bioihbjkbjnl/mcl2 huggingface dataset:
The Norwegian Nucleoside Analogue Stop Study
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Globally, an estimated 257 million individuals have chronic hepatitis B-virus infection
      (CHB). In the absence of treatment 15-40% of these will progress to liver cirrhosis and/or
      hepatocellular carcinoma. Oral antiviral treatment suppresses the virus and improves
      prognosis, but less than 0.5% per year achieve a "functional cure" (i.e. HBsAg loss). One
      remaining controversy, therefore, is whether antiviral treatment must continue life-long.
      Observational studies have assessed stopping antiviral treatment after years of viral
      suppression; however, HBsAg loss has rarely been seen. But interestingly, a few small trials
      that chose watchful waiting instead of re-initiation of treatment when reactivation occurred,
      achieved 40% HBsAg loss during 6 years follow-up.

      The present proposal is a randomized controlled trial that will assess the safety, efficacy,
      and cost-effectiveness of treatment discontinuation - and delayed restart - in HBeAg negative
      CHB. The study is sufficiently powered to address the hypotheses, and a pilot study that
      demonstrates feasibility has been performed. Patients will be enrolled at 12 Norwegian
      hospitals, in addition to our collaborating institution in Ethiopia - the largest CHB
      treatment center in sub-Saharan Africa. If the study shows that discontinuation is safe and
      effective, it will directly impact both national and international treatment guidelines.

      Main objective:

      -To study whether stopping nucleoside analogue (NA) therapy - and delaying re-start - can
      trigger an immune response and set off a functional cure (viz HBsAg loss)

      Secondary objectives:

        -  Assess whether stopping NA therapy - and delaying re-start - leads to a higher chance of
           HBsAg loss

        -  Assess the safety of stopping NA therapy - and delaying re-start - in terms of hepatic
           decompensation, fibrosis progression, and/or adverse events

        -  Study whether stopping NA therapy - and delaying re-start - leads to a higher chance of
           sustained off-therapy immune control (low viral load and normal ALT)

        -  Assess the quality of life and cost-effectiveness of stopping NA therapy - and delaying
           re-start

        -  Identify predictors of HBsAg loss
    


Intervention name(s): Stop of therapy
Intervention type(s): Other
Intervention description(s): The active intervention is to stop antiviral therapy, and delay re-start in the high-threshold group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine which, if any, allelic variants of mycophenolic acid (MPA)
      metabolizing enzymes, drug transporters and drug targets are associated with the observed
      variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage.
      Patients participating in study ML17225 will be eligible for this pharmacogenetic
      investigation, and will have one additional blood sample taken during the study. The
      anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size
      is 500+ individuals.
    


Intervention name(s): mycophenolate mofetil [CellCept]; mycophenolate mofetil [CellCept]; Cyclosporine or tacrolimus; Cyclosporine or tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Concentration-controlled; 1g po bid; Reduced; Standard, as prescribed
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Antiepileptics in Patients on CRRT
Condition: Acute Kidney Injury; Renal Insufficiency; Renal Failure; Pharmacokinetics
MeSH terms: Acute Kidney Injury; Renal Insufficiency
Study type: Observational

Summary: 
      The purpose of the study is to measure levels of any of the following AEDs (levetiracetam,
      phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on
      critically ill patients receiving CRRT in order to characterize drug pharmacokinetics and
      optimize dosing strategies in patients on CRRT.
    


Intervention name(s): Levetiracetam; Lacosamide; Phenytoin; Phenobarbital; Ketamine; Valproic Acid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Standard of care; Standard of care; Standard of care; Standard of care; Standard of care; Standard of care
Intervention MeSH terms: Lacosamide; Phenytoin; Ketamine; Levetiracetam; Valproic Acid; Phenobarbital
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing CRRT who are also being treated with an antiepileptic drug
      
Keywords: Antiepileptics; Continuous Renal Replacement Therapy
Intraosseous PRP for Knee Osteoarthritis: Pilot Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to assess a novel approach to treating severe knee osteoarthritis
      by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and
      subchondral bone by combining intra-articular injections and intraosseous infiltrations of
      platelet rich plasma.This study explored a new strategy consisting of intraosseous
      infiltrations of platelet rich plasma into the subchondral bone in combination with the
      conventional intra-articular injection in order to tackle several knee joint tissues
      simultaneously.
    


Intervention name(s): Platelet Rich Plasma
Intervention type(s): Biological
Intervention description(s): Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Condition: Decreased Fetal Movements Affecting Care of Mother; Pregnancy; Stillbirth
MeSH terms: Stillbirth
Study type: Interventional

Summary: 
      Rates of stillbirth in Scotland are among the highest in resource rich countries. The
      majority of stillbirths occur in normally formed infants, with (retrospective) evidence of
      placental insufficiency being the commonest clinical finding. Maternal perception of
      decreased fetal movements appears to be an early biomarker both of placental insufficiency
      and subsequent stillbirth.

      The study proposed here will test the hypothesis that rates of stillbirth will be reduced by
      introduction of a package of care consisting of strategies for increasing pregnant women's
      awareness of the need for prompt reporting of decreased fetal movements, followed by a
      management plan for identification of placental insufficiency with timely delivery in
      confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar
      package of care in Norway but the efficacy of this intervention (and possible adverse effects
      and implications for service delivery) have not been tested in a randomized trial.

      The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland
      and Ireland will be randomized to the timing of introduction of the care package. Outcomes
      (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's
      detailed routinely collected maternity data, allowing the investigators to robustly test the
      hypothesis. A nested qualitative study will examine the acceptability of the intervention to
      patients and health care providers and identify process issues (barriers to implementation).
    


Intervention name(s): A package of interventions
Intervention type(s): Other
Intervention description(s): A package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Education, Stillbirth, Prevention, Management
Sweeping the Membranes, Cervical Length and Duration of Labor
Condition: Disorder of Amniotic Cavity and/or Membrane
Study type: Interventional

Summary: 
      Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to
      delivery.
    

Detailed description: 
      Cervical length will be measured in both groups. The membranes will be swept in pregnancies
      beyond 38 weeks by digital examination in the study group. The control group will only be
      examined for Bishop score. Two days later cervical length will be Measured once more.
    

Intervention name(s): sweeping the membranes; No sweeping group
Intervention type(s): Procedure; Other
Intervention description(s): The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.; Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.
Other intervention name(s): stripping the membranes; digital examination; bishop score; digital examination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical length; sweeping the membranes
The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination
Condition: Pain; Pediatric Patient; Fear; Virtual Reality; Nursing Caries
Study type: Interventional

Summary: 
      This study was designed to examine the effects of using virtual reality and kaleidoscope
      during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children
      aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into
      three groups. Accordingly, the study sample consisted of a virtual reality group with 42
      children, a kaleidoscope group with 42 children, and a control group with 42 children,
      totaling 126 children. Fear and pain were evaluated by both the researcher and the child
      before and after the procedure. Anxiety was assessed by the child after the procedure. The
      Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and
      the Child Anxiety Scale-State Version for anxiety.
    


Intervention name(s): VR; Kaleidoscope
Intervention type(s): Procedure; Procedure
Intervention description(s): Virtual reality glasses were used as a distraction method for children during vaccination.; Kaleidoscope toys were used as a distraction method for children during vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective, randomised controlled study
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke
Condition: Stroke; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for
      treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in
      the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5
      hours of symptom onset. It is current practice that post-tPA patients are monitored in an
      intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part
      due to frequent vital sign and neurological monitoring that is currently the standard of
      care. However, rigorous evidence to support this practice is largely lacking. In a
      retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and
      Johns Hopkins Bayview Medical Center (JHBMC), investigators have shown that most patients who
      have ICU needs in the first 24 hours after tPA administration develop such needs by the end
      of the tPA infusion. Patients without ICU needs by the end of the tPA infusion, do not
      require further ICU resources if patients' presenting NIH Stroke Scale (NIHSS) is below 10.
      This study is a prospective clinical trial that aims at establishing the first
      proof-of-concept and feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and
      that do not need ICU care by the end of the tPA infusion, can be monitored safely in a
      non-ICU setting with a novel monitoring protocol. Identifying post-tPA patients who can be
      safely monitored in a non-ICU environment may improve cost-effective utilization of ICU
      resources and reduce the length of hospitalization for stroke patients.
    


