bioihbjkbjnl/mcl2 huggingface dataset:
Oocyte Cryopreservation Registry (HOPE Registry)
Condition: Oocyte Cryopreservation
Study type: Observational

Summary: 
      Phase IV, prospective multicenter, observational Registry will track cycle outcomes for
      subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization
      (IVF) and embryo transfer (ET)
    

Detailed description: 
      Subjects will be enrolled at as many ART clinics that offer oocyte cryopreservation and are
      willing to participate in the Registry. Oocytes will be retrieved and cryopreserved from
      autologous or heterologous donors. When the subject decides she would like to get pregnant,
      oocytes will be thawed, fertilized and the resultant embryos will be transferred to the
      oocyte donor (for autologous use) or to another recipient (for heterologous use). The
      treatment regimen will be completed with births and well-baby follow-up of children at 12
      months of age. Information on children will be submitted by their parents to the
      Investigators. Data collection for the Registry will be active for a maximum of five (5)
      years, including three (3) years of enrollment and two (2) additional years to complete the
      well-baby follow-up for all the children.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women of reproductive age who, in order to achieve a pregnancy, will have embryos created
        from thawed autologously or heterologously implanted oocytes that were either:

          -  cryopreserved at the time of or following the Registry's launch, or

          -  cryopreserved prior to the Registry's launch, but will undergo
             thaw/fertilization/transfer procedures while the subject is enrolled in the Registry.
Optimizing Treatment to Improve TBM Outcomes in Children
Condition: Tuberculosis, Meningeal
MeSH terms: Tuberculosis; Tuberculosis, Meningeal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this open-labeled, randomized clinical trial, the Investigator will assess the safety and
      pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without
      levofloxacin (LEVO) given to children as part of multidrug treatment for tuberculous
      meningitis (TBM) versus standard treatment. The Investigators will also assess functional and
      neurocognitive outcomes by treatment group, as measured by the Pediatric Modified Rankin
      Score (MRS) and the Mullen Scales of Early Learning (MSEL), respectively.
    

Detailed description: 
      Open-label, randomized clinical trial in three treatment groups. Patients with probable or
      definite TB meningitis (TBM) will all receive isoniazid and pyrazinamide at standard doses
      for 8 weeks. Arm 1 participants will receive high-dose rifampicin plus ethambutol (EMB) at
      standard doses for 8 weeks. Arm 2 participants will receive high-dose rifampicin plus
      levofloxacin for 8 weeks. Arm 3 participants will receive rifampicin plus ethambutol at
      standard doses for 8 weeks (control arm). Patients will be screened to confirm TBM diagnosis,
      will receive 8 weeks of study treatment, and then will receive isoniazid (INH)/rifampicin for
      an additional 40 weeks, to complete 12 months of TBM treatment. All participants will receive
      oral steroids. PK sampling will be performed within first week and 6 (+/- 2) weeks following
      treatment initiation. Participants will have scheduled follow-up visits to assess safety and
      clinical status. In addition, functional and neurocognitive outcomes up to 18 months
      following treatment initiation will be assessed. Interim PK and safety analyses will be
      performed to ensure dosing is producing predefined PK targets and safety is acceptable. It is
      anticipated that a majority of children will be hospitalized for the initial 2-8 weeks of the
      study.
    

Intervention name(s): High-dose: RIF, INH, PZA, EMB; High dose: RIF, INH, PZA, LEVO; Standard of care: RIF, INH, PZA, EMB
Intervention type(s): Drug; Drug; Drug
Intervention description(s): high-dose rifampicin plus standard dose H,Z,E, given for 8 weeks in treatment Arms 1 and 2; high-dose rifampicin plus standard dose H,Z, with levofloxacin substituted for ethambutol for 8 weeks in treatment Arm 2; standard doses of R,H,Z,E given for 8 weeks in treatment Arm 3, control arm.
Other intervention name(s): Rifampin; Levaquin; control group
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial of Emotion-Focused Skills Training for Parents
Condition: F01.318 Child Rearing; F01.470 Emotions; F01.145.179 Child Behavior
Study type: Interventional

