Kornimate/medical-research-clean huggingface dataset:
non-us study of aa4500 (xiaflex™, proposed name) in the treatment of advanced dupuytren's disease

Conditions: Advanced Dupuytren's Disease

Summary: this 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled phase and a nine-month open-label extension phase. before treatment, eligible subjects were stratified by the primary joint type (30 metacarpophalangeal \[mp\] joints and 30 proximal interphalangeal \[pip\] joints) and by severity of the primary joint contracture (ie, up to 50° or \>50° for mp joints and up to 40° or \>40° for pip joints) and then randomized in a 2:1 ratio to either aa4500 0.58 mg or placebo. upon completion of the double-blind phase (ie, 90-day evaluation after the first injection), all subjects were eligible to enter the open-label extension phase of the study in which they were followed for an additional nine months. subjects who required further treatment because they either did not achieve reduction in contracture to 5° or less, the cord affecting the primary joint received placebo, another cord received less than three injections of aa4500, or they had untreated cords that were affecting other joints had the option to receive up to five additional injections of aa4500 0.58 mg in the open-label extension phase, with individual cords receiving up to three injections of aa4500. this study was designed to be part of the larger clinical program, for adult patients with dupuytren's contracture with a palpable cord, where the data from 2 pivotal placebo-controlled studies (aux-cc-857 \[nct00528606\] and aux-cc-859 \[nct00533273\]) and 7 non-pivotal studies were evaluated.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of advanced dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for mp (80° for pip) joints, caused by a palpable cord. * had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. * were naive to aa4500 treatment * were judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. exclusion criteria: * had a chronic muscular, neurological, or neuromuscular disorder that affected the hands. * had received a treatment for advanced dupuytren's disease, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug. * had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
zotepine versus risperidone in aggressive schizophrenic patients of acute ward

Conditions: Schizophrenia

Summary: the purpose of this study is to compare the efficacy and tolerability of zotepine versus risperidone in aggressive schizophrenic patients.


Eligibility criteria:
inclusion criteria: * aged 18 to 65 years, male or female * in-patients suffering from schizophrenia according to dsm-iv diagnostic criteria with panss total score of greater than or equal to 60. * patients with panss-ec total score of greater than or equal to 14 and with at least one panss-ec symptom score greater than or equal to 4 exclusion criteria: * patients with history of seizure or with alcohol or substance abuse in the last 6 months * diabetes, parkinson's disease or phaeochromocytoma * patients with hypertension and current use of antihypertensive agents * women who are pregnant, lactating or intend to become pregnant during the study period * poor response to two different antipsychotics in full dose and full course or use of clozapine previously * renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation

Keywords: schizophrenia zotepine risperidone second generation antipsychotic
efficacy of multiple micronutrient fortified biscuits and deworming in vietnamese school children

Conditions: Healthy

Summary: the aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in vietnamese primary schoolchildren.

concurrent micronutrient deficiencies are prevalent in schoolchildren in vietnam. these deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. the risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in vietnam. furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.

Eligibility criteria:
inclusion criteria: * school children aged 6-8 years with written informed consent from parents/caregivers exclusion criteria: * hemoglobin concentrations \< 80g/l * chronic disease * congenital abnormalities * mental or severe physical handicap * severe malnutrition * obesity * receiving deworming within the previous 6 mo

Keywords: efficacy vietnam school children anemia fortification micronutrient
cognitive behavioural therapy (cbt) and recreational activity for autism spectrum disorders (asd)

Conditions: Asperger Syndrome; Autistic Disorder; Atypical Autism

Summary: the purpose of this study is to determine if adults with autism spectrum disorder and with normal intelligence improve from 36 sessions (1 calendar year) of group treatment with cognitive behavioural therapy or recreational activity in groups with 6-8 participants.

the purpose of this study was to compare two group interventions for psychiatric patients with autism spectrum disorder and normal intelligence: cognitive behavioural therapy developed to suit adults with autism spectrum disorder, and recreational activity, enabling social interaction. the recreational activity intervention served as a low-impact option, easily organised within the community. it is not a placebo; rather it controls for the positive effects that come out of a structured social environment and group setting. the investigators hypothesized that both interventions would lead to improvement in quality of life, well-being and relief in psychiatric symptoms, with a greater effect in the cognitive behavioural therapy intervention compared to recreational activity. a cumulative follow-up was made, within 5 1/2 years after the start of the treatments. additional questions adapted to the patient group were added at this 5 1/2 year time point.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism spectrum disorders * normal intelligence as assumed by mainstream schooling * acceptance of a group setting * being able to transport themselves to the clinic (with or without support) exclusion criteria: * current substance abuse * current psychosis

Keywords: asperger syndrome autistic disorder adult psychotherapy
diagnosis of bone metastases in breast cancer: bone scintigraphy, fluoride-pet and fdg-pet

Conditions: Breast Cancer

Summary: breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. the purpose of the study is to determine, if fluoride pet/ct is superior to bone scintigraphy with technetium. on the other side, the investigators would like to see if fdg-pet/ct is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.


Eligibility criteria:
inclusion criteria: * histologically proven c. mammae * clinically suspicion of bone metastases exclusion criteria: * age under 18 years * diabetes mellitus * pregnancy * other known malignant disease

Keywords: breast cancer bone metastasis comparison of diagnostic methods bone scintigraphy fluoride pet/ct fdg-pet/ct
study of oral tlr8 agonist selgantolimod on hbsag in participants with both chronic hepatitis b and hiv

Conditions: Hepatitis B; HIV Infections

Summary: the study aims to assess safety and tolerability of oral toll-like receptor (tlr) 8 agonist selgantolimod (slgn) administered for 24 weeks in participants with both chb and hiv who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qhbsag level \>1000 (3 log10) iu/ml at screening. the study will also evaluate if tlr8 stimulation with slgn will reduce hepatitis b surface antigen (hbsag) titers in the blood.

a5394 is a phase ii, double-blinded, placebo-controlled trial. forty-eight study participants will be randomized 3:1 to receive slgn or its placebo (36 active and 12 placebo), and randomization will be stratified by hbeag status. one-half of the study participants will be hbeag positive (n=24) at screening, and the other half will be hbeag negative (n=24). all participants will remain on their non-study-provided antiviral therapy throughout the study.

Eligibility criteria:
inclusion criteria: 1. hiv-1 infection 2. effective antiviral therapy for hiv (art) and hbv that includes tdf, taf, tdf/ftc, tdf/3tc (tenofovir disoproxil fumarate plus lamivudine), taf/ftc, or entecavir (etv), for ≥5 years immediately prior to study entry. art is defined as including a minimum of two anti-hiv antivirals. 3. cd4+ cell count ≥350 cells/mm3 4. hiv-1 rna \ 200 copies/ml, over the 12 months prior to study entry. 5. positive or negative hbeag 6. negative anti-hdv 7. current chb infection 8. hbv dna level \<50 iu/ml measured on at least two occasions at least 12 weeks apart, with no documented value ≥50 iu/ml, over the 12 months prior to study entry. 9. quantitative hbsag \>1000 iu/ml 10. hepatitis c virus (hcv) antibody negative, or if the participant is hcv antibody positive, an undetectable hcv rna. 11. participants age ≥18 years and ≤70 years at study entry 12. participants must agree to stay on an effective antiviral therapy for hiv (art) and hbv throughout the study. exclusion criteria: 1. receipt of treatment for hcv within 24 weeks prior to study entry 2. evidence of advanced fibrosis or cirrhosis (metavir ≥f3 or equivalent). 3. current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage) 4. history of hcc or cholangiocarcinoma 5. malignancy within 5 years prior to study entry. note: a history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary. 6. history of solid organ transplantation 7. presence of any active or acute aids-defining opportunistic infections within 60 days prior to study entry 8. history of uveitis or posterior synechiae 9. breastfeeding
neurocovid rehab and recovery related to covid-19 diagnosis

Conditions: Coronavirus; Covid19

Summary: the purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. this is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (tavns) which means that the participant will receive stimulation through the ear. the tavns device looks like an ear bud used with a smart phone or computer. the study team is investigating whether or not tavns can treat neurologic symptoms of covid-19 which are termed neurocovid. some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. this study is entirely online and all assessments will be completed virtually.


Eligibility criteria:
inclusion criteria: * covid positive * at home * afebrile * anxiety * depression * vertigo * anosmia * headaches * irritability * cognitive processing exclusion criteria: * damage to left ear anatomy * unstable hemodynamic effects * ischemic or hemorrhagic stroke after developing covid * unable to give consent, follow instructions * unable to read or write or speak english * no access to home wifi
development and evaluation of highalert

Conditions: Cannabis; Youth Drinking

Summary: in canada, youth ages 16-24 have the highest rates of cannabis use, impaired driving, and express the least concern for driving under the influence of cannabis (duic). as such, developing effective and practical duic prevention efforts is crucial. this study aims to evaluate the effects of 'high alert' in reducing 3-month risky cannabis use and duic among young ontarian drivers. 'high alert' is an interactive web-based smartphone application developed by the research team with the feedback of experts and youth. 'high alert' modules focus on recognizing what constitutes risky cannabis use, the effects of cannabis on driving, the risks of duic, and strategies to avoid duic. a pilot randomized controlled trial will compare the effects of 'high alert' with an active control (duic information) and passive control (no contact). overall, effectively preventing duic among youth is critically needed and time-sensitive.


Eligibility criteria:
inclusion: * ages 18-24 * valid ontario driver's license * access to a motor vehicle * report duic at least three times in the past three months * proficient in english * have a smartphone they can complete the intervention with. exclusion criteria: * individuals under 18 and those over 24 * resides outside ontario * non-drivers
impact of chronic circadian disruption vs. chronic sleep restriction on metabolism

Conditions: Aging; Sleep Restriction; Circadian Disruption

Summary: the overall objectives of the proposed study are to examine the consequences of chronic circadian disruption and chronic sleep restriction on metabolic function in healthy adults.

it has long been recognized that sleep patterns change with age. a common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. these age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. in addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) when compared to young adults. whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. in fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality. an understanding of how the circadian and sleep homeostatic neurobiological processes responds to increasing homeostatic sleep pressure, and the effects of sleep restriction on metabolism at different ages, should provide information on the regulation of sleep and metabolism in aging, as well as direction for future treatments. in the present study, we will study the separate impacts of chronic sleep restriction (while minimizing circadian disruption) and chronic circadian disruption (while minimizing sleep disruption) and a poor diet on metabolism.

Eligibility criteria:
inclusion criteria: * healthy adults with conventional and regular sleep-wake timing * non-smokers * completion of medical, psychological, and sleep screening tests * able to spend 37 consecutive days/nights in the laboratory exclusion criteria: * history of neurological or psychiatric disorder * history of sleep disorder or regular use of sleep-promoting medication * current prescription, herbal, or over-the-counter medication use * traveling across 2 or more time zones within past 3 months * donating blood within past 8 weeks * worked night or rotating shift work within past 3 years * hearing impairment * drug or alcohol dependency

Keywords: sleep aging metabolism circadian genetic alertness
atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (active a)

Conditions: Atrial Fibrillation; Vascular Risk

Summary: the purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. the study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.


Eligibility criteria:
inclusion criteria: to be eligible for active a patients must have in same time the three following conditions : * evidence of atrial fibrillation either on one current electrocardiogram (ecg) or two ecgs recorded at two weeks a part during 6 months prior to study enrollment. * evidence of high risk of vascular events : at least one of the following risk criteria must be present : * are 75 years greater; * on treatment for systemic hypertension; * prior stroke, transient ischemic attack (tia) or non-central nervous system (non-cns) systemic embolus; * left ventricular dysfunction with left ventricular ejection fraction (ef) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%; * peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9); * age 55 to 74 years and either; f1) diabetes mellitus requiring drug therapy, or f2) documented previous myocardial infarction or documented coronary artery disease. * to have either a contraindication to use an oral anticoagulant treatment or they are unwilling to take an oral anticoagulant treatment. exclusion criteria: patients will be excluded from active if any of the following are present : * requirement for clopidogrel (such as recent coronary stent procedure) * requirement for oral anticoagulant (such as prosthetic mechanical heart valve); * prior intolerance to asa or clopidogrel; * documented peptic ulcer disease within the previous 6 months; * prior intracerebral hemorrhage; * significant thrombocytopenia; (platelet count \< 50 x 10(9)/l) * psychosocial reason making study participation impractical; * geographic reason making study participation impractical; * ongoing alcohol abuse; * mitral stenosis, * pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study; (severe comorbid condition such that the patient is not expected to survive 6 months; * patient currently receiving an investigational pharmacologic agent;

Keywords: atrial fibrillation anticoagulant therapy thromboembolic prevention
hiv risk reduction in subutex injectors in tbilisi

Conditions: HIV

Summary: this study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on hiv risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the uranti methadone program, affiliated with the addiction research center, union alternative of georgia in tbilisi.


Eligibility criteria:
inclusion criteria: * current opioid dependence; * injecting buprenorphine 10 or more times in the last 30 days; * between 25 and 50 years of age; * buprenorphine and/or opiate positive urine test; * not on methadone maintenance in last 4 weeks; * stable address within tbilisi and not planning to move; * home or cellular phone number where can be reached; * able to provide name of family member who knows whereabouts; * willingness and ability to give informed consent. exclusion criteria: * currently dependent on alcohol, benzodiazepines or other cns depressants; * legan charges with impending incarceration; * plans to move from tbilisi within next 6 months; * current participation in another treatment study; * serious medical problems that would impair or make hazardous ability to participate; * active tb; * currently psychotic/suicidal; * uncontrolled seizure disorder.

Keywords: buprenorphine injecting opiate dependence hiv risk treatment outcome opiate dependence with buprenorphine injecting
adhesion performance study of lidocaine topical system 1.8% compared to lidocaine patch 5% and lidocaine medicated plaster 5% in healthy, adult, human subjects

Conditions: Healthy

Summary: the primary objective of this study was to evaluate the adhesion performance of ztlido® (lidocaine topical system) 1.8% compared to adhesion performance for lidoderm® (lidocaine patch 5%) and versatis® (lidocaine medicated plaster 5%).


Eligibility criteria:
key inclusion criteria: * must be healthy based on by medical history, laboratory work, and physical exam with bmi range between 18.00 and 30.00 kg/m2 inclusive. * non-smokers * be at least 18 years of age * if childbearing potential, use of acceptable form of birth control * in the case of females of childbearing potential, have a negative serum pregnancy test key exclusion criteria: * allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation * any major medical illness 3 months prior or any significant history or ongoing chronic medical illness * presence of any current dermatological condition including psoriasis, eczema, and atopic dermatitis * presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, irritated (e.g., redness, rash or having blister, etc.) or excessively oily skin at the application areas that may affect the application of the product or adhesion properties of the product. * history of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and do not involve the investigative site * history of addiction, abuse, and misuse of any drug