Kornimate/medical-research-clean huggingface dataset:
electronic cigarettes (e-cigarettes) as a harm reduction strategy

Conditions: Tobacco Use Disorder; Smoking

Summary: the purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.

this pilot study will be a two-arm, randomized controlled trial. the investigator will randomize 40 participants into each intervention arm. participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. participants will be asked to track their nicotine use via text message. all participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. participants will be given a supply of e-cigarettes and followed for 3 weeks

Eligibility criteria:
inclusion criteria: * 21-35 years old * daily smokers who smoke at least 10 cigarettes per day (cpd) * interested in reducing cpds * able to provide consent * use a cell phone and are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone * willing to use an e-cigarette for 3 weeks exclusion criteria: * pregnant and/or breast feeding * currently using smoking cessation medications (including other forms of nicotine replacement therapy (nrt), buproprion, or varenicline) * enrolled in a smoking cessation program or another cessation trial * have used an e-cigarette in the past 14 days * have used any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in the past 30 days * score ≥7 (men) or ≥5 (women) on the alcohol use disorders identification test (audit-c), * score ≥ 5 on the drug abuse screening test-10 (dast) * report having a history of asthma, other airways diseases, or heart disease.

Keywords: smoking cigarettes
comparison of manual super small incision cataract surgery and phacoemulsification

Conditions: Cataract; Phacoemulsification

Summary: the purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (mssics) and phacoemulsification.


Eligibility criteria:
inclusion criteria: * age related cataract patients * cataract density grade ii-iii according to the emery-little system classification system exclusion criteria: * legal guardian(s) is/are not present for permission * other eye diseases impairing visual acuity (ie. glaucoma) * patients with severe systemic diseases not good for ocular surgery

Keywords: age related cataract phacoemulsification manual super small incision cataract surgery
an analysis of the effect of topical cromolyn sodium on rosacea-associated erythema

Conditions: Papulopustular Rosacea

Summary: this study is designed to investigate whether topical application of a cromolyn sodium solution is able to decrease the facial redness seen in patients with papulopustular rosacea. previous work in the lab of dr. di nardo on mice has suggested that cromolyn may be able to have this effect. the study will enroll a total of 10 patients. 5 will randomly be assigned to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive the placebo solution. all participants will be instructed to apply their assigned solution twice daily to their face. patients will return to the clinic 3, 6, and 8 weeks after the distribution of the solutions to measure the efficacy of their assigned solution.


Eligibility criteria:
inclusion criteria: * subject is male or non-pregnant female, 18 - 80 years of age. * subjects willing and able to give informed consent. * subjects willing and able to comply with the requirements of the study. * subject has the clinical diagnosis of at least mild erythema. * subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) or the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study * subject is in general good health in the opinion of the investigator. exclusion criteria: * subject has a diagnosis of steroid rosacea or pyoderma faciale (rosacea fulminans) * subject has a history of carcinoid, pheochromocytoma, serotonin syndrome or other systemic flushing causes. subject has used facial topical therapies (otc drug products or prescription products) for any reason within the prior 28 days * subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days. * subject has had laser or light-based treatment for rosacea within the prior 3 months. * subject has had systemic retinoids and retinoid derivatives over the past 6 months * subject has any history of renal or hepatic insufficiency. * subject has a known hypersensitivity or allergy to cromolyn sodium or components of the vehicle. * subject is pregnant or lactating or planning a pregnancy during the duration of the study * subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study * subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation. subject has a known hypersensitivity or allergy to tape or other adhesive materials

Keywords: rosacea cromolyn sodium
navigator ii continuous glucose monitor home use study

Conditions: Diabetes

Summary: this research study will test a new investigational continuous glucose monitoring system (system). the purpose of this study is to find out about the performance of the system in a home use environment over a 15 day period, in people with diabetes.


Eligibility criteria:
inclusion criteria: the subject must: * have type 1 or 2 diabetes for at least 2 years prior to enrollment. * require insulin therapy administered through an insulin pump or multiple daily injections (mdi) for at least 6 months prior to enrollment. * be at least 18 years of age. * be able to read and understand english. * in the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. * be available for all study visits. * be willing to provide written signed and dated informed consent. exclusion criteria: the subject must not: * be pregnant or likely to become pregnant during the study duration. * have skin abnormalities at the insertion sites. * have known allergy to medical grade adhesive or skin disinfectant. * be using a continuous glucose monitor currently or within the past 6 months * have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject. * be participating in another clinical trial.
effect of plant stanol ester-containing spread on estimated cardiovascular risk in comparison to mediterranean diet

Conditions: Hypercholesterolemia

Summary: since it is very difficult to have the real thing (mediterranean diet) we need to find an alternative to reduce cardiovascular disease (cvd) risk in subjects with moderate hypercholesterolaemia (a major cvd risk factor) living in western countries. therefore, this proposed study is designed to assess if giving olive oil supplements, with or without stanol ester, is equivalent to following a mediterranean diet. furthermore, the stanol-olive oil combination may prove to be superior to olive oil alone.

design: randomised, double blind, placebo controlled study number of participants: 150 (3 groups with 50 subjects each). intervention: one group will be assigned to stanol ester spread (2 g/day) based on olive oil, another on spread with olive oil containing placebo stanol ester (in identical containers with the stanol ester spread). in the third group, a structured effort will be made to improve adherence to mediterranean diet by at least 2 points in a 10-level scale. adherence to the mediterranean diet will be improved by a dietician with detailed explanation of the composition of the diet, preparation of several week specific programs according to dietary preferences of the specific subject. dietician interviews with a 5 day questionnaire on consumed foods will establish the degree of adherence to mediterranean diet. duration: 16 weeks (4 weeks of lifestyle advice and 12 weeks of treatment). prespecified analyses: 1. postmenopausal women vs women with child bearing potential. 2. older (\>65 years of age) vs younger subjects, 3. subjects with impaired fasting glucose levels.

Eligibility criteria:
inclusion criteria: * male and female subjects over 45 years of age with mild hypercholesterolaemia (tc levels: 200 mg/dl - 230 mg/dl) exclusion criteria: subjects with * established cvd (coronary heart disease, peripheral arterial disease, aortic aneurysm, or symptomatic carotid artery disease) or t2dm * chronic diseases (including liver diseases) * pregnancy * malignancies * unwillingness to participate

Keywords: cholesterol, stanol-ester, mediterranean diet, cardiac risk
the association of cardiac ion channel related gene polymorphism and prolonged qtc interval after endotracheal intubation

Conditions: Emergence Delirium

Summary: the qtc interval is affected by heart rate, medications and changes in the autonomic nervous system. the endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs qtc interval. changes in the flow of ion currents could result from the genetic variation of myocardial ion channels by gene polymorphism. this study is to investigate the association of cardiac ion channel related gene polymorphism and prolonged qtc interval after endotracheal intubation in adult patients.


Eligibility criteria:
inclusion criteria: 1. 20-65 years old 2. scheduled for general anesthesia requiring direct laryngoscopy exclusion criteria: 1. patients taking antihypertensive medication (beta-blocker, ccb) 2. patients taking other medications known to affect qtc interval 3. patients with abnormal ecg and prolonged qtc (\>500 msec) 4. diabetes, liver disease, kidney disease, heart failure, congenital heart disease 5. severe electrolyte imbalance 6. illiterate, foreigners who cannot understand the consent form
platelet-rich plasma(prp) injection in ed

Conditions: Erectile Dysfunction; PRP

Summary: rpr contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. in theory, it is possibility of curing ed.

there are many reasons of erectile dysfunction(ed). if left untreated, there is a major impact on relationships, self-esteem, and overall health. rpr contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. the main purpose of this study is to study the safety and effectiveness of prp injection for the treatment of ed.

Eligibility criteria:
inclusion criteria: * male * between 20 and 70 years old * sexual dysfunction exists for at least 6 months * iief-5 score 8-2 * sign an informed consent form exclusion criteria: * ever radical prostatectomy or extensive pelvic surgery * radiation therapy to the pelvic area within 12 months before recruiting * cancer * nervous system diseases that affect erectile function * have any blood disease * history of coronary artery disease
effect of early vs late drainage removal in women after radical mastectomy with axillary clearance

Conditions: Breast Cancer

Summary: the aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml

Eligibility criteria:
inclusion criteria: * stage iia and iib breast cancer treated with radical mastectomy * obtaining informed consent * total amount of lymph in postoperative day 1 \<150ml exclusion criteria: * stage i, iii-iv breast cancer * history of benign breast neoplasm or malignant disease of any origin * any breast surgery in the past * weight \<50kg

Keywords: breast cancer axillary clearance lymphorrhoea
primary infection cohort

Conditions: HIV-1-infection

Summary: open, prospective, multicenter french cohort study enrolling subjects aged of 15 years or more, during or immediately after hiv-1 primary infection. this cohort was organized from the outset to be highly multidisciplinary, bringing together immunologists, virologists, clinicians and epidemiologists.

objectives: follow up of patients infected by hiv-1 for less than three months. 1. improve the physiological and pathological knowledge of primary hiv infection * study of the immune mechanisms involved early after infection * kinetics of viral replication and establishment of cellular reservoirs at an early stage * relationships between virological markers and immune response kinetics * impact of resistance mutations, subtype and tropism on the disease progression and the response to treatment * study of sub-groups of specific patients followed since primary infection, spontaneous or post treatment controllers, subjects with specific hla 2. assessing the impact of early, transient or prolonged treatment versus deferred treatment on the long-term prognosis of patients followed since primary infection, in terms of activation / inflammation and decrease in viral reservoirs 3. contribute to knowledge in the epidemiology of hiv infection: * modes of transmission * sexual behavior after hiv diagnosis * calendar trend of transmitted viral strains diversity (arv resistance and subtypes) * calendar trend of marker levels measured at primary infection 4. contribute to national recommendations for therapeutic care, evaluate their implementation 5. use observational data from the cohort for the development of therapeutic clinical trials at primary infection

Eligibility criteria:
inclusion criteria: * symptomatic or asymptomatic hiv-1 primary infection. * infection date based on one of the following criteria: 1. positive p24 antigenemia or detectable plasma hiv rna with a negative elisa within the previous six weeks. 2. positive p24 antigenemia or detectable plasma hiv rna with a positive elisa and negative western blot within the previous six weeks. 3. positive p24 antigenemia or detectable plasma hiv rna or positive elisa with incompleted western blot (no anti-p34 and/or anti-p68) within the previous six weeks. 4. positive elisa with a negative elisa within the last three months. * age≥ 15 years old at the enrollment. * naive of antiretroviral treatment except for transient treatment taken in the context of pmtct, pre-exposition prophylaxis or post exposition prophylaxis. * affiliate or beneficiary of a social security system (state medical assistance is not a social security scheme). exclusion criteria: * inability to give informed consent. * predictable difficult follow-up. * contraindication to repeated blood samples. * under protection (saving) of justice * life-threatening pathology (deferred inclusion is possible)
a prospective multicenter clinical study to evaluate the safety and effectiveness of the synchrony dual optic intraocular lens in patients undergoing cataract extraction

Conditions: Cataract

Summary: the purpose of the study is to determine if the synchrony dual optic accommodating intraocular lens can be used safely and effectively in post cataract extraction subjects


Eligibility criteria:
inclusion criteria: 1. patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract. 2. patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with bat on medium setting. 3. patients must require synchrony® lens correction of 16d - 28d or, if participating in the control study, patients must require a clariflex® (amo®), phacoflex® ii models si30nb (amo®) or a si40nb (amo®). 4. patients must have ≤ 1.0 d of preoperative keratometric astigmatism. 5. patients must have clear intraocular media other than cataract(s). 6. patients must be age 50 or older at the time of implantation. 7. patient must be willing and able to return for all scheduled follow-up examinations and have signed a written informed consent form. exclusion criteria: 1. patients with any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.). 2. patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., iop \> 22 mmhg. 3. patients with previous retinal detachment or retinal pathology including age- related macular degeneration. 4. patients with diabetes, currently being treated systemically. 5. patients with systemic or ocular disease that may prevent the patient from achieving uncorrected distance visual acuity of 20/32 or better post operatively. 6. patients with congenital bilateral cataract. 7. patients who require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents. the use of tamsulosin hydrochloride (flomax®) is also excluded preoperatively due to floppy iris syndrome. 8. patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract. 9. patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days. 10. patients who have had previous ocular surgery in the operative eye, including refractive surgery.
safety and tolerability of odm-201 in castrate resistant prostate cancer; extension study to study 3104001

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate safety and tolerability of odm-201 in patients with castrate resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * written informed consent * successful completion of study protocol 3104001 * response or stable disease in study 3104001 at week 12 exclusion criteria: * new serious concurrent medical condition * not able to swallow the study drug
the effects of group exercise and basketball on obese children

Conditions: Childhood Obesity; Physical Activity

Summary: this study aimed to compare the effects of group exercises under physiotherapist control and basketball program on body composition and motor skills of obese children. 45 obese children aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and control group (n:15). the children were assessed before and after 12-week study duration. body mass index (bmi), the percentage of body fat, and circumference values of the children were recorded. bruininks-oseretsky test of motor proficiency-brief form (botmp-bf) was used to determine motor skills of children.

the roles of active physiotherapy programs and sport programs on the management of the problems arising from childhood obesity should be determined. although the effects of exercise and various sport branches on decrease obesity and obesity related problems, the effects of group exercises managed by physiotherapists and team sports on body composition and motor skills of obese children are not clear so health professionals may have difficulties while suggesting better physical activity for this population. thus, body composition and motor skills of the included children were recorded at the beginning. they were then grouped into three in order to compare the effects of group exercises and basketball. children in the control group did not participate in any of them. intervention lasted 12 weeks so they were then taken to the assessments at the end of this duration.

Eligibility criteria:
inclusion criteria: * children who were born in 2006 (10 years old), * children whose bmi values were ≥95. percentiles, * a report which was given by a doctor to state that the child could participate in aerobic exercise, * children who had not continued to a diet program for 3 months, * children who had not participated regularly in any sport or exercise for 6 months. exclusion criteria: * children who had any disease requiring use of medicine, * children who had any pain to prevent doing exercise or sport, * children who had any neuromuscular disease

Keywords: obese children motor skills physiotherapy basketball