bioihbjkbjnl/mcl2 huggingface dataset:
CT Screening For Lung Cancer in High Risk Patients: the Russian Study.
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This prospective cohort trial was planned to assess the feasibility of establishing a lung
      cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic
      patients with at least a 30 pack-year history of cigarette smoking.
    

Detailed description: 
      Low dose computer tomography (LDCT) showed promising results in recently published studied.
      Lung cancer screening programs with fluorography introduced in USSR in 70s-80s showed shift
      to earlier stages with no data on mortality. No other studies or programs on lung cancer
      screening were introduced in Russia since then.

      The purpose of this study is to assess the feasibility of establishing a lung cancer
      screening program in Russian Federation using LDCT scanning in asymptomatic patients with at
      least a 30 pack-year history of cigarette smoking. This cohort prospective study is planned
      to enroll at least 500 current or former smokers.

      Patients will be screened by LDCT scan at baseline with recommendation to perform follow-up
      in case of any positive result. For nodes more than 10 mm full clinical examination is
      recommended. For nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. For nodes
      smaller than 3 mm and negative results annual LDCT is recommended. Patient with positive
      results will be followed until final clinical diagnosis.

      Secondary outcomes include:

        -  Lung cancer diagnoses

        -  Lung cancer and overall mortality

        -  Quality of life assessment

        -  Complications of diagnostic and surgical procedures following a positive result.

        -  Comparison of independent radiological evaluation of scans.
    

Intervention name(s): Low dose computed tomography
Intervention type(s): Procedure
Intervention description(s): Low dose computed tomography scan
Other intervention name(s): CT scan; LDCT scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: lung cancer; screening; low dose; computed tomography
High Intensity Interval Training After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to examine if high intensity interval training after stroke is
      more effective than standard care to increase maximal oxygen uptake, reduce known risk
      factors for recurrent stroke and improve function.
    

Detailed description: 
      Stroke is a leading cause of adult disability. Well designed studies have shown that the
      majority of the stroke population have low aerobic capacity and many are inactive. This is
      negative for their health and well-being. Physical inactivity may increase their risk of
      having recurrent stroke.

      The optimal training mode and intensity to improve aerobic capacity after stroke are not
      clear. High intensity interval training (ie. 90-95% of peak heart rate) has been proven to be
      more beneficial than moderate and low intensity exercise in order to improve maximal oxygen
      uptake in patients with cardiac disease. The response from this training on aerobic capacity
      and physical function in the stroke population are not known.
    

Intervention name(s): High intensity interval training; General information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Uphill treadmill walking; Standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise training; Oxygen consumption
Effect of 3 Years of Exercise in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a substudy of "Generation 100". The investigators will follow the persons with atrial
      fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial
      fibrillation, symptoms, use of health services or echocardiographic findings.
    


Intervention name(s): Interval exercise; Moderate exercise; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 3 years.; Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.; Given information on recommendations for physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atrial fibrillation; Exercise
Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty
Condition: Knee Replacement Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo
      on muscle strength, mobility and pain on the first postoperative day after total knee
      alloplastic (TKA).
    

Detailed description: 
      Patients will be included on the first day after TKA surgery and randomized in two groups.
      Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug,
      Ropivacaine, and another ACB with a placebo drug, Saline.

      At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the
      placebo ACB at T60 (60 minutes after T0).

      At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active
      ACB with Ropivacaine at T60 (60 minutes after T0).

      Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in
      outcome between the groups will be compared.

      Baseline values will be measured prior to the first ACB. Final measurements at T120 (120
      minutes after the initial ACB), will determine if the differences between the groups are
      eliminated, since both groups then have received an active ACB.
    

Intervention name(s): Ropivacaine 7,5 mg/ml; Saline
Intervention type(s): Drug; Drug
Other intervention name(s): Product name: Ropivacain "Fresenius Kabi"; Ropivacainhydrochloridmonohydrat; Importet to Denmark by Fresenius Kabi AB; Injection mixture; Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml; Sodium 9g/l; Electrolyte content: Na+ 154 mmol/l; Cl- 154 mmol/l; Infusion mixture
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee surgery; Saphenous nerve; Perineural block; Adductor Canal Block; Postoperative Pain; Mobilization
Feeling of Being in Control of One's Own Action
Condition: Schizophrenia; Bipolar Disorders
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional

Summary: 
      The investigators aim is to understand the cognitive mechanisms that contribute to the
      emergence of delusions of control (the belief that one's own actions or thoughts are
      controlled by an external force). These symptoms are mainly encountered in patients with
      schizophrenia, and the investigators will distinguish patients with schizophrenia with or
      without this symptom together with patients with bipolar disorder. Based on the investigators
      previous studies, this project will help to determine the role of two elementary mechanisms
      in the ability to feel in control of voluntary actions: (1) the processing of the sensory
      consequences of action, and (2) the ability to build mental representations for sequenced
      actions.
    


Intervention name(s): Experimental psychology methods (computer tests)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
Condition: Cancer; Advanced Solid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study will be to investigate the safety and tolerability of olaparib
      tablet when given orally to Japanese patients with advanced solid malignancies. In addition,
      the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.
    

Detailed description: 
      MTD - maximum tolerated dose
    

Intervention name(s): olaparib
Intervention type(s): Drug
Intervention description(s): tablet oral
Intervention MeSH terms: Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Tumour; Solid Malignancies
Supported Employment and Preventing Early Disability
Condition: Unemployment
Study type: Interventional

Summary: 
      The share of young workers falling into early work disability is an increasingly important
      problem in Norway. Early withdrawal or exclusion from the labor market leads to large
      individual and societal costs. The SEED-trial is a randomized controlled trial aiming to
      provide evidence-based knowledge about different approaches to prevent permanent disability
      and increase labor market participation in this important and vulnerable group. The trial
      includes young adults aged 18-30 years who are at risk of early work disability, and the
      participants will be randomly assigned to 1 of 2 interventions, both aimed at facilitating
      participation in working life:

        1. Traditional Vocational Rehabilitation (TVR), offering training and preparation for the
           labor market in a sheltered environment

        2. Supported Employment (SE), focusing on competitive employment in real-life settings
           without long-lasting preceding training

      Both interventions are currently provided by The Norwegian Labor and Welfare Administration
      (NAV). Supported Employment was introduced recently and is currently being implemented, while
      traditional vocational rehabilitation with sheltered employment has been around for years.
      However, no Norwegian controlled studies have been conducted on these practices in this
      population. The current study will therefore provide new knowledge of the effect of
      traditional as well as new and promising interventions to increase labor market participation
      and prevent early disability.
    

Detailed description: 
      A detailed study protocol was published in BMC Public Health in 2016, and is openly available
      in fulltext at: https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3280-x
    

Intervention name(s): Supported Employment; Traditional Vocational Rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training.; Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Supported Employment; Vocational Rehabilitation; Youth; Sick leave; Disability; Coping; Work; Occupational; Labor market participation; Randomized Controlled Trial
Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      The main objective of this study is to evaluate the safety and effectiveness of
      paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic
      hepatitis C virus (HCV) genotype 2 in daily practice in Japan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with Chronic hepatitis C virus (HCV) genotype 2
      
Keywords: Genotype 2; Paritaprevir; Hepatitis C Virus (HCV); Ritonavir; Ombitasvir
A Study of the Effect of Food and Posture on the Pharmacokinetics of a Single Dose of ER OROS Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the effect of food on the pharmacokinetics of
      extended-release (ER) OROS paliperidone in healthy men, and to evaluate the effect of posture
      on the pharmacokinetics of ER OROS paliperidone under fasting conditions. Additionally, the
      safety and tolerability of the treatments in healthy men will be assessed.
    

Detailed description: 
      The current study was designed to evaluate the effect of food on the pharmacokinetics of the
      to be marketed formulation of ER OROS paliperidone in mobile healthy men, which represents
      the normal conditions. The 12-mg ER OROS paliperidone ER by oral administration single dose
      used in this study does not require prolonged bed rest as a precautionary measure to prevent
      orthostatic hypotension. To support an evaluation of the effect of posture on the
      pharmacokinetics of ER OROS paliperidone under fasting conditions, study medication was also
      administered to healthy men in the fasted state while confined to bed for approximately 36
      hours. The safety and tolerability of the treatments in healthy men will be assessed. 12 mg
      ER OROS paliperidone ER, oral administration, single dose
    

Intervention name(s): Extended release OROS paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mood disorders; Antipsychotic drugs; Extended release OROS paliperidone
Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification
Condition: Posterior Capsule Opacification; Cataract
MeSH terms: Cataract; Capsule Opacification
Study type: Interventional

Summary: 
      Age-related cataract is the main cause of impaired vision in the elderly population
      worldwide.

      The only treatment that can restore functional visual ability is cataract surgery where the
      opacified crystalline lens is removed by phacoemulsification and an artificial intraocular
      lens is implanted into the remaining capsular bag. Cataract operations are generally very
      successful, with a low risk of serious complications.

      The most common reason for impaired vision after uneventful cataract surgery in otherwise
      healthy eyes is the development of posterior capsule opacification (PCO). PCO is a
      physiological change (thickening, opacification and clouding) of the capsular bag expected
      after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and
      cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that
      uses a laser to open a central hole in the posterior capsular bag.

      Modifications in IOL design and material lead to a decrease in the incidence of PCO.

      During the past two decades, refinements in surgical technique were made resulting in today's
      small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are
      available, many of them similar but of course with some differences in regard to the chemical
      composition of the acrylic material and the IOL design.

      The purpose of this study is to compare the development of posterior capsule opacification
      (PCO) and the frequency of treatment between two different microincision IOLs over a period
      of 2 years.
    


Intervention name(s): bilateral cataract surgery
Intervention type(s): Procedure
Intervention description(s): same-day bilateral cataract surgery with implantation of intraocular lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Condition: Laceration
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare how well three different doses of ketamine, given as
      a spray into the nose, help to sedate children and help them tolerate repairs of cuts on
      their faces.
    

Detailed description: 
      Procedural sedation is frequently used to facilitate distressing and painful procedures in
      the pediatric emergency department. However, administering an intramuscular medication or
      placing an intravenous line to give intravenous medications can be as distressing as the
      procedure itself. Oral medications generally take longer to work and are subject to
      first-pass metabolism. Another alternative is to give the medication by the intranasal route,
      which only requires a spray into the nose. Ketamine is a good sedative drug with favorable
      qualities, and is often used intramuscularly or intravenously. It has been used intranasally
      as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but
      its use has not yet been demonstrated in the setting of the pediatric emergency department
      for procedural sedation. We will be comparing three different doses of ketamine, applied
      intranasally using a mucosal atomization device, and determining if there are any differences
      in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and
      physician satisfaction, and number of adverse events. We will also use this opportunity to
      determine ketamine bioavailability when given intranasally using the mucosal atomization
      device.
    

Intervention name(s): Intranasal ketamine
Intervention type(s): Drug
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Prospective; Randomized; Double blinded; Sedation; Ketamine; Intranasal
Pain Control in Renal Colic
Condition: Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional
Phase: Phase 1

Summary: 
      Renal colic is very common in emergency department patients. Our aim of this study is which
      combination of drug is more effective in renal colic.
    


Intervention name(s): buscopan
Intervention type(s): Drug
Intervention MeSH terms: Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: renal colic
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, multicenter, partially double-blind, placebo-controlled study is designed to
      evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects
      of treatment with RO6864018 in virologically suppressed participants with chronic HBV
      infection.
    


Intervention name(s): Entecavir; Placebo; RO6864018; Tenofovir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Entecavir will be administered as per local labeling.; Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.; Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.; Tenofovir will be administered as per local labeling.
Intervention MeSH terms: Tenofovir; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Post-prandial Glucose Response From Phytochemical Rich Potato Products
Condition: Glycemic Response; Appetitive Behavior
Study type: Interventional

Summary: 
      Assess the impact of high antioxidant potato products on postprandial glycemic response and
      subsequent appetite and food intake.
    

Detailed description: 
      Preliminary results from anthocyanin rich potato products suggest that a reduced postprandial
      glycemic response might be expected from certain types of potato products and that phenolic
      antioxidants may play a critical role in predicting the physiological response from potato
      products. Further, if consumed early in the day, such as at breakfast, a reduced glycemic
      response may serve to mitigate appetite and food consumption later in the day. Investigators
      aim to better understand how characteristics of commercial potato products (i.e. frozen
      potato products) with different phenolic profiles and content, may alter postprandial
      glycemic response and subsequent appetitive behavior. Specifically, investigators will assess
      the glycemic response from a serving of potato products in the morning using continuous
      glucose monitoring. Further, appetite and subsequent food consumption later in the day will
      be assessed through appetite logs and continuous glucose monitoring.
    

Intervention name(s): Skin Off French Fry; Skin On French Fry; Hash brown; Carbohydrate control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Skin Off French Fries will be provided at breakfast and lunch; Skin On French Fries will be provided at breakfast and lunch; Hash brown potatoes will be provided at breakfast and lunch.; A pancake will be provided at breakfast, and pretzels will be provided at lunch.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science