Kornimate/medical-research-clean huggingface dataset:
an open-label study of telaprevir administered every 12 or 8 hours in combination with one of two pegylated interferons and ribavirin in treatment-naive genotype 1 chronic hepatitis c participants

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 hepatitis (inflammation of the liver) c virus (hcv) infection.

this is a phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 hcv infection. the trial consists of a screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. all participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. at week 12, telaprevir dosing will end and participants will continue on standard therapy only. participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram \[mg\] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon \[peg-ifn\]-alfa-2a and ribavirin \[rbv\] or peg-ifn-alfa-2b and rbv at the standard doses). efficacy will be evaluated by hcv ribonucleic acid (rna) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. pharmacokinetics, pharmacokinetic-pharmacodynamic relationship will also be evaluated. safety will be monitored throughout the study duration.

Eligibility criteria:
inclusion criteria: * chronic genotype 1 hepatitis (inflammation of the liver) c infection * never been treated for hepatitis c viral (hcv) infection * no clinically significant lab abnormalities * amount of hcv ribonucleic acid (rna) in the blood more than 10,000 international units/milliliter (iu/ml) at entry * liver biopsy or "fibroscan" test performed during screening or in the past 3 years exclusion criteria: * contra-indications for starting anti-hcv therapy * history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease * any evidence of significant liver disease in addition to hepatitis c * infected with human immunodeficiency virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or hepatitis b * women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

Keywords: chronic hepatitis c genotype 1 telaprevir treatment-naïve vx-950-c208 vx-950-tidp24-c208
remote symptom review in patients with implantable diagnostic holter

Conditions: Atrial Fibrillation; Syncope; Bradycardia; Arrythmia

Summary: to study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic biomonitor iii holter and successive models, consisting of remote review of alerts sent by the device via the home monitoring remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. the efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.

population of patients: patients over 18 years old who require the implantation of an implantable diagnostic holter due to indications of syncope or atrial fibrillation, and who are willing to use an application installed on their phone to telematically send clinical symptoms that may occur during the active study period. design: clinical, randomized, prospective, single-center study. investigational device: biomonitor iii implantable cardiac holter and successive models with homemonitoring remote monitoring system for constant monitoring of patient's cardiac signals. installation of the patient app on the patient's phone for symptom transmission. overall objective: to study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic biomonitor iii holter and successive models, consisting of remote review of alerts sent by the device via the home monitoring remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. the efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.

Eligibility criteria:
inclusion criteria: * patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection) * patients over 18 years old. * patients who consent to the installation of a patient application for telematic submission of patient-related symptoms. * patients capable of using the patient application. exclusion criteria: * patients over 80 years of age or, failing that, not able to use an application to send their symptoms. * life expectancy of less than 12 months for any reason.

Keywords: implantable loop recorder arrythmia atrial fibrillation home monitoring
effect of dietary polyphenols on insulin sensitivity

Conditions: Insulin Resistance

Summary: a large and growing segment of the population is prediabetic. dietary interventions that improve insulin sensitivity may be important in preventing the progression to full-blown diabetes in these individuals. foods and dietary compounds that increase insulin sensitivity are likely to help maintain a healthier body composition. this pilot study will provide data to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.

how does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and oligomers) affect insulin sensitivity in insulin resistant individuals?

Eligibility criteria:
inclusion criteria: * individuals who are insulin resistant based on routine clinical measurements (stern et al., 2005). exclusion criteria: * bmi \< 27 kg/m² * age \ 65 years * pregnant women or women who plan on becoming pregnant during the study * postpartum women * lactating women * diabetes mellitus * kidney disease * liver disease * certain cancers * smokers
efficacy of albumin interferon alfa-2b with ribavirin compared with peg-ifn alfa-2a with ribavirin in ifn naive patients

Conditions: Chronic Hepatitis C

Summary: this is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-ifn)in combination with ribavirin compared with peginterferon alfa-2a (pegasys or peg-ifna2a) in combination with ribavirin in subjects with chronic hepatitis c, genotype 1 who are ifna treatment naive.


Eligibility criteria:
key inclusion criteria: * diagnosis of chronic hepatitis c. * liver biopsy performed within 2 years of day 0 or during screening. * infected with hepatitis c virus genotype 1. * interferon alfa treatment naïve (ie, have never been treated with an interferon product). * subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin. * have compensated liver disease. key exclusion criteria: * decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy. * history of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt. * positive for human immunodeficiency virus (hiv-1) or hepatitis b surface antigen (hbsag). * clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis b, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, wilson's disease, or alpha 1-antitrypsin deficiency. * a history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus). * active seizure disorder within the last 2 years. * organ transplant other than cornea and hair transplant. * clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia). * cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix). * drug or alcohol addiction within the last 6 months. subjects in a supervised methadone treatment program may be enrolled in the study. * received any experimental agent within 28 days prior to day 0.

Keywords: chronic hepatitis c hepatitis c chc hepc genotype 1 hepatitis hcv
a study to learn more about chronic kidney disease (ckd) in patients with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease

Summary: in this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied. type 2 diabetes mellitus (t2dm) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. this results in high blood sugar levels. about half of people with t2dm also have a condition called chronic kidney disease (ckd). in people with ckd, the kidneys' ability to work as how it should decreases over time. in this study, researchers want to learn more about the ckd in t2dm patients in alberta, canada. this will help them to know the chances to improve the care of these patients. the researchers will look at the health information from adult men and women in alberta who were diagnosed with t2dm before 2018 and visited a doctor to have check-ups in 2018. they will find out about how many of these people had ckd and how severe their ckd was. the researchers will collect data about the age and gender of these patients, how long they had t2dm and if they had other related medical problems. the researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments. this study will collect information from the health records of about 270,000 patients with t2dm who were living in alberta, canada. this information will come from the alberta kidney disease network (akdn) database. besides this data collection, no further tests or examinations are planned in this study.


Eligibility criteria:
inclusion criteria: * a cohort of adults (18 years and older) with type 2 diabetes mellitus (t2dm) who resided in alberta on the index date (december 31, 2018) and were registered with alberta health will be included. all alberta residents are eligible for alberta health insurance plan coverage and over 99% participate. exclusion criteria: * patients with type 1 dm (t1dm) (international classification of diseases, ninth revision \[icd-9\] code: 250.x1 and 250.x3) in any of their previous records.

Keywords: cardiovascular diseases kidney diseases renal insufficiency, chronic diabetes mellitus , type 1 diabetes mellitus, type 2
acute neurological complications and neurodevelopmental outcome in children undergoing extracorporeal membrane oxygenation.

Conditions: Extra Corporeal Membrane Oxygenation

Summary: the purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent extracorporeal membrane oxygenation (ecmo), and their risk factors. the research will also assess the child health at 1 year after withdrawal from ecmo and in 2020 in terms of neurological state and quality of life.

neurological complications are relatively common (around 30%) in patients undergoing extra corporeal membrane oxygenation (ecmo). they can be hemorrhagic or ischemic and are partly due to the difficulty of balancing heparin therapy. few pediatric studies have estimated the incidence and risk factors for these lesions. in addition, the developmental monitoring and quality of life of these children is not systematic or standardized, and their long-term outcome deserves to be better evaluated. the purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent veno-veinous or veno-arterial ecmo and their risk factors. the study is being conducted at necker enfants malades hospital between 2014 and 2019. the research will also assess the child health at 1 year after withdrawal from ecmo and in 2020 in terms of neurological state and quality of life.

Eligibility criteria:
inclusion criteria: * children from 0 to 18 years hospitalized in picu (pediatric intensive care unit) and who underwent veno-venous or veno-arterial extra corporeal membrane oxygenation (ecmo) between 2014 and 2019. * adult patients not oppose to participation in research or holders of parental authority of minor patients not opposed to participation in the study. exclusion criteria: - other type of assistance than an ecmo (berlin heart).

Keywords: extra corporeal membrane oxygenation pediatric patients neurological complications neurological outcome quality of life
selfcare management intervention in heart failure ii (smart hf ii)

Conditions: Heart Failure

Summary: the purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure. to evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide: 1. improved self-care 2. improved quality of life and reduced number of patient-assessed symptoms 3. reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits


Eligibility criteria:
inclusion criteria: * diagnosed heart failure i.50 (newly discovered or existing) in nyha class i-iv in principle with esc guidelines 2016. * have completed the "consent form" or consent form, see §4.2 exclusion criteria: \* patient who refuses to participate in the trial. * it is assessed that they can handle the intervention themselves or with the help of personal or relatives. exclusion criteria: * patient who declines to participate in the trial. * impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner. * life expectancy \<8 months * in other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
pt001 mdi versus atrovent study in moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the overall objective of this study is to determine an optimal dose and dosing regimen of pt001 mdi for further evaluation in later stage studies.

the primary objective of this study is to demonstrate efficacy relative to placebo of pt001 mdi in patients with moderate to severe chronic obstructive pulmonary disease (copd) within the range of doses evaluated in this protocol. to this end, each dose of pt001 mdi will be compared to placebo with respect to the primary efficacy endpoint, fev1 auc0-12 relative to baseline.

Eligibility criteria:
key inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol key exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives other inclusion/exclusion criteria as defined in the protocol

Keywords: copd
effectiveness of virtual fibrowalk study

Conditions: Fibromyalgia

Summary: the main objective of this study is to analyse the effectiveness of the virtual fibrowalk multicomponent treatment program as coadjuvant of treatment-as-usual (tau) compared to tau alone. in this randomized controlled trial (rct), in addition to evaluating the clinical effects of virtual fibrowalk treatment in the short- and longterm.

this is a tree-arm rct focused on the safety and potential effectiveness of the multicomponent program virtual fibrowalk as coadjuvant of treatment-as-usual (tau) vs. tau alone and on the comparation of the physiotherapy part of the multicomponent program. * virtual fibrowalk combines multicomponent approach based on pain neuroscience education (pne), therapeutic exercise, cognitive behavioural therapy (cbt) and mindfulness training. * physiotherapy part of virtual fibrowalk combines multicomponent approach based on pain neuroscience education (pne) and therapeutic exercise. * the main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Eligibility criteria:
inclusion criteria: * adults from 18 to 75 years-old. * 1990 american college of rheumatology (acr) classification criteria + the 2011 modified acr diagnostic criteria for fibromyalgia * able to understand spanish and accept to participate in the study. exclusion criteria: * participating in concurrent or past rcts (previous year). * comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. alzheimer) that that would limit the ability of the patient to participate in the rct.

Keywords: multicomponent treatment fibromyalgia chronic pain pain neuroscience education therapeutic exercise cognitive behavioural therapy mindfulness randomized controlled trial
effect of personality traits on reporting outcomes of orthodontic treatment

Conditions: Malocclusion

Summary: the study will monitor changes induced by orthodontic treatment and in the retention period, two years after the end of orthodontic treatment. the alignment of teeth, hygiene and gingiva will be assessed. efficiency of two types of fixed appliances in active phase will be compared - esthetic and metal. efficiency of two types of retention appliances in retention phase will be compared - fixed and removable. the benefits of orthodontic treatment to be studied are aesthetic concerns, dental self-confidence, self-esteem, social contacts, psychological influences, and chewing limitation. the stability of personality traits, body image and perfectionism will also be analyzed, as well as the extent to which these dimensions modify the reporting of psychosocial effects of malocclusion treatment.

the aim is to analyze: 1. the extent to which the type of device (metal / aesthetic) affects changes in quality of life (qol) 2. whether the change in qol is influenced by personality traits during therapy 3. long-term change in qol and personality traits (before therapy, during, at the end and in retention for 2 years) 4. whether long-term qol change is influenced by personality traits 5. dependence of relapse (incidence and intensity) on the type of retention appliance 6. change in qol and personality trait depending on relapse 7. whether the change in qol due to relapse is influenced by personality traits

Eligibility criteria:
inclusion criteria: - malocclusion with moderate or great need for orthodontic treatment (index of orthodontic treatment need grades \>=3) exclusion criteria: - neurodevelopmental disorders, intellectual disability, oligodontia, congenital craniofacial anomalies, orofacial clefts

Keywords: malocclusion personality trait quality of life
low intensity shockwaves therapy for the treatment of erectile dysfunction. 12- month follow-up

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat erectile dysfunction.


Eligibility criteria:
inclusion criteria: * the patient must be able willing and able to provide informed consent. * the patient is a male between 30 and 70 years of age (inclusive). * the patient has erectile dysfunction (ed) based of iief scores. * the patient has been in a stable relationship for over 3 months prior to enrollment. * a minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by international index of erectile dysfunction (iief) * the patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient. * iief-ef score between 16 and 25. * testosterone level 300-1000 ng/dl within 1 month prior to enrollment. a1c level ≤ 7% within 1 month prior to enrollment exclusion criteria: * the patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study. * the patient is under judicial protection (prison or custody). * the patient is an adult under guardianship. * the patient refuses to sign the consent. * history of radical prostatectomy or extensive pelvic surgery. * evidence of venous leak. * past radiation therapy of the pelvic region within 12 months prior to enrollment. * recovering from any cancer within 12 months prior to enrollment. * neurological disease such as alzheimers or parkinson's disease which affects erectile function at the discretion of the investigator. * psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator. * anatomical malformation of the penis, including peyronie's disease. * testosterone level \ 1000 ng/dl within 1 month prior to enrollment. * a1c level \> 7% within 1 month prior to enrollment or history of insulin dependent diabetes. * the patient is taking blood thinners and has an international normalized ratio \>3. * received shockwave treatment at least 6 months before enrollment.