bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Condition: Lumbosacral Radiculopathy
MeSH terms: Neuralgia; Radiculopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy
      of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.
    

Detailed description: 
      The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or
      placebo administered twice daily. In addition, single blind placebo will be administered
      during a two week run-in, a two week wash-out period between the two treatment periods, and a
      one week run-out phase.

      This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been
      acquired by Biogen.
    

Intervention name(s): CNV1014802; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in treatment arm.; Administered as specified in treatment arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)
Condition: PTSD
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      This is a prospective, longitudinal cohort study to evaluate the associations between indices
      of brain structure and function (measured at baseline, as soon as possible after injury) and
      course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members
      who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or
      "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of
      traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment
      battery at baseline and 6 months later that includes (1) structural magnetic resonance
      imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2)
      event-related brain potentials (ERPs) derived from brain electrical activity; (3)
      neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain
      structure and function derived from these assessments are hypothesized to demonstrate a
      significant relationship with course of PTSD symptoms, which will be measured at baseline, 3
      months, and 6 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Service members who have sustained mild TBI or extracranial injury (ECI), and have received
        care at Walter Reed National Military Medical Center or Fort Belvoir Community Hospital.
      
Keywords: PTSD; mTBI; mild TBI; extracranial injury; ECI; Brain Indices
Assessment of Exposure of BI 409306 in Cerebrospinal Fluid (CSF) Relative to Plasma as Well as to Evaluation of the Effect of Different Doses of BI 409306 on the cGMP (Cyclic Guanosine Monophosphate) Levels in CSF in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Due to the exploratory nature of this trial, there is no primary objective in a confirmatory
      sense. The study aims

      - to evaluate the effect of different doses of BI 409306 on biomarker and to assess the
      exposure of BI 409306
    


Intervention name(s): BI 409306; BI 409306; BI 409306; BI 409306 Placebo; BI 409306
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): High dose film-coated tablet; Low dose film-coated tablet; Low dose film-coated tablet; Film-coated tablet; Medium dose film-coated tablet
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Annovera™ Drug-Drug Interaction Study
Condition: Women; Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      A Drug-Drug Interaction (DDI) study to evaluate the effects of itraconazole and rifampin on
      the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol from the Annovera
      Contraceptive Vaginal System (CVS)
    


Intervention name(s): Segesterone Acetate and Ethinyl Estradiol; Rifampin; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Contraceptive Vaginal System; CYP3A inducer; CYP3A inhibitor
Other intervention name(s): Annovera
Intervention MeSH terms: Itraconazole; Rifampin; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two cohort, open label, randomized, two period (Cycle 1 and Cycle 2) crossover study. Subjects may only participate in one randomized sequence of one cohort. Subjects will be assigned to either Cohort 1 (itraconazole) or Cohort 2 (rifampin). Once assigned, a subject will then be randomized to a Sequence Group within the cohort. There will be at least a 4-week washout between Treatment Cycle 1 and Cycle 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rifampin; itraconazole; CYP3A
Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
Condition: Ear Aplasia
Study type: Observational

Summary: 
      The objective of the study is to analyse :

        -  Psychic experience of ear aplasia in children ;

        -  the modalities of their psychic functioning ;

        -  and the psychological repercussions of the plastic reconstruction surgery
    

Detailed description: 
      Children with an ear aplasia have various cares (ENT, speech therapy, hearing aids and
      tomodensiometry) up to the proposal of the plastic reconstruction surgery at 9/10 years old.

      The surgical technique used and preferred within Necker Hospital for these children is that
      of Saturo Nagata (1994).

      This surgical protocol takes place in two times, spaced by 9 months. This surgery does not
      allow hearing better since it targets is only a reconstruction of the pinna. To date, no
      research has highlighted the subjective experience of a child with an aplasia of ear and of
      what this surgery engages and demands on the side of psychological work.

      The purpose of this research is to interrogate the children's subjective experience with an
      unilateral ear aplasia and who wishes a plastic reconstruction surgery for their aplase ear.
    

Intervention name(s): Psychological monitoring
Intervention type(s): Behavioral
Intervention description(s): Discussions with the psychologist PhD student before and after every surgery times : 3 discussions.
Before the first surgery (about 1 month before) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)
Before the second surgery (3 months later the first surgery) Clinical interview Drawing a person
After the second surgery (15 months later the first surgery) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Minors with ear aplasia with or without articulatory disorders, without syndromic
        impairment and initiating a reconstructive plastic surgery procedure at Necker Hospital.
      
Keywords: Ear aplasia; Reconstructive plastic surgery; Subjective experience; Psychic stakes; Psychodynamic evaluation
The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's
Condition: Comforf, Procedural (During Newborn Care İn Newborn's); Physiological Parameters During Newborn Care İn Newborn's
Study type: Interventional

Summary: 
      Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and
      nurturing was applied respectively to the study groups for approximately 20 minutes. The baby
      was made listen to the lullaby recorded in the voice of parents starting with, during and
      after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour
      scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
      The data was evaluated in SPSS 21.0 program with convenient statistical methods.İt is
      detected that heart rate, respiration rateand comfort behiavour scores of the newborns who
      listen to lullaby in the mother's voice are low compared to the newborns listening to lullaby
      in the father's voice and those in the control group .
    


Intervention name(s): LISTENING TO THE RECORDINGS SAYING BY PARENTS
Intervention type(s): Behavioral
Intervention description(s): The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mother's voice; Father's voice; Lullaby; Comfort; Physiological Parameters
Psychosocial Risks in Liver Transplant Recipients
Condition: End Stage Liver Disease
MeSH terms: Liver Diseases; End Stage Liver Disease
Study type: Observational

Summary: 
      A retrospective chart review in which the information in the standard psychosocial
      evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and
      correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include
      rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication Level
      Variability Index). The researchers will evaluate the degree to which both single elements in
      the evaluation as well as a cumulative score derived by a structured review of the chart
      using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) model can
      predict posttransplant outcomes.
    

Detailed description: 
      The research team will perform a chart review and extract data without identifiers from paper
      charts and electronic charts and data tracking system. This data will be obtained from OTTR
      /EPIC as well as paper charts if needed. Those charts will be accessed to obtain demographic
      data (age, gender, income, employment status, marital/relationship status, insurance payer);
      transplant specific data (primary diagnosis, transplant year, tacrolimus blood levels,
      rejection episodes (yes/ no and number of), graft loss (yes/no), re-transplantation (yes/no);
      related medical data (creatinine levels, dialysis dependence (yes/no), ICD diagnoses; and
      psychosocial variables (social worker risk assessment before transplant, presence of social
      and family support, conviction history (yes/no), psychiatric history (diagnoses yes/no).

      Variables will be obtained from the psychosocial pretransplant evaluation write-up (which in
      different years was attached to OTTR or EPIC datasets, or may be present in paper form, and
      from electronic datasets (OTTR / EPIC).

      The data extraction as well as dataset building and data entry will be performed in office
      spaces at ISMMS. No patient contact is anticipated for this study. The predictive model will
      include evaluations of single variables as well as an evaluation of the predictive ability of
      a pre-defined scoring system (the SIPAT) which will be applied to existing data.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients whose information is available to RMTI, who received a liver transplant in the
        year 2012 or earlier, who received tacrolimus, and who had at least 3 tacrolimus blood
        tests, are eligible.
      
Keywords: Transplant; Adherence
Study of Biomarkers of Airway Inflammation (0000-128)
Condition: Airway Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory
      mediators measured in sputum of healthy volunteers following exposure to inhaled
      lipopolysaccharide.
    


Intervention name(s): fluticasone propionate; Comparator: Placebo to fluticasone; Comparator: Lipopolysaccharide (LPS); Comparator: albuterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods; Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods; 20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods; Albuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit.
Intervention MeSH terms: Fluticasone; Xhance; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Sputum inflammatory biomarkers
Homeostatic Sleep Regulation in Older Persons
Condition: Healthy; Aging
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that sleep homeostasis, also known as
      sleep pressure or sleep drive, is different in healthy older and younger individuals.
    

Detailed description: 
      This was an inpatient study of healthy individuals to determine whether homeostatic "sleep
      drive" effects on sleep change with healthy aging. Sleep, performance, and mood were studied
      on individuals sleeping different lengths of time and during wake periods of different
      durations.
    

Intervention name(s): Amount of sleep and wake
Intervention type(s): Behavioral
Intervention description(s): 4 groups with different patterns of sleep and wake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Changes in sleep with aging
Effect of Weight on Hip Excursion During Gait
Condition: Gait, Spastic
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Background: Children with diplegia had considerably larger hip and knee excursion during gait
      cycle than did normal developing children.

      Objective: To investigate the effect of using weight around the ankle on hip excursion in
      children with diplegia.
    

Detailed description: 
      Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random
      (A, B). Both groups had received the same prescribed exercise program with classical gait
      training for group A and gait training while using weight around ankle for group B. Treatment
      was conducted for one hour three sessions per week for successive 3 months. Two-dimensional
      (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and
      after three months of therapy.
    

Intervention name(s): gait training exercises
Intervention type(s): Other
Intervention description(s): walking exercises in different directions
Other intervention name(s): gait rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ankle;; diplegia; gait; hip excursion; weight
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-centered, randomized, controlled study to assess the efficacy, indications
      and adverse reactions of combined administration of nebulized amikacin in patients with acute
      exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled
      antibiotics are more likely to cause bacterial resistance.
    

Detailed description: 
      Objective: To assess the efficacy, indications and adverse reactions of combined
      administration of nebulized amikacin in patients with acute exacerbation of non-cystic
      fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause
      bacterial resistance.

      Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be
      randomly assigned to the observer group (participants receive nebulized amikacin BID for 14
      days in combination with standard treatment) or the control group (participants receive
      nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary
      endpoint was bacterial clearance rate of sputum.

      Expected results: Compared with the control group, bacterial clearance rate of sputum of the
      observer Group will increase significantly.
    

Intervention name(s): Amikacin; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.; Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
Intervention MeSH terms: Amikacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nebulized amikacin;; Non-Cystic Fibrosis Bronchiectasis;; Bacterial clearance rate of sputum；; Acute exacerbation.
A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population
Condition: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders
MeSH terms: Alzheimer Disease; Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases; Tauopathies; Mental Disorders; Neurocognitive Disorders
Study type: Interventional

Summary: 
      This is a bridging study to visually and quantitatively assess PET images obtained after
      single application of 300 MBq [18F]florbetaben and PET scanning of patients with Alzheimer
      disease.
    

Detailed description: 
      This is a bridging study to visually and quantitatively assess PET images obtained after
      single application of 300 MBq [18F]florbetaben and PET scanning of patients with healthy
      subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease
      subjects. The diagnostic efficacy of the visual and quantitative assessments of 18FBB PET
      images for diagnosis of Alzheimer disease will be determined by comparison to the standard of
      truth (SoT) obtained through standard of care clinical diagnosis. Imaging results were
      compared with reference standards to assess the ability of 18FBB PET imaging to differentiate
      non-cognitively impaired subjects from mild to moderate AD subjects. To investigate the
      pharmacokinetic characteristics of healthy subjects after single intravenous administration
      of 18FBB in Chinese population. Verify the safety of subjects after a single intravenous
      administration of 18FBB in Chinese population.
    

Intervention name(s): Drug: [18F]florbetaben
Intervention type(s): Drug
Intervention description(s): All eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq.
Intervention model: Single Group Assignment
Intervention model description: All eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Florbetaben; Amyloid beta-protein; Alzheimer disease
A Trial of Hetrombopag in Healthy Subjects
Condition: Sever Aplastic Anaemia
MeSH terms: Anemia, Aplastic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A
      total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK
      drug-drug interaction between ciclosporin and hetrombopag.
    


Intervention name(s): Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule
Intervention type(s): Drug
Intervention description(s): Drug:
Hetrombopag Olamine Tablet Ciclosporin Soft Capsule
Intervention MeSH terms: Cyclosporine; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Valve of Hyaluronic Binding Selection (PICSI) in Improving IVF Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The investigators would like to assess whether selecting mature sperm using PICSI (selecting
      for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .

      Aim

        1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection
           using PICSI plates in terms of implantation and fertilization rates for couples with
           male factor fertility

        2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage
           rates for couples with male factor infertility using routine sperm selection with ICSI
           compared to using PICSI plates for sperm selection

      Hypothesis:

      Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison
      to sperm selected for conventional ICSI
    


Intervention name(s): PICSI
Intervention type(s): Procedure
Intervention description(s): If the oocytes are randomized to ICSI during the retrieval they will be ordered by the 1,4,5 8th best oocyte and PICSI to the 2,3, 6 7th best oocytes or the reverse if PICSI is selected. If one cohort is superior that cohort should be chosen by the blinded physician and the alternate cohort frozen or discarded based on their quality. This will ensure that the couple will always have the opportunity to have good quality embryo transferred regardless of how they are randomized. If there are no good quality embryos in the selected cycle we will consider it a failed transfer for that cycle and we will transfer the good quality embryos from the non- selected group as a fresh embryo transfer. For example if a couple is randomized to ICSI and all the ICSI embryos are poor quality but the PICSI embryos are good quality we will consider it a failed ICSI transfer and transfer the PICSI embryos as a fresh embryo transfer.
Other intervention name(s): The PICSI® dish is based on the research documenting that mature and structurally sound sperm will bind to hyaluronan.; CE marked (CE 0120)
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment