bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of ChAdOx1 LS2 and MVA LS2
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety, immunogenicity and efficacy of the
      candidate malaria vaccines ChAdOx1 LS2 and MVA LS2.

      Healthy adult volunteers will be recruited and vaccinated in Oxford.
    

Detailed description: 
      This is an open label, dose-escalation, first in human, partially blinded, phase I/IIa
      controlled human malaria infection (CHMI) study. The study will assess the safety,
      immunogenicity and protective efficacy of the novel malaria vaccine candidates ChAdOx1 LS2
      and MVA LS2 in healthy UK adults.

      Healthy, malaria naive adults, aged between 18 and 45 years, will be recruited and vaccinated
      in Oxford.

      A total of between 23 and 31 volunteers will be recruited across four groups:

      Group 1 volunteers will receive a low dose ChAdOx1 LS2 vaccination on day 0. Group 2
      volunteers will receive a high dose ChAdOx1 LS2 vaccination on day 0 and a dose of MVA LS2 on
      day 56, followed by a CHMI on day 77. Volunteers exhibiting sterile protection will undergo a
      repeat CHMI 5-7 months later.

      Control Group A will not receive any vaccinations and will undergo CHMI on day 77.

      Control Group B will not receive any vaccinations and will undergo CHMI during the repeat
      challenge.
    

Intervention name(s): ChAdOx1 LS2; MVA LS2
Intervention type(s): Biological; Biological
Intervention description(s): A viral vectored vaccine, using a chimpanzee adenovirus as a vector encoding malaria liver-stage dual antigen LS2 (LSA1 and LSAP2) fused with the transmembrane domain from shark invariant chain.; Modified vaccinia Ankara vector encoding liver-stage dual antigen LS2 (LSA1 ad LSAP2) fused to the C-terminal end of the leader sequence of tPA.
Intervention MeSH terms: Heparin Cofactor II
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate Safety and Effectiveness of Spinal Sealant
Condition: Spinal Procedure Requiring Dura Incision
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural
      repair compared with standard of care methods (control) to obtain watertight dural closure in
      patients undergoing spinal surgery.
    

Detailed description: 
      Neurosurgical procedures in the spine often involve incision of the dura mater to access the
      spinal cord. If the dural incision is not properly repaired and watertight closure is not
      achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity.
      The most frequent complication of CSF leak is recurring headache complicated with symptoms of
      nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing
      and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak
      has also been associated with the development of cerebellar hemorrhage and subdural hematoma.
      Primary repair and watertight closure are paramount to minimizing risk and sequelae
      associated with CSF leak.
    

Intervention name(s): Spinal Sealant System; Standard of care
Intervention type(s): Device; Device
Intervention description(s): Standard of care: devices intended to provide a watertight closure
Other intervention name(s): (i.e. devices intended to provide a watertight closure)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spinal procedure; Dura incision
Atezolizumab Immunotherapy in Patients With Advanced NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable
      stage IIIA and IIIB NSCLC eligible for chemoradiotherapy with curative intent.
    

Detailed description: 
      This phase II pilot trial will combine neoadjuvant immunotherapy with Atezolizumab q 21 days
      for 12 weeks with standard chemoradiotherapy with curative intent for good PS patients with
      unresectable stage IIIA/B NSCLC. Because of the consequences of progression in this
      curative-intent population, restaging CT scans will be carried out after the first 2 cycles
      of neoadjuvant therapy. Non progressing patients will complete a total of one year of
      anti-PDL1 therapy with an interruption during chemoradiotherapy. Patients with evidence of
      progression at the first restaging evaluation will proceed immediately to chemoradiotherapy
      if still eligible for curative intent therapy.
    

Intervention name(s): Atezolizumab
Intervention type(s): Drug
Intervention description(s): Single arm phase II trial of induction immunotherapy with anti-PD-L1 for patients with unresectable stage III NSCLC and PS 0-1.
Intervention MeSH terms: Atezolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the functional immune response 28 days after administration of one dose of Men
      ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY
      polysaccharide (PS) vaccine
    


Intervention name(s): MenACWY-CRM conjugate vaccine, adjuvanted; MenACWY polysaccharide vaccine; MenACWY-CRM conjugate vaccine, unadjuvanted
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: meningitis; children; vaccine
A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the
      effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a
      recommended substrate of CYP3A4.
    


Intervention name(s): midazolam; BI 425809
Intervention type(s): Drug; Drug
Intervention description(s): midazolam; BI 425809
Other intervention name(s): Midazolam-ratiopharm® 2 mg/ml solution
Intervention MeSH terms: Midazolam; BI 425809
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of the Efficacy of Vitamin D-fortified Bread in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of daily intake of fortified bread with
      vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy
      subjects compared to vitamin D supplement.
    

Detailed description: 
      Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D,
      calcium or omega-3 supplements within the last three months will be excluded. Subjects will
      be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2.
      plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g
      of bread and supplement or placebo every day for 2 months.

      At the first and last visits, dietary and laboratory assessments will be performed for all
      subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is
      improvement of glycemic and lipidemic