bioihbjkbjnl/mcl2 huggingface dataset:
The Norwegian Drug Monitoring Study
Condition: Rheumatoid Arthritis; Spondyloarthritis; Ankylosing Spondylitis; Crohn Disease; Ulcerative Colitis; Psoriasis; Psoriatic Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Crohn Disease; Psoriasis
Study type: Interventional

Summary: 
      Infliximab and other TNF-inhibitors have revolutionised the treatment of several
      immunological inflammatory diseases. Still, more than half of the patients either do not
      respond sufficiently to infliximab therapy or loose efficacy over time. The large individual
      variation in the serum drug concentrations on standard doses and the development of anti-drug
      antibodies are thought to be main reasons for these treatment failures. An individualised
      treatment strategy based on systematic assessments of serum drug concentrations, therapeutic
      drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab
      treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an
      economical point of view, but the effectiveness of this treatment strategy still remain to be
      shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial
      in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to
      achieve remission in patients with immunological inflammatory diseases starting infliximab
      treatment (part A) and in order to maintain disease control in patients on maintenance
      infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to
      an implementation of a personalised medicine approach to treatment with infliximab and other
      biological drugs.
    


Intervention name(s): Therapeutic drug monitoring; Standard care
Intervention type(s): Other; Other
Intervention description(s): Treatment algorithm based on assessments of serum drug levels and anti-drug antibodies; Treatment algorithm based on standard clinical assessments, without knowledge of serum drug levels and anti-drug antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infliximab; therapeutic drug monitoring; anti drug antibodies; TDM
A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      A single center, open-label, phase IIa, single arm, window of opportunity trial with IO103
      and Montanide adjuvant in patients with surgically resectable BCC.
    

Detailed description: 
      10 patients with BCC will be vaccinated with a peptide derived from the immune checkpoint
      molecule PD-L1. Patients will be vaccinated once every 2 weeks (Q2W) for 10 weeks and then
      evaluated for a clinical response.

      Patients with clinical response to vaccination will continue with one vaccination once every
      4 weeks (Q4W) for 12 weeks and thus receive 9 vaccinations in total over the course of 22
      weeks.

      Patients with no effect of treatment after 6 vaccinations will be treated with standard of
      care (SOC).
    

Intervention name(s): PD-L1
Intervention type(s): Biological
Intervention description(s): IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.
Other intervention name(s): IO103
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subsyndromal Delirium in Intensive Care Unit
Condition: Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive
      impairment in comparison to delirium. To date there is no published consensus on SSD
      definitions and has been commonly reported as an intermediate stage between delirium and
      normal mental states.

      SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care
      Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).

      The objective of this study is to identify subsyndromal delirium prevalence, the association
      between SSD and clinical outcomes and understanding the relationship between SSD and
      conversion to delirium.

      The relevance of this study is understanding of subsyndromal delirium in ICU, namely the
      importance of early presentations of acute brain dysfunction in the patients outcome.
    

Detailed description: 
      SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients
      in Intensive Care Units, to assess subsyndromal delirium.

      A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive
      Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).
      Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.

      The investigators access three different groups of patients: non-delirium, delirium and
      subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond
      Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment
      in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying
      cause of delirium and SSD are included. In addition, data regarding baseline demographic and
      clinical characteristics will be collected as well as data regarding the procedure performed
      (see Case Report Form (CRF)).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Intensive Care Unit patients
      
Keywords: Delirium; Subsyndromal delirium; Intensive Care Unit
Dexmedetomidine and Blood Coagulation
Condition: Blood Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Dexmedetomidine may alter whole blood coagulation. However, little is known about the
      dose-response relationships according to the blood concentration of dexmedetomidine. The
      investigators have therefore performed the present study to measure the effect of
      dexmedetomidine on the coagulation pathway according to the drug concentration level using a
      rotational thromboelastometry test.
    


Intervention name(s): 0 ul of dexmedetomidine; 0.25 ul of dexmedetomidine; 0.5 ul of dexmedetomidine; 0.75 ul of dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine; Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine; Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine; Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
Ruxolitinib for Steroid-refractory GVHD
Condition: Graft Vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic
      stem cell transplantation, while steroid-refractory chronic GVHD significantly increases
      morbidity, aggravates quality of life and may also impact survival. Currently there is no
      standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK)
      inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate
      and survival of patients with either acute or chronic srGVHD. This study prospectively
      evaluates the efficacy of ruxolitinib in srGVHD patients.
    


Intervention name(s): Ruxolitinib Oral Tablet
Intervention type(s): Drug
Intervention description(s): Dose reduction criteria for acute GVHD: grade 4 neutropenia or grade 4 thrombocytopenia related to ruxolitinib administration based on the decision of attending physician.
Dose reduction criteria for chronic GVHD: grade 3 neutropenia, grade 3 thrombocytopenia or anemia requiring transfusion, related to ruxolitinib administration based on the decision of attending physician.
Reduced dose schedule: 5 mg bid for adults and children with body weight > 40 kg, 0.08 mg/kg bid for children with body weight < 40 kg.
Treatment discontinuation criteria: complete response; absence of response after 28 days or progressive disease after 7 days for acute GVHD; absence of response after 84 days or progressive disease after 28 days for chronic GVHD; life-threatening complications.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute graft-versus-host disease; chronic graft-versus-host disease; Steroid-refractory GVHD; ruxolitinib; JAK inhibitors
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled
      bronchodilators (β2 agonists) for children with severe asthma exacerbation.

      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)
      for children with severe asthma exacerbation.

      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose
      of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects
      20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by
      an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23
      gauge one inch needle.

      In addition to the study intervention, the standardized treatment pathway based on the
      current asthma guidelines in use at the investigator's center will be utilized. This pathway
      includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration
      and dosages of these other interventions will be administered at the discretion of the
      treating provider.
    


Intervention name(s): IM epinephrine 1:1000; No intervention
Intervention type(s): Drug; Other
Intervention description(s): IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.; A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Status asthmaticus; Asthma exacerbation; Epinephrine; Adjunctive therapy
Performance Attributes and User Progression While Using Ekso
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study is to evaluate the performance attributes and user progression of participants
      with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic
      exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in
      progression and overall health while using Ekso.
    


Intervention name(s): Ekso
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study for Various Skin Conditions
Condition: Dyschromia; Photodamaged Skin
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.
    

Detailed description: 
      The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured
      by changes in skin tone, texture and pigment.
    

Intervention name(s): HALO
Intervention type(s): Device
Intervention description(s): Laser Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Condition: Colorectal Neoplasms; Melanoma; Prostatic Neoplasms; Renal Cell Carcinoma; Neoplasms; Patients Who Have/Have Had Melanoma and Other Tumors
MeSH terms: Neoplasms; Melanoma; Carcinoma, Renal Cell; Colorectal Neoplasms; Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to provide access to tremelimumab for patients who have previously
      received tremelimumab in a clinical trial.
    


Intervention name(s): CP-675,206 (Tremelimumab)
Intervention type(s): Drug
Intervention description(s): 15 mg/kg IV every 3 months as long as required
Other intervention name(s): anti-CTLA4 human monoclonal antibody
Intervention MeSH terms: Tremelimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma and other tumors
The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide
      1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in
      healthy subjects and patients with type 2 diabetes mellitus (T2DM).
    


Intervention name(s): exendin(9-39)amide; saline; duodenal meal; duodenal saline
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): intravenous infusion of exendin(9-39); intravenous infusion of saline; duodenal perfusion of a meal; duodenal perfusion of saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: GLP-1; Exendin(9-39); Insulin; Glucagon; T2DM; incretin effect; human physiology
A Single and Multiple Dose Study of AMAZ-02 to Evaluate Safety and Pharmacokinetics in Elderly Subjects
Condition: Aging; Mitochondrial Dysfunction; Muscle Function
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A:

      The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly
      male and female volunteers. Each subject will be randomized for two subsequent doses in three
      cohorts.

      Part B:

      The study is a double-blind, randomized, multiple ascending doses study in 36 healthy elderly
      male and female volunteers. Subjects will be randomized to receive study product or placebo
      for 28 days.
    

Detailed description: 
      Part A: Single Ascending Dose study of AMAZ-02 with 3 cohorts (each cohort n=8 subjects,
      total n=24 subjects). Cohorts undergo two periods of single dose intervention separated by 3
      week washout. Adverse events, clinical biochemistry for safety assessment and plasma and
      urine collected for pharmacokinetic measurement for parent and metabolite levels in
      circulation.

      Part B: Multiple Ascending Dose study with 3 cohorts (each cohort n=12 subjects, total n=36
      subjects). 28 day administration with AMAZ-02 for safety, PK and PD assessment.
    

Intervention name(s): Mitopure
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when
      given as a single dose and multidose to a defined area of one knee of healthy subjects.
    

Detailed description: 
      OLT1177 Gel is being developed for the topical treatment of pain and inflammation emanating
      from musculoskeletal and certain skin inflammatory conditions.

      This is a Phase 1 study evaluating the safety and tolerability of OLT1177 Gel in healthy
      subjects when given as single-dose or multi-dose applications. The study will be conducted in
      two parts, Part A and Part B. In Part A, approximately 18 healthy subjects in 3 dose
      escalating cohorts will be randomized to receive a single dose of the investigational drug (5
      subjects OLT1177 Gel and 1 subject placebo gel). Upon completion of Part A, a new subject
      population of approximately 18 subjects in 3 dose escalating cohorts will be randomized in
      Part B of the study. Subjects will receive a total of 8 doses over 3 consecutive days given 6
      hours apart while awake during the day and will be followed for up to 30 days for safety
      assessment.
    

Intervention name(s): OLT1177 Gel; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
Intervention MeSH terms: Dapansutrile
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Dose escalation; Randomized; Healthy volunteers; Topical; OLT1177; Olatec; Pain; Inflammation
Assessment of Oxygenation With Oxygen Reserve Index for General Anesthesia
Condition: Hyperoxia
MeSH terms: Hyperoxia
Study type: Observational

Summary: 
      To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration
      using low and high fresh gas flows for tympanomastoidectomy surgeries.
    


Intervention name(s): Oxygen reserve index
Intervention type(s): Device
Intervention description(s): eveluating oxygen reserve in blood
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Aged between 18-65 years undergoing tympanomastoidectomy surgery
      
Keywords: General anesthesia; Oxygen reserve index; Oxygenation; Hyperoxia
Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is
      similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.
    

Detailed description: 
      Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.

      Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post
      operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is
      used as adjuvant to sevoflurane, the total dose of the latter is reduced.

      Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to
      propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24
      hours.

      In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a
      visual analogue score. Vomiting was registered.
    

Intervention name(s): Sevoflurane-remifentanil anaesthesia
Intervention type(s): Procedure
Intervention MeSH terms: Remifentanil; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Nausea; Vomiting; Post operative; Propofol remifentanil anaesthesia; Sevoflurane remifentanil anaesthesia
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
Condition: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases
MeSH terms: Osteoporosis; Bone Diseases; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate the effects of food intake on the plasma concentration
      profile of YNO-5920/YM529 in post menopausal women.
    


Intervention name(s): ONO-5920 / YM529
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Minodronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ONO-5920; YM529; Minodronic Acid; Food Effect
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol
Condition: Anxiety Disorders; Depression; Posttraumatic Stress Disorder
MeSH terms: Anxiety Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The proposed project aims to test the cognitive and neural effects of a cognitive training in
      a sample of individuals seeking treatment for anxiety, depression, or traumatic stress
      symptoms. Participants will be randomly assigned to a high dose, low dose, or assessment only
      condition. Participants will be compared on cognitive performance and brain response during
      cognitive tasks from baseline to post-treatment.
    

Detailed description: 
      Mood, anxiety, and traumatic stress disorders are common psychiatric conditions - affecting
      over 40 million U.S. adults - and are leading causes of disability worldwide. People with
      these conditions are commonly plagued by difficulty controlling distressing personal thoughts
      and memories, collectively referred to as repetitive negative thinking symptoms. Models
      suggest that repetitive negative thinking is driven by executive functioning deficits, such
      that cognitive resources are insufficient to downregulate unwanted thoughts. Executive
      functioning deficits could be a promising treatment target but are not typically addressed
      with existing interventions. The long-term goal advanced by this project is to develop
      effective, mechanistic cognitive training programs that can improve cognition and reduce
      symptoms associated with mood, anxiety, and traumatic stress disorders. The objectives of
      this proposal are first to determine the optimal dose of a cognitive training program
      designed to improve executive functioning in this population using behavioral and neural
      outcomes. The central hypothesis is that repeated training exercises will enhance executive
      functioning and will lead to a reduction of repetitive negative thinking in mood, anxiety,
      and traumatic stress disorders. The project will randomize participants with depression,
      anxiety, and/or traumatic stress disorders to one of two doses of cognitive training or a
      no-treatment control condition. The investigators will examine executive functioning change
      with cognitive task performance and functional neuroimaging assessments.
    

Intervention name(s): COGENT
Intervention type(s): Behavioral
Intervention description(s): COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment