Kornimate/medical-research-clean huggingface dataset:
effects of a high viscosity dietary fibre, as part of a medically supervised weight management program

Conditions: Obesity

Summary: the aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. all subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.


Eligibility criteria:
inclusion criteria: * bmi 27 - 30 kg/m2 with 1 weight-related comorbidity and/or bmi 30 - 50 kg/m2 * ability to provide written informed consent in accordance with good clinical practice (gcp) and local legislation in english exclusion criteria: * medications and supplements that affect body weight and appetite * type 2 diabetes on insulin treatment * contraindications to low calorie diet * any allergies to study product ingredients * any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
preemptive analgesia for postlaminectomy

Conditions: Laminectomy

Summary: to relieve post laminectomy pain, we have tried intraoperative perineural injection of lidocaine right after the exposure in expecting that this would be preemptive analgesia by blocking the nerve transmission so that postoperative pain starts later and lighter.

a randomized double-blind 40 patients aged 18-50 of asa i and ii undergoing laminectomy were included in the study. all the patients were followed for their heart rate, arterial pressure , respiratory rate, oxygen saturation, end tidal co2 and postoperative vas scores. all the patients were premedicated with midazolam 0.1 mg/kg intramuscularly 40 minutes prior to surgery. the induction was made 2 mg/kg propofol, 1 ug/kg remifentanyl, 0.5mg/kg rocuronium. after the orotracheal intubation anesthesia was maintained with isoflurane (%0.5-2.0) and 0.1 mg/kg rocuronium.just before the exposure of dorsal root, 0.5 cc %2 lidocaine was injected on the dorsal root.the patients postoperative analgesic period, vas scores and additional analgesic need was recorded. for the postoperative analgesia tramadol 1 mg/kg tramadol was used.

Eligibility criteria:
inclusion criteria: * laminectomy * 18-50 age * asa 1-2 * both sex exclusion criteria: * under 18 or older than 50 * any disease other than back pain\\ * asa 3-4

Keywords: analgesia, postlaminectomy , lidocaine, dorsal root
microbiological assessment after chemo-mechanical caries removal using papain-based enzyme versus conventional rotary tools in occlusal carious lesions

Conditions: Microbial Colonization

Summary: this study will be conducted to assess the efficacy of caries excavation using the papain-based chemo-mechanical method (brix 3000) in comparison to conventional rotary tools in the reduction of the bacterial population in occlusal carious cavities

twenty-three patients who will fulfill the inclusion criteria will be enrolled to the study. for every patient two contra-lateral class i carious molars will be selected, so the total number of included molars will be 46 molars. one contra-lateral molar will be randomly assigned to the chemo-mechanical (brix 3000) caries removal technique and the other will be assigned to the conventional rotary one. from every molar two dentin specimens will be collected (baseline and after excavation) with a total of 92 samples

Eligibility criteria:
inclusion criteria: 1. class i carious lesions 2. lower molars 3. bilateral lesions 4. 18 -50 years 5. males or females (both genders) 6. good oral hygiene 7. co-operative patients approving the trial exclusion criteria: 1. pregnancy 2. systemic disease or severe medical complications 3. periodontal problem 4. mobile teeth, arrest caries and non-vital teeth 5. smokers 6. xerostomia 7. lack of compliance 8. not received antibiotic therapy since 1 month before sampling
assessment of primary prevention patients receiving an icd - systematic evaluation of atp

Conditions: Sudden Cardiac Death

Summary: the primary objective is to understand the role of antitachycardia pacing (atp) in primary prevention patients indicated for implantable cardioverter-defibrillator (icd) therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. the time to first all-cause shock will be tested in subjects with standard therapy (atp and shocks) compared to subjects programmed to shock only to assess equivalency.


Eligibility criteria:
inclusion criteria: * subject with a boston scientific transvenous icd (de novo implant or upgrade from pacemaker to icd) implanted because of one of the following: * prior myocardial infarction (mi) and left ventricular ejection fraction (lvef) ≤ 30% or * ischemic or non-ischemic cardiomyopathy, and lvef ≤ 35%, and a new york heart association (nyha) class ii or iii * subject is age 21 or above, or is considered of legal age per given geography * subject is willing and capable of providing informed consent * subject is willing and capable of complying with follow-up visits as defined by this protocol exclusion criteria: * history of spontaneous sustained ventricular tachycardia (vt) (≥ 160 bpm at ≥ 30 seconds in duration) or ventricular fibrillation (vf) not due to a reversible cause * nyha class iv documented in the medical records within 90 calendar days prior to enrollment * subject is eligible and scheduled for cardiac resynchronization (crt) implant * subjects with a previous subcutaneous icd (s-icd) * subject with existing transvenous icd (tv-icd) device implanted for greater than 60 days * subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment * subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment * subjects on the active heart transplant list * subject who has a ventricular assist device (vad) or is to receive a vad * life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...) * subjects currently requiring hemodialysis * subject who is known to pregnant or plans to become pregnant over the course of the trial * subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from boston scientific

Keywords: antitachycardia pacing therapy shock therapy primary prevention
postmarketing surveillance study with mobec®

Conditions: Osteoarthritis

Summary: the aim of the study is to investigate * the indication for mobec in a dose of 15 mg per day * the treatments patients were receiving before switching to 15 mg mobec * how treatment with 15 mg is assessed compared with previous treatment * how effective and safe treatment with 15 mg mobec is considered


Eligibility criteria:
inclusion criteria: * an indication for a treatment with 15 mg mobec of at least four weeks * the symptomatic short-term treatment of osteoarthritis * the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg) * the symptomatic treatment of ankylosing spondylitis exclusion criteria: * treatment with mobec prior to the start of the study * patients with any of the general or specific contraindications of mobec
paclitaxel-hdfl for locally advanced and recurrent/metastatic gastric cancers

Conditions: Locally Advanced and Recurrent/Metastatic Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy,response rate,time to treatment failure,overall survival,toxicities of paclitaxel-hdfl regimen in locally advanced/inoperable and recurrent/metastatic gastric cancers. to evaluate the resectability and relapse pattern after potentially curative resection of neoadjuvant paclitaxel-hdfl regimen

in the treatment of metastatic breast cancer, paclitaxel followed by weekly hdfl has been shown to have a 55% response rate in anthracycline-resistant patient. recently, regimen combining paclitaxel and moderately-high-dose 5-fu (1500mg/m2) has had response rate up to 61.5% (including 23%cr) in a small group of gastric cancer patients (8 responders in 13 patients). thus, the sequential use of weekly paclitaxel followed by weekly hdfl regimen may become a new generation of chemotherapeutic regimen for the treatment of gastric cancer. further study with a larger group of patients and further testing of possible schedules of administration are warranted.

Eligibility criteria:
inclusion criteria: 1.histologically or cytologically confirmed gastric adenocarcinoma 2.measurable or evaluable disease 3.no previous c/t 4.age 18 \~ 70 years 5.kps \>=60% 6.wbc\>=4,000, pltate\>=100k, creatinine\<=1.5mg/dl, serum bil\<=1x unl, transaminase\<=3.5x uln exclusion criteria: 1.cns metastasis 2.patients receive concomitant anti-cancer c/t or r/t 3.patients who are pregnant and with an expected life expectancy less than 3months 4.symptomatic heart disease,active infection, extensive liver disease or liver cirrhosis 5.tg\<=70mg/dl 6.mental status is not fit for clinical trial -

Keywords: paclitaxel-hdfl,locally advanced and recurrent/metastatic gastric cancer
remote alcohol monitoring to facilitate abstinence from alcohol: exp 1

Conditions: Alcohol Use Disorder

Summary: directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. the goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. this treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual (dsm)-5 criteria for alcohol use disorder * average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the timeline follow-back. * must endorse alcohol as their primary drug of use. * express a desire to abstain from drinking. exclusion criteria: * are currently enrolled in an alcohol treatment program (not including attendance at alcoholics anonymous or similar community support meetings). * score 23 or greater on the alcohol withdrawal symptom checklist, a score indicating that medication would be likely required to manage alcohol detoxification. * pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.
prevention of s. aureus pneumonia study in mechanically ventilated subjects who are heavily colonized with s. aureus.

Conditions: Pneumonia, Ventilator-associated; Pneumonia, Staphylococcal

Summary: the purpose of this study is the prevention of staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with s. aureus. staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. hospital-acquired bacterial pneumonia (habp) caused by s. aureus, including ventilator-associated bacterial pneumonia (vabp) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. asn100 is an investigational monoclonal antibody product that targets the toxins produced by s. aureus to protect subjects from developing s. aureus pneumonia.

this is a double-blind, randomized, single-dose, placebo-controlled study of asn100 for the prevention of s. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with s. aureus. this will be a global study conducted at approximately 65 sites to assess the safety, tolerability, and efficacy of asn100. eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria will be screened by semi-quantitative culture of an endotracheal aspirate (eta) to identify those who are heavily colonized with s. aureus (3+ to 4+). upon determination of eligibility, subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups, asn100 or placebo.

Eligibility criteria:
inclusion criteria: - subject is currently hospitalized and is mechanically ventilated endotracheally (i.e., orotracheal or nasotracheal) and, in the investigator's opinion, will require ongoing ventilator support for at least 48 hours; exclusion criteria: * subject has a chest x-ray or thoracic computed tomography (ct) scan that is definitive for a diagnosis of pneumonia * subject has a known and documented eta culture showing heavy colonization with a -gram-negative organism at enrollment or at any time during the screening period; * significant neutropenia * severe non-pulmonary source of infection. * subjects with a known history or current (suspected) diagnosis of cytokine release syndrome associated with the administration of peptides, proteins, and/or antibodies.

Keywords: pneumonia s. aureus mechanically ventilated
clinical evaluation of gw815sf for chronic obstructive pulmonary disease (chronic bronchitis, emphysema)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study compares the effect of two medicines on copd (chronic obstructive pulmonary disease). this study will last up to 18 weeks, and subjects will visit the clinic 5 times. subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

clinical evaluation of gw815sf for chronic obstructive pulmonary disease (chronic bronchitis, emphysema) "assessment of the effect of addition of fluticasone dipropionate to salmeterol xinafoate 50µg after switching under double-blinded conditions to gw815sf 50/250µg in chronic obstructive pulmonary disease

Eligibility criteria:
inclusion criteria: * diagnosis of copd. exclusion criteria: * diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than copd. * other inclusion and exclusion criteria will be evaluated at the first study visit.

Keywords: copd chronic bronchitis emphysema
research to improve smoke alarm functioning and maintenance

Conditions: Wounds and Injuries; Burns

Summary: the purpose of this study to evaluate whether (1) targeted smoke alarm education, (2) general fire safety education with a smoke alarm component, (3) basic fire safety education, or (4) an unrelated intervention is most effective way to improve smoke alarm maintenance and function.


Eligibility criteria:
inclusion criteria: * live within four target neighborhoods in prince george's county, md that are at high risk for residential fire and injury. exclusion criteria: * primary decision maker of home is less than 18 years old * speak a language other than english or spanish * nobody at home after six return visits to the home
alemtuzumab/fludarabine for relapsed/refractory b-cell chronic lymphocytic leukemia (b-cll)

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: this is a multi-center, phase ii, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of b-cell chronic lymphocytic leukemia (b-cll) patients who have received at least one prior therapy. treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during cycle 4 to permit re-staging. alemtuzumab and fludarabine will be administered on days 1-5 of each cycle. patients will be assessed for response at the time of re-staging at cycle 4 and at the end of cycle 6. at the time of the re-staging, patients achieving a partial remission (pr) or stable disease (sd) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a complete remission (cr) will receive no further treatment but will be followed for response.

as of april, 2011 bayer transferred this record to genzyme. genzyme is now the sponsor of this trial. note: this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.

Eligibility criteria:
inclusion criteria: * patient must have confirmed b-cll. * patients must have received at least one prior therapy and must require treatment for active disease exclusion criteria: * treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study. * history of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy * history of human immunodeficiency virus (hiv) positivity. * active infection requiring treatment * pregnancy or lactation * other severe, concurrent diseases or mental disorders * central nervous system involvement of chronic lymphocytic leukemia (cll)
evaluation of the effect of the flowaid device in increasing local circulation in the leg

Conditions: Peripheral Vascular Disease

Summary: this is an open label pilot study to evaluate the efficacy and the safety of the flowaid device in increasing local circulation in the legs. 15 patients with a diagnosis of peripheral vascular disease will be enrolled in this study. they will recieve tratment with the flowaid device and monitored continuously by means of laser doppler flowmetry as well as by tcpo2 and digital thermography. subjective data will also be collected.

this is a 15 patient pilot study to evaluate efficacy and safety of use of the flowaid device in increasing local circulation in the legs of patients with peripheral vascular disease. patients will be evaluated and scored prior to treatment and then treated with the flowaid device for a period of two hours. during the treatment period patients will be continuously monitored by digital thermograph as well as by tcpo2 and laser doppler flowmetry. patients will also be monitored for a brief period immediately after cessation of treatment to evaluate continued effect of the device on local circulation in the leg. the study will be individually controlled with each patients treated leg evaluated against the contralateral non- treated leg. subjective data including distance able to walk, pain and vibratory sensation threshold will also be collected and evaluated appropriately.

Eligibility criteria:
inclusion criteria: * give appropriate written informed consent prior to participation in the study * have a current diagnosis of type i or type ii diabetes mellitus * have an ankle-arm index between 0.35 and 0.8 on the study limb * be in reasonable metabolic control, exhibited by hba1c values of less than12% as observed by serum test results obtained within 3 months prior to the screening visit * subject and caregiver must be accessible for, and willing to comply with, the safety procedures and available for the 12 week follow-up period exclusion criteria: * clinical evidence of gangrene on any part of affected foot * active charcot's foot on the study limb * scheduled to undergo vascular surgery, angioplasty, or thrombolysis within 30 days from the end of the study * malnourished as evidenced by a pre-albumin of \< 11 mg/dl * pregnancy or lactating * history of bleeding disorder * participation in another device study for the treatment of peripheral vascular disease 30 days prior to screening visit * vascular procedures performed 30 days prior to screening visit
virtual smas in lifestyle approach for type 2 diabetes

Conditions: Diabetes Type 2

Summary: this study protocol presents the design of a randomized pragmatic trial. this study aims to determine the effectiveness of virtual shared medical appointments (smas) lifestyle approach in improving glycaemic control, compared to usual care in type 2 diabetes (t2d) subjects.


Eligibility criteria:
inclusion criteria: * (1) be 18 years old or older * (2) have a diagnosis of t2d with hba1c ≥ 6.5% within the preceding 6 months * (3) have body mass index (bmi) ≥ 25.0 kg/m2 within the preceding 6 months * (4) have access to a camera and internet exclusion criteria: * unable to attend virtual smas for diagnosis of dementia or other cognitive impairment and any behavioral problem, which interferes with group participation and discussion * not fluent in portuguese, and unable to follow conversations, read instructions, and read in portuguese * being pregnant or planning a pregnancy in the next year * attending a weight loss and/or physical activity counseling program
a study of guselkumab in naive or bio-experienced participants with regional (facial and genital) psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis. effectiveness will be evaluated using the static physicians global assessment (spga) for the facial region and the spga for the genital region.


Eligibility criteria:
inclusion criteria: participants included in the study: * must have a first or confirmed diagnosis of psoriasis, requiring systemic treatment with significant involvement (defined as a static physician's global assessment \[spga\] score greater than or equal to \[\>=\] 3) involving the facial and/or genital regions * must have started treatment according to the approved indication as described in the current version of summary of product characteristics (smpc) of the product approved in italy. enrollment may occur at any time after the first injection of guselkumab but before completion of the next visit at week 4 or 12 as scheduled according to common clinical practice * must sign an informed consent form (icf) allowing data collection and source data verification in accordance with local requirements exclusion criteria: participants will be excluded from the study if they: * have any contraindication to the use of guselkumab, as stated in the current smpc of the product approved in italy * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of guselkumab treatment * are currently enrolled in another clinical trial or investigational study * are currently enrolled in an observational study sponsored or managed by a janssen company * participant unable to read, to write, to understand and sign the informed consent form (icf)

Keywords: facial genital
brief intervention in substance use in adolescent psychiatric patients

Conditions: Substance-Related Disorders

Summary: the objective of the study was to assess the efficacy in decreasing the likelihood of substance use of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment. 237 adolescents consecutively admitted to a psychiatry department completed an evaluation of their substance use. subjects identified as users were randomly allocated to one of two groups: an experimental group that received a brief intervention aimed at increasing their awareness of the risks of substance use, or a control group. all subjects received standard treatment according to the primary diagnosis. structured questionnaires assessing knowledge, attitudes, perception of risks and intention of use of psychoactive substances were administered upon admission and 1 month later.


Eligibility criteria:
inclusion criteria: * subjects aged 12-17 * consecutively referred for psychiatric or psychological assessment and treatment to a child and adolescent psychiatry and psychology department exclusion criteria: * not willing to take part. * mentally retarded * non completion of a substantial part of the assessment protocol. * presenting severe acute psychopathological disturbances that interfere with the assessment.

Keywords: adolescent substance use brief intervention child psychiatry