bioihbjkbjnl/mcl2 huggingface dataset:
The Role of the Circadian System in Neurological Sleep-wake Disorders
Condition: Narcolepsy 1; Idiopathic Hypersomnia
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Idiopathic Hypersomnia; Sleep Wake Disorders
Study type: Interventional

Summary: 
      The aim of this study is to investigate the role of the circadian system in patients with
      neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours
      into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at
      different circadian phases. Vigilance, attention, risk behavior as well as sleep onset
      latency will be observed.

      Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of
      sleep disorders, as they allow to also include the everyday rest-activity rhythm before
      examinations in the sleep laboratory. Advances of novel devices should improve the detection
      of rest and activity and therefore the estimation of sleep and wake, especially in patients
      with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters
      will be applied throughout our study protocol to explore better classification of sleep and
      wake phases and patterns of the rest-activity rhythm.

      This study is designed as an observational case-controlled study targeting the disorders of
      narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the
      healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.
    


Intervention name(s): Sleep restriction; Sleep deprivation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Restricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination; Sleep deprivation during first night of sleep laboratory examination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Comparison Between Conventional Surgery and Piezosurgery
Condition: Third Molars Extraction
Study type: Interventional

Summary: 
      Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock
      Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal
      of impacted mandibular third molars on both sides of the jaw.
    

Detailed description: 
      The study is about measuring the amount of HSP70 using Elisa kit for detecting HSP70 and
      mason trichrome for histological findings in which the study samples are patients who have
      bilateral impacted mandibular third molar to be extracted with bone removal. First we collect
      bone sample for mason trichrome with either method then we collect the second samples after
      removing most of the bones cover the impacted third molar for checking HSP70 levels. Then the
      bone samples are treated using a special protocol to eliminate the protein from bone samples
      for the Elisa analysis. The other bone samples are going to be studied under the microscope.
    

Intervention name(s): Piezosurgery
Intervention type(s): Device
Intervention description(s): This intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tenaculum in Endometrial Sampling Procedure
Condition: Endometrium; Biopsy
Study type: Interventional

Summary: 
      Most of gynecological office procedure such as endometrial sampling procedure,
      hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device,
      difficult intrauterine insemination or embryo transfer procedures often require the
      application of a single tooth tenaculum to the cervix for steady the cervix, straighten the
      cervicouterine angle and provide countertraction. However, grasping the cervix with a
      tenaculum can be a painful experience for the patient.A randomized controlled trial was
      conducted to evaluate using of tenaculum on pain perception of the patients and the procedure
      performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.
    

Detailed description: 
      One hundred fifteen patients included for assessing pain perception and procedure performance
      during endometrial with pipelle. Patients were randomly assigned to one of two groups as
      Group 1( with tenaculum) and Group 2 (without tenaculum).
    

Intervention name(s): Tenaculum
Intervention type(s): Device
Intervention description(s): Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Endometrial Sampling Procedure; Likert Scala; Pipelle; Tenaculum; Visual Analog Pain Scala
PK and Safety of SI-722 in IC/BPS
Condition: Interstitial Cystitis; Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed randomized, double-blind, placebo-controlled trial in Interstitial
      Cystitis/Bladder Pain Syndrome patients.
    


Intervention name(s): SI-722; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SI-722 will be intravesically instilled.; Placebo will be intravesically instilled.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bladder; Intravesical Injection; Interstitial Cystitis
Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation
Condition: Disorder Related to Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Current practice of immune suppressive standard therapy after renal transplantation in
      non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and
      MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a
      concept of not using steroids in order to establish an immunosuppressive regimen in
      immunologically non-risk patients that is efficient and causes as few side effects as
      possible.
    

Detailed description: 
      In this triple arm, prospectively randomized multi centre phase IV study 200 patients per
      study arm will be investigated for 12 months.

      Based on the results of the Symphony study the low dose tacrolimus study arm will be modified
      to further improve efficacy (prevention of BPAR, best possible renal function) and safety
      (adverse event profile regarding infections, cardiovascular risk factors, malignant tumours)
      of immunosuppression. For this, CNI will be reduced and in addition the rate of steroid free
      patients after 1 week will be maximized to achieve a long lasting improved post surgical
      cardiovascular risk profile (in particular concerning de novo induction of diabetes mellitus
      and other adverse events caused by steroids). Safety should be increased without loss of
      efficacy of immunosuppression (measured in rejection rate and allograft loss rate) as
      compared to an immune suppressive therapy comprising steroids. Therefore, following the
      successful study arm of the Symphony study, immunosuppression in the first of the three study
      arms comprises a steroid in combination with Advagraf and CellCept in addition to a two dose
      induction therapy with Simulect (group A). The regimen of the second study arm is similar but
      discontinues steroids on day seven after transplantation (group B). Therapy of group three is
      similar to group B but Simulect is replaced by T-cell depleting polyclonal antibodies
      (Thymoglobulin) (group C).
    

Intervention name(s): Basiliximab, Tacrolimus, MMF, Prednisolon; Basiliximab, Tacrolimus, MMF; Tacrolimus, MMF, rATG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Control group. Therapy with Prednisolon.; No Prednisolon after 7 days; Induction therapy: rATG instead of Basiliximab. No Prednisolon.
Other intervention name(s): Simulect; Advagraf; CellCept; Decortin; Simulect; Advagraf; CellCept; Advagraf; CellCept; Thymoglobulin
Intervention MeSH terms: Mycophenolic Acid; Prednisolone; Tacrolimus; Thymoglobulin; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney transplant status; Steroid free; Reduced; Calcineurin; Inhibitor; Immunosuppression
DAW1033B2 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal subjects. In this protocol the investigators will test the effect of DAW1033B2
      administered before sleep on OSA phenotype traits and OSA severity during sleep.
    


Intervention name(s): Placebo oral capsule; DAW1033B2 oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsule 30 minutes before sleep; DAW1033B2 capsule 30 minutes before sleep
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to
      evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC)
      injection for a period of seven days. Blood samples will be obtained at screening and for
      drug concentration data.
    


Intervention name(s): Methylnaltrexone bromide
Intervention type(s): Drug
Intervention description(s): Subcutaneous MNTX
Intervention MeSH terms: Bromides; Methylnaltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Condition: Urology
Study type: Interventional

Summary: 
      In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will
      be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry
      method. In the home setting a human factor/usability study will be conducted to measure the
      subject's ability to perform a successful SMIP assessment at full and empty bladder with the
      Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean
      intermittent catheter (CIC).
    


Intervention name(s): Peritron+
Intervention type(s): Device
Intervention description(s): Peritron+ device to measure intravesical pressure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm,
      dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy,
      safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of
      fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.

      Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a
      clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a
      total of 4 treatment arms. Each arm includes a single intra-articular injection of one of
      three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation
      ratio will be 1:1:1:1.

      The primary efficacy variable will be the change of the Western Ontario and McMaster
      Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline
      up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and
      clinical laboratory tests; local tolerability at the injection site will also be assessed. In
      addition, the population pharmacokinetics and the exposure-response relationship will be
      evaluated.

      The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7
      planned visits at site, including screening, randomisation, 4 follow-up visits and the End of
      study visit.
    


Intervention name(s): Fasitibant- low dose; Fasitibant- intermediate dose; Fasitibant- high dose; Placebo comparator
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single intra-articular injection of low dose of fasitibant; Single intra-articular injection of intermediate dose of fasitibant; Single intra-articular injection of high dose of fasitibant; Single intra-articular injection of placebo
Intervention MeSH terms: (4-amino-5-(4-(4-(2,4-dichloro-3-(2,4-dimethyl-8-quinolyloxymethyl)phenylsulfonamido)tetrahydro-2H-4-pyranoylcarbonyl)piperazino)-5-oxopentyl)(trimethyl)ammonium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Arthritis; WOMAC; Injections, intra-articular; Fasitibant; MEN 16132
Functional MRI Study in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD)
Condition: Developmental Dyslexia; Developmental Coordination Disorder
MeSH terms: Dyslexia; Motor Skills Disorders
Study type: Interventional

Summary: 
      All the studies underlined the high frequency of co-morbid associations in specific learning
      disorders. Understanding the reasons for these associations could enable us to determine the
      cerebral bases that underlie each disorder. Their frequent association suggests the
      etiological bases are partly common, it seems logical to turn to explanatory models of
      various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007)
      suggests a specific disorder of procedural learning. But the brain networks involved in this
      learning could be achieved separately. We intend therefore to study the neural networks
      involved in learning procedural and compare networks recruited among children with specific
      learning disorder alone or in combination (co-morbidity). The children included in the study
      have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The
      procedure includes a neuropsychological evaluation and a brain MRI study with a morphological
      and a functional part. During fMRI the child realizes a automated motor task contrasting with
      a task involving learning procedural.
    


Intervention name(s): Neuropsychological assessment; MRI Study
Intervention type(s): Behavioral; Other
Intervention description(s): The neuropsychological assessment will include an assessment of:
Intellectual ability
Laterality
Reading Skills
Motor skills
Oral Language
Attention
Child's behaviour; It will include a first session of about an hour outside MRI for familiarization with the environment of the MRI. The MRI will then be made after a break of 15 minutes
Morphological time: this time include the initial acquisition of a sequence of anatomical 3D T1-weighted high-resolution contiguous axial slices and the imaging of diffusion tensor.
Functional time: The experimental paradigm is a paradigm as a block with alternating phase of motor and rest conditions. The two motor tasks are: a Learning motor sequence or motor sequence task and Automated motor sequence or AT (automated task).
Other intervention name(s): structural and functional MRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Essential Amino Acids Supplementation and Muscle Protein Synthesis
Condition: Muscle Loss; Muscle Anabolism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The modern warfighter faces numerous physiological challenges including sleep deprivation,
      sustained intense physical activity, and caloric restriction, the combined effects of which
      may result in the loss of lean body mass and decreased physical performance. Dietary
      interventions may help preserve lean body mass and facilitate recovery from periods of
      intense physical demand. For example, dietary strategies that increase amino acid
      availability have been shown to stimulate protein synthesis in skeletal muscle following
      resistance exercise. Because military tasks also incorporate endurance exercise components,
      studies regarding the effects of increasing dietary amino acids following endurance exercise
      are warranted. The objectives of this study are to characterize the effect of endurance
      exercise on protein synthesis and breakdown as well as the ability of an essential amino acid
      supplement to influence skeletal muscle protein metabolism and its cellular and molecular
      regulation following endurance exercise.
    


Intervention name(s): Essential Amino Acids; Endurance exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials; 60 minute endurance exercise session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: protein turnover; whole body protein turnover; essential amino acids; leucine
Effect of High Dose Naloxone on Secondary Hyperalgesia
Condition: Hyperalgesia; Pain; Naloxone; Opioid Antagonist
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      Recent studies have focused on the role of endogenous opioids on central sensitization.
      Central sensitization is known to be impaired or altered in chronic pain conditions, as
      fibromyalgia or chronic tension headache.

      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone
      administration after resolution of an injury. This suggests latent sensitization.

      In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate
      secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim
      therefore to show that latent sensitization is present in humans and is modulated by
      endogenous opioids.
    


Intervention name(s): Naloxone (2 mg/kg); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: secondary hyperalgesia; allodynia; mechanical pain threshold; naloxone; endogenous opioids; pain
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after
      administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma
      concentration of C3G and the antioxidative markers such as total antioxidative capacity and
      attack of free oxygen radical will be measured.

      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg
      black bean seed coat extract.

      This study, as an exploratory trial, does not required statistical hypothesis
    


Intervention name(s): Black bean seed coat extract
Intervention type(s): Other
Intervention description(s): 1000 mg oral daily dose for 2 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: C3G; Oxidative stress; Antioxidant; Black bean
Validity Reliability of FrailBESTest in Older Adults
Condition: Frail Elderly Syndrome; Balance; Distorted; Assessment, Self
Study type: Observational

Summary: 
      Fraility; It is an age-related biological syndrome. It is characterized by decreased
      resistance to stressors due to changes in functional reserves and physiological systems.

      BESTest, which is frequently used in the literature, was modified and Frail'BESTest was
      developed to detect balance problems in fragile individuals. The test consists of 6
      subtitles. These are participation, reaction, movement ability, sensory organization,
      biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version
      of Frail'BESTest has not been found. For this reason, the aim of study is to examine the
      validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and
      to question the effectiveness of its clinical use and to bring it to the use of other
      researchers.
    

Detailed description: 
      Fraility; It is an age-related biological syndrome. It is characterized by decreased
      resistance to stressors due to changes in functional reserves and physiological
      systems.Especially, the increase in the incidence of falls, loss of mobility, dependence in
      basic life activities, increase in hospitalizations and increased incidence of death make the
      diagnosis and treatment of frailty important in elderly individuals.

      BESTest, which is frequently used in the literature, was modified and Frail'BESTest was
      developed to detect balance problems in fragile individuals. The test consists of 6
      subtitles. These are participation, reaction, movement ability, sensory organization,
      biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version
      of Frail'BESTest has not been found. For this reason, the aim of study is to examine the
      validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and
      to question the effectiveness of its clinical use and to bring it to the use of other
      researchers.
    

Intervention name(s): Frail older adults, assessment
Intervention type(s): Other
Intervention description(s): Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinnetti Balance and gait sacale
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals aged 65 and over, Volunteering to participate in research, No cooperation and
        communication problem