bioihbjkbjnl/mcl2 huggingface dataset:
LEO 27847 - Single Dose Bioavailability Study of Oral Solution Versus Tablet in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase 1 study is to determine the relative bioavailability following
      single oral dose administration of LEO 27847 solution compared to LEO 27847 tablets in
      healthy male subjects as well as to determine the effect of food on the single oral dose
      pharmacokinetics of LEO 27847 tablets in healthy male subjects.
    


Intervention name(s): LEO 27847 oral solution
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney Disease, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective

      • To assess the dose response relationship between RGLS4326 and ADPKD biomarkers

      Secondary Objectives

        -  To characterize the pharmacokinetic (PK) properties of RGLS4326 in plasma and urine

        -  To assess the safety and tolerability of RGLS4326
    

Detailed description: 
      This is a Phase 1b, open-label, adaptive design dose-ranging study to evaluate ADPKD
      biomarkers, PK, safety, tolerability, and pharmacodynamics (PD) of RGLS4326 administered via
      SC injection to patients with ADPKD. The goal is to assess the dose response relationship
      between RGLS4326 and ADPKD biomarkers. The study will consist of three sequential cohorts
      with approximately 18 to 27 subjects total.
    

Intervention name(s): RGLS4326
Intervention type(s): Drug
Intervention description(s): Solution for subcutaneous injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Cohorts will be enrolled and treated sequentially. Dosing decisions will be made based on prior cohort's safety and biomarker data. Six to 9 subjects will be enrolled in each cohort based on the magnitude and/or variability of the increase in PC1 and PC2 or to allow for replacement of subjects that do not complete the study. The highest dose (1 mg/kg) will be administered in cohort 1. If the Sponsor determines that the increase in PC1 and PC2 from baseline for cohort 1 is inadequate, the study may be stopped for futility. If the Sponsor determines that the increase from baseline for cohort 1 is adequate, then 0.3 mg/kg will be administered in cohort 2. Based on the increase of PC1 and PC2 from baseline in cohort 2, Sponsor may determine a higher dose needs to be evaluated, then 0.5 mg/kg will be administered in cohort 3. If the Sponsor determines that lower dose needs to be evaluated, then 0.1 mg/kg will be administered in cohort 3.
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
Condition: Japanese Patients With ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients
      with Amyotrophic Lateral Sclerosis
    


Intervention name(s): MT-1186
Intervention type(s): Drug
Intervention description(s): Suspension
Other intervention name(s): Edaravone
Intervention MeSH terms: Edaravone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.
Condition: Achilles Tendon Ruptures
MeSH terms: Rupture
Study type: Observational

Summary: 
      Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types:
      open, percutaneous and conservative (non-operative) treatments.

      Comparing force torque measurements, muscle volume and clinical scores.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        -  Age 20-65 years

          -  BMI < 40

          -  no injury to leg

          -  no injury on contralateral leg
      
Keywords: Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS
Feasibility and Efficacy of a Brief Digital Self-efficacy Training
Condition: Stress; Self Efficacy
Study type: Interventional

Summary: 
      The study investigates the effects of a digital, scalable self-efficacy training of repeated
      recall of self-efficacy memories on mental health outcomes, such as self-efficacy, anxiety,
      stress, hopelessness, and other mental health outcomes. A total of 94 students with elevated
      stress levels (≤ 13 on the Perceived Stress Scale) will be recruited and randomly assigned to
      training and control group. Individuals will either engage in the self-efficacy training app
      combined with Ecological Momentary Assessment (EMA) for 1 week (training group) or in EMA
      only for 1 week (control group). Baseline and post assessments will measure changes in
      self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes.
    

Detailed description: 
      Self-efficacy is associated with positive mental health outcomes and has been proposed as a
      putative contributor to therapeutic outcomes in the treatment of mental health problems. It
      can be enhanced through experimental inductions and the recall of autobiographical mastery
      experiences, which have mostly been conducted in person and in the laboratory until today.

      The study will investigate effects of a digital, scalable self-efficacy training of repeated
      recall of self-efficacy memories on mental health outcomes, such as self-efficacy, anxiety,
      stress, hopelessness, and other mental health outcomes. The study will recruit 94 students
      with elevated stress levels (≤ 13 on the Perceived Stress Scale) and randomly assigned them
      to training and control group. Individuals will either engage in the self-efficacy training
      app combined with Ecological Momentary Assessment (EMA) for 1 week (training group) or in EMA
      only for 1 week (control group). Baseline and post assessments will measure changes in
      self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes.
    

Intervention name(s): Self-efficacy App
Intervention type(s): Behavioral
Intervention description(s): The training starts with a psychoeducational video and instructions to define two autobiographical self-efficacy The individuals will then receive three self-efficacy trainings per day based on their autobiographical memories and combined with a slow breathing exercise. Additionally, they will receive 10 daily EMA questionnaires on mood, social contacts, and virtual context.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial testing a brief digital intervention (SeApp) against a control group receiving only EMA
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: self-efficacy, stress, digital, intervention
Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
Condition: Steroid-Sensitive Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in
      children with standard prednisolone treatment, once complete remission has occurred, that the
      use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of
      subsequent relapse during 12-month of follow-up.
    

Detailed description: 
      NS is the most frequent glomerular disease in children. Between 80% and 90% of children with
      steroid-sensitive nephrotic syndrome (SSNS) will relapse following an initial response to
      corticosteroids. Half of these children will experience frequent relapses (FRNS) or become
      steroid-dependent (SDNS).

      The results of multiple observational studies and randomized control trials have shown that
      Rituximab, a chimeric monoclonal antibody against the cluster of differentiation antigen 20
      (CD20) antigen on B cells, is safe and effective for children with FRNS/SDNS without
      corticosteroid or immunosuppressive therapy. To the investigators' knowledge, Rituximab has
      never been investigated for the initial episode of NS with the aim to reduce the subsequent
      risk of relapse that is a major concern in the management of children with NS.

      Children aged 1-18 years with the first episode of the SSNS will be treated with a single
      intravenous infusion of Rituximab 375 mg/m2. The prednisolone at a dose of 2 mg/kg per day
      (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg)
      as a single morning dose on alternate days for the next 6 weeks; therapy is then
      discontinued.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Intervention model description: Rituximab
Masking: None (Open Label)
Primary purpose: Treatment
BIO.MASTER.BioMonitor 2 Study
Condition: Tachyarrhythmia; Atrial Fibrillation; Syncope
MeSH terms: Syncope; Atrial Fibrillation; Tachycardia
Study type: Observational [Patient Registry]

Summary: 
      The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is
      collected to support the regulatory approval of this product in countries outside the CE
      region.
    


Intervention name(s): BioMonitor 2
Intervention type(s): Device
Intervention description(s): Implantation of BioMonitor 2
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient collective consists mainly of patients with indications of an insertable
        cardiac monitor or who are planned for loop recorded guided AF-therapy management. The
        investigator will select patients who are appropriate for particiation from his general
        patient population.
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
Condition: Spinal Cord Injuries; Paraplegia; Paralysis, Lower Limbs; Lower Extremity; Robotics
MeSH terms: Spinal Cord Injuries; Paralysis; Paraplegia
Study type: Interventional

Summary: 
      The study is a prospective, open, bicentric and observational study. It is conducted to
      assess the safety and performance of the Atalante exoskeleton system with patients with lower
      limb paralysis.

      The principal objective is to assess the performance of the Atalante system in performing
      ambulatory functions with motor complete SCI patients characterized by the success rate in
      performing a 10mWT at the last session of training with the Atalante system.
    


Intervention name(s): Use of the Atalante exoskeleton
Intervention type(s): Device
Intervention description(s): A session basically includes a stand up, walks over a distance of 10 meters, exercises, U-turns and a sitting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spinal Cord Injuries; Paraplegia; Paralysis, Lower Limbs; Lower Extremity; Robotics; Physiotherapy; Rehabilitation; Powered Exoskeleton; Walking; Ambulation
A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of the study is to demonstrate that an investigational 4-dose presentation of
      the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of
      Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal
      serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first
      secondary objective), after administration of a 3-dose primary vaccination course at 6, 10
      and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at
      6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).

      In addition, the study will also assess the safety, reactogenicity, immunogenicity and
      antibody persistence (approximately 7 months following primary vaccination) of the 4-dose
      presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18
      weeks of age followed by a booster dose at 38 weeks.

      This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose
      presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9
      months of age.
    


Intervention name(s): Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation); Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation); DTPw-HBV/Hib
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 4 doses by intramuscular injection in the right left anterolateral thigh; 4 doses by intramuscular injection in the right anterolateral thigh; 3 doses by intramuscular injection in the left anterolateral thigh
Other intervention name(s): 10Pn; 10PN-PD-DiT; GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT); Synflorix™; GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT) vaccine; GSK Biologicals' diphtheria-tetanus-whole cell pertussis-hepatitis B and Haemophilus influenzae type b vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Invasive disease by Streptococcus pneumoniae (S. pneumoniae) (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media); Infants; Multidose; Haemophilus influenzae; Streptococcus pneumoniae; Preservative; Safety; Pneumonia; Immunogenicity; Pneumococcal conjugate vaccine; Acute otitis media caused by non-typeable Haemophilus influenzae (NTHi).; Respiratory tract infections
A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will see how PF-06372865, an experimental drug distributes in the brain after one
      dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also
      evaluate the safety and tolerability of PF-06372865in these subjects and will measure the
      level of PF-06372865 in the blood.
    


Intervention name(s): PF-06372865; PF-06372865; PF-06372865
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.; Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.; Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.
Intervention MeSH terms: PF-06372865
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06372865; phase 1; open-label; GABA-A receptor occupancy; positron emission tomography; healthy subjects
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and
      safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in
      healthy, vaccinia-naïve subjects.
    


Intervention name(s): IMVAMUNE®; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose); 0.5 ml TBS
Other intervention name(s): IMVANEX; MVA-BN®; Tris-buffered-saline
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Minimum Effective Volume for Selective Trunk Block
Condition: Musculoskeletal Diseases or Conditions
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The objective of this study is to identify the minimum effective dosage of a mixture of two
      local anaesthetic drugs called 'levobupivacaine' and 'lignocaine with epinephrine" used to
      produce an effective ultrasound guided selective trunk block for surgical anaesthesia of the
      upper limb.
    

Detailed description: 
      Ultrasound is widely used for brachial plexus block (BPB) and current evidence indicates that
      it is feasible to accurately identify majority of the main components of the brachial plexus
      above the clavicle, including the three trunks. Since majority of the innervation to the
      upper extremity, including the shoulder, arises from the three trunks (superior, middle and
      inferior) of the brachial plexus, so targeted injections of the individual trunks of the
      brachial plexus under ultrasound guidance will produce surgical anaesthesia of the entire
      upper extremity (C5-T1). Principal Investigator refers to this novel technique "selective
      trunk block" (SeTB) and the preliminary experience with SeTB for surgical anaesthesia of the
      entire upper extremity has been very encouraging. Currently there are no data describing an
      optimal dose or volume of local anaesthetic for SeTB. The aim of this study is to identify
      the minimum dosage of 1:1 mixture of 'levobupivacaine' and "lignocaine with epinephrine"
      required to produce effective surgical anaesthesia in at least 90% of patients presented for
      upper limb surgery.
    

Intervention name(s): a 1: 1 mixture of 2% lidocaine with 5ug/ml epinephrine and 0.5% levobupivacaine
Intervention type(s): Drug
Intervention description(s): This study adopts a "Modified Narayana rule (MNR)", a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELAV90) of cases of the aforementioned local anaesthetic (LA) mixture, in order to produce the surgical anaesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries. Based on the principal investigator's clinical experience, the initial volume of 21ml will be used. Depending on the success or failure of the SeTB, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 3ml (1ml for each trunk of brachial plexus located above the clavicle). The upper dose limit of the study to minimize the potential for local anaesthetic systemic toxicity will be 30ml and the lower dose limit will be 12ml, which will be of no clinical importance.
Other intervention name(s): Selective trunk block
Intervention MeSH terms: Lidocaine; Epinephrine; Levobupivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Selective Trunk nerve block
Effects of Dextromethorphan on Opioid Tolerance in Methadone Patients - 1
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if addition of dextromethorphan to a stable dose of
      methadone in opioid dependent subjects will significantly affect physical and psychological
      aspects of opioid tolerance.
    


Intervention name(s): Dextromethorphan
Intervention type(s): Drug
Intervention MeSH terms: Dextromethorphan
Primary purpose: Treatment
Keywords: opiate dependence
Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate reactions to, and choices to self-administer,
      cigarette smoke with varying nicotine content among low-frequency, non-dependent
      adolescent/young adult smokers between the ages of 15-25 years.
    

Detailed description: 
      Participants will undergo three sessions in which their reactions to fixed doses of smoke
      from investigational cigarettes with three different nicotine contents (15.8 mg/gram of
      tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session,
      participants will return to the lab to choose one of the cigarettes to self-administer.
    

Intervention name(s): Very Low Nicotine Content Cigarettes; Intermediate Nicotine Content Cigarettes; Normal Nicotine Content Cigarettes
Intervention type(s): Other; Other; Other
Intervention description(s): cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield; cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield; cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other intervention name(s): Tobacco; Cigarettes; Tobacco; Cigarettes; Tobacco; Cigarettes
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: smoker; young adult; adolescent