Summary: 
      Children with externalizing and internalizing symptoms has been linked to poor emotional
      competence, problematic understanding and regulation of emotions. A number of recent studies
      demonstrates the importance of parents' active involvement in the child's recovery process
      and support the empirical relationship between parenting style and child symptoms. Emotional
      awareness and acceptance of painful emotional experience in parents leads to reduction in how
      these emotions are experienced in response to stressors in children. This makes the parent
      less vulnerable to rumination or suppression of negative emotional experience related to the
      child. In addition, it releases parents' emotional capacity to be mentally present and
      emotionally available for their child. Although neuro-affective principles from research have
      been incorporated in the therapeutic approaches for adults, there are currently no programs
      that target these mechanisms in working with children with mental health difficulties.
      Emotion Focused Skills Training (EFST) is an easily administrated, cost efficient treatment
      program specifically directed towards the parental role in promoting change in children. In
      this randomized controlled trial, we will compare experiential process oriented EFST with a
      psycho-educational version of EFST on parents of children aged 6-13 with externalizing or
      internalizing symptoms. Parents of 236 children will receive a two days course and 6 hours of
      individually delivered treatment within a 10 weeks period, either with the experiential
      version of EFST or the psycho-educational version. Feedback regarding outcome on
      externalizing and internalizing problems will be obtained from parents and teachers at 5
      different periods: baseline, treatment completion and at 3, 6 and 9 months follow-up.
    


Intervention name(s): Emotion-Focused Skills Training for Parents - Experiential; Emotion-Focused Skills Training for Parents - Psychoeducational
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.; The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Single (Participant)
Primary purpose: Treatment
Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The overall objective is the histological and radiological assessment of bony consolidation
      of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous
      spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.

      Clinical correlation with the histological and radiological results using the SF36
      questionnaire.
    

Detailed description: 
      * Study design: Monocentric, prospective, randomised study. Patients who need revision
      anterior cruciate ligament reconstruction and show a tunnel enlargement of >10mm will have a
      first operation filling the tibial/femoral tunnel either with bone graft substitute
      (Actifuse) or autologous spongiosa.

      5 - 6 months after this first operation a CT will be performed to assess the bony
      consolidation of the former tibial/femoral tunnel. An MRI will be performed to assess
      vitality of the bone substitute.

      An osseous biopsy will be taken from the tibial/femoral tunnel at the revision anterior
      cruciate ligament reconstruction approximately 6 months after bone grafting.

      Clinical evaluation will be performed 6 weeks, 3 months and 6 months postoperative. At 6
      months postoperative additional radiological evaluation and clinical assessment using the
      SF36 questionnaire will be performed.

        -  Treatment: Either autologous spongiosa or Actifuse (MIS applicator) will be administered
           by the investigator as a bone graft substitute for tunnel enlargement in patients
           undergoing revision anterior cruciate ligament reconstruction.

        -  Duration of Participation: The participation of each subject will be approximately 12
           months.

      Each subject will undergo revision anterior cruciate ligament reconstruction approximately 6
      months after bone grafting. A biopsy will be taken at this operation. A clinical and
      radiological follow up is planned for further 6 months.

      * Subjects: Male and female patients ≥ 18 years. Approximately 40 patients who undergo
      revision anterior cruciate ligament reconstruction will be included in the study.

      Inclusion criteria: Patients in need of revision anterior cruciate ligament reconstruction
      Exclusion criteria: Infection, wound healing complications
    

Intervention name(s): Actifuse; bone graft
Intervention type(s): Procedure; Procedure
Intervention description(s): bone tunnel filled with Actifuse; bone graft to fill bone tunnel
Other intervention name(s): Baxter Actifuse MIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; Revision surgery; tunnel enlargement; bone substitute material; bone graft
Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to identify all the bacterial species present in the respiratory
      tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information.
      Traditional culture methods of throat swab and sputum samples can only identify the most
      prevalent bacteria in samples, those of which there are over about 5 million bacteria per
      teaspoon. A recently developed method has been found to be more sensitive and can detect up
      to several hundred bacterial species in throat swab or sputum sample of individual CF
      patients.
    

Detailed description: 
      This study does not include testing of any investigational drugs and this is a noninvasive
      study requiring only a sputum/swab sample paired with information contained in the routine
      clinic letters and laboratory results your CF physicians obtain at your regular clinic
      visits.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pulmonary clinic
      
Biospecimen description: 
      sputum or throat culture
Compression Feedback for Patients With In-hospital Cardiac Arrest
Condition: Cardiopulmonary Arrest; Cardiopulmonary Resuscitation
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      A prospective, randomized, controlled, parallel study was conducted in patients undergoing
      resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed
      medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized
      into 2 groups: 1) standard chest compression, 2) chest compression with real-time
      audio-visual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device.
      The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary
      outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.
    

Detailed description: 
      A prospective, randomized, controlled, parallel study was conducted in patients undergoing
      resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed
      medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized
      into 2 groups: 1) standard chest compression, 2) chest compression with real-time
      audio-visual feedback using the Cardio First Angel™ (INOTECH, Nubberg, Germany) device.
      Randomization accomplished using Random Allocation Software© (RAS; Informer Technologies,
      Inc., Madrid, Spain). Crossover was not allowed. The patient and data analyzer were blinded.
      The clinical provider was not blinded. The primary outcome was sustained return of
      spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital
      discharge, incidence of sternum and rib fractures.
    

Intervention name(s): Audiovisual compression feedback; Standard Manual Chest Compression
Intervention type(s): Device; Other
Intervention description(s): The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a handheld device consisting of three components. The rescuer-side has a red palm-sized push-button with a pictogram illustrating proper use. The center unit is composed of a stable plastic base containing an arrangement of springs, and the patient-side consists of liquid-absorbent polyurethane foam. Application of 400 ± 30 Newtons of force results in an audible click alerting the rescuer to cease compression, and an additional click on decompression alerts the rescuer to resume compression.; Cardiopulmonary resuscitation according to published international guidelines.
Other intervention name(s): Cardio First Angel™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardio first angle; CPR; Cardiopulmonary Arrest; Clinical trial
Furcation Therapy With Enamel Matrix Derivative
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium
      phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD +
      βTCP/HA) and EMD alone.

      Material and Methods: 39 patients, presenting at least one mandibular class II furcation
      defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The defects
      were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA filling;
      βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n = 13) OFD +
      EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin position
      (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation diagnosis
      were evaluated at baseline, 6 and 12 months.
    

Detailed description: 
      Although enamel matrix derivative (EMD) has been used to promote periodontal regeneration,
      little is known of its effect on the microbiome. Therefore, this investigation aimed to
      identify the changes in periodontal microbiome following treatment with EMD using a
      deep-sequencing approach. Thirty-nine patients having mandibular class II buccal furcation
      defects were randomized to beta-tricalcium-phosphate/hydroxyapatite graft (BONE group),
      EMD+BONE or EMD alone. Plaque was collected from furcation defects at baseline, 3 and 6
      months post-treatment. Bacterial DNA was analyzed using terminal restriction fragment length
      polymorphism (t-RFLP) and 16S pyrotag sequencing. 169,000 classifiable sequences were
      compared to HOMD using the QIIME and PhyloToAST pipelines. Statistical comparisons were made
      using parametric tests. At baseline, a total of 422 species were identified from the 39
      defects, belonging to Fusobacterium, Pseudomonas, Streptococcus, Filifactor and Parvimonas.
      All three regenerative procedures predictably altered the disease-associated microbiome, with
      a restitution of health-compatible species. However, EMD and BONE+EMD groups demonstrated
      more long-term reductions in higher number of species than in BONE group (p<0.05), especially
      disease-associated species e.g. Selenomonas noxia, F.alocis, and Fusobacterium. EMD may
      promote periodontal regeneration by predictably altering a dysbiotic subgingival microbiome,
      decreasing pathogen richness and increasing commensal abundance.
    

Intervention name(s): Bone; EMD
Intervention type(s): Biological; Biological
Intervention description(s): Furcation defect regenerated with bone graft material; Furcation defect regenerated with EMD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic Study With Repeated Doses of Stalevo
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to show that higher minimum concentration values are obtained
      following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment
      with corresponding dosing regimen.
    


Intervention name(s): levodopa, carbidopa, entacapone; levodopa, carbidopa
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Focus of the study is pharmacokinetics of the study drug
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department
Condition: Pain; Distress
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Many medical procedures aimed at helping children can cause them pain and distress. If
      children experience certain levels of pain or distress, it can have long lasting negative
      effects. The emergency department can be a particularly stressful place for children and
      their parents. There are also many procedures that children may have in the emergency
      department that can cause pain and distress. These include procedures such as needle pokes,
      stitches, or setting a broken bone. Two common methods of managing a child's pain in the
      emergency department are drugs and distraction. Drugs are not always practical and may come
      with unwanted side effects. Distraction is often used formally or informally and by parents
      or the health professionals. One form of distraction involves listening to music. This can
      lower the child's pain and distress by moving their attention from the painful stimulus, for
      example a needle poke, to a more pleasant sensation such as familiar children's songs. This
      study will test whether music is useful to help lower pain and distress for young children
      (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line.
      Music is safe and pleasant for children. The results from this study could be important for
      many children receiving medical care.
    


Intervention name(s): music
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: children undergoing intravenous placement in the pediatric emergency department
Safety of and Immune Response to Two HIV Vaccines: SAAVI DNA-C2 Boosted With SAAVIMVA-C, in HIV-Negative Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of and immune response to an experimental
      DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA)
      in HIV uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of
      a safe and effective vaccine that will prevent HIV infection. Due to the high prevalence of
      HIV-1 subtype C in southern Africa, the South African AIDS Vaccine Initiative (SAAVI), the
      HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious
      Diseases (NIAID) are evaluating two subtype C HIV vaccines, SAAVI DNA-C2 and SAAVI MVA-C
      through this study . These two vaccines will be used together in a prime-boost regimen. The
      SAAVI DNA-C2 vaccine is a multigene DNA vaccine consisting of two DNA plasmids in equal
      amounts that express an HIV-1 subtype C polyprotein comprising of Gag-Reverse
      Transcriptase-Tat-Nef and an HIV-1 subtype C truncated Env. SAAVI MVA-C is a recombinant MVA
      vaccine expressing the same immunogens as the SAAVI DNA-C2 vaccine. MVA is a highly
      attenuated vaccinia virus. The purpose of this study is to evaluate the safety and
      immunogenicity of an experimental DNA HIV vaccine, SAAVI DNA C2, followed by boosting with an
      experimental recombinant MVA HIV vaccine, SAAVI MVA-C, in HIV uninfected adults.

      Participants will actively participate in this study for 12 months and will then be contacted
      and asked questions about their health once annually for 3 years following initial study
      injection. Participants will be randomly assigned to receive either the SAAVI prime-boost
      preventive vaccine regimen or placebo. Vaccination with the SAAVI DNA-C2 vaccine will occur
      at Months 0, 1, and 2; boost vaccinations with the SAAVI MVA-C vaccine will occur at Months 4
      and 5. Additional study visits will occur at Weeks 2, 6, 10, 16, 18, and 20 and Days 147,
      154, 273, and 364.

      Study procedures include physical exams, blood and urine collection, HIV testing, an
      electrocardiogram, and questionnaire. Some blood collected from participants will be stored
      and used in future research. Risk-reduction counseling will be conducted at all study visits.
    

Intervention name(s): SAAVI DNA-C2 vaccine; SAAVI MVA-C vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): DNA vaccine; Boost vaccine; Placebo vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
Condition: Lumbar Vertebra Hernia
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation
      patients.
    


Intervention name(s): SI-6603
Intervention type(s): Drug
Intervention description(s): SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemonucleolysis; Lumbar Vertebrae; Hernia