diabetes 8. pregnancy 9. presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study. nclusion criteria: - exclusion criteria: -

Keywords: vision improvement
exploring men s prostate cancer genetic risk perceptions

Conditions: Prostate Cancer

Summary: the exploring men's prostate cancer genetic risk perceptions and willingness to give a biospecimen for genetic risk testing study aims to assess prostate cancer genetic risk and susceptibility beliefs among unaffected men of diverse races/ethnicities who are considering undergoing prostate cancer screening and their willingness of men to provide a biospecimen (saliva sample) and test the samples for prostate cancer aggressiveness and determine risk category based on snp genetic profile.


Eligibility criteria:
inclusion criteria: * racially/ethnically diverse men with emphasis on men of african ancestry. * age 40 and older . * no personal prostate cancer history/diagnosis. * with or without family history of prostate cancer. exclusion criteria: * previous personal prostate cancer history/diagnosis * under 40 years of age

Keywords: genetic risk perception and beliefs biospecimen donation for genetic risk testing
exogenous ketone supplementation and exercise performance

Conditions: Ketonemia; Ketosis

Summary: 20 healthy recreationally active men and woman aged 18-35 will participate in the study. there will be three treatments involved: caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. the three main trials will be separated by at least 1 week. after providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out wingate test.

some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. to attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. one of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (\~1 hour). unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. hyperketonemia (blood ketone concentration \> 0.2 mm) seems to elevate the rate of utilization of ketone bodies. these changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. manufacturers now provide ketones salts combined with other ingredients such as caffeine. however it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. caffeine alone has been shown to improve athletic performance in several studies. therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out wingate test.

Eligibility criteria:
inclusion criteria: * healthy male and female recreationally active individuals * aged 15-35 years * non regular caffeine users. exclusion criteria: * smoker * taking part in other research * sedentary * for women, if they are pregnant or become pregnant during the study * injury limiting exercise ability. * have symptoms or take medication for respiratory disease * have symptoms or take medication for cardiovascular disease * have symptoms or take mediation for neuromuscular disease * use heart rate or blood pressure medications * use any medications with side effects of dizziness, lack of motor control, or slowed reaction time