Kornimate/medical-research-clean huggingface dataset:
the role of spreader grafts in reduction rhinoseptoplasty: a randomized clinical trial with quality of life assessment

Conditions: Rhinoplasty; Nasal Obstruction

Summary: nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it affects quality of life and surgical outcomes. is the association of middle third grafts with reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal obstruction when compared to reduction rhinoseptoplasty without the placement of these grafts?

reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in plastic surgery and otorhinolaryngology. nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. the gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by sheen. studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.

Eligibility criteria:
inclusion criteria: * patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria exclusion criteria: * absence of nasal obstruction; * previous nasosinusal surgery; * symmetrical or asymmetric insufficiency of the middle third that would justify the placement of middle third grafts for the treatment of these problems; * presence of nasal valve insufficiency as the only cause of nasal obstruction; * cranio-facial anomalies; * presence of nasosinusal tumors; * active acute rhinosinusitis; * patients undergoing treatment of other entities concomitant to rhinoseptoplasty such as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation correction, otoplasty or blepharoplasty.
human photoallergy test (824/2016)

Conditions: Sunscreening Agents

Summary: to evaluate the potential of a test material to produce a photoallergic response


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive * be lightly pigmented (fitzpatrick skin type i, ii, iii) * have read and signed the written informed consent form and have completed a hipaa authorization form (health insurance portability and accountability act) in conformance with 45cfr parts 160 and 164 * be in general good health as determined by the subject's medical history and in the discretion of the investigator exclusion criteria: * have a visible sunburn * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products * subjects who are employees of the cro (contract research organization) and/or bayer or is a household member of an employee
ph1 marinol interaction study - part 2 - 1

Conditions: Marijuana Dependence

Summary: this study will examine the effects of oral dronabinol tetrahydrocannabinol (thc) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (pk), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.


Eligibility criteria:
inclusion criteria: * must be between 18 and 45 years of age * must be in good general health and who meet dsm-iv diagnostic criteria for marijuana dependence * must be seeking treatment at time of study entry * must be able to understand and provide written informed consent * must provide 1 marijuana positive urine specimen (\> 50 ng/ml) within the 28-day screening period * if female and of child bearing potential, agrees to use birth control. exclusion criteria: * please contact site for more information

Keywords: marijuana dependence
study of dupilumab (regn668/sar231893) monotherapy administered to adult patients with moderate-to-severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: 1. chronic ad that has been present for at least 3 years before the screening visit; 2. ≥10% body surface area (bsa) of ad involvement at the screening and baseline visits; 3. documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). exclusion criteria: 1. participation in a prior dupilumab clinical study. 2. treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit; 3. having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: * immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, ifn-γ, janus kinase inhibitors, azathioprine, methotrexate, etc.) * phototherapy for ad 4. regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit; 5. treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit; 6. history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening; 7. positive with hepatitis b surface antigen (hbsag) or hepatitis c antibody at the screening visit; 8. active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit; 9. known or suspected history of immunosuppression; 10. pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; 11. women unwilling to use adequate birth control, if of reproductive potential and sexually active. note: the information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
training for injury prevention in collegiate soccer players

Conditions: Athletic Injuries

Summary: the purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.

the purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players. the hypothesis is that measures of sensorimotor control will improve and injury incidence rate will decrease after participation in an intervention aimed at restoration/refinement of sensorimotor control. this study will be conducted as a 1-arm intervention with pre- and post-participation measurement of sensorimotor control and completion of an exercise intervention. statistical analyses will be completed to determine within group change pre-to post-intervention and injury risk by comparing injury rate in 2018 to injury rate of a historical control.

Eligibility criteria:
inclusion criteria: * male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at mississippi college exclusion criteria: * any athlete who has a current diagnosis of concussion (i.e. a non-medically cleared concussion), lower-extremity musculoskeletal injury, or other medical diagnosis that will prevent the athlete from participation in the intervention.
cardiovascular risk reduction for adults with food insecurity using structured incentives

Conditions: Cardiovascular Diseases

Summary: the overarching aim of this proposal is to test the efficacy and cost-effectiveness of cvd-fit, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered cvd risk reduction education and skills training in african americans with food insecurity.

study overview: 200 african american adults at risk for cvd with food insecurity will be randomized 1:1 to cvd-fit or enhanced usual care (cvd risk reduction education). each patient will be followed for 12 months, with study visits at baseline, 3, 6, and 12 months. the primary outcome will be 10-year cvd risk using the pooled cohort equation at 12 months post-randomization while the secondary outcomes will be quality of life at 12 months post-randomization and cost-effectiveness of the cvd-fit intervention compared to enhanced usual care. patient randomization. a permuted block randomization method will be used to assign subjects to intervention or control. all subjects who are randomized will be entered into the study database and analyzed according to consort guidelines. description of the cvd-fit intervention: the cvd-fit intervention will incorporate 1) $100 monthly income supplementation; 2) $50 weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered cvd risk reduction education and skills training. enhanced usual care control group: participants randomized to the enhanced usual care group will receive the same mailed education and health educator delivered education and skills training sessions as the cvd-fit intervention group.

Eligibility criteria:
inclusion criteria: * self-report as african american/non-hispanic black * screen positive for food insecurity over the past 12-months using a food insecurity risk tool developed through completion of the research team's current nih funded r01 (r01md013826) * at risk for cvd defined as age ≥40 years and having a clinical diagnosis of diabetes, or hypertension, or hyperlipidemia, or being overweight/obese (defined as a bmi\>25), or being a current smoker * able to communicate in english. exclusion criteria: * mental confusion on interview suggesting significant dementia * participation in other cardiovascular disease clinical trials * alcohol or drug abuse/dependency based on screening using cage questionnaire * active psychosis or acute mental disorder based on self-report * life expectancy \<12 months.

Keywords: food insecurity financial incentives
seroprevalence of pertussis among children and adolescents in croatia

Conditions: Immunogenicity, Vaccine

Summary: pertussis is a vaccine preventable disease caused by bordetella pertussis. older children and adolescents with pertussis continue to be a significant source of infection for incompletely vaccinated infants who are in harm for developing severe disease. the primary objective of our study is to estimate the duration of protection elicited by the current vaccination schedule against pertussis in croatia.


Eligibility criteria:
inclusion criteria: * children and adolescents from 6 to 18 years of age treated through emergency room and/or day hospital of pediatric infectious diseases department at uhid; * appropriate vaccination with pertussis component containing vaccine by date and at the appropriate time, according to croatian nip proven by insight in the vaccination record card * written informed consent obtained from the subject's parent or caregiver, as well as from participants ≥ 16 years old. exclusion criteria: * children under 6 years * children and adolescents with acute respiratory symptoms * children and adolescents with pertussis-like illness within 12 months * children and adolescents with unknown, uncompleted or irregular vaccination record * inpatients * children and adolescents with immunodeficiencies
car-t therapy for central nervous system b-cell acute lymphocytic leukemia

Conditions: B-cell Acute Lymphocytic Leukemia

Summary: this study will evaluates the safety and efficacy of chimeric antigen receptor t cells (car-t) in treating central nervous system b-cell acute lymphocytic leukemia.

cns leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Eligibility criteria:
inclusion criteria: 1. patients with cd19 positive central nervous system b-cell acute lymphocytic leukemia 2. alt/ ast 《 3x normal 3. creatinine 《 3x normal 4. age:10-60. 5. signed informed consent exclusion criteria: 1. active hepatitis b , hepatitis c or hiv infection 2. uncontrolled active infection 3. pregnancy or breast-feeding women 4. survival less than four weeks

Keywords: cns b cell acute lymphocytic leukemia
efficacy of 10-day concomitant regimen versus high dose dual therapy in anti-helicobacter pylori rescue therapy

Conditions: Helicobacter Pylori Infection

Summary: currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-helicobacter pylori(h. pylori) therapy. to our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy. the aims of this study are: 1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in h. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence h. pylori eradication by these treatment regimens.

patients, aged 18, having h. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. all undergo endoscopy with biopsy before treatment. four to eight weeks after termination of treatment, h. pylori infection status will be examined by endoscopy with biopsy or the carbon 13-urea breath test if the patients refuse the second endoscopy. the cytochrome p450 (cyp)2c19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (pcr-rflp) method. a computed generated random numbers sequence will be blocked into two subgroups, say a and b. if the patients had received anti-h. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. after giving their written informed consent, all patients will be labeled with numbers by enrolling order. each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days: group a - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group b - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days). all patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. post-treatment, the patients will be seen at the outpatient clinic to investigate patient adherence and adverse effects of treatment.

Eligibility criteria:
inclusion criteria: * patients having h. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy. exclusion criteria: * pregnant or nursing woman * serious concomitant illness and malignant tumor of any kind * history of hypersensitivity to test drugs * serious bleeding during the course of this ulcer * previous gastric surgery * receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.

Keywords: helicobacter pylori concomitant therapy high dose dual therapy antibiotic resistance
effect of probiotics on lipid management

Conditions: Primary Hypercholesterolemia

Summary: dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. probiotics have been reported to have ameliorative effects in murine models. however, whether probiotics could help alleviate dyslipidemia in adults remain obscure.

probiotics are live microorganisms that have been associated with multiple health benefits. however, its protective role in adults has long been controversial. this study aims to examine the effect of 12-week probiotics supplementation on lipid management in chinese adults. by understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, which is a major risk factor for cardiovascular diseases.

Eligibility criteria:
inclusion criteria: * eligible subjects include men and women 18 to 75 years of age with primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/l or higher and/ or an ldl cholesterol level of 2.59 mmol/l or higher; * absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics. exclusion criteria: * triglyceride levels higher than 3.95 mmol/l, or any other systemic, metabolic and cardiovascular or cerebrovascular diseases; * type 1 diabetes, type 2 diabetes treated with insulin or other medications; * acute illness or current evidence of acute or chronic inflammatory or infective diseases; * participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment; * mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.

Keywords: primary hypercholesterolemia probiotics cardiovascular risk
study of botox injections in prevention of migraine in adult participants with episodic migraine

Conditions: Episodic Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ichd 2018). migraine can be further categorized according to the frequency of attacks as episodic migraine (em) or chronic migraine (cm). this study will assess the effects of botox in preventing migraine in adult participants with em. botox is being developed for the prevention of migraine in adults with episodic migraine (em). participants will be enrolled in 3 different treatment groups. there is 1 in 3 chance that participants will be assigned to receive placebo. approximately 777 adult participants with em will be enrolled in approximately 125 sites across the world. participants will receive intramuscular injections (injected into the muscle) of botox or placebo on week 0 and week 12. eligible participants will receive botox on week 24 and week 36. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * history of migraine headache disorder meeting international classification of headache disorders (ichd)-3 diagnostic criteria for migraine with aura or migraine without aura for \>= 12 months. * onset of migraine before 50 years of age. * history of 6 to 14 migraine days/month in each of the 3 months prior to visit 1. * six to 14 migraine/probable migraine days during the 4-week screening/baseline phase. * less than 15 headache days/month in each of the 3 months prior to visit 1 and during the 4-week screening/baseline phase. exclusion criteria: * current diagnosis of chronic migraine according to ichd-3. * history or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. * history of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ichd-3 criteria is allowed. * history of inadequate response to \> 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action. * female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.

Keywords: migraine episodic migraine botox botulinum toxin type a
foot orthoses and elderly women with osteoporosis

Conditions: Osteoporosis

Summary: the objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.

aging has been associated with balance impairment. the use of foot orthoses has been shown to be a feasible strategy for improving postural control.the objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of osteoporosis exclusion criteria: * reduced tactile and thermal foot sensibility * compromised skin integrity of the lower limbs * autoimmune rheumatic diseases * vestibular symptoms * central nervous system pathologies * peripheral neuropathy * use of insoles in the last month * lower limb prostheses * previous history of foot surgery * amputation of the lower limbs * inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol

Keywords: elderly balance insole foot orthosis orthotics