bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety and Tolerability of PBF-1650 in Healthy Volunteers.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, randomized, double-blind, placebo-controlled clinical study to assess the
      safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).
    

Detailed description: 
      The clinical trial will be a dose escalation study without therapeutic benefit, in which
      PBF-1650 will be administered as single oral ascending- dose to healthy young male
      volunteers. Up to four different rising doses will be tested (40 mg, 80 mg, 120 and 240 mg)
      in groups/cohorts of 8 participants. Thus, four groups/cohorts will participate. For each
      dose level / group, the participants will be randomized to active or placebo with 2
      participants being randomly assigned to placebo and 6 to the active drug. First, one
      volunteer will receive active drug (subgroup 1); after at least 48h of safety and
      tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1
      placebo; after at least another 48h of safety and tolerability parameters assessment a third
      subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety
      parameters of corresponding dose level, the process will replicate one week afterwards in the
      following dosages.

      The pharmacokinetics profile of PBF-1650 after single oral dose administration of the four
      dose levels will be also assessed.
    

Intervention name(s): PBF-1650 oral capsules; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Adenosine A3 receptor (AA3R) antagonist; solid microcrystalline cellulose
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single center, randomized, double-blind, placebo-controlled clinical study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adenosine A3 receptor antagonist; autoimmune diseases; Immune modulator
The Effect of AyuFlex® Supplementation on Joint Health
Condition: Arthralgia
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      The purpose of this 12-week, prospective study is to determine the effects of oral
      supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility,
      joint comfort and functional capacity in healthy overweight subjects.
    

Detailed description: 
      This interventional study is a 12-week, randomized, double-blind, placebo and dose-response
      controlled clinical trial (in 3 parallel groups) of male and female subjects without active
      osteoarthritis of the knee to be recruited at a single investigational center in the U.S. A
      two-week placebo lead-in period will precede the study to enhance statistical power.
      One-hundred and five (105) overweight, apparently healthy subjects, pre-screened using health
      history questionnaires, vital signs, blood work and a standardized lower extremity exercise
      performance test will be randomized to one of three groups for 84 days: placebo, AyuFlex1
      (500 mg/d) or AyuFlex2 (1000 mg/d). AyuFlex is an organic, non-GMO, over-the-counter joint
      health product derived from the edible fruits of Terminalia chebula.
    

Intervention name(s): AyuFlex; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active product; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg
      b.i.d. in subjects aged 18 years and above.

      We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from
      baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects
      with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however,
      this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample
      size for statistical power while retaining trial feasibility in an orphan disease population
    

Detailed description: 
      This is a double-blind, randomized, parallel arm, controlled, multicenter, and interventional
      clinical trial. Potential subjects will sign the informed consent form (ICF) and be assessed
      for eligibility. After satisfying all inclusion & exclusion criteria, subjects will be given
      a mannitol tolerance test (MTT). Those subjects that pass the MTT will be randomized to
      receive inhaled mannitol (400 mg b.i.d.) or control b.i.d. for a period of 26-weeks.
    

Intervention name(s): Inhaled mannitol; Placebo Comparator: Arm B - Control
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled mannitol 400 mg BD for 26 weeks; Placebo Comparator: Arm B - Control BD for 26 weeks
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.
Condition: Spinal Cord Injuries; Tetraplegia
MeSH terms: Spinal Cord Injuries; Quadriplegia
Study type: Interventional

Summary: 
      Functional Electrical Stimulation is an established technique in which small electrical
      impulses are used to cause a contraction in muscles and thereby enable movement, in people
      with neurological or musculoskeletal problems who are unable to undertake those movements
      themselves. People with spinal cord injuries of the neck at C5, C6 and C7 account for 35% of
      all spinal cord injuries. Despite this, there is only one commercial FES (Functional
      Electrical Stimulation) based orthosis currently available. Even that has limitations in that
      it as it has a single size rigid exoskeleton it does not fit all people who could benefit and
      also due to its rigidity it does not allow people with lower injuries to utilise any
      remaining tenodesis grip. As a result, it is not widely used within the spinal injured
      communities. Therefore what is required is a more flexible system that can benefit a larger
      number of people whilst still being affordable within the constraints of the NHS. A previous
      INSPIRE funded project, TETRAGRIP I demonstrated that a surface FES system controlled by an
      inertial sensor, measuring movement of the opposite shoulder, could meet this specification
      and was successfully tried on two people with tetraplegia. What is now required is a more
      detailed study in which the principle components of that system are incorporated into a
      practical device suitable for use at home without clinical supervision. It is therefore
      proposed to develop and build such a system and to conduct extended home based trials in
      three people with tetraplegia.
    


Intervention name(s): TetraGrip II system
Intervention type(s): Device
Intervention description(s): This main aim of this whole research project is to evaluate the performance of the TetraGrip II system in improving the upper limb functions in people with C4-C7 tetraplegia i.e. people who have damaged their spinal cord in the neck resulting in loss of function in all four limbs. The Tetragrip system uses a technique called Functional Electrical Stimulation (FES) in which small electrical impulses are used to activate paralysed muscles and hence provide movement. The stimulation is controlled by sensors which measure the movement of the other shoulder and enable the person to regain the use of their hand via stimulating electrodes placed on the skin over the relevant muscles.
The feasibility of using this FES based system in restoring the upper arm functions will be evaluated by clinically trying the device on participants with C4-C7 tetraplegia.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Condition: Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib
      (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus
      erythematosus (CLE).
    


Intervention name(s): Lanraplenib; Filgotinib; Lanraplenib placebo; Filgotinib placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30 mg tablets administered orally once daily with or without food; 200 mg tablets administered orally once daily with or without food; Tablets administered orally once daily with or without food; Tablets administered orally once daily with or without food
Other intervention name(s): GS-9876; GS-6034
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of
      CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).
    


Intervention name(s): CC-93538; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dosages on specified days; Specified dosages on specified days
Other intervention name(s): RPC4064; cendakimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Cendakimab; CC-93538
Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density
Condition: Rehabilitation
Study type: Interventional

Summary: 
      One group will receive today's standard rehabilitation program following hip fracture
      surgery. The intervention group will have maximal strength training incorporated in their
      program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over
      4 sets for leg press and abduction resistance exercise at ~85% of maximal strength is carried
      out. Muscle strength, balance and bone density will be compared between the groups following
      the 8-week rehabilitation period. The feasibility of the intervention for the patient group
      will be evaluated based on compliance with training program and possible adverse events
      related to the operated hip.
    


Intervention name(s): Maximal Strength Training
Intervention type(s): Other
Intervention description(s): leg pres and abduction exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determine the Relationship Between Circadian Rhythms and Nocturnal Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a disease that affects the lungs. Symptoms include repeated episodes of wheezing,
      breathlessness, chest tightness, and nighttime or early morning coughing. Some people with
      asthma experience worse symptoms at night, which is known as nocturnal asthma (NA). The
      reason for the decline in lung function at night in some asthmatics is not well understood,
      but it may be linked to the human biological clock, which controls daily activity and sleep
      rhythms. To determine whether differences in biological clocks relate to worsening nocturnal
      lung function, this study will evaluate the circadian rhythms of people with NA, people with
      non-nocturnal asthma, and healthy people.
    

Detailed description: 
      Nocturnal worsening of asthma, frequently called NA, is a common problem among some people
      with asthma and one that leads to increased morbidity and mortality. It is still unknown why
      lung function worsens at night in some asthmatics and not others. There is a possible
      relationship between NA, biological clocks, and circadian rhythms, but more research is
      needed to understand this relationship. Although the diurnal nature of NA has been shown
      repeatedly in studies, circadian rhythms have not yet been implicated as a related factor.
      This study will examine the pathophysiology of NA as it relates to circadian biology and will
      specifically explore physiological and molecular aspects.

      This study will include people with asthma, people with NA, and healthy people. Potential
      participants will attend a screening visit to assess general health and severity of asthma,
      if present. They will also complete 2 weeks of diary recordings of their daily symptoms and
      airway function.

      Eligible participants will then attend two study visits. The first study visit will last 1
      hour and may include a methacholine challenge and bronchodilator testing, both of which will
      measure lung function. For 2 weeks before the second study visit, participants will keep
      records of their sleep patterns. The second study visit will be a hospital stay that will
      last for 2.5 days. While in the hospital, participants will undergo periodic blood draws and
      lung function testing. During waking hours, participants will remain quietly awake. During
      the first night, participants will be monitored while they sleep. During the second night,
      participants will stay awake for 28 hours, which will continue into the third day. Then, on
      the third day, participants will sleep for 8 hours while again being monitored. Upon waking,
      participants will be given a regular meal and discharged.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy and asthmatic participants
      
Keywords: Circadian Rhythm
Safety and Pharmacology of Stanate
Condition: Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in
      infants who are at risk for an exchange transfusion and meet the criteria of the protocol.
    

Detailed description: 
      The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy
      in a non randomised sequential open label cohort design, in 55 patients. Subjects were term
      and near term infants at medium or high risk of hyperbilirubinemia with TSB levels
      approaching the threshold for exchange transfusion. The first cohort began at a dose of
      stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5
      mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted
      of hepatic, renal and hematologic clinical laboratory tests along with serial physical
      examinations. Long term follow up of all patients to age 6 is planned.
    

Intervention name(s): Stanate
Intervention type(s): Drug
Intervention description(s): Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
Intervention MeSH terms: Tin mesoporphyrin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonatal; jaundice; hyperbilirubinemia
Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients
      with Type I and Type II diabetes.
    

Detailed description: 
      The primary objective is to demonstrate improved A1c in study subjects with type 1 and type 2
      diabetes using the OneTouch Verio® Flex BGM and the OneTouch Reveal® Mobile APP system over a
      period of 24 weeks, compared to subjects using the OneTouch Verio® Flex BGM.
    

Intervention name(s): OneTouch Reveal® Mobile APP; OneTouch Verio® Flex BGMS
Intervention type(s): Device; Device
Intervention description(s): Diabetes management application for use on a mobile phone.; Blood Glucose Monitoring System (BGMS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus; A1c
Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant
Condition: Infant; Pain
Study type: Interventional

Summary: 
      Background: Healthy newborns undergo many painful procedures in the first hours of life.
      Damage caused by painful procedures can lead to structural and functional changes that can
      affect adult life. Various non-pharmacological methods have been reported in the literature
      for pain management. The aim of the study is to investigate the effect of the method that
      appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the
      level of pain during heel blood collection.

      Method: The population of the study consisted of babies who were hospitalized in a hospital's
      neonatal unit between December 2022 and May 2023 and who heel blood taken. The
      Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120
      newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2
      (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before
      the heel blood collection and continued until the 5th minute after the procedure. The mother
      called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto
      the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze and the gauze was then
      placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and
      baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood
      collection and continued until the 5th minute after the procedure for all groups.
    


Intervention name(s): Sensory Interventions
Intervention type(s): Behavioral
Intervention description(s): Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure.
Group 3 will be skin contact with mother's before, during and after the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: infant; pain; mother's milk; mother's voice; skin contact
Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Down syndrome can be characterized by global mental and physical dysfunction or isolated
      gait, cognition, growth, or sensory disturbances. This study was conducted to investigate the
      effect of the sensory integration approach on improving balance and motor coordination in
      children with Down syndrome.
    

Detailed description: 
      Thirty children were enrolled in this study and randomly assigned to two groups: Group A
      received (sensory integration therapy program and training in physical therapy) and received
      group B (physical therapy training program only). Motor coordination and balance were
      assessed before and after exercise for all children using Bruininks - Oseretsky Test of Motor
      Proficiency - 2nd Edition.
    

Intervention name(s): sensory integration approach; traditional physical therapy program
Intervention type(s): Other; Other
Intervention description(s): Sensory integration refers to how the nervous system receives messages from multimodal sensory information systems to maintain balance, posture, and balance by monitoring head movement and stabilizing the eyes about the environment; conventional physiotherapy training programs such as the following: 1)Hand function training by locating the Grading of the hand and training this level until it is well developed to transfer to the next level according to 8 parameters (partner's height-shape-weight-texture -reaction time-speed-accuracy-number of trials).
2) equilibrium training by promoting posture reaction. 3)ADL activity training (nutrition training-dressing training-toilet training). 4) Functional skill training through walking (walking on sand, weight on legs, and Climbing stairs ).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trisomy 21, Neurodevelopmental disorder
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
Condition: Healthy Subjects; Pharmacokinetics of ASP015K; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to explore safety and tolerability of multiple oral doses of
      ASP015K in healthy volunteers.
    

Detailed description: 
      Subjects will be confined to the clinical research unit for 19 days. Subjects will receive a
      follow-up phone call to asses safety 1 to 5 days after being discharged from the study.

      Subjects will receive study drug twice per day (BID) on days 1 to 13 of the 14 day treatment
      period, and will receive a single dose of study drug on the morning of day 14 of the
      treatment period.
    

Intervention name(s): ASP015K; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ASP015K; Healthy subjects