bioihbjkbjnl/mcl2 huggingface dataset:
Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
Condition: Disorders of Consciousness
MeSH terms: Consciousness Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims at comparing the effects of transcranial direct current stimulation and
      transcranial pulsed current stimulation on neurophysiological outcomes on patients with
      disorders of consciousness. This study also aims to evaluate the effects of these techniques
      on patients' level of consciousness.
    


Intervention name(s): Active tPCS; Active tDCS; Sham tPCS; Sham tDCS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): A current intensity of 2na and a stimulation frequency range of 6-10 Hz will be used with a peri-auricular ear-clip electrode montage for 20 minutes.; A current intensity of 2mA will be used for 20minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be place over the left prefrontal cortex and the cathode over the right supraorbitofrontal area.; Sham tPCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tPCS condition and the electrodes placement as well.; Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to collect information regarding the long-term (6 and 12 months)
      safety of Tramadol HCl Once-A-Day(OAD) 300 mg.
    


Intervention name(s): Tramadol Once A Day
Intervention type(s): Drug
Intervention MeSH terms: Tramadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate to severe symptomatic osteoarthritis of the knee
The $Ensible Weight Program: An Intervention Tailored for Low Income Women
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to learn if a weight loss program especially designed to address
      food insecurity is more effective compared to a standard weight loss program.
    

Detailed description: 
      Low income women are at greater risk of both obesity and food insecurity (not having
      consistent access to nutritious and adequate amounts of food). Most weight loss programs
      targeted at low income women do not focus on gaining skills and knowledge to reduce food
      insecurity.

      Eligible participants will be randomized into one of two groups. The two groups will follow
      different weight management programs. One group will follow a standard weight management
      program. The other group with follow the investigations program, the $ensible Weigh Program.
      Participation in the study will last about 9 months.
    

Intervention name(s): Standard Weight Management Program; Sensible Weigh Program
Intervention type(s): Other; Other
Intervention description(s): Standard Diet program based on diet and exercise.; Weight loss program designed for low income women.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      This is a decentralized study to primarily explore a novel objective digital biomarker (i.e.,
      Gluten Dependency Index) for celiac disease-related responses triggered by gluten exposure
      using a wearable biosensor. This study also explores a novel objective blood biomarker
      specific to celiac disease activity and evaluates participant symptoms, lifestyle and an
      objective comprehensive measurement (e.g., activity, stress and sleep) in celiac disease
      participants.

      Approximately 170 well-controlled celiac disease participants (Cohort A) and 40 celiac
      disease participants with persistent symptoms (Cohort B) will be monitored for 13 and 8 weeks
      in the observation period, respectively, in a home-based setting using the wearable biosensor
      along with a mobile platform including some electronic questionnaires.

      The wearable biosensor continuously records biosensor data. These data will be used to
      develop a new algorithm for Gluten Dependency Index and calculate the Gluten Dependency
      Index, Activity Value, Stress Value, or Sleep Time. Participants will report celiac
      disease-related symptoms, diet (including any accidental gluten exposures), exercise,
      menstruation questionnaires in CDSD and mobile platform questionnaire (MPFQ), which is
      originally designed by the Sponsor.

      All participants both in Cohort A and B are required to maintain gluten-free diet throughout
      the study. Only participant who are enrolled in Cohort A will be required gluten challenge.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Cohort A: Well-controlled celiac disease participants who should be asymptomatic or mildly
        symptomatic Cohort B: Celiac disease participants with persistent symptoms who are known to
        be symptomatic and show positivity to serum auto-antibodies even though participants have
        been adhering to gluten-free diet
Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment
      with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three
      thereof, in a group of patients with an index episode of a mixed state in BD.
    


Intervention name(s): quetiapine SR; quetiapine sr placebo
Intervention type(s): Drug; Drug
Intervention description(s): quetiapine SR, dose range 200-600mg, each night QHS for 6mos; quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos
Other intervention name(s): Seroquel SR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bipolar disorder, mania, depression
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent
      Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.
      Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11,
      16, and 18.
    


Intervention name(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Intervention type(s): Biological
Intervention description(s): Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars
Condition: Space Maintenance
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of N-TPA appliance compared to Nance SM in
      maintaining the arch dimensions after bilateral premature extraction of primary molars in
      children.
    

Detailed description: 
      In this randomized controlled clinical trial, 30 healthy children, 8-9 years of age with
      premature extraction of bilateral maxillary primary molars will be selected. Children will be
      randomly allocated into two equal groups of 15 children each according to the type of the
      appliance that will be used. Group I will receive a a Nance SM, and Group II a combined N-TPA
      appliance . Panoramic X-rays and study casts will be made, and baseline measurements will be
      recorded including arch circumference, intermolar width and arch depth. The appliances will
      be fabricated and cemented intra-orally.

      The patients will be followed up at 3, 6 and 9 months for re-evaluation of arch
      circumference, intermolar width, arch depth, and patient acceptance.
    

Intervention name(s): Nance/Transpalatal arch space maintainer; Nance space maintainer
Intervention type(s): Device; Device
Intervention description(s): A combined design of both Nance and Transpalatal arch space maintainers as a space maintainer for the maxillary arch in mixed dentition; Conventional space maintainer for the maxillary arch used in mixed dentition
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized parallel controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nance/transpalatal arch; Nance space maintainer; Space maintainer; Space maintenance
Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a two part study. During period one there will be a comparison of Etanercept (ETN)
      against a placebo with both arms maintaining the background anti inflammatory drug prescribed
      by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as
      determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis
      (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone
      in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory
      drug(NSAID).
    


Intervention name(s): etanercept; Background NSAID; PLACEBO; Background NSAID
Intervention type(s): Biological; Drug; Other; Drug
Intervention description(s): In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.; Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.; In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.; Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).
Other intervention name(s): ENBREL
Intervention MeSH terms: Etanercept; Anti-Inflammatory Agents, Non-Steroidal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine
      GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined
      vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months
      of age.
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Synflorix; Infanrix hexa; Rotarix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses.; Intramuscular injection, 3 doses.; Oral, 2 doses.
Other intervention name(s): Pneumococcal conjugate vaccine GSK1024850A.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary vaccination; Safety; Pneumococcal vaccine.; Pneumococcal disease; Immunogenicity
Exploring the Visual Sensitivity for Topological Properties in Newborn Infants
Condition: Visual Sensitivity in Newborns
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The topological perception theory proposed a precise description for how one organizes the
      visual world that eliminates the vagueness of subjective phenomenology. In addition, the
      topological theory challenges the dominant computational view on the part-to-whole hierarchy
      of visual information processing. Lines of evidence from adult psychophysics, brain imaging
      data, and even honeybee's behavior have supported the notion that the global topological
      properties are the very primitives of visual representation. However, the question of how the
      sensitivity to topological properties originates during development has not been explored
      much. In a previous study, the investigators found that 2- to 6 month old infants could
      reliably discriminate stimuli based on topological differences, but failed to do so based on
      geometric differences. Using familiarization/novelty preference procedure, the present study
      intends to explore the visual sensitivity for topological properties in newborn infants.
      Experiment 1 focuses on whether neonates can discriminate a disk (no hole) and a ring (with a
      hole) that are topologically different, and/or a disk (no hole) and a triangle (no hole) that
      are geometrically different. Experiment 2 focuses on whether neonates can detect a change in
      the number of holes and/or the size of the hole. If newborn infants are only sensitive to
      topological properties and not to geometric properties, this will be a strong proof for the
      claim that topological property is the very "primitive" visual representation at empirical as
      well as theoretical level.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        full-term and healthy newborns
      
Keywords: perceptual development; topological perception theory; familiarization/novelty preference method; Discriminate a disk and a ring (topologically different),; Discriminate a disk and a triangle (geometrically different); Detect a change in the number of holes; Detect the size of the hole
Tandem High Dose Melphalan Versus Triple Intermediate Dose Melphalan and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an international,multicenter, prospective, open, double randomised and controlled
      phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus
      triple intermediate dose Melpahaln in newly-diagnosed myeloma patients
    

Detailed description: 
      Patients will be enrolled into this protocol before start of Induction therapy which consists
      of 3 cycles or VAD with a 4 week interval followed by 1 cycle of IEV after which stem cell
      harvesting is performed. After stem cell harvesting is completed Patients will be randomised
      to one of the high dose therapy arms after response evaluation (Complete remission, Partial
      remission or stable disease). One group is receiving 2 Cycles of Melphalan 200mg/m² each
      followed by stem cell transplantation, the other group is receiving 3 Cycles of Melphalan
      100mg/m² also followed by stem cell transplantation each time.

      After completing high dose therapy patients will be randomised into Maintenance responding
      with CR, PR or SD. The maintenance therapy will be continued until relapse or progression of
      disease as defined by the response criteria.
    

Intervention name(s): Melphalan
Intervention type(s): Drug
Intervention MeSH terms: Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; first line tretment; high dose chemotherapy; stem cell transplantation; maintenance therapy
Physical Activity in Children With Type 1 Diabetes Study
Condition: Type 1 Diabetes Mellitus; Physical Activity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study aims to test the feasibility of a physical activity intervention called the Steps
      To Active Kids (STAK) programme in children aged 9 - 11 years with Type 1 Diabetes Mellitus
      (T1DM).
    

Detailed description: 
      The STAK programme promotes physical activity in children who have a chronic condition, low
      levels of physical activity, are overweight or who lack confidence to take part in physical
      activity. The intervention involves an Activity Diary, circuit training, pedometer step
      counting, daily physical activity monitoring and goal setting to promote long-term increases
      in physical activity and its associated health benefits. This randomised single-centre
      feasibility study will test whether the STAK programme is feasible for children with T1DM, in
      terms of acceptability, attractiveness and compliance and a qualitative process evaluation
      will aid the assessment of feasibility.
    

Intervention name(s): Steps To Active Kids (STAK) programme
Intervention type(s): Behavioral
Intervention description(s): Intervention described in Arm/Group Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Physical activity; Type 1 Diabetes Mellitus; Children; Intervention
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen)
      can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary
      data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine
      infusion of G-CSF can improve endometrial development and can increase implantation rates of
      embryos.
    

Detailed description: 
      Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in
      vitro fertilization (IVF).

      Design: Double blinded crossover randomized controlled clinical trial

      Setting: Academically affiliated private infertility centers

      Subjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing
      to be randomized to treatment.

      Interventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow
      uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who
      do not conceive will, after one month washout time, continue treatment in the opposite study
      arm.

      Main Outcome Measures: Implantation rate(IR) and pregnancy rates.

      Second Outcome Measures: Live birth rates and miscarriage rates.

      Statistical and Power considerations: Analysis will be by regression with IR as dependent and
      treatment as independent. Results will be adjusted by age and indices of ovarian reserve,
      such as antiMulerian Hormone (AMH). Presuming an implantation rate of 10% and anticipating a
      10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm,
      will have to be recruited for 80% power and alpha of 0.05.
    

Intervention name(s): G-CSF; Saline
Intervention type(s): Drug; Drug
Intervention description(s): One infusion of G-CSF 300 units administered by intrauterine infusion; intrauterine saline infusion 1 cc
Other intervention name(s): Neupogen (Filgrastim); Normal Saline; 0.91% w/v of NaCl, about 300 mOsm/L
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fertility Agents, Female; In vitro fertilization