Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetic study of n6022 in subjects with cystic fibrosis homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to investigate the safety, tolerability and pharmacokinetics of n6022, and to obtain descriptive information on the effect of n6022 on biomarkers of cftr function and inflammation in adult cystic fibrosis subjects who are homozygous for the f508del-cftr mutation.

this is a double-blind, randomized, placebo-controlled, multicenter, sequential dose-escalation study which will occur in two parts. all selection criteria, assessments and procedures described in this protocol will be applied to both parts. up to 5 cohorts will be studied with a total of 67 patients at approximately 18 clinical sites in the united states.

Eligibility criteria:
inclusion criteria: * homozygous for f508del-cftr gene * sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis * body weight ≥ 40 kg * fev1 ≥ 40% predicted * oxygen saturation ≥ 90% breathing ambient air * hematology and clinical chemistry of blood and urine results with no clinically significant abnormalities that would interfere with the study assessments * negative pregnancy test for women of child bearing potential * sexually active subjects of child bearing potential willing to follow contraception requirements exclusion criteria: * previous enrollment in another cohort for this study. * any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment within 4 weeks of study day 1. * any change in chronic therapies for cf lung disease within 4 weeks of study day 1. * blood hemoglobin \<10 g/dl at screening. * serum albumin \<2.5 g/dl at screening. * abnormal liver function defined as ≥ 3 x upper limit of normal (uln) in three or more of the following: ast, alt, ggt, alp, total bilirubin at screening. * history of abnormal renal function (creatinine clearance \< 50 ml/min using cockcroft-gault equation) within a year at screening. * history, including the screening assessment, of ventricular tachycardia or other ventricular arrhythmias. * history, including the screening assessment, of prolonged qt and/or qtcf interval (\> 450 msec). * history of solid organ or hematological transplantation. * intranasal medication changes within 14 days prior to study day 1 * required use of continuous (24 hr/d) or nocturnal supplemental oxygen. * concomitant use of any inhibitors or inducers of cyp3a4.

Keywords: cystic fibrosis f508del-cftr n6022 s-nitrosoglutathione
diet/activity of mexican american and anglo children

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to perform a follow-up study of physical activity and dietary behaviors and their determinants in 10- to 11-year-old anglo and mexican-american children from low- and middle-socioeconomic status (ses) families who were studied initially when they were 4 to 7 years old.

background: it is well documented that the roots of cardiovascular diseases (cvd) are evident in childhood, and elevated levels of serum lipids, blood pressure and body fat are common in childhood. these risk factors are, in turn, related to childhood dietary and physical activity habits. to understand the early development of cvd, it is therefore important to study factors that influence diet and physical activity behaviors in children. most studies concerned with the determinants of diet and physical activity in children are cross-sectional, limiting their utility for improving understanding of the development of these key health behaviors. the study allowed prospective analyses of the behaviors over a significant portion of the prepubertal age range. knowledge of the determinants, stability, and relationships of childhood dietary and physical activity behaviors to physiologic risk variables could be useful for setting priorities and designing public health interventions for the next generations of youth. the major contribution of this san diego scan study was in the longitudinal analysis of dietary and physical activity behaviors in children. the follow-up assessment of the 10-to 11-year-old cohort and their mothers produced data that substantially improved understanding of the determinants and tracking of children's dietary and physical activity behaviors, as well as their relations to cvd risk factors. design narrative: selection of subjects studied was based on social learning/cognitive theory, which states that behaviors are a function of personal and environmental factors. the specific aims of the study were as follows: 1) to study the determinants of physical activity and dietary intake of fat, sodium, and calories, and changes in these behaviors in children from ages 4 to 10-11. 2) to determine the relationships between diet and physical activity practices and physiologic indicators of risk, such as blood pressure, adiposity, body mass, and serum lipoproteins at ages 4 to 10-11. 3) to describe the time trends and the degree of tracking of physical activity habits and nutritional intake of fat, sodium, and calories in children from ages 4 to 10-11. the study was renewed in 1999. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
clinical characterization of an investigational frequent replacement daily wear silicone hydrogel sphere contact lens

Conditions: Refractive Errors

Summary: the primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.

participants will attend a screening visit, a dispense visit, and a week 1 follow-up/exit visit.

Eligibility criteria:
inclusion criteria: * understand and sign an informed consent that has been approved by an institutional review board. * successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * willing to stop wearing habitual contact lenses for the duration of study participation. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any condition that contraindicates contact lens wear, as determined by the investigator. * any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the investigator. * history of refractive surgery or plan to have refractive surgery during the study. * current or history of dry eye in either eye that, in the opinion of the investigator, would preclude contact lens wear. * wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: vision contact lenses
study in polish acromegalic patients treated with somatuline autogel

Conditions: Acromegaly

Summary: the purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in poland with somatuline autogel 120 mg including extended injection intervals.


Eligibility criteria:
inclusion criteria: * adult patients with acromegaly treated for at least three injections with somatuline autogel 120 mg * subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. one year historical data must be available exclusion criteria: * active participation in any interventional or any other non-interventional acromegaly clinical study. previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
hepmet-1: evaluate the feasibility, mental sideeffects and the efficacy of hepatitis c treatment in a mmt group.

Conditions: Opiate Dependence; Hepatitis

Summary: * to evaluate if weekly psychological follow-up make opioid dependent patients in mmt able to accomplish 14 weeks treatment with peginterferon alfa-2a (peg-inf) and ribavirin to the same extent than non-opioid dependents. * to determine the efficacy of this anti-hcv treatment

chronic infection with the hepatitis c virus (hcv) is a health problem worldwide. in norway, there are about 3000 patients participating in methadone maintenance treatment(mmt) programs. a prevalence study at the mmt treatment unit in kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis c. a major problem with anti-hcv treatment for this group is the lack of compliance and retention in treatment. further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-hcv treatment. drug addicted in mmt treatments programs may find themselves excluded from hepatitis c treatment. due to better treatment efficacy with the new peg-inf's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in mmt to be able to complete anti-hcv treatment. the aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. we therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.

Eligibility criteria:
inclusion criteria: * serologic evidence of hepatitis c infection, genotype 2 and 3 * normal or elevated serum alt activity * in mmt-programme and with at least 6 months with satisfactory drug abuse control. that means no iv injections and no or minimal use of drugs. * male and female patients exclusion criteria: * women with ongoing pregnancy or breast feeding * untreated serious psychiatric disorders, particularly depression. * serious drug abuse or alcohol abuse last 6 months * intravenous drug abuse last 6 months * hepatitis a, b or hiv infection * hcv genotype 1, 4, 5 and 6 * leucocytes \< 3000 cells/mm3 at screening (neutrophil count \<1500 cells/mm3) * platelet count \< 80 000 cells/mm3 at screening * hb \<11 g/dl in women or \<12 g/dl in men at screening * documented or presumed coronary artery disease or cerebrovascular disease * thyroid dysfunction not adequately controlled * epilepsy * malignant disease

Keywords: chronical hepatitis c treatment methadone maintenance treatment pegylated interferon and ribavirin 14 weeks treatment genotype 2 and 3
effect of music prehabilitation on preoperative anxiety before surgery

Conditions: Cancer of Colon; Surgery; Anxiety

Summary: the goal of this multicenter randomized controlled trial is to investigate the effect of music prehabilitation on preoperative anxiety in patients undergoing elective oncological colorectal resection. patients will be asked to listen to music three times a day starting one week before day of surgery. anxiety levels will be compared with the control group that is not explicitly instructed to listen to music by using validated questionnaires

perioperative music interventions have been proven to have a positive effect on surgical patients regarding postoperative pain, anxiety and stress. preoperative anxiety is a predictor for postoperative pain. it is hypothesized that preoperative anxiety develops at home. unfortunately, data on this subject is scarce. prehabilitation is a relatively new concept, which improves the patient's condition at home waiting for a surgical intervention. no studies exist in which music is implemented as a prehabilitation method. music interventions are relatively simple low cost, sustainable and know no side effects. the researchers hypothesize that the use of pre-admittance music interventions as a prehabilitation modality in oncological colorectal surgical patients will decrease preoperative anxiety.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 16 years * patients undergoing elective oncological colorectal surgery at participating center * minimal hospital stay of 2 days postoperatively. * sufficient knowledge of the dutch language * communicable and able to assess the questionnaires * patients who have access to personal music playing device and headphones/earphones. - written informed consent acquired from the patient exclusion criteria: * patients with severe hearing impairment (defined as no or barely verbal communication possible). * patients with an expected stay of less than two nights in the hospital * patients who are professional musicians. * active music players or singers who may play or sing every week * patients who actively listen to music with a duration of \> 30 minutes daily. active listening is defined as music listening with headphones/earphones, while this is not combined with any other activity (e.g. exercising, working, driving or religious activities). * patients who have a preoperative waiting period of less than five days. * participation in another study that may possibly intervene with the outcome measures. (e.g. use of psychiatric medication during inclusion or prehabilitation interventions or similar procedures according to the judgement of the research team) * assessment of primary outcome is not possible. * patients with mental disorders influencing their ability to adhere to the study protocol and/or assess the questionnaires. * inability or unwillingness to receive the music intervention.

Keywords: music colon cancer surgery anxiety perioperative care prehabilitation non pharmacological intervention
the influence of 3d surgical template on the contour of bone augmentation, in patient with labial alveolar ridge defect and simultaneous implantation

Conditions: Bone Deformity

Summary: evaluate the impact of using 3d surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation.

because adequate bone wrapping around the implant is critical for long-term effectiveness of dental implant treatment, bone augmentation in the bone defect area is required to repair the width and height of the alveolar bone, as bone resorption occurs following tooth extraction. many bone augmentation techniques, such as onlay block grafting, bone splitting, distraction osteogenesis, and guided bone regeneration, are currently accessible in clinics (gbr). surgical options vary depending on the severity of the bone deformity. gbr is a bone augmentation technique that has more evidence-based medicine support and therapeutic applications, as well as the benefits of less surgical stress and low technical sensitivity. establishing aesthetics and guaranteeing long-term success in implant therapy can be challenging. long-term stable implant success has been linked to the presence of more than 2mm labial graft thickness, and appropriate labial graft thickness is essential to preserve crestal bone level and prevent marginal soft tissue recession. according to a meta-analysis of 15 randomized-controlled trials, the estimated mean (sd) bone resorption for gbr in lateral ridge augmentation throughout the 6-month healing period was 1.22-0.28 mm. as a result, a 3.5 mm thickness of labial graft at all levels may be necessary following wound closure to compensate for potential graft loss. traditional bone augmentation is often dependent on the operator's skill, therefore virtually digital guided bone regeneration (gbr) process offers the digital options for precise and controllable bone augmentation in the field of oral implantology . specific aim: to compare the contour of bone augmentation (peri-implant bone volume) between various (gbr) procedures in patients with lateral alveolar ridge defect and simultaneous implantation. hypothesis: patients with lateral alveolar ridge defect and simultaneous implantation subjected to a 3d printing surgical template with gbr are associated with radiographic evidence of more labial graft thickness and volume stability after six months post-surgical than patients with conventional gbr protocol.

Eligibility criteria:
inclusion criteria: 1. healthy patients between the ages of 18 and 65 with edentulous ridge and seek for implant replacement. 2. in the anterior region, there is a labial bone defect. 3. patients need the surgery in the first place to compensate for bone loss around implant. exclusion criteria: 1. systemic disorders that are out of control. 2. heavy smokers (those who smoke more than 20 per day). 3. women who are pregnant or nursing. 4. thin gingival bio-type.

Keywords: 3d surgical template, guided bone regeneration , the contour of bone augmentation ,horizontal labial ridge defect and simultaneous implantation.
efficacy and safety of aripiprazole in first episode psychosis

Conditions: First Episode Psychosis

Summary: the aim of the study is to investigate the efficacy and safety of aripiprazole in patients with first episode psychosis.


Eligibility criteria:
inclusion criteria: * aged 18-59 years and meet dsm-iv diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder nos as assessed by using the structured clinical interview for dsm-iv, research version. exclusion criteria: * meeting dsm-iv criteria for another axis i diagnosis, including substance abuse or dependence * needing another nonantipsychotic psychotropic medication at enrollment * having a serious or unstable medical illness. * pregnant or lactating women or women without adequate contraception will be also excluded.
physical activity intervention in african american men after radical prostatectomy

Conditions: Prostatectomy; Prostate Cancer

Summary: the purpose of this pilot study is to evaluate the feasibility of recruiting african american prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. in addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on african american men's urinary and sexual functions. these data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the national institutes of health.


Eligibility criteria:
inclusion criteria: * speaks english * african american * radical prostatectomy for treatment of prostate cancer within the past 12 months * cleared by physician to safely participate in a physical exercise program exclusion criteria: * does not speak english * non-african american * previously undergone radiation treatment to the pelvis * previously undergone major pelvic surgery * known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter
virtual diabetes care for low socioeconomic status adults with type 2 diabetes on insulin therapy

Conditions: Type 2 Diabetes

Summary: this 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for low-socioeconomic status patients. it includes mychart messing to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. the study aims to enhance self-management behaviors through health technology.

guided by the self- and family management framework, which specifies facilitators and barriers to self- management behaviors, this project tests strategies for delivering virtual diabetes care to help low-socioeconomic status patients and clinicians use health information technology to support self-management behaviors. it is a 12-month pilot nurse-led, app-based behavioral intervention consisting of three evidence-based interventions: (1) education on a1c results and goal-setting via mychart, the epic electronic health record's patient portal; (2) a problem-solving action plan developed collaboratively by clinicians and patients; and (3) remote monitoring via mysugr, a top- rated diabetes app, to track blood glucose and identify the need for treatment adjustments.

Eligibility criteria:
inclusion criteria: * a1c\>8% within 12 months prior baseline * a1c\>8% at baseline * low-ses (defined as a medicaid recipient or dual medicaid and medicare recipient or self-reported low income based on national poverty guidelines) * age 18 or older * type 2 diabetes * on insulin therapy * owning and using android or ios smartphone for at least 6 months * english proficiency * adequate vision to read text messages on their current smartphone * smartphone use proficiency. smartphone proficiency will be self-reported and determined by telephone as the ability to use a smartphone in ways other than emailing, texting, and making phone calls. exclusion criteria: * pregnancy * patients with cognitive impairment who will be screened with the six-item screener to identify cognitive impairment among potential research subjects.

Keywords: diabetes app behavioral intervention self-management diabetes
effectiveness and efficiency of a voriconazole preemptive genotyping strategy

Conditions: Invasive Fungal Infections

Summary: this is a phase iv pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. the main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.

primary outcome is serum level of voriconazole on fifth day. secondary outcome is a combined variable of therapeutic failure and adverse events, associated with voriconazole. a total of 146 patients with risk of undergoing invasive aspergillosis who potentially will receive voriconazole will be recruited, and cyp2c19 will be genotyped. if the patient receives voriconazole finally, he will be randomized (1:1 experimental/control). in the experimental arm patients receive dose according to pharmacogenetic algorithm including cyp2c19 genotype and clinical and demographic information. in the control arm patients receive dose according to clinical practice guidelines. in addition, a spain national health system (nhs) point-of-view cost-effectiveness evaluation is going to be done. direct costs calculation of each arm will be done.

Eligibility criteria:
inclusion criteria: 1. patient at risk of developing invasive aspergillosis, that will potentially receive treatment or prophylaxis with voriconazole: a. pediatric population: children who are going to receive a transplant of hematopoietic precursors (hsct) and acute myeloid leukemias, as well as relapses of it. b. adult population: patients diagnosed with acute leukemia, and those patients with expected prolonged neutropenia, secondary to hematological process and / or after specific treatment (aplastic anemia and variants, myelodysplastic syndrome, solid organ or bone marrow transplant, etc.), and those whose responsible clinician consider individually that they could present a risk of developing a fungal infection. 2. those who agree to participate in the study by signing informed consent (patients equal or over 18 years old) 3. subjects under 18 years old whose representative / legal guardian has voluntarily signed the informed consent. 4. in the case of mature under 18 years subjects (12-17 years of age), in addition to the consent signed by the legal guardian, the consent of the subject will be obtained. exclusion criteria: 1. patients who for any reason should not be included in the study according to the criteria of the research team. 2. subjects who are not capable to understand the information sheet and unable to sign the informed consent.