bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Condition: Lumbar Degenerative Disease
MeSH terms: Radiculopathy
Study type: Observational

Summary: 
      Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved,
      has increased recently due to the morbidity associated with harvest of iliac crest bone graft
      in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT
      Cage, other clinical applications of these proteins is becoming widely adopted due to their
      effectiveness in forming bone and facilitating fusion. Clinicians have realized while these
      proteins are potent stimulators of bone formation there have been anecdotal reports of
      increased rates of radicular pain in the postoperative period when used in interbody
      arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to
      be due to the inflammatory effects of these proteins. Excess bone overgrowth around the
      spinal nerves in proximity to the fusion cage has been reported. No prospective studies have
      been performed assessing the incidence and etiology of this complication. The investigators
      propose a prospective study evaluating the incidence of this complication as well as
      postoperative imaging studies to help determine whether bony overgrowth is indeed occurring
      adjacent to the effected spinal nerves.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients age 18-75 with lumbar degenerative conditions including degenerative disk disease,
        spondylolisthesis with significant back and or leg complaints that have failed greater than
        6 weeks of conservative therapy that are felt to be candidates for posterior lumbar
        instrumented fusion with transforaminal interbody fusion (TLIF).
      
Keywords: Lumbar Degenerative Disease; Bone Morphogenetic Protein; TLIF
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
Condition: Ocular Hypertension (OHT); Mild Open Angle-glaucoma (OAG)
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of 3 planned
      doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension
      (OHT) or mild open angle-glaucoma (OAG).

      The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the
      pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its
      tolerability following morning and evening dosing.
    


Intervention name(s): ONO-9054; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-9054; ocular hypertension; OHT; Open angle-glaucoma; OAG; Glaucoma; Eye diseases
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Invasive Hib Infections
MeSH terms: Hepatitis A; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV-
      Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14
      weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface
      antigen (HBsAg) serology negative in India.

      Primary Objective:

        -  To evaluate the immunogenicity of the study vaccine in terms of seroprotection
           [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae
           type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for
           pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one
           month after the third dose.

      Secondary Objectives:

        -  To further describe the immunogenicity of the study vaccine, before the first dose and
           one month after the third dose.

        -  To describe the safety after each and any doses of the study vaccine.
    

Detailed description: 
      All participants will receive a total 4 doses of Hep B, i.e. one dose of Hep B monovalent
      vaccine given at birth followed by 3 doses of Sanofi Pasteur's hexavalent vaccine given at 6,
      10 and 14 weeks of age in the context of the study. Participants and parents will attend four
      clinic visits; the expected participation in the study is approximately 3 months.
    

Intervention name(s): Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Hexaxim™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; DTaP IPV-Hep B-PRP~T combined vaccine (Hexaxim™)
18750-Sun Protection Factor Assay
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor (SPF) efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. Formulation number - SR16-01.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and
      effective in treating people with chronic urticaria (persistent hives).
    


Intervention name(s): abatacept (Orencia ®)
Intervention type(s): Drug
Intervention description(s): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.
Other intervention name(s): orencia
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hives; rash; pruritis
Colorectal Cancer Prehabilitation in Changi General Hospital
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Cancer prehabilitation typically involves multiple pre-op visits. The investigators aim to
      assess the impact of their novel model, a "one-stop "service by a small, "levelled-up" core
      team on newly diagnosed colorectal cancer patients planned for surgery.
    

Detailed description: 
      Objective Cancer prehabilitation typically involves multiple pre-op visits. The investigators
      aim to assess the impact of their novel model, a "one-stop "service by a small, "levelled-up"
      core team on newly diagnosed colorectal cancer patients planned for surgery.

      Design This is a before-after trial in a tertiary public hospital in Singapore, involving all
      newly diagnosed colorectal cancer patients planned for surgery who are referred to the Cancer
      Prehabilitation Program. The primary outcome measure is the 6-minute-walk-test. Others
      include physical, psychological, quality-of-life and post-operative measures, and
      patient-satisfaction-surveys, taken at baseline, pre-operatively (post-prehabilitation), and
      3-months-post-operatively.

      Keywords: Colorectal; Cancer Prehabilitation; Novel; Model of Care
    

Intervention name(s): Colorectal Cancer Prehabilitation Programme
Intervention type(s): Other
Intervention description(s): Assessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation
Intervention model: Single Group Assignment
Intervention model description: before-after trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Colorectal; Cancer Prehabilitation; Novel; Model of Care
Asthma in Central Texas Project
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is the most common chronic childhood illness and disproportionately affects children
      who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with
      children who live in rural areas or have included Mexican American children in their samples.
      This study builds on the original R01NR007770 with findings that demonstrated the
      intervention could improve children's asthma self-management, asthma knowledge, metered dose
      inhaler skill, asthma severity, and parents' asthma management and access to care. In this
      competing continuation, the investigators added a third arm to the current research design
      with schools randomized into either an in-school asthma intervention, an in-school
      attention-control intervention, or an alternate intervention-delivery format of a single
      5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American,
      African-American, and White rural school-aged children (grades 2-5) who have asthma and their
      parents. In addition, the investigators propose adding a non-invasive measure of chronic
      airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma
      management on airway inflammation. Families will be followed for a full year with data
      collection at baseline and at 1-month, 4-months, and 7-months after the intervention to
      assess improvement in children's asthma morbidity, asthma severity, airway inflammation,
      family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop
      group and the School-Home group will demonstrate equivalent improvements, but greater
      improvements than the Attention-Control group in:(H1.1) their asthma severity and airway
      inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office
      visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time
      4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms
      will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the
      pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to
      the Attention-Control group.
    

Detailed description: 
      Families are recruited at the beginning of the school year (Time 1, October-November);
      parents consent and child assent obtained and baseline data collected in fall. The
      intervention is provided in December-January. Follow-up data are collected at February (Time
      2), April (Time 3), and August (Time 4).
    

Intervention name(s): Asthma in-school class; Asthma Day Camp; Health Promotion in-school class
Intervention type(s): Behavioral; Behavioral; Behavioral
Other intervention name(s): Asthma Plan for Kids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: children; asthma; quality of life; self-management
A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Study that will look at an investigational medication, SEP-363856 (called "study
      medication") in patients with schizophrenia and assess whether it changes:

        -  how the body processes (uses) glucose (blood sugar)

        -  how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar
           levels in the body.

      The information from this study will help to understand any effect the study medication may
      have on how the body uses and stores glucose.

      This study is accepting both male and female subjects. It will be held in approximately 6
      locations in the United States. Participation could last up to 12 weeks.
    

Detailed description: 
      This is an open-label, fixed sequence, multiple dose design. Following screening evaluations,
      subjects will check-in to the clinical research unit. After confirmation of continuation
      criteria, subjects will undergo an oral glucose tolerance test (oGTT), mixed meal tolerance
      test (MMTT) and spirulina breath test (GEBT). After these assessments are completed, subjects
      will have their prior antipsychotic (PA) or any other medication with psychotropic propensity
      washed out (dependent on their antipsychotic elimination half-life).

      Subjects will undergo SEP-363856 titration schedule, followed by the oGTT, MMTT and GEBT
      tests during the SEP-363856 Stable Dose Period.

      Subjects will be stabilized on their prior antipsychotic, discharged from the clinical
      research unit, and return to the unit for the follow-up visit 7 + 2 days after discharge.
    

Intervention name(s): SEP-363856
Intervention type(s): Drug
Intervention description(s): SEP-363856, 12.5 mg, 25 mg, and 50 mg tablets. The dose taken at the same time each day, in the evening and in the morning. Multiple tablets may be required to achieve a single dose.
Intervention model: Single Group Assignment
Intervention model description: This is an open-label, fixed sequence, multiple dose design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia
Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Recurrence; Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with
      Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.
    

Detailed description: 
      GAD is a common and disabling mental disorder associated with substantial medical and
      psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or
      excessive anxiety and worrying that persists over time for more than six months. Common
      features include apprehension, with worries about future misfortune; inner tension and
      difficulty in concentrating; motor tension, with restlessness, tremor and headache; and
      autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort.
      GAD is typically a chronic disorder with a high relapse rate and therefore requires effective
      long-term treatment. Long-term studies are necessary to demonstrate that the short-term
      effect is maintained.
    

Intervention name(s): Lu AA21004; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 or 10 mg/day; Once daily
Other intervention name(s): Vortioxetine
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Relapse prevention; GAD; Maintenance; Double-blind; Multicentre
Resistance Exercise Training in Children.
Condition: Resistance Training
Study type: Interventional

Summary: 
      The purpose of this study is examine the effects of 8 weeks (3 days/week) of resistance
      exercise training in children 8 to 10 years of age on muscle strength, activation, and lipids
      of the vastus lateralis.
    


Intervention name(s): Resistance exercise training
Intervention type(s): Other
Intervention description(s): Traditional linear periodization resistance training.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; muscle cross-sectional area; intramyocellular lipids; extramyocellular lipids; strength
Use of ACTIMMUNE in Patients With ADO2
Condition: Autosomal Dominant Osteopetrosis Type 2
MeSH terms: Osteopetrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open label use of ACTIMMUNE for patients with Autosomal Dominant
      Osteopetrosis Type 2(ADO2). Effects of treatment will be evaluated after 14 weeks on
      ACTIMMUNE by bone resorption markers. This study will treat 12 patients with ADO2 recruited
      from Indiana University and Riley Hospital for Children at Indiana University Health.
    

Detailed description: 
      This is a single center, open-label, dose-escalation study evaluating the efficacy, as
      defined by biochemical endpoints, and safety profiles of ACTIMMUNE in ADO2 subject.

      The investigators will treat 12 ADO2 subjects (children or adults age 3-65) with Actimmune®
      via a dose escalation protocol to a dose of 50 µg/m2 subcutaneously three times per week
      (TIW) for 8 weeks. If serum CTX does not increase by more than 25% by week 8, the dose will
      be increased to 100 µg/m2 subcutaneously TIW.

      Individual subjects in whom ACTIMMUNE administration increases bone resorption markers during
      the 14 weeks of this trial will be eligible for a 1 year extension trial.
    

Intervention name(s): ACTIMMUNE
Intervention type(s): Drug
Intervention MeSH terms: Interferon-gamma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called
      cortisol. Under normal conditions, cortisol and other hormones are created by the body in
      response to physical and emotional stress, triggering a healthy stress response. People who
      suffer from psychotic major depression may have unusually high levels of cortisol circulating
      within them or abnormal patterns of cortisol levels, overloading the stress response
      mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If
      Corlux can keep the body's cortisol receptors from being overloaded, the stress response
      system may return to normal function, which may result in improvement of symptoms. The
      purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients
      who have been diagnosed with psychotic major depression (PMD).
    


Intervention name(s): Mifepristone; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psychotic Major Depression; PMD; Depression; Major Depression; Psychosis
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to conduct long-term surveillance for efficacy, safety and
      immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria
      vaccine in infants and children in Africa following a primary vaccination series
      (NCT00866619). No new subjects will be enrolled in this extension study.
    


Intervention name(s): Blood sampling; Malaria Vaccine 257049 (MALARIA-055 PRI); Meningococcal C Conjugate Vaccine (MALARIA-055 PRI); Cell-culture rabies vaccine (MALARIA-055 PRI); TritanrixHepB/Hib (MALARIA-055 PRI); Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Intervention type(s): Procedure; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).; Administered orally, during the MALARIA-055 study (NCT00866619).
Other intervention name(s): Menjugate; VeroRab
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infants; Efficacy; Children; Malaria; Plasmodium falciparum; Safety; Surveillance; Immunogenicity; RTS,S/AS01E; Africa
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
Condition: Fibromyalgia; Hormonal Responses to Exercise in Patients With Fibromyalgia.
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the acute and chronic effect of whole-body
      vibration exercise on serum insulin-like growth factor-1 levels in women with fibromyalgia
      (FM). It was hypothesized that women with FM would exhibit an increase in IGF-1 following
      both acute and chronic WBV. Twenty-four women with FM were randomized into two groups:
      Vibration Group (VG) and Control Group (CG). The VG underwent a protocol with WBV exercise
      twice a week for a total of six weeks, whereas the CG performed the same protocol without
      vibratory stimulus. Both groups continued with their usual pharmacological treatment. Serum
      IGF-1 levels were determined using Enzyme-Linked Immunosorbent Assay (ELISA). To test the
      effect of chronic WBV, serum IGF-1 measurements were taken at baseline and at weeks 1,3, and
      6 of intervention. To test the effect of acute WBV, within week 1, serum IGF-1 measurements
      were taken before and immediately following a session of WBV.
    


Intervention name(s): Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands; Placebo Whole-body vibration exercise
Intervention type(s): Device; Device
Intervention description(s): Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. The Whole-body vibration intensity was kept constant at 30 Hz of frequency and 2 mm of amplitude.; Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. All exercises were performed without the influence of a vibratory stimulus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibromyalgia; Whole-Body vibration; Exercise; IGF-1