Kornimate/medical-research-clean huggingface dataset:
study evaluating the efficacy and safety of triptergium wilfordii and acitretin in psoriasis vulgaris - china201002016-2

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to determine whether triptergium wilfordii, and acitretin are effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.


Eligibility criteria:
inclusion criteria: * adults of both sexes, between the age 18 and 75 years. * have a diagnosis of psoriasis vulgaris,pasi score of 7 or greater. * capable of giving informed consent and the consent must be obtained prior to any study related procedures. exclusion criteria: * currently have erythrodermic,guttate or pustular psoriasis. * have any active dermatoses which may affect disease assessment of psoriasis. * have used any investigational drug,any biologic or any systemic immunosuppressants within the previous 1 month.. * have used topical medications/treatments that could affect psoriasis or pasi evaluation (eg, corticosteroids, tar, phototherapy et al.) within 2 weeks. * have any acute or chronic or recurrent infectious disease,which was difficult to control. * have the history of hbv or hcv infection,or hiv antibody test positive. * ast, alt or blood fat levels must be within 1.5 times the uln range for the laboratory conducting the test. * are pregnant, nursing, or planning pregnancy in the coming two years(both men and women) while enrolled in the study. * have any severe systemic disease or have a history of malignancy. * have shown a previous hypersensitivity to triptergium wilfordii or acitretin. * have any other condition not suitable to join in trial,which are judged by investigator.

Keywords: triptergium wilfordii acitretin psoriasis vulgaris
effect of statins on lipid levels following the first acute coronary event (mk-0000-204)

Conditions: Dyslipidemias; Hypercholesterolemia; Hypertriglyceridemia; High LDL-C; Low HDL-C

Summary: the current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in india experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins. dyslipidemia definitions are per the national cholesterol education program - adult treatment panel iii (ncep-atp iii).


Eligibility criteria:
inclusion criteria: * currently admitted with a confirmed diagnosis of first acute coronary event (stemi/nstemi/unstable angina) * access to medical records covering the entire study period, and availability of data required for the study * potential to collect blood sample within 24 hours of onset for symptoms * considered for initiation/maintenance/modification of statin therapy before discharge from hospital * willing to comply with the study requirements exclusion criteria: * participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview * known inherited disorder of lipoprotein metabolism * history of hypothyroidism, nephrotic syndrome, chronic alcoholism, cushing syndrome
corneal tissue inlay for keratoconus

Conditions: Keratoconus

Summary: this study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.

the objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing thickness, stability, and optical conformation.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age, male or female, of any race * provide written informed consent and sign a hipaa form * willingness and ability to follow all instructions and comply with schedule for follow-up visits * for females: must not be pregnant * having topographic evidence of keratoconus which is graded as moderate or severe keratoconus. exclusion criteria: * contraindications, sensitivity or known allergy to the use of the test article(s) or their components * if female, pregnant * eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme * previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications for example: a history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.) * a history of delayed corneal healing in the eye to be treated * have used an investigational drug or device within 30 days of the study

Keywords: keratoconus corneal tissue inlay
ginger for colorectal cancer prevention

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine if ginger root extract when taken daily for 28 days is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of people who are at normal risk and those at increased of developing colorectal cancer compared to people taking placebo.


Eligibility criteria:
inclusion criteria normal risk: * 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry. * no chronic medication use was allowed and participants could not have taken aspirin or related nsaids during the study or 14 days before the first dose of the study medication. * participants also had to be classified as being at normal-risk for developing colorectal cancer. normal-risk was defined as having: no first-degree relatives with colon cancer diagnosed before the age of 60; no personal history of colorectal cancer and no adenomas \>1 cm in size or containing carcinoma in situ exclusion criteria for both normal and increased risk for colorectal cancer: 1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors; 2. pregnant or lactating women; 3. history of cardiovascular disease; 4. lactose intolerance; 5. or an allergy to ginger 6. a history of familial colorectal cancer syndromes;. inclusion criteria increased risk: * 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry. * no chronic medication use was allowed and participants could not have taken aspirin or related nsaids during the study or 14 days before the first dose of the study medication. * participants also had to be classified as being at increased-risk for developing colorectal cancer. increased-risk is defined as having at least one of the following: a first-degree relatives with colon cancer diagnosed before the age of 60; a personal history of early stage colorectal cancer and/or no adenomas \>1 cm in size or containing carcinoma in situ

Keywords: ginger zingiber officinale cancer risk reductive eicosanoids colorectal cancer inflammation
clonidine is better than zopiclone for insomnia treatment in chronic pain patients

Conditions: Insomnia Chronic; Pain, Chronic

Summary: a prospective observational crossover study of 160 consenting adult patients who underwent pain management. for insomnia treatment, each patient ingested different prescribed doses of zopiclone or clonidine on alternate nights. each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. each patient completed the diary for 3 continuous weeks. pain was measured using the numeric pain rating scale. sleep score was measured using the likert sleep scale. a change in the pain or sleep scores by 2-points was considered significant.

objectives: chronic pain is associated with insomnia. the objective of this clinical study is to compare the efficacy and safety of different prescribed doses of zopiclone and clonidine; for the management of insomnia in patients with chronic pain. methods: a prospective observational crossover study of 160 consenting adult patients who underwent pain management. for insomnia treatment, each patient ingested different prescribed doses of zopiclone or clonidine on alternate nights. each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. each patient completed the diary for 3 continuous weeks. pain was measured using the numeric pain rating scale. sleep score was measured using the likert sleep scale. a change in the pain or sleep scores by 2-points was considered significant. data were analyzed with ibm® spss® statistics 25 (ibm corp, armonk, ny); using student's t-test, anova, pearson chi-square test, and regression analysis. p-value \<0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * adult chronic pain patients * good treatment compliance * severe chronic insomnia * failure of non-pharmacologic sleep therapy * regular zopiclone therapy for 3 months or more * regular sleep diary * regular pain diary * informed consent for diary review * consent for clinical record quality assurance review. exclusion criteria: * obstructive sleep apnoea * body mass index (bmi) ≥40 * organ insufficiency * cognitive disorder * inability to provide consent * major neuropsychiatric disorder * unreliable diary * cannabis use * regular alcohol intake * stimulant use * substance abuse * poor treatment compliance * high dose opioid * gabapentinoid use * sedative use * mild insomina * irregular zopiclone intake * regular zopiclone therapy for less than 3 months * previous adverse/allergic reactions to clonidine or zopiclone.

Keywords: sedative hypnotic
calcium folinate treatment of spastic paraplegia 56

Conditions: Hereditary Spastic Paraplegia

Summary: spg56 is one of the complicated and early-onset hsp subtypes caused by genetic mutations in cyp2u1. so far, there is no standardized and specific clinical therapy for spg56. the goal of this clinical trial is to explore the efficacy and safety of calcium folinate in the treatment of spg56 patients. this study is prospective, open-label and single arm and this trial will last for 6 years. a total of 10 patients will participate and they will receive calcium folinate treatment and professional clinical evaluation regularly.


Eligibility criteria:
inclusion criteria: 1. patients meet the clinical diagnostic standard of hereditary spastic paraplegia (hsp); 2. spastic paraplegia type 56 (spg56) was diagnosed by cyp2u1 pathogenic mutation; 3. patients are willing to participate in clinical trials and able to understand and comply with the research program. exclusion criteria: 1. patients are allergic to the drugs involved in the study; 2. other neurological diseases likely affecting the evaluation of study treatment; 3. other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year; 4. pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial; 5. participating in another study drug trial and used the investigational drug in the past 30 days; 6. subjects have poor compliance or other factors that are not suitable for participating in the clinical trial.
evaluation of a training course for educational professionals

Conditions: Depression; Depression in Children; Depression in Adolescence

Summary: the aim of this study is to evaluate the efficacy of a two-hour online training course on depression and mental health in childhood and adolescence in educational professionals to improve depression and mental health literacy. it will further be investigated whether the course leads to changes in attitudes towards the illness (reduction of stigma) and to an increased behavioural confidence and behavioral change in dealing with pupils with symptoms and illnesses.

depressive disorders are among the most common psychiatric disorders in childhood and adolescence and yet often are unnoticed and not treated for a long time. depressive disorders often begin in adolescence and young adulthood. school stress, caused by bullying experiences at school or high performance expectations from parents and teachers, has been identified as an important factor in the development of depressive disorders in students school, as a central area of life for children and young people, is an important place for promoting pupils' mental health. the rising prevalence of depressive disorders among adolescence in recent years and the delayed start of interventions show a clear need for action in the everyday lives of adolescents. a training for educational professionals in schools on depression in youths is intended to reduce the large treatment gap. by educating about depression, reducing stigma and fostering confidence in dealing with pupils with depression, educational professionals at schools should be sensitised to youth depression so that they can better respond to pupils with mental health problems. as part of the planned scientific study, a training course on depression and mental health in childhood and adolescence for educational professionals is to be evaluated. the study will investigate the extent to which a two-hour online training course on depression and mental health in childhood and adolescence (including symptoms, causes of depression, comorbid diseases, prevention) and practical tips for everyday school life leads to an increase in knowledge regarding these topics. additionally, the study will investigate the impact of the training on changes in attitudes towards depression (reduction of stigma), increased behavioural confidence dealing with pupils with mental health problems and changes in behavior deadling pupils with mental health problems. moreover, the influence of teachers' emotions (assessed via the teachers emotion scales) and self-efficacy on the outcomes will be exploratively investigated. to this end, the educational professionals will take part in 3 online surveys (before the training, shortly after the training and 4 weeks after the training) via limesurvey.

Eligibility criteria:
inclusion criteria: * current teaching profession (teacher) / working in the school environment (e.g. school psychologist, social worker) exclusion criteria: -

Keywords: knowledge mental health depression literacy training course educational professionals school intervention evaluation
influence of oatp1b1 and brcp genotype on rosuvastatin pk, pd and lipidomics in hyperlipidemic patients

Conditions: Hypercholesterolemia

Summary: the aim of this study is to investigate the pharmacokinetics, lipid lowering effect and lipidomic profiles of 8-weeks rosuvastatin treatment by oatp1b1 genotype in hyperlipidemia patients.

within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. study drugs will be administered at about 9 a.m. in the morning of the first drug administration day, after blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomic and genetic analyses. subjects should take the investigational product by themselves every morning for 8 weeks. on the days of 2nd, 4th, 6 and 8th week, blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomics will be conducted by visiting the clinical trials center. on the days of 2nd, 4th and 6th week, the study drug will be taken after blood and urine collection.

Eligibility criteria:
inclusion criteria: * adults aged 35 to 55 years at the time of screening * serum ldl cholesterol (ldl-c) level ≤130 mg/dl * must be reliable and willing to make themselves available during the study period * must be willing to give blood sample for genotyping exclusion criteria: * a subject with present clinical manifestation or past medical history of hepatic, renal, respiratory, neurologic, hematologic, oncologic, psychiatric, cardiovascular or endocrine disease, except hyperlipidemia and mild hypertension (sbp \< 160 mmg, dbp \<100 mmhg). * administration of lipid lowering agent within 2 weeks before the first study drug administration. * a subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which could influence the absorption of the study drug. * a subject with a history of drug abuse, or a positive urine drug screening test * a subject who takes or should take any medication that can influence lipid lowering effects or metabolic profiles of the study drug during the study period. (investigators judge the wash-out period of the previously used medication before the administration of the study drug.) * a subject who has participated in any other clinical trial within 3 months before the study drug administration. * a subject who is judged to be ineligible to participate in the study due to abnormal clinical laboratory results or other reasons by investigators.

Keywords: oatp1b1 rosuvastatin lipidomics pharmacodynamics
a study of ly3437943 in japanese participants with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to learn about the side effects of ly3437943 when given to japanese participants with type 2 diabetes mellitus. blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. each enrolled participant will receive injections of ly3437943 or placebo given just under the skin. for each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) diagnosed for at least 1 year. * have glycated hemoglobin (hba1c) value ≥ 7.0% and ≤10.0% for participants treated with diet and exercise or hba1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at lead-in and screening * have a body mass index (bmi) within the range 23 to 35 kilograms per square meter (kg/m²), inclusive, and a body weight of at least 54 kilograms (kg). * males and females not of childbearing potential exclusion criteria: * have type 1 diabetes mellitus (t1dm) * have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization * have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligram per deciliter (mg/dl). * have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[alt\] and aspartate aminotransferase \[ast\]) greater than 3× upper limit of normal (uln).
second primary cancers in patients with castration resistant prostate cancer

Conditions: Prostatic Neoplasms

Summary: this study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mpc) and metastasized castrate-resistant prostate cancer (mcrpc) patients not treated with radium-223-dichloride.

this study aims at estimating the incidence of second primary malignancies as well as the overall survival among mpc and mcrpc patients not treated with radium-223-dichloride. the source of data for this study will be the german pharmacoepidemiological research database (gepard). a retrospective cohort study covering the time period from 2004 to 2013 will be conducted. the study population will comprise crpc patients developing bone metastases. these patients will be followed up for the occurrence of second primary malignancies, end of study, or death due to any cause. as this study serves as a historical control group for a single-arm observational study, incidence rates of second primary malignancies obtained from these studies will be compared by the standardized incidence ratio using results from this study as a reference.

Eligibility criteria:
inclusion criteria: * members of the mpc cohort will have to fulfill all of the following criteria: * valid information on sex, age and the region of residence * a period of at least 12 months of continuous insurance preceding cohort entry * diagnosis of pc (icd-10 code c61) in the study period (01-jan-2004 to 31-dec-2011) * diagnosis of bone metastases (icd-10 code c79.5) in the enrolment period (01-jan-2005 to 31-dec-2011) * in addition to the criteria of the mpc cohort, members of the mcrpc will additionally have to fulfill: * one of the following in the enrolment period and before or at the same time with bone metastases * discontinuation of the initial chemical castration, change of the agent or modality of the androgen deprivation therapy (adt), or start of treatment for advanced prostate cancer (pc) after the primary adt. * surgical castration and initiation of adt treatment * treatment with medication specific to mcrpc. exclusion criteria: * patients will be excluded from the mpc and from the mcrpc populations if they meet one of the following criteria: * first pc diagnosis later than 2 months after the diagnosis of bone metastases, or * use of any radiopharmaceuticals for bone metastases (e.g., samarium, strontium, rhenium, radium)
effects of training intensity on the chd risk factors in postmenopausal women

Conditions: Cardiovascular Diseases; Coronary Disease

Summary: the purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (cvd) to a different extent. heart attacks and stroke are the leading cause of death in older women. reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing cvd as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of ldl-cholesterol (\>160mg/dl). we will be measuring all of these risk factors and any changes in your body fat level before you start training and after 15 and 30 weeks of training in the form of walking. at the present time the effects of exercise intensity on these factors are not well understood. this study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing cvd.


Eligibility criteria:
inclusion criteria: * postmenopausal and preferably on hormone replacement therapy * in good general health * have a body mass index (bmi, weight in kg/height in m2) of between 25 and 40 * exercise less than 20 min/day two days a week

Keywords: exercise