Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and pharmacokinetics of oral nx-13 in active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and pk of nx-13. approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 nx-13 treatment regimens (nx-13 250 mg ir, 500 mg ir, 500 mg mr) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

following screening period (up to 28 days in length), a total of 40 subjects are planned to be enrolled into this study from multiple sites in the united states, australia, new zealand, and moldova. eligible subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 nx-13 treatment regimens (nx-13 250 mg ir, 500 mg ir, 500 mg mr) or placebo via a computer-generated interactive web response system (iwrs). each of the nx-13 treatment groups will comprise 12 subjects and 4 subjects will be randomized to receive placebo. the study will include a maximum of 25% of subjects who have had prior exposure to biologic therapy for uc. dosing will extend over a 28-day period at each dose level. subjects will receive the first dose of study drug in clinic on day 1 (visit 2) and day 28 (visit 4/eot) but will self-administer ip at home once daily for the remaining dosing days. the study duration will be approximately 63 days: screening period (28 days) + treatment period (28 days) + safety follow-up (7 days after last dose). there will be a follow-up visit on day 35 (visit 5).

Eligibility criteria:
key inclusion criteria: * male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of uc ≥ 90 days before screening; * active uc defined as a total mayo score of 4 to 10 (inclusive), at baseline, with a mayo endoscopic subscore (mes) ≥ 2 confirmed by a central reader; * baseline fecal calprotectin ≥ 250 μg/g; * biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study; * 5-aminosalicylates must be stable for ≥ 1 month prior to randomization. key exclusion criteria: * crohn's disease (cd), indeterminate colitis, or presence or history of fistula with cd; * a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; * history of or at imminent risk of colectomy; * history of or current colonic dysplasia ; * recent history (within 2 years prior to randomization) or current adenomatous colonic polyps; * treatment with an immunosuppressant within 3 months of randomization; * bacterial or parasitic pathogenic enteric infection; * live virus vaccination within 1 month prior to screening.
observational safety study of adjuvanted swine origin a (h1n1) pandemic subunit egg derived vaccine

Conditions: Pandemic Influenza A (H1N1); A New Flu Virus of Swine Origin

Summary: this is an observational safety study of a prophylactic use of flu egg derived adjuvanted swine origin a(h1n1) vaccine in subjects 6 months of age and older. subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.


Eligibility criteria:
inclusion criteria: * subject's age in accordance with the approved product label of the country where the study is conducted * subjects will be vaccinated with focetria®, independently of this study. * subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact exclusion criteria: • received any prior h1n1 vaccination

Keywords: pandemic influenza a (h1n1) vaccine adjuvanted
targeting cd5 car-t cells in the treatment of r/r cd5+ t-lymphoma

Conditions: T-lymphoblastic Lymphoma

Summary: a clinical study on the safety and effectiveness of targeting cd5 car-t cells in the treatment of r/r cd5+ t-lymphoma

in this study, 30 patients with relapsed refractory t-lymphoma were proposed to undergo cd5 car-t cells therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of cd5 car-t cells therapy for relapsed refractory t-lymphoma; at the same time, on the basis of expanding the sample size, more safety data on cd5 car-t cells treatment for relapsed refractory t-lymphoma were accumulated.

Eligibility criteria:
inclusion criteria: * 1. according to the 2016 who classification of lymphocyte tumors, histologically confirmed cd5-positive t-cell non-hodgkin lymphoma (t-nhl), r/r t-nhl(meets one of the following conditions) : 1. subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments; 2. primary drug resistance; 3. relapse after autologous hematopoietic stem cell transplantation; * 2.cd5 expression rate was \>90%; * 3. according to lugano 2014, there should be at least one evaluable tumor lesion; * 4. total bilirubin ≤51 (mol/l), alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/l); * 5. echocardiography showed left ventricular ejection fraction (lvef) ≥50%; * 6. refers to the pulse oxygen saturation 92% or higher oxygen (state); * 7. estimated life expectancy of minimum of 12 weeks; * 8. ecog 0-2; * 9. pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 10. those who voluntarily participated in this trial and provided informed consent; exclusion criteria: * 1. history of epilepsy or other central nervous system disorders; * 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; * 3. active infection of hepatitis b virus, c virus or hepatitis e virus; * 4. active infected persons who are not cured; * 5. before using any gene therapy products; * 6. received anti-tumor therapy before infusion, should meet the following any one should be ruled out: 1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug); 2. received within 72 hours of small molecule targeted therapy; 3. 2 weeks received systemic chemotherapy except (pretreatment); 4. four weeks received radiotherapy; * 7. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 8. any unsuitable to participate in this trial judged by the investigator; * 9. any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Keywords: cd5 car-t
the effects of a nursing trauma care bundle

Conditions: Patient Portals

Summary: to examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. a longitudinal and two group experimental design will be used. outcome measures for the trauma care bundles will use the barthel's index, the posttraumatic diagnostic scale, and the world health organization quality of life questionnaire. the results may influence health policy and clinical practice, and a wide range of injured patient outcomes.

background: over 50% of injuries are accompanied by musculoskeletal injuries that are life-threatening, require amputation or lead to major extremity dysfunctions. some barriers exist to deliver evidence-based care in the trauma group. based on recent research findings, this project will be an evidence-based project and evaluation of care bundles combined with e health care to establish and refine evidence-based care guidelines for patients with extremity injuries in taiwan. aims: to examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. methods: a longitudinal and two group experimental design will be used. the trauma care bundles combined with internet platform will be implemented over 24-hour admission and ended in 10-14 days after hospital discharge. participants will be patients with extremity injuries that meet the criteria. the experimental group and the control group will be given the same routine care except for the trauma care bundles. both groups will be followed up at 3 and 6 months after hospital discharge. fifty-eight participants for each group will be expected. the generalized estimating equations will be used to analyze the data. outcome measures for the trauma care bundles will use the barthel's index, the posttraumatic diagnostic scale, and the world health organization quality of life questionnaire. expected outcomes: this is an innovation project as it combines a comprehensive trauma care bundles with internet platform, and applied in the biggest injury population in taiwan. it may be the pioneer study to integrate care bundle and e-health care in trauma care. the results may influence health policy and clinical practice, and a wide range of injured patient outcomes. the internet platform established by the research team may be an important template for domestic e-health in hospital-based settings and long-term care facilities.

Eligibility criteria:
inclusion criteria: * iss (injury severe score)\>9 * agree to participate in this examination for 6 months after discharge * accidental extremity injuries * have a smart phone and access to the internet exclusion criteria: * discharged within 24 hours * cognitive dysfunction and unable to provide formal consent * severe brain damage * burned patient * severe psychosis

Keywords: trauma care bundles internet platform patients with extremity injuries experimental design
chitosan versus glucosamine phonophoresis in the management of knee osteoarthritis

Conditions: Knee Osteoarthritis; Knee Arthritis

Summary: the study will be conducted to answer the following questions: * is there an effect of phonophoresis using glucosamine on pain level , function and range of motion in knee osteoarthritis patients ? * is there an effect of phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ? * is there a difference between the effect of phonophoresis using glucosamine and phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ?


Eligibility criteria:
inclusion criteria: * unilateral or bilateral grade ii knee osteoarthritis (clinical and imaging diagnosis x-ray). * knee pain intensity ≥ 5 on the visual analogue scale (vas) exclusion criteria: * anterior cruciate ligament (acl) and meniscus injury * use of oral or injected corticosteroids in the last 3 months * history of knee surgery or fracture * acute infectious synovitis or arthritis conditions * presence of malignancy * individuals with, topical lesions, contact dermatitis and history of cutaneous hypersensitivity
cross-cultural adaptation, reliability and validity of the turkish version of the japanese orthopaedic association hip disease evaluation questionnaire

Conditions: Hip Disease; Hip Pain Chronic

Summary: the purpose of this study was to investigate adaptation, validity, and reliability of the turkish version of the japanese orthopaedic association hip disease evaluation questionnaire (joahdeq).

there are a number of medical assessment tools for various diseases, but in most cases such tools are designed to reflect the perspective of healthcare providers, not perspective of patients. in addition to clinical results, it is necessary to evaluate the quality of life of patients when measuring the effect of medical treatments. thus, evaluation criteria which can be useful as patient-reported outcome indices, have received increasing attention in recent years. health-related quality of life provides a patient-reported assessment. japanese orthopaedic association hip disease evaluation questionnaire (joahdeq) evaluates quality of life related to hip disorders. it is also a guide in determining the expectations of individuals in the treatment process. it consists of 3 subscales (pain, movement and mental) and 20 items. hip condition and pain are evaluated with a 100 mm scale. 20 items are scaled likert with values between 0 and 4. "0" means "strongly agree", "1" means "agree", "2" means "uncertain", "3" means "disagree" and "4" means "strongly disagree". the study is planned with 105 individuals with hip disease. after questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in joahdeq, oxford hip score, international hip outcome tool-12, short form-36, and visual analog scale test-retest will be re-applied to those of the same individuals who can be reached after 1 week. the results will be analyzed using the spss version 22.0 computer package program.

Eligibility criteria:
inclusion criteria: * any diagnosed hip disease, * chronic hip pain, * history of pain when lying or during weight-bearing activities, aggravated by activity for more than 3 months. exclusion criteria: * lumbar spine nerve root findings, * history of lumbar spine or hip surgery, * corticosteroid injection to hip in the past 3 months.

Keywords: hip disease reliability validity cross-cultural adaptation
treatment of alcohol withdrawal syndrome with alpha-2 agonists and/or anticonvulsants

Conditions: Alcohol Withdrawal Syndrome

Summary: complicated alcohol withdrawal syndrome (aws) increases morbidity and mortality of hospitalized, medically ill patients. the psychosomatic medicine service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. during the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. the bzdp-sparing protocol consists of a combination of alpha-2 agonist and/or anticonvulsant agents; all currently being used for the management of other medical conditions. this project intends to collect and analyze the data of all subjects managed with this approach to better understand its effectiveness and assess for potential adverse effects.

complicated alcohol withdrawal syndrome (c-aws) increases morbidity and mortality of hospitalized, medically ill patients. the psychosomatic medicine service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. during the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. the bzdp-sparing protocol consists of a combination of alpha-2 agonist (e.g., clonidine, guanfacine, dexmedetomidine) and/or anticonvulsant agents (e.g., gabapentin, valproic acid, carbamazepine); all currently being used for the management of other medical conditions. the proposed study consists of an exhaustive chart review of these records to better understand the safety and effectiveness of alpha-2 agonists and anticonvulsants in the prophylaxis and treatment of aws. specifically the investigators want to understand the time to resolution of aws symptoms, whether there are any limiting side effects to this regimen, and the need of for rescue with benzodiazepine agents. the information obtained from this study will be very helpful in assisting in the design of safer and more effective treatment of aws.

Eligibility criteria:
inclusion criteria: * all the cases referred to the psychosomatic medicine service for assistance with prophylactic or symptomatic management of aws starting 8/1/2011 until 8/31/2014. exclusion criteria: * patients who through chart review were found to have been primarily suffering from delirium from causes other than aws.

Keywords: alcohol withdrawal withdrawal seizures dt delirium tremens rum fits the shakes
longterm efficiency and safety of intravitreal injections with bevacizumab in patients with neovascularisation or macular edema

Conditions: Retinal Neovascularization; Macular Edema

Summary: although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions. therefore the investigators evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available. this will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years of either gender 2. written informed consent must be obtained before any intravitreal injection of bevacizumab is performed 3. visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. the presence of fluid (intraretinal, subretinal or sub-rpe) detected clinically or on the ocular coherence tomography. if both eyes are eligible for the study, both eyes can be included in the study. exclusion criteria: 1. women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (\> 5miu/ml) 2. women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication 3. tromboembolic event (cva or transient ischemic attack, ami) less than 3 months prior to the intravitreal injection of bevacizumab 4. history of hypersensitivity for bevacizumab.

Keywords: bevacizumab
efficacy, safety and tolerability of the combination of tropifexor & licogliflozin and each monotherapy, compared with placebo in adult patients with nash and liver fibrosis.

Conditions: Non Alcoholic Steatohepatitis (NASH)

Summary: randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (nash) and liver fibrosis.

the study consisted of 1) a screening period, 2) a treatment period starting from randomization on day 0 and running to week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. the study duration from first dose of study medication was 52 weeks.

Eligibility criteria:
inclusion criteria: presence of nash with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following: 1. nash using nafld activity score (nas) ≥ 4 with at least 1 point each in inflammation and ballooning and 2. fibrosis stage 2 or 3 using nash crn fibrosis criteria exclusion criteria: * type 1 diabetes mellitus * uncontrolled type 2 diabetes defined as glycated hemoglobin (hba1c) ≥ 9.0% at screening * hba1c \< 6.5% at screening in type 2 diabetics currently treated with insulin or sulfonylureas * clinical evidence of liver impairment as defined by the presence of any of the following abnormalities: * platelet count \< lln (see central laboratory manual). * serum albumin \< lln (see central laboratory manual). * international normalized ratio (inr) \> uln (see central laboratory manual). * alt or ast \> 5× uln (confirmed by 2 values during screening). * total bilirubin \> uln (see central laboratory manual) (confirmed by 2 values during screening), including gilbert's syndrome. * alkaline phosphatase \> 300 iu/l (confirmed by 2 values during screening). * history of esophageal varices, ascites or hepatic encephalopathy * splenomegaly * meld score \>12

Keywords: nash non alcoholic steatohepatitis tropifexor ljn452 licogliflozin lik066 placebo
computer-assisted tailored cue-card health [catch] study

Conditions: Human Immunodeficiency Virus; STDs; Hepatitis, Viral, Human

Summary: this study will draw from proven interventions to refine and pilot test a cue card driven computer-assisted intervention, along with hiv/sti testing, that will be tailored to each participant's demographic characteristics, risk behaviors, and biological test results. the specific aims of the proposed study are: 1. to refine a cue card driven computer-assisted risk reduction intervention that will be tailored to each participant's demographic characteristics (e.g., gender, ethnicity), risk behaviors, and biological test results (hiv, hepatitis b and c, syphilis and herpes). 2. to pilot test the tailored intervention's effects on sexual risk behaviors (e.g., frequency of unprotected sex, condom use), drug use during sex and injection risk behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group randomized design that compares the tailored intervention with a delayed treatment control condition. 3. to assess the feasibility and acceptability of the tailored intervention in a rural setting.


Eligibility criteria:
inclusion criteria: the sample of 120 will be drawn from the raleigh-durham, nc metro area with the following targets: * 40 msm (at least 12 african american, 12 non-hispanic white and 12 hispanic) - eligibility includes unprotected sex with another male in the past 30 days * 40 sex workers (at least 6 male and 6 female of each race/ethnicity) - eligibility includes unprotected sex within the last 30 days and exchange of sex for money or drugs within the past 30 days * 40 drug users who are not sex workers or msm (at least 2 males and 2 females of each race/ethnicity) - eligibility includes use of methamphetamine, crack or powder cocaine, or heroin in the past 30 days and unprotected intercourse and/or syringe sharing in the past 30 days. additional eligibility criteria include the following: * be 18 years of age or older * self-identify as male or female * self-identify as african american, non-hispanic white or hispanic * not currently be in or seeking substance use treatment * speak and understand written english proficiently * be a resident of wake, durham, orange, johnston or chatham counties, with no plans to move in the next 3 months
effectiveness of a psychoeducation program in patients with severe mental disorder

Conditions: Mental Health Disorder; Healthy Lifestyle

Summary: patients with severe mental disorder (smd) show a life expectancy of 13 to 30 years lower than the general population. among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. the objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.

it will be selected sixty patients diagnosed with smd from a community mental health unit from spain. it will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. the patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.

Eligibility criteria:
inclusion criteria: * over 40 years old, * a body mass index higher than 30 * psychopathologically stabilized exclusion criteria: * cognitive impairment

Keywords: cardiovascular risk metabolic syndrome independency psychopathology
predictive biomarkers for igf1r targeted therapy in ovarian cancer: a retrospective study

Conditions: Ovarian Cancer

Summary: the main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (igf1r) targeted therapy in epithelial ovarian cancer. it is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.


Eligibility criteria:
inclusion criteria: * women who underwent surgery for ovarian cancer exclusion criteria: * none