Intervention name(s): "Hopkins" post tPA for ischemic stroke monitoring protocol
Intervention type(s): Other
Intervention description(s): The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Intervention model: Single Group Assignment
Intervention model description: Single arm study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: IV tPA; Thrombolysis; Stroke; Ischemic; Monitoring
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
Condition: Specific Phobia; Separation Anxiety; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Anxiety, Separation
Study type: Interventional

Summary: 
      An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the
      rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered
      Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting.
      20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation
      anxiety, specific phobia and their parents will be recruited from the CAMHS-center in
      Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by
      clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month
      follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale
      (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and
      parent-rated anxiety and functioning.
    


Intervention name(s): Internet-delivered Cognitive Behavior Therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate the drug interaction between LC15-0444 and
      pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and
      pioglitazone are administered concomitantly and each alone in healthy male subjects.
    

Detailed description: 
      This study is a randomized, open-label, three-treatment, three-period, three-sequence and
      crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics
      after the multiple administration of LC15-0444 and pioglitazone concomitantly or each alone.

      Eligibility for participation of this study will be determined by demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 3 weeks(-21 d ~ -2 d) before drug administration(1 d). Eligible subjects will be
      randomized to one of three sequence groups.

      According to the characteristics of anti-diabetic drugs, it is expected to be administered
      with other anti-diabetic drugs. Therefore, Drug-Drug Interaction with Pioglitazone should be
      identified in this trial.
    

Intervention name(s): LC15-0444, Pioglitazone
Intervention type(s): Drug
Intervention description(s): LC15-0444 200 mg (100 mg x 2) qd (12 days once daily) Pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) LC15-0444 200 mg (100 mg x 2) qd + pioglitazone 30 mg (15 mg x 2) qd (12 days once daily)
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
Condition: Iron Deficiency; Neonatal Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia, Neonatal; Iron Deficiencies; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by
      increasing the infant's iron endowment at birth. Compared with early clamping, a delay of
      around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.

      The results of previous intervention studies on delayed clamping are mixed, and few followed
      up infants beyond the perinatal period. All longer follow up studies have been performed in
      low income countries. The main objectives, therefore, was to assess whether delayed cord
      clamping improves hematological and iron status at 4 respective 12 months of age in a large
      sample of full-term, Swedish infants.

      The investigators also choose to investigate if the timing of clamping the umbilical cord
      could affect rate of infections during the first four months of life and to assess the
      infants development at 4 and 12 months of age.
    


Intervention name(s): Timing of clamping the umbilical cord
Intervention type(s): Procedure
Intervention description(s): The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
Other intervention name(s): Delayed cord clamping is also called Late cord claming
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Umbilical cord; cord clamping; iron; Ferritin; newborn; jaundice; infant; development; infections
Working Memory Training for Substance Dependent Individuals
Condition: Substance Dependency; Addiction; Anxiety; Depression
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      Background: Substance abusers show impaired working memory (WM) functioning. Promising
      findings show training WM results in an improved working memory capacity (WMC) and a decrease
      of clinical symptoms in a range of disorders, including alcohol addiction.

      Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance
      use, craving, WMC, impulsivity, attention bias and psychopathology.

      Design: A randomized double-blind placebo-controlled trial with a parallel group design. The
      WM training adapted to participants' WMC whereas the placebo training consisted of
      non-adaptive easy versions of these tasks.

      Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.

      Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who
      were in treatment as usual .

      Measurements: Primary outcome measures: Substance use and craving. Secondary outcome
      measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed
      before and after 24 sessions of WM training as well as two months after the training.
    


Intervention name(s): Working memory training; Placebo training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the experimental group executed versions of these task that adapt to their working memory capacity, to train their working memory optimally.; The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the placebo group executed easy versions of these task that did not adapt to their level, to prevent training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Substance abuse; Addiction; Working memory; Craving; Impulsivity; Attention control