bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
Condition: Healthy Subjects; Pharmacokinetics of ASP6294
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single ascending
      intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and
      female subjects.

      This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses
      and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered
      intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF);
      explore a potential gender difference in safety, tolerability and pk of single intravenous
      dose and single sc doses administrations of ASP6294 as well as determine the maximum
      tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294.

      Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.
    

Detailed description: 
      The study consists of two parts: Part 1 (ascending intravenous dose) and Part 2 (ascending
      subcutaneous dose). Subjects will participate in either Part 1 or Part 2. Subjects in Part 1
      and Part 2 will have a residential period of 6 days followed by outpatient visits.
    

Intervention name(s): ASP6294 Intravenous; ASP6294 Subcutaneous; Placebo Intravenous; Placebo Subcutaneous
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous (IV); Subcutaneous (SC); Intravenous (IV); Subcutaneous (SC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacodynamics; Pharmacokinetics; ASP6294; Maximum tolerated dose; Healthy subjects
Direct and Reversed Dorsal Digital Island Flaps: A Review of 65 Cases
Condition: Soft Tissue Reconstruction; Sensory Restoration
Study type: Interventional

Summary: 
      Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The
      study reports reconstruction of small to moderate defects of the fingers with the direct and
      reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The
      main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of
      the flap and joint motion.
    

Detailed description: 
      At final follow-up, sensory restoration of the flap is measured using the static 2-point
      discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) test. Active motion of the
      joints is measured using a standard hand goniometer. For the direct DDIF, total active motion
      is calculated as the sum of degrees of active flexion of the interphalangeal and the
      metacarpophalangeal joints subtracted from the degrees of extension deficit. For the reversed
      DDIF, total active motion of the donor finger is calculated as the sum of degrees of active
      flexion of the proximal and distal interphalangeal joints subtracted from the degrees of
      extension deficit.
    

Intervention name(s): Direct and reversed dorsal digital island flap
Intervention type(s): Procedure
Intervention description(s): The direct dorsal digital island flap is used to cover the defects of adjacent fingers. The reversed dorsal digital island flap is used to cover the defects of the same fingers.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: defect; dorsal branch of the proper digital nerve; dorsal digital island flap; sensory reconstruction.
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and clinical activity of long-term
      dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being
      followed-up for safety.
    


Intervention name(s): Revusiran (ALN-TTRSC)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiomyopathy; Heart Failure; FAC; Amyloid; Transthyretin; TTR; RNAi therapeutic
Fish Oil and Muscle Function
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on
      changes in muscle mass, muscular strength and physical function.
    

Detailed description: 
      Loss of muscle mass is a normal consequence of aging in many older adults, worsened by
      chronic illness, poor appetite and diet, and reduced physical activity. The ensuing decline
      in physical function is a major cause of frailty, disability and death. Treatments that can
      reverse or reduce the age-associated loss of muscle mass are therefore much needed. Evidence
      is emerging that consumption of fish or fish oil derived long-chain omega-3 polyunsaturated
      fatty acids (LCn-3PUFA) may be important for maintenance of muscle mass and physical function
      throughout the life-span. However, the effect of LCn-3PUFA supplementation on muscle mass,
      muscle strength and overall physical function is not known. The goal of this study therefore
      is to determine the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and
      physical function in older adults.
    

Intervention name(s): Omega-3 fatty acids; corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 grams per day for 24 weeks; 4 grams per day for 24 weeks
Other intervention name(s): Lovaza
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will look at the efficacy and safety of NNC0268-0965 (referred to as insulin 965).
      The study aims to show that insulin 965 has positive effects on the blood vessels.
      Participants will get either the new insulin 965 or insulin glargine - a medicine that
      doctors already can prescribe (Lantus®). Which treatment participants get is decided by
      chance. Participants will self-administer 2 injections per day under the skin of the thighs
      for 26 weeks. Study participation will last for about 32 weeks. Participants will have 15
      clinic visits, 2 magnetic resonance imaging (MRI) visits and 14 phone calls with the study
      doctor. There will be a number of in-house assessments to study the effect of the new
      insulin. The assessments will be explained later in detail. The treatment of disease is not
      an aim of this study. Participants cannot be in the study if the study doctor thinks that
      there are risks for their health. Women can only take part in the study if they are not able
      to become pregnant.
    


Intervention name(s): NNC0268-0965; Insulin glargine; Placebo (NNC0268-0965); Placebo (insulin glargine)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): For subcutaneous (s.c., under the skin) injection once daily for 26 weeks; For s.c. injection once daily for 26 weeks; For s.c. injection once daily for 26 weeks; For s.c. injection once daily for 26 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device
Condition: Neurologic Disorder
MeSH terms: Nervous System Diseases
Study type: Interventional

Summary: 
      SWITCH Study
    

Detailed description: 
      STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the
      safety of the StentrodeTM device in participants with loss of motor function due to paralysis
      from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs.

      Research has shown that in individuals with neurological conditions, brain signals can be
      recorded using electrical sensors implanted on to the brain. These signals could be used by
      the individuals to control assistive technology (e.g. spelling devices) that help with daily
      life, just by thinking. However, implanting these electrical sensors often requires open
      brain surgery.

      A new medical device and surgical technique has been developed, which allows implantation of
      the electrical sensors without open brain surgery. The device, called Stentrode™, is a small
      metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent
      structure. It can be placed inside a blood vessel of the brain located in the motor cortex.
      This does not involve open brain surgery.

      The purpose of this research is to evaluate the safety of the Stentrode™ device in humans.
      This is an experimental device. This research will be the first of its kind to be performed
      in humans and may help find safer, more effective ways to introduce/implant electrical
      sensors in patients. This could foster the development of user friendly biotechnology for
      patients with neurological conditions.
    

Intervention name(s): Stentrode
Intervention type(s): Device
Intervention description(s): Implantation of Stentrode device
Intervention model: Single Group Assignment
Intervention model description: Insertion of Stentrode TM device
Masking: None (Open Label)
Primary purpose: Device Feasibility
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment
Condition: Malocclusion
MeSH terms: Malocclusion; Inflammation
Study type: Interventional

Summary: 
      The purpose of this research study is to assess the clinical effectiveness of the procedure
      of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth
      movement in patients undergoing orthodontic treatment. "Accelerated tooth movement" means
      that using the PROPEL™ device may help complete your treatment with braces on one side of
      your mouth sooner than would be expected if the device were not to be used.
    

Detailed description: 
      Following informed consent and satisfying the screening/enrollment assessments, a panoramic
      and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to
      be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one
      minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical
      anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to either
      the left or right side in each subject. Following the procedure, Chlorhexidine rinses are to
      begin twice a day for a week.

      The subjects will be advised to take Tylenol only in case of significant pain. Subjects will
      be seen four to six weeks after completion of treatment for the first follow-up. Subjects
      will be followed up with a telephone consult 24 hours after micro-osteoperforation is
      performed. They will be asked if any pain medication was taken after being dismissed from the
      research center and if so, they will be asked the name and dose of medication taken.

      Study will conclude at the 6 month follow up visit or when space on the treating side is
      closed.
    

Intervention name(s): Micro-osteoperforation; Anesthestic; Chlorhexidine
Intervention type(s): Device; Drug; Other
Intervention description(s): Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.; Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.; Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
Other intervention name(s): PROPEL™; Topical or local anesthetic; Peridex
Intervention MeSH terms: Chlorhexidine; Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malocclusion; Accelerated tooth movement; Braces; Orthodontic treatment; Propel
Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices (H2M1)
Condition: Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      This research compared the efficacy of two parenting interventions that vary according to the
      number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The
      goal was to identify which parenting intervention format (one-variable versus two-variable)
      caused higher behavioral adjustment in children.
    

Detailed description: 
      The first format was a one-variable intervention manipulating parental self-efficacy beliefs.
      The second format was a two-variable intervention manipulating both parents' self-efficacy
      beliefs and emotion coaching practices. The two interventions shared exactly the same design,
      consisting of eight parent group sessions. Effect on children's EB and observed behaviors
      were evaluated through a multi-method assessment at three points (pre-test, post-test and
      follow-up).
    

Intervention name(s): Parenting program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parenting intervention; externalizing behavior; emotion coaching practices; self-efficacy beliefs
Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or
      placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have
      not achieved their blood glucose goal using insulin alone. This study requires a total of
      seven visits during 28 weeks.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus Thiazolidinediones Insulin
To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled study to assess the
      pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125
      (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy
      subjects.
    


Intervention name(s): TEV-48125 - 1; TEV-48125 - 2; TEV-48125 - 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous administration Dose Regimen 1; Subcutaneous administration Dose Regimen 2; Subcutaneous administration Dose Regimen 3; Matching Placebo
Other intervention name(s): monoclonal antibody; monoclonal antibody; monoclonal antibody
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Wheezing Diagnosis Using a Smartphone
Condition: Bronchiolitis
MeSH terms: Bronchiolitis; Respiratory Sounds
Study type: Observational

Summary: 
      Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute
      bronchiolitis. One third of these infants will develop recurrent episodes, leading to the
      diagnosis of infant asthma. Nowadays, no available treatment shortens the course of
      bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our
      hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help
      to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of
      wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value.
      The investigators developed a wheezing recognition algorithm from recorded respiratory sounds
      with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of
      the present cross sectional, observational study are 1/ to further validate our approach in a
      larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint
      during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing
      by respiratory sound recording (Littmann) and subsequent analysis by two experienced
      pediatricians.
    

Detailed description: 
      Infants (1 to 24 months old) are recruited in two emergency departments (Robert Debré;
      Antoine Béclère hospitals of Assistance publique - Hôpitaux de Paris) based on a respiratory
      complaint. Six characteristics are recorded (age, sex, SpO2, presence or absence of wheezing,
      other respiratory sound, initial diagnosis). Two recordings of respiratory sounds are
      obtained almost simultaneously: one with a Smartphone at the mouth (5 cm) and one with an
      electronic stetoscope (Littmann). Two expert pediatricians listen the recordings giving thee
      groups: with wheezing (agreement), without wheezing (agreement) and non agreement diagnosis.
      The recordings made with the Smartphone are subjected to the wheezing recognition algorithm
      as previously described. The sensitivity, specificity, PPV, NPP are then evaluated. The
      algorithm will further be improved if necessary using the true negative and true positive
      recordings (those with expert agreement).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Infant selected in the emergency department: respiratory complaint
      
Keywords: wheezing; bronchiolitis; respiratory sound algorithm
A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
Condition: Non-emergent, Abdominal or Thoracic Procedures
Study type: Interventional

Summary: 
      A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.
    

Detailed description: 
      The objective of this prospective, two-arm, multicenter, post-market study is to evaluate
      safety through the incidence of reported device-related adverse events (AEs) through 30 days
      following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects
      undergoing indicated abdominal or thoracic procedures.
    

Intervention name(s): Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
Intervention type(s): Device
Intervention description(s): Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to compare the short-term effects and mechanisms of action of
      exenatide with those of sitagliptin when either is added to an oral agent(metformin or a
      thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with
      inadequate glycemic control.
    


Intervention name(s): exenatide; sitagliptin; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous injection (5mcg or 10mcg), twice a day; oral administration (100mg), once a day in the morning; subcutaneous injection (5mcg or 10mcg), twice a day; oral administration (100mg), once a day in the morning
Other intervention name(s): Byetta; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exenatide; sitagliptin; Amylin; Lilly; metformin; thiazolidinedione
Concussion Testing: A Novel Non-invasive Concussion Detection Device
Condition: Concussion
Study type: Observational

Summary: 
      The purpose of this study is to establish and evaluate a distinctive signal for concussion.
    

Detailed description: 
      The purpose of this study is to establish a non-invasive objective measurement for the
      detection of concussions with the Jan Medical Device (JMD). The study will assess the ability
      of this device to demonstrate unique signals that correlate with concussions. The study will
      also test the athletes at baseline at rest and during exertion to determine if there is a
      difference in the signal from exertion alone. The JMD is a non-invasive band that is placed
      around the participants head. The JMD detects a unique pattern of signals based on
      displacement of the skull from changes in blood flow during individual heartbeats. The
      athletes will be tested longitudinally to assess to changes over time, in addition to changes
      after impact
    

Intervention name(s): Nautilus NeuroWaveTM System; SCAT
Intervention type(s): Device; Behavioral
Intervention description(s): Recording of subjects with Nautilus NeuroWave diagnostic device; A Neurocognitive evaluation of the patients to assess for concussion.
Other intervention name(s): Jan Medical Nautilus NeuroWave; Sports Concussion Assessment Test, SCAT2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Varsity high school football players at a local High School.
      
Keywords: Concussion