Kornimate/medical-research-clean huggingface dataset:
bioavailability of subcutaneous dexmedetomidine

Conditions: Pain

Summary: the aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. the absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. in addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. the investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.


Eligibility criteria:
inclusion criteria: * fluent skills in the finnish language in order to be able to give informed consent and communicate with the study personnel. * age ≥ 18 years. * male gender. * weight ≥ 60 kg. * written informed consent from the subject. exclusion criteria: * previous history of intolerance to the study drug or related compounds and additives. * concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study. * existing or recent significant disease. * history of any kind of drug allergy. * previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements. * donation of blood within six weeks prior to and during the study. * body weight \ 30 kg / m2. * participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study. * smoking during one month before the start of the study or during the study period. * clinically significant abnormal findings in physical examination, ecg or laboratory screening

Keywords: palliative therapy
celiac disease and diabetes mellitus

Conditions: Celiac Disease in Children

Summary: the aim of the present study is to detect celiac disease among suspected patients with type 1 diabetes mellitus who admitted to assiut university children's hospital during one year duration

type 1 diabetes mellitus (t1dm) is an immune-mediated disease characterized by reduced insulin secretion by islet beta cells in the pancreas that leads to insulin deficiency . because of a common genetic background and interaction between environmental and immunological factors, patients with t1dm are at a great risk for developing autoimmune diseases. it is well recognized that t1dm can be associated with celiac disease (cd) and autoimmune thyroid disorders (atd). recent studies regarding cd and t1dm have indicated that the frequency of this association can vary from 1.7% to 16% . also other autoimmune diseases may be noted such as addison's disease and vitiligo. celiac disease is an autoimmune enteropathy that is caused by permanent susceptibility to gluten (a protein found in wheat, barley, and rye) in genetically susceptible individuals . cd develops with symptoms, such as steatorrhea, weight loss, developmental disorder, abdominal pain, and nutritional symptoms (e.g. vitamin deficiency), and is improved shortly after elimination of gluten-containing foods . extraintestinal signs and symptoms include iron-deficiency anemia, chronic fatigue, failure to thrive, stunted or short stature, delayed puberty, amenorrhea, recurrent aphthous stomatitis, dermatitis herpetiformis - like rash, fracture with inadequate traumas, osteopenia, osteoporosis. since the majority of cd patients can be asymptomatic, screening for cd at the time of t1dm diagnosis is recommended . in seronegative cases at the first screening, if there are no cd symptoms, regular screening every 2-5 years is recommended. however, in patients with cd symptoms or history of cd in first-degree relatives more frequent screening is recommended . testing of asymptomatic cd would provide a prompt diagnosis of cd and enable better metabolic control for t1dm patients . however, recently, some studies have shown normalization of celiac serology in patients with t1dm, even with no gluten-free dietary intervention. in the mentioned studies, spontaneous normalization developed in 20-35% of the cases . therefore, considering all of the serologically positive individuals as cd and giving a gluten-free diet (gfd) imposes an additional psychological burden for children and families. in the latest european society for pediatric gastroenterology, hepatology and nutrition (espghan) guidelines, it was highlighted that the level of anti-tissue transglutaminase-iga (anti-ttg iga) should be at least 10 times higher than the upper limit of normal (uln) for diagnosis of cd without duodenal biopsy.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * symptoms and signs suggestive of celiac disease. * age : 1-18 years old exclusion criteria: * no symptoms or signs suggestive of celiac disease. * patients who are non cd gluten hypersensitivity * age : less than 1 year old.
a post market device study for the treatment of acne

Conditions: Acne Vulgaris

Summary: to evaluate the safety and efficacy of the cutera laser system for the treatment of acne vulgaris.


Eligibility criteria:
inclusion criteria: 1. female or male, fitzpatrick skin types i-vi, 16 to 60 years of age (inclusive). 2. has clinically diagnosed acne vulgaris of severity grade 3 - 4 (moderate to severe) on the face based on photographic review by expert dermatologist grader(s) using the investigator's global assessment scale. 3. has ≥ 10 inflammatory acne lesions on the face as determined by the investigator (or qualified designee). 4. subject (and parent or legal guardian if subject is a minor under age 18) must be able to read, speak, and understand english and sign the informed consent form. 5. willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions. 6. willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an investigator approved sunblock or sunscreen of spf 30 or higher on the face every day for the duration of the study, including the follow-up period. 7. must maintain the same acne treatment regimen, including topical and systemic medications for at least 2 weeks prior to enrollment, and for the duration of the study, including the follow-up period unless approved by the investigator. 8. willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes. 9. agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study unless approved by investigator. 10. willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study. exclusion criteria: 1. has clinically diagnosed acne vulgaris of severity grade 0, 1, 2 (clear, almost clear, mild) on the face based on photographic review by expert dermatologist grader(s) using the investigator's global assessment scale. 2. prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation. 3. still healing from another treatment in the target area according to investigator's discretion. 4. currently pregnant or planning on becoming pregnant anytime during the duration of the study. 5. excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area. 6. currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer. 7. as per the investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study or might interfere with patient's participation in the full study protocol. 8. known hypersensitivity to, history of allergic reaction to, or contraindication to pro-nox or mild oral anti-anxiety or pain medication, if administered.
short-term exposure for ptsd

Conditions: Chronic Post-Traumatic Stress Disorder; Marijuana Abuse

Summary: this study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (ptsd). half the participants will be individuals with chronic ptsd and heavy marijuana use and half will be individuals with chronic ptsd and no marijuana use. this study will assess how individuals with ptsd with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to ptsd symptom reduction.

in this study, 36 patients with chronic ptsd and heavy marijuana use (heavy) and 36 patients with chronic ptsd and no marijuana use (no use) will be recruited to examine the effects of marijuana use on behavioral (emotional experiencing), physiological (skin conductance, acoustic startle) and biological (cortisol, blood pressure) responding on a well-established discriminative conditioning and extinction paradigm. to examine real world therapeutic implications, we will also examine how individuals with ptsd and heavy or no marijuana use differentially respond to a brief (6 session, 50 min) daily imaginal exposure (ie) treatment. throughout treatment, we will monitor level of cannabis metabolites in urine samples of marijuana users to correlate effects to outcomes and preliminarily explore how varying levels of cannabis metabolites affect extinction processes. independent evaluators will assess patients at baseline, 4 weeks, and 12 weeks following study entry.

Eligibility criteria:
inclusion criteria: 1. current ptsd diagnosis based on dsm-5 criteria, with a minimum duration of 12 weeks since the traumatic event; 2. between the age of 18 and 65; 3. current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months 4. current diagnosis of a cannabis use disorder based on dsm-5 or no current diagnosis of a substance use disorder exclusion criteria: 1. current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the dsm-5. 2. current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan). 3. unwilling or unable to discontinue current trauma-focused psychotherapy 4. any previous experience with prolonged exposure (pe) treatment 5. no clear trauma memory or trauma before age 3 6. unstable dose of psychotropic medications in the prior 3 months 7. ongoing intimate relationship with the perpetrator (in assault related ptsd cases). 8. current diagnosis of a substance use disorder according to dsm-5, other than marijuana in the last 3 months.
a trial of hr091506 tablets in treatment of primary gout with hyperuricemia in adults

Conditions: Primary Gout With Hyperuricemia in Adults

Summary: the study is being conducted to evaluate the efficacy and safety of hr091506 tablets for treatment of primary gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.


Eligibility criteria:
inclusion criteria: 1. 18 - 65 years old, male or female. 2. bmi: 18.0 - 30 kg/m2. 3. meet the 2015 acr (american college of rheumatology) gout classification criteria. 4. fasting serum uric acid ≥480 μmol/l on 2 different days during the screening period. 5. willing to use contraceptive measures during the study. 6. able and willing to provide a written informed consent. exclusion criteria: 1. history of acute gout attack within 4 weeks before randomization. 2. urinary calculi diagnosed by b-ultrasound within 4 weeks before randomization. 3. subjects who have undergone major surgery or organ transplantation within 3 months before randomization. 4. major cardiovascular disease within 6 months before randomization. 5. history of chronic infection or recurrent infection within 1 year before randomization. 6. history of malignant tumor or current history of combined malignant tumor within 5 years before screening. 7. history of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder. 8. subjects with poorly controlled blood pressure or diabetes mellitus. 9. history of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease. 10. history of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research. 11. abnormal laboratory tests that may affect subjects participating in the research. 12. combined use of prohibited drugs. 13. allergic to ingredient or component of the experimental drug. 14. participated in other clinical trials within 1 month before randomization. 15. pregnant or nursing women. 16. history of drug abuse, drug use and/or excessive drinking within 1 year before screening. 17. the inestigators determined that other conditions were inappropriate for participation in this clinical trial.
immunogenicity, safety of measles-mumps-rubella-varicella vaccine (memuru-oka) compared to priorix™ given with varilrix™

Conditions: Mumps; Rubella; Measles; Varicella

Summary: since measles-mumps-rubella (mmr) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (memuru-oka) vaccine is fully justified. such a combined vaccine was developed and extensively studied in susceptible children. in countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of mmr and varicella will receive a single shot of the combined vaccine as the second dose. to account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate mmr and varicella vaccines as a second dose.


Eligibility criteria:
inclusion criteria: * children must be healthy to participate exclusion criteria: * immunosuppressive (including hiv) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to mmr vaccine, and fever (axillary temperature ³ 37.5°c at the time of vaccination) are excluding factors. children must have received one dose (but not more) of mmr and of varicella vaccine at least 6 weeks before entering the study. they must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination. they must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start. new-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
role of fxr in hepatitis c virus replication

Conditions: Chronic Hepatitis C

Summary: in vitro in the hepatitis c virus (hcv) replicon system, modulation of the biliary salts nuclear receptor fxr by either agonists or antagonists respectively increases or decreases the replication of hcv (j hepatol, 2008, 48: 192-9). one antagonist of fxr is a vegetal sterol, guggulsterone, that is extracted from the commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (jama 2003, 290: 765-72). the aim of this trial is to test the effect of the fxr antagonist guggulsterone given orally, three times a day, on the viral load in 15 hcv genotype 1 chronically infected patients.


Eligibility criteria:
inclusion criteria: * male patients infected by hcv genotype 1, with anti-hcv antibodies, non responders to at least one first line of therapy * viral load \> 1 x 105 ui/ml for more than 6 months and not treated for at least the last two months. * metavir score \< f4 exclusion criteria: * alcohol intake \> 20 g/day * immuno - suppressive therapy * obesity bmi \> 30, diabetes * dyslipidemia requiring specific therapy * liver cirrhosis or carcinoma * hiv or hbv co-infections * other liver diseases * major organ failures * therapy with cytochrome p450 metabolized drugs

Keywords: hepatitis c virus biliary salts farnesoid x receptor guggulsterone
aripiprazole im depot for chinese patients with schizophrenia

Conditions: Schizophrenia

Summary: this study assess pharmacokinetics and safety of single-administration of aripiprazole im depot formulation at doses of 300 and 400mg in patients with schizophrenia.

in this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to the diagnostic and statistical manual of mental disorders (dsm-iv-tr), to evaluate pharmacokinetics and safety of single-administration aripiprazole im depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug. in this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleim depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.

Eligibility criteria:
inclusion criteria: 1. subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(icf); 2. patients with a diagnosis of schizophrenia as defined by dsm-iv-tr (295.30, 295.10, 295.20,295.90 , 295.60); 3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent. exclusion criteria: 1. patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of dsm-iv-tr; 2. score of positive and negative syndrome scale (panss): ≥120; 3. patients with a complication or a history of diabetic mellitus; 4. subjects who are alcoholemia overdependent of drug, or have drug abuse history; other protocol-defined inclusion and exclusion criteria may apply.
effect of virtual reality on balance and gait speed with alzheimer's dementia

Conditions: Alzheimer's Dementia

Summary: the aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with alzheimer's dementia.

the aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with alzheimer's dementia. the study consisted of 32 subjects, which were diagnosed as mild or moderate ad by the neurologist. the balance, fall risks and gait speed were assessed. training group was trained with games selected from different categories such as balance and aerobic exercises with nintendo wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week.

Eligibility criteria:
inclusion criteria: * having mild or moderate severity of ad * lack of communication difficulties or problems * volunteering to participate in the study * cerebrovascular event, * having disturbing the balance and coordination of neurological disease such as parkinson, ms, * mini mental test score, 18 to 24 points from being scored * being 65-80 aged. exclusion criteria: * patients diagnosed with dementia (infection, vascular, hematological diseases), patients who could not be contacted during the follow-up period or who did not come to control, cardiac and cerebrovascular event, * endocrine disorder, fluid-electrolyte imbalance and infection * patients with malignancy and malignancy, chemotherapy and radiotherapy, * patients with delirium or depression * those with protective sensation loss (those with semmes-weinstein monofilament thickness 4.56 and above) * patients with lower or upper extremity amputations at any level

Keywords: alzheimer's dementia balance gait speed virtual reality
child results following preventive children of parents with psychiatric and addictive problems (copp) groups

Conditions: Psychiatric Disorder NOS

Summary: this is a study evaluating changes in quality of life and global functioning across and after a manualized peer-group preventive intervention for children of parents with psychiatric or addictive problems.

self-reported quality of life and based on the group-interviews "ilk" and "kindl" and general adaptive functioning (cgas) as reported by teachers and parents will be measured before, after and at follow-up relative to the manualized peer-group preventive intervention. parents will also complete self-reports on anxiety and depressive symptoms, personality, bonding and attribution before the intervention.

Eligibility criteria:
inclusion criteria: * family including parent with psychiatric or addictive problems exclusion criteria: * acute severe disorder

Keywords: parents with psychiatric or addictive problems
rotavirus vs. sucrose for vaccine injection pain

Conditions: Vaccination Pain Management

Summary: this randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.


Eligibility criteria:
inclusion criteria: * healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life exclusion criteria: * impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial

Keywords: vaccination pain management sucrose rotavirus