Kornimate/medical-research-clean huggingface dataset:
assessment of interactions between methamphetamine and aripiprazole - 1

Conditions: Amphetamine-Related Disorders

Summary: the purpose of this study is to assess the interactions between intravenous methamphetamine and aripiprazole.

this is a double-blind, placebo-controlled human laboratory clinical pharmacology study to assess potential interactions between intravenous d-methamphetamine infusion and treatment with oral aripiprazole.

Eligibility criteria:
inclusion criteria: * must meet dsm-4 criteria for methamphetamine abuse or dependence and are non-treatment seeking. * ability to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures. exclusion criteria: * please contact the site for more information.
efficacy and safety of summers non-pesticide lice asphyxiator (l.a.)for the treatment of head lice

Conditions: Head Lice

Summary: summers laboratories has developed a non-pesticide treatment for head lice. lice asphyxiator (l.a.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance. the objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% l.a. (applied one week apart).


Eligibility criteria:
inclusion criteria: 1. males and females 6 months of age or older. 2. have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline, or treatment failure with any live lice from protocol su-01-2005 or protocol su-02-2005. 3. agree not to use any other pediculicides or medicated hair grooming products during the duration of the study. 4. be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. 5. subject or guardian is able to understand the new hipaa regulations and sign the hipaa form. 6. subject or guardian has read, understood, and signed appropriate informed consent in english. if english is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language. 7. subject is willing to participate in the study, and abide by the protocol requirements. - exclusion criteria: 1. participation in any clinical study, excluding protocols su-01-2005 and su-02-2005, within the past 30 days. 2. known hypersensitivity to any ingredient in the product formulation.
resilience for young people with adhd - a randomized controlled trial of a brief intervention program.

Conditions: ADHD

Summary: in this project we invite 8.000 young persons (age 18-27) in denmark and to participate in a randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). the complete consort trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

the complete consort trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Eligibility criteria:
inclusion criteria: a random sample with 8.000 patients registered in the danish national patient register: * age 18-27 * adhd diagnosis exclusion criteria: • request for legal protection against contacts from researchers.
clinical trial using pupillometry to measure nociception in healthy volunteers.

Conditions: Nociceptive Pain; Pupillary Light Reflex Lost; Healthy; Pain, Procedural; Gender; Anxiety

Summary: pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. in this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. one of these devices is the algiscan® portable pupillometer (idmed, marseille, france), which we propose to use in the present study. this pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia. this study in healthy volunteers aims to evaluate whether the pdr can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. if so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.


Eligibility criteria:
inclusion criteria: 1. subjects of both sexes (balanced) 2. caucasian race 3. ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65) 4. body weight within the normal range (quetelet index: 19-30) 5. clinical history, physical examination and vital signs within normality 6. free acceptance to participate, with written informed consent exclusion criteria: 1. previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption\> 40 gr / day for men or\> 24 gr / day for women) 2. significant consumption of stimulating drinks (\> 5 coffees, teas, chocolate or cola drinks / day). 3. taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). oral contraceptives and paracetamol will be allowed. 4. pregnancy (β-hcg test). 5. menstruation and / or dysmenorrhea on the day of the study 6. family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes 7. pupillary diameter ≥ 5mm 8. smokers or ex-smokers \<6 months. 9. have participated in a clinical trial in the 3 months prior to the start of this study.
post marketing clinical follow up of the bioprotect balloon implant system

Conditions: Prostate Cancer

Summary: long-term prospective post marketing clinical follow up for evaluation of the bioprotect balloon implant™ system

multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of imrt following implantation of the bioprotect balloon implant system.

Eligibility criteria:
inclusion criteria: 1. subject has previously participated in the bp-007 clinical study and completed their imrt treatment. 2. subject agrees to complete all required follow-up visits. 3. subject provides written informed consent prior to any study related procedure exclusion criteria: 1. subject who completed 48 months of follow-up in the bp-007 study. 2. subjects who are receiving at the time of the study, any other investigational agents/ devices. 3. subjects unwilling and/or unable to comply with the provisions of the study protocol.
immunogenicity and safety study of a third vaccination with fsme-immun 0.5 ml in subjects previously vaccinated according to a rapid immunization schedule (follow-up to study 225)

Conditions: Encephalitis, Tick-borne

Summary: the objective of this study is to investigate the immunogenicity and safety of a third vaccination with fsme-immun 0.5 ml given approximately 12 months after the second vaccination in study 225. in study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.


Eligibility criteria:
inclusion criteria: * male and female subjects who: * received 2 vaccinations with fsme-immun 0.5 ml during study 225 * understand the nature of the study, agree to its provisions and provide written informed consent * are clinically healthy (i.e. the physician would have no reservation vaccinating with fsme-immun 0.5 ml outside the scope of the clinical trial) * have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) * agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) * agree to keep a subject diary exclusion criteria: subjects who: * have already been administered a third tbe vaccination elsewhere since receiving two vaccinations in study 225 * have a history of infection with, or vaccination against, other flaviviruses since participation in study 225 (e.g. yellow fever, dengue fever, japanese b encephalitis) * have had an allergic reaction to one of the components of the vaccine since participation in study 225 * suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions * have a known or suspected problem with drug or alcohol abuse (\>4 liters wine/week or equivalent doses of other alcoholic beverages) * have donated blood or plasma within 30 days of study entry * have received a blood transfusion or immunoglobulins within 30 days of study entry * are known to be hiv positive (an hiv test is not required specifically for this study) * are simultaneously participating in another clinical trial including administration of an investigational product * have participated in any other clinical study within 6 weeks prior to study start * have participated in another baxter vaccine study in the past 6 months (with the exception of follow-up studies) * for female subjects: pregnancy or lactation

Keywords: tick-borne encephalitis
a study of two formulations (both refrigerated and room temperature) using an autoinjector device in healthy participants

Conditions: Healthy Participants

Summary: the main purpose of the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants.


Eligibility criteria:
inclusion criteria: * non-smoker * bmi greater than (\>)18.5 and less than (\<) 30.0 kilograms per square meter (kg/m2) * body weight greater than or equal to (≥) 50.0 kg for males and ≥45.0 kg for females * are in good health, as determined by the investigator (or designee) to have no clinically significant findings from medical and surgical history, physical examination, 12 lead ecg, vital signs measurements, and clinical laboratory evaluations * are reliable and willing to make themselves available for the duration of the study, are willing to follow study procedures, and demonstrate the ability to self-inject exclusion criteria: * are pregnant or breastfeeding * have a positive urine drug screen or alcohol breath test at screening have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing or concomitant participation in an investigational study involving no drug or device administration * have known allergic reactions to any components of mannitol or the placebo matrix or related compounds or history of significant atopy * have self-perceived dullness or loss of sensation on either side of the body or the abdomen * have tattoos or scars over the abdomen or other factors (e.g., rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments * are currently using painkillers, aspirin, or other non-steroidal anti-inflammatory drugs (nsaids). intend to use prescription or over-the-counter medication for pain or inflammation within 7 days prior to the first injection * have any reason which, in the opinion of the investigator, would prevent the participant from participating in the study
study determining the frequency of duchenne muscular dystrophy and late-onset pompe disease

Conditions: Duchenne Muscular Dystrophy; Pompe Disease (Late-onset)

Summary: this is a multicenter prospective non-drug screening study. the working period is 12 months. there is no research product to be followed or used in the study. demographic data, medical and family histories of the patients included in the study will be collected at the first admission. the following laboratory values of the patients will be collected: * alanine transaminase (alt) * aspartate transaminase (ast) * gamma glutamyl transferase (ggt) * creatine phosphokinase (cpk) * in addition, physical examination information and abdominal usg and liver biopsy results, if any, will be collected. following the above scans, enzyme analysis for late-onset pompe disease in boys and girls and adolescents with high cpk levels and molecular genetic tests for duchenne muscular dystrophy in boys and adolescents with high cpk levels will be performed.


Eligibility criteria:
inclusion criteria: * 3 months -18 years old boys and girls * serum transaminase levels (serum alt and / or ast levels\> 1.52 upper limit of normal (uln)) for at least 3 months * the willingness of the patient and / or legal representative to sign the written consent form exclusion criteria: * patients less than 3 months * patients with a known history of liver disease * patients with a known history of muscle disease * patients with a known history of rheumatologic disease * patients with clinical history or physical examination findings that support the possibility of liver disease (jaundice, variceal bleeding, hepatomegaly, splenomegaly, ascites) * icu patients * patients with known congenital anomalies * patients with organ failure * patients with elevated serum ggt, total bliribun or direct bilirubin levels

Keywords: cpk transaminase dmd pompe
end-stage renal disease intra-dialysis lifestyle education study

Conditions: End-stage Renal Disease

Summary: the purpose of this study is to compare the effects of intra-dialysis yoga to an educational program among patients with end-stage renal disease. the investigators hypothesize that yoga as compared to the educational program will significantly improve quality of life.

the investigators propose a prospective, randomized clinical trial among on maintenance hemodialysis to compare the effects of intra-dialysis yoga to an educational program. in a sample of 68 patients the investigators will compare the clinical effects of a 12-week program of yoga to a 12-week education program during dialysis. outcome assessment of study participants will occur at baseline, 6-weeks, 12-weeks, and 24 weeks for: disease-related quality of life (physical component primary outcome of the study), physical performance, blood pressure, fatigue, satisfaction with dialysis, sleep quality, and mood. among a sub-sample of 20 participants, the investigators will measure the potential effects of the interventions on endothelial function, arterial stiffness, and autonomic tone. the sub-study will collect outcomes at baseline and 12 weeks.

Eligibility criteria:
inclusion criteria: * maintenance hemodialysis for ≥3 or months * adequately dialyzed (kt/v ≥1.2 measured within last 3 months) * expected to remain in present hemodialysis shift for next 4 months * expected to remain on hemodialysis for at least 6 months * 18 years or older exclusion criteria: * acute or chronic medical conditions that would make intra-dialysis yoga potentially hazardous * unstable cardiac disease e.g. angina, life threatening arrhythmia * chronic lung disease that prevents gentle exercise or deep breathing exercises * active cerebrovascular disease * major depression * chronic symptoms of nausea, vomiting, or diarrhea * current participation in exercise or mind body program/practice * cognitive impairment (mme ≤ 24) measured at baseline testing visit

Keywords: end-stage renal disease hemodialysis yoga mind-body medicine meditation
comparing efficacy of azithromycin and probiotics for treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris

this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions \& improving quality of life? total 75 patients were divided into 3 groups. group a received azithromycin, group b received probiotics and group c received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in dermatology life quality index score.

Eligibility criteria:
inclusion criteria: * diagnosed patients of mild and moderate acne * aged between 15 and 35 years exclusion criteria: * severe acne or any systemic inflammatory disease * other oral treatment for acne * allergic to any drug being used in the study * pregnancy * pcos * any drug which can interact with azithromycin
5 years of eye screening for arf in children aged <3 years in flanders

Conditions: Amblyopia

Summary: researchers will investigate the distribution and evolution of amblyopia risk factors and other refractive errors in children younger than 3 years of age. the significance and magnitude of current global evolutions in arf and refractive errors will be verified to update current guidelines and practices. better insight in associated factors of amblyopia risk factors will contribute to current understanding of amblyopia.

the eye screening program of the flemish governmental agency 'kind en gezin' is a well-implemented screening program for detection of arf in children under the age of 3 years. this screening covers almost 85% of all children born in the flemish community. valuable information about distribution and determinants of refractive errors and arf are collected at 'kind en gezin', but remain unstudied until today. the aim is to analyze the distribution and evolution of refractive errors in children under the age of 3 years in flanders. one supposes that identification of patterns in this distribution, and identification of determinants that influence arf, will lead to improved knowledge about amblyopia (risk factors) and on their turn help optimize the arf screening program. evaluation of the distribution and evolution of refractive errors over time, and comparison with global results, will also give researchers insight in the significance of the myopia epidemic in flanders.

Eligibility criteria:
inclusion criteria: * we include all children with a plusoptix screening between 2013 and 2018 with the age of 12±1 months or 30±1 months. children who were screened twice, can be included twice with both screening results. exclusion criteria: * none
buprenorphine hiv care integration project

Conditions: HIV Infection; Opioid-Related Disorders

Summary: a007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated hiv care setting.

design: a007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated hiv care setting. duration: subjects will participate in this study for approximately 48 weeks. chart abstractions will continue for up to four years. sample size: this study will enroll 60 subjects (30 per arm) over 72 weeks. population: hiv-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for hiv-1 infection. stratification: subjects will be stratified at screening based on hiv care setting (integrated hiv care vs. nonintegrated hiv care) interventon at entry subjects will be randomized to one of the following: arm a: standard drug addiction counseling + buprenorphine / naloxone arm b: enhanced behavioral motivation counseling + buprenorphine / naloxone the three primary outcomes are: 1. cessation of illicit opioid use 2. reduction in high risk behavior 3. improved hiv therapy adherence

Eligibility criteria:
inclusion criteria: * hiv infection * receiving or seeking outpatient hiv care * seeking outpatient treatment for opioid dependence and be willing to take buprenorphine * meets dsm-iv criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given * men and women age ≥ 18 years * women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine * within 30 days: (sgot), alt (sgpt), and alkaline phosphatase \<=5 x uln, total bilirubin \<= 2.5 x uln exclusion criteria: * serious medical problem * acute and/or severe psychiatric conditions * high dose methadone (\>30 mg/day) * documented co-dependence on alcohol and/or benzodiazepines, barbiturates * chronic pain management requiring opioids * pregnancy or breast-feeding * imprisonment or involuntary incarceration in a medical facility for psychiatric or physical

Keywords: hiv infection opioid dependence dsm-iv criteria for opioid dependence