bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B
      surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary
      vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix
      Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited
      for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the
      persistence of immune response. For subjects detected with decreased immunity, the presence
      of immune memory against hepatitis A & B antigens will be investigated by the administration
      of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up
      time-point.

      No new subjects will be recruited during this booster phase of the study.
    


Intervention name(s): Blood sampling; Additional challenge dose
Intervention type(s): Procedure; Biological
Intervention description(s): Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.; If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Monovalent Hepatitis A; hepatitis B vaccine; Belgium and Czech Republic
Deep Inferior Epigastric Artery Flap for Breast Reconstruction
Condition: Breast Cancer; Perforator Flap; Anti-Infectives Adverse Reaction; Infections
Study type: Observational

Summary: 
      Background: There is no consensus on the duration of prophylactic antibiotics for autologous
      breast reconstruction after mastectomy. We try to standardize prophylactic antibiotics use
      during breast reconstruction with deep inferior epigastric perforator flap following
      mastectomy.

      Methods: This retrospective case series involved 108 patients who underwent immediate breast
      reconstruction with deep inferior epigastric perforator flap in Ditmanson Medical Foundation
      Chia-Yi Christian Hospital between 2012 and 2019. Patients were divided into three groups
      based on prophylactic antibiotic duration: 1 day, 3 days and >7 days for patients with drains
      Data were analyzed between January and April, 2021.
    


Intervention name(s): prophylactic antibiotics duration
Intervention type(s): Drug
Intervention description(s): Prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative care. Different discontinued duration of antibiotics was divided to 3 groups in one day, 3 days and until to drain removal.
Intervention MeSH terms: Anti-Bacterial Agents
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective study involved 108 patients who underwent immediate DIEP flap breast
        reconstruction after unilateral or bilateral mastectomy at the Ditmanson Medical Foundation
        Chia-Yi Christian Hospital between 2012 and 2019.
      
Keywords: Prophylatic antibiotics; DIEP flap
Weight Loss Maintenance and Compensatory Mechanisms Activated With a Very-low Calorie Diet
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      Very-low calorie diets are relatively safe and effective in inducing significant weight loss,
      when used in selective individuals and under clinical supervision. However, weight loss
      maintenance in the long-term remains the main challenge, with many experiencing a significant
      weight regain. Several compensatory mechanisms are activated under weight reduction, both at
      the level of energy intake (such as increased appetite) and energy expenditure (such as
      reduced energy expenditure), and increase the risk of relapse.

      The main aim of this study is to compare the effect of two multidisciplinary lifestyle
      interventions on weight loss maintenance at one year, after initial weight loss during 8
      weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an
      outpatient program in the obesity unit of the local hospital, or to an inpatient program
      consisting of a "continuous care" intervention, with three intermittent stays (each with
      three-week duration) in a rehabilitation center over a one year period. Moreover, the
      investigators aim to assess the impact of weight loss (achieved with a very low calorie diet)
      and weight loss maintenance on compensatory mechanisms activated during weight reduction.
    

Detailed description: 
      This study included a sub-study (n=30) to determine the timeline over which compensatory
      mechanisms (at both the level of energy expenditure and appetite control system) are
      activated with progressive weight loss. Additional measurements were taken at day-3, 5 and 10
      % weight loss, and after 4 weeks weight stabilization (after gradually reintroduction of
      food).
    

Intervention name(s): Multidisciplinary outpatient program; Inpatient lifestyle program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2); Diet (phase 1) and lifestyle intervention (phase 2)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight reduction programs; diet; Caloric restriction; weight loss; weight gain
Validation of Serum Creatinine Dosage and Renal Clearance
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has an open study design. The GFR will be measured using the renal clearance of
      inulin (Inutest) in volunteers with different stage of renal disease or without renal
      disease. A blood sample will be obtained for measuring serum creatinine in different
      laboratories.
    

Detailed description: 
      In this study we will investigate the correlation between the GFR as measured by inulin
      clearance (golden standard) and the estimated GFR as measured by laboratories which used
      different serum creatinine assays in patients without renal disease and in patients with
      different stage of kidney failure.
    

Intervention name(s): Calculation of inuline clearance; Measuring serum creatinine
Intervention type(s): Procedure; Procedure
Intervention description(s): Calculation of inuline clearance.; Measuring serum creatinine.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Impulsivity and Time Perception
Condition: Cannabis Use
MeSH terms: Impulsive Behavior
Study type: Observational

Summary: 
      Cannabis smokers having begun prematurely their consumption (before 16 years) present a
      persistent impulsivity much later after have stopped their consumptions. The literature
      highlights that the impulsivity promotes the passage towards a compulsive consumption, and
      the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity
      would lead the subjects to overestimate the duration of events and to choose immediate
      rewards than preferred but delayed rewards. This hypothesis questions the role of the
      temporal anticipation in the impulsive choices. In a first hypothesis, the temporal
      impulsivity could be an endogenous deficit bound to the reward, and would be responsible for
      disorders of the temporal anticipation. In this case, the disorders should be observed
      especially when the subject anticipates a reward. Alternately, a disorder of the temporal
      anticipation could provoke impulsivity, and in this case, would be present with or without
      reward. To separate these hypotheses, we propose to test the capacities of temporal
      anticipation of non-smokers and early smokers of cannabis by means of a behavioral task "
      Hazard function task ", which allow to measure the capacity of a subject to anticipate the
      apparition of an event on the basis of a temporal cue. The neuronal correlates will be
      measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which
      reflects the temporal accumulation and the processes of anticipation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cannabis use Versus Non-smokers
      
Keywords: Early onset of cannabis use; Addiction; Time perception
Determine the Safety and Dose of EN001 in Patients With Charcot-Marie-Tooth Disease (CMT) Type 1A
Condition: Charcot-Marie-Tooth Disease, Type IA
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, Dose-escalation, Phase 1 Clinical Trial to Determine the Safety and Dose of EN001
      in Patients with Charcot-Marie-Tooth disease (CMT) type 1A
    

Detailed description: 
      It is the first in human (FIH), 3+3 design clinical trial to evaluate the safety and
      tolerability and determine the maximum tolerated dose (MTD) of EN001 (allogeneic umbilical
      cord-derived mesenchymal stem cells) in the treatment of Charcot-Marie-Tooth disease (CMT)
      type 1A.
    

Intervention name(s): EN001; EN001
Intervention type(s): Drug; Drug
Intervention description(s): EN001 intravenously (IV) in the treatment of Charcot-Marie-Tooth disease (CMT) type 1A Dosage for each group is as follows.
Dose group A (Low dose): 5.0x10^5 cells/kg; EN001 intravenously (IV) in the treatment of Charcot-Marie-Tooth disease (CMT) type 1A Dosage for each group is as follows.
Dose group B (High dose): 2.5x10^6 cells/kg
Other intervention name(s): EN001 (allogeneic umbilical cord-derived mesenchymal stem cells); EN001 (allogeneic umbilical cord-derived mesenchymal stem cells)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes
Condition: Cardiovascular Disease; Peripheral Artery Disease; Ischemic Stroke; Diabetes
MeSH terms: Ischemic Stroke; Cardiovascular Diseases; Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The investigators propose an evaluation that will assess three important components of risk
      communication:

        1. provide patients with personalized risk communication using the risk calculator
           developed by FIMDM and health information taken from the Living with Coronary Artery
           Disease program

        2. provide personalized tailored patient feedback to help initiate and maintain specific
           cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking
           cessation) to reduce their risks.

        3. evaluate how this feedback can be incorporated into clinical care by examining 3 month
           patient outcome and provider responses to the risk information.
    

Detailed description: 
      Patients at high risk for CVD events frequently underestimate their risk. Programs to improve
      CVD outcomes have largely focused on single risk factors and do not contextualize the
      information with a patient's global risk. An easy, accessible strategy to address global CVD
      risk based on personalized risk communication feedback with assistance with initiating and
      maintaining health behaviors has several advantages, but has not formally been tested. A
      patient's perceived risk of stroke or heart attack is an important factor in understanding
      motivation for risk reducing behaviors. Lower perceived risk has been associated with poorer
      adherence to recommended health behaviors. Additionally, a person's beliefs about his or her
      risk for a disease increased the likelihood of a more informed and activated patient, and
      figures prominently in models of health behavior (e.g., Health Belief Model). People tend to
      underestimate their own risk; Therefore providing accurate risk communication has the
      potential to activate patients to initiate and maintain behavior changes.
    

Intervention name(s): Web-Based Intervention
Intervention type(s): Behavioral
Intervention description(s): Health Dialog Cardiac Risk Calculator
Health Dialog's Living with Coronary Heart Disease
Tailored intervention including health behavior modules such as smoking cessation, exercise, diet, and weight
Other intervention name(s): Health Dialog Cardiac Risk Calculator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cardiovascular disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
Condition: Hepatitis C; Pharmacokinetics
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The current Standard of Care (SOC) for chronic HCV infection, which is pegylated
      interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is
      effective in only part of the patients and is often associated with severe adverse effects
      leading to discontinuation of treatment and dose modifications.

      A number of compounds with direct activity are currently under clinical development, incl. BI
      201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to
      the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see
      how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN
      and RBV in HCV infected patients
    


Intervention name(s): ribavirin (RBV); pegylated interferon (PegIFN) alfa-2a; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); BI 201335 NA low placebo; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); BI 201335 NA high; BI 201335 NA low; BI 201335 NA high placebo; BI 201335 NA high; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ribavirin (RBV); pegylated interferon (PegIFN) alfa-2a; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); Placebo; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); BI 201335 NA high; BI 201335 NA; placebo; BI 201335 NA high
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Construction of Computerized Intraoperative Keratometer and Experimental Study
Condition: Corneal Astigmatism; Orientation
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      To construct a computerized intraoperative keratometer to analyze the axis of corneal
      astigmatism accurately as well as rapidly by self-designed software during surgery.
    

Detailed description: 
      The study is designed to construct a computerized intraoperative keratometer to analyze the
      axis of corneal astigmatism accurately as well as rapidly by self-designed software during
      surgery.
    

Intervention name(s): computerized intraoperative keratomer
Intervention type(s): Device
Intervention description(s): computerized intraoperative keratomer can analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery
Other intervention name(s): Experimental: computerized intraoperative keratomer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being
      tested for its' palatability in adults.
    

Detailed description: 
      Taste assessment of new formulation. Subjects will not ingest the drug.
    

Intervention name(s): crizotinib
Intervention type(s): Drug
Intervention description(s): Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.
Intervention MeSH terms: Crizotinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Crizotinib
Neurofeedback for Treatment of Central Neuropathic Pain (CNP) in Sub-acute Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Study type: Interventional

Summary: 
      Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.
      SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP).
      This pain typically develops several months after the injury. In 30-40% of SCI patients,
      severe CNP affects their everyday living including sleep and mood. Many patients give up
      work, not because of the injury, but because of pain. Medical treatment of CNP is moderately
      effective and costly, both to the patient and to the health care system.

      In previous research, characteristic 'signatures' of brain waves that are probably related to
      CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was
      developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to
      record patients' brain waves and these were shown to patients on a computer screen in a
      simple graphical form (e.g. bars). Patients were trained to change their brain activity at
      will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for
      years received up to 40 neurofeedback treatment sessions, reducing their pain for several
      days after each session.

      The primary aim of this study is to apply neurofeedback therapy to a larger number of
      recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback
      treatment will be more effective in people who have suffered from CNP for a shorter period of
      time.

      The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in
      recently injured patients with no chronic pain, knowing that a certain number of patients
      will develop CNP within weeks or months. These patients will be followed up for a year and
      the EEGs of patients who develop CNP will be compared with those who do not.
    


Intervention name(s): Neurofeedback therapy; No neurofeedback therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Apneic Oxygenation With a Nasal Cannula in the Obese and Morbidly Obese Surgical Patient
Condition: Apneic; Oxygenation
MeSH terms: Apnea
Study type: Interventional

Summary: 
      This prospective, randomized, double-blind study is intended to enroll a total of 100
      patients with a BMI ≥ 40 kg/m2 and another 100 patients with a BMI ≥ 30 kg/m2 (but less than
      40 kg/m2) undergoing surgery with general endotracheal anesthesia at Parkland Hospital.
      Patients will be randomized to receive either 15 L/min O2 or 15 L/min air from a standard
      nasal cannula during a simulated prolonged laryngoscopy. The anesthesia provider will do a
      direct laryngoscopy to ensure that the patient has a Cormack-Lehane grade I-II airway.
      Patients who have grade III-IV airways will be excluded from further study procedures and not
      analyzed. The rest of the anesthetic will not deviate from the standard of care. Anesthesia
      providers will be blinded as to whether patients are receiving oxygen or air during the
      apneic period.
    


Intervention name(s): Oxygen; Air
Intervention type(s): Other; Other
Intervention description(s): 15 L/min O2; 15 L/min air
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
Condition: Gastroesophageal Reflux Disease; Reflux, Gastroesophageal
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in
      patients, based on slow onset of action and an inability to provide 24-hour gastric-acid
      suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency,
      and prolonged duration of effect. The present study endeavors, in part, to compare
      lavoltidine to two GERD drugs, NEXIUM and ranitidine.
    

Detailed description: 
      A three-part study in healthy male volunteers to determine the most effective of four
      different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM
      (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine
      (300mg/day) for the amount of pharmacodynamic tolerance
    

Intervention name(s): AH23844 (lavoltidine); NEXIUM (esomeprazole); ZANTAC (ranitidine)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): AH23844 (lavoltidine); NEXIUM (esomeprazole)
Intervention MeSH terms: Esomeprazole; Ranitidine; Ranitidine bismuth citrate; Loxtidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: tolerance; pharmacodynamics; ranitidine; esomeprazole; pharmacokinetics; gastroesophageal reflux disease (GERD); AH23844
Nordic Luveris Study
Condition: Infertility; In Vitro Fertilization
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To study whether addition of human LH hormone (Luveris) during the final days of stimulation
      with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for
      patients undergoing in vitro fertilisation.
    


Intervention name(s): recombinant luteinizing hormone (Luveris); recombinant follicle stimulating hormone (Gonal-f)
Intervention type(s): Drug; Drug
Intervention description(s): 75 iu/day form cycle day 6; rFSH 150 iu/day
Other intervention name(s): Luveris; Gonal-f
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infertility; in vitro fertilization; LH supplementation; Benefits