bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a multicenter, open label, randomized, controlled, safety trial in subjects aged
      6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899
      subjects were randomized (2:1) to either the active treatment group or the control group.
      Upon successful completion of the screening period (~2 weeks), each subject entered the 24
      week study.
    


Intervention name(s): Xolair (omalizumab)
Intervention type(s): Drug
Intervention MeSH terms: Omalizumab
Primary purpose: Treatment
Keywords: ALTO
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
Condition: Sleep Disordered Breathing; Sleep Apnea, Central
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Central
Study type: Interventional

Summary: 
      This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo
      Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to
      confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat
      participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the
      BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative,
      randomized design with the participants blinded to the therapy. Additionally, attempts will
      be made to blind the central scorer(s) with respect to which device is in use.
    

Detailed description: 
      This study was conducted to evaluate the therapeutic performance of a new auto Servo
      Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central
      sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory
      pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed
      airway apnea, a modified auto backup rate which is proportional to subject's baseline
      breathing rate, and a variable inspiratory support. Our primary aim was to compare the
      performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional
      servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).

      Study Design: A prospective, multicenter, randomized, controlled trial.

      Setting: Five sleep laboratories in the United States.

      Participants: Thirty-seven participants were included.
    

Intervention name(s): Respironics BiPAP autoSV2; Respironics BiPAP autoSV3
Intervention type(s): Device; Device
Intervention description(s): Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.; Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Other intervention name(s): Respironics BiPAP autoSV3 advanced
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A long-term follow-up study to obtain safety and efficacy data in subjects who completed
      phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups
      for up to 36 months after the initial administration in patients suffering from Alzheimer's
      disease
    

Detailed description: 
      The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the
      initial administration of NEUROSTEM®.
    

Intervention name(s): human umbilical cord blood derived mesenchymal stem cells; Normal saline 2mL
Intervention type(s): Biological; Other
Intervention description(s): Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals; Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
Other intervention name(s): NEUROSTEM®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Should my New Knee Rotate?
Condition: Arthritis of the Knee Joint
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to
      relieve pain, restore function and correct deformity. It is a very common surgical procedure
      with figures showing more than 500'000 arthroplasties performed annually worldwide. Total
      knee arthroplasty is considered one of the most successful types of joint reconstruction in
      that surgical results usually meet and even exceed expectations. Much of the current
      literature focuses on the issues relating to implant wear as a potential failure mode for
      artificial knee implants. It has been suggested that knee with mobile or rotating bearing
      options, such as the comparative device proposed for this clinical investigation, may survive
      longer than fixed bearing knee designs because of the greater contact surface area possible
      with more congruent components with unconstrained, mobile component design.
    

Detailed description: 
      This is a prospective, comparative, randomised, open-label, single center, multiple surgeons
      clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be
      implanted for evaluation in this study. Patients will be randomised to one of two equal sized
      groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in
      the second group patients will be treated with the Scorpio PS mobile bearing implant.

      Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology
      assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3
      months, 6 months 1 year, 2 years and 5 years post-operatively.
    

Intervention name(s): mobile bearing knee system for total knee arthroplasty; fixed bearing total knee prosthesis
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mobile bearing knee prosthesis
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Observational

Summary: 
      This investigation aims to understand the following issues in pediatric patients, as well as
      to assess the need of a special investigation and a post-marketing clinical study:

        -  The frequency of treatment related adverse events.

        -  The frequency of efficacy assessment.

        -  Treatment related unlisted adverse events in Japanese Package Insert.

        -  Risk factors likely to affect the frequency of treatment related adverse event.
    

Detailed description: 
      All the patients whom an investigator prescribes the first gabapentin should be registered
      consecutively until the number of subjects reaches target number in order to extract patients
      enrolled into the investigation at random.
    

Intervention name(s): gabapentin
Intervention type(s): Drug
Intervention description(s): According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult.
Intervention MeSH terms: Gabapentin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study whom an investigator involving A9451175 prescribes the Gabapentin
      
Keywords: Gabapentin; Epilepsies; safety
A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost
      regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA)
      -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1
      (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
    


Intervention name(s): Ad26.Mos4.HIV; MVA-Mosaic; Clade C gp140 + Mosaic gp140; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.; Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36.; Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.; Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 3

Summary: 
      To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a
      child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12
      months after initiation of GH treatment.
    


Intervention name(s): Genotonorm (Somatropin)
Intervention type(s): Drug
Intervention description(s): 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycemic Response in Adults With Type 2 Diabetes
Condition: Glycemic Control
Study type: Interventional

Summary: 
      This is a randomized, controlled, crossover study to compare the effects of two treatments on
      postprandial glucose in adults with type 2 diabetes.
    


Intervention name(s): Experimental Formula; Test Meal
Intervention type(s): Other; Other
Intervention description(s): Diabetes-specific study formula; Instant oatmeal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia
Condition: Affective Disorders; Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional

Summary: 
      This study applied a randomized parallel case-controlled design. The study purpose was to
      evaluate the effects of progressive muscle relaxation on anxiety, psychiatric symptoms and
      quality of life among patients with chronic schizophrenia compared with an active control.
    

Detailed description: 
      Background: Anti-psychotic drugs are limited in their ability to improve psychiatric
      symptoms, quality of life, and anxiety status in patients with chronic schizophrenia.
      Progressive Muscle Relaxation (PMR) can potentially reduce anxiety status and improve
      subjective welling in acute patients. It is an ideal rehabilitation intervention for patients
      with chronic schizophrenia. However, no study has investigated the effects of PMR on outcomes
      among patients with chronic schizophrenia.

      Design: This study applied a randomized parallel case-controlled design.

      Methods: Hospital-based randomized control trial in Taiwan. Eighty subjects with chronic
      schizophrenia were recruited from a psychotic ward and randomized into PMR, or control
      groups. Patients in the intervention group participated in progressive muscle relaxation for
      12 weeks; while patients in the control group members received supportive treatment-as-usual
      (TAU). All participants completed anxiety, psychotic syndromes and quality of life measures
      at baseline, 3-month, and 3-month follow-up.
    

Intervention name(s): progressive muscle relaxation
Intervention type(s): Behavioral
Intervention description(s): intervention group: The experimental group received muscle relaxation training once a week for 3 consecutive months. The results were measured and followed up after 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study applied a randomized parallel case-controlled design.
Hospital-based randomized control trial . Subjects were chronic schizophrenia who were recruited from a psychotic ward complex and randomized into PMR, or control groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: PMR, anxiety, psychotic syndrome, quality of life
Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      Patients with mandibular sub-condylar fractures underwent either either open reduction with
      internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed
      up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to
      CREF.
    


Intervention name(s): Open Reduction & Internal Fixation; Closed Reduction & External Fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws; Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mandibular Subcondylar Fractures; Mouth Opening; Open Reduction and Internal Fixation; Closed Reduction with External Fixation
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The Centers for Disease Control and Prevention estimates that 1 in 59 U.S. children have been
      diagnosed with an autism spectrum disorder (ASD). Peer relationships, social skills, and
      repetitive behaviors are a challenge for those with ASD. Exercise in the ASD population has
      been examined as a means to improve some of these challenges for children with ASD. This
      research study will try to see if a structured exercise program called CrossFit Kids can help
      with these challenges. This study is potentially beneficial in developing an exercise program
      for children with ASD that can help promote social skill development, reduce stereotypical
      behaviors, and provide overall health benefits.
    


Intervention name(s): CrossFit Kids exercise program
Intervention type(s): Behavioral
Intervention description(s): Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Wait List Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASD, Autism Spectrum Disorder
A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 4

Summary: 
      It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not
      known in detail. The primary objective of this study was to investigate the specificity of
      antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP)
      who have shown signs of clinically relevant hemolysis following treatment with the
      intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of
      hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish
      between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an
      independent adjudication by a committee was performed for each patient with signs of
      hemolysis determined in the laboratory or in the clinic.

      This study was requested as a post-marketing commitment study by the United States Food and
      Drug Administration (FDA). By September 2014, no case of clinically significant intravascular
      hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant
      endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol.
      The study was not restarted.
    


Intervention name(s): IgPro10
Intervention type(s): Biological
Intervention description(s): IgPro10 will be administrated by IV infusion either a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first treatment.
Other intervention name(s): Privigen
Intervention MeSH terms: Immunoglobulins, Intravenous
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ITP
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the tolerability (effect of drug on body) and
      pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
    


Intervention name(s): AZD9668; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30mg oral tablets twice daily (bid) for 14 days; Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Chronic; obstructive; pulmonary; lung; respiratory disease; tolerability; placebo-controlled; pharmacokinetics; COPD
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
Condition: Meningococcal Disease; Meningococcal Meningitis; Typhoid; Yellow Fever; Rabies; Japanese Encephalitis
MeSH terms: Rabies; Encephalitis, Japanese; Typhoid Fever; Yellow Fever; Meningococcal Infections; Meningitis, Meningococcal; Meningitis; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the safety and immunogenicity profile of several travel vaccines given
      alone or concomitantly with MenACWY-CRM to healthy adults.
    


Intervention name(s): Typhoid Vi Polysaccharide Vaccine; Yellow Fever Vaccine; Japanese Encephalitis Vaccine; Rabies Vaccine; MenACWY-CRM Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose of typhoid Vi polysaccharide vaccine.; One dose of yellow fever vaccine.; Two doses of Japanese Encephalitis Vaccine.; Three doses of Rabies vaccine.; One dose of MenACWY-CRM vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adults; international travel vaccination; Meningococcal disease; meningococcal meningitis; typhoid; yellow fever; rabies; Japanese encephalitis
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is the first study of the safety of increasing dose levels of AEB1102 in patients with
      Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will
      also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid
      levels and the antitumor effects of AEB1102.
    


Intervention name(s): Co-ArgI-PEG modified human arginase I
Intervention type(s): Drug
Other intervention name(s): AEB1102
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; MDS
A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,
      inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in
      healthy adult volunteers aged between 18 and 60 years.
    


Intervention name(s): Trivalent Influenza Vaccine
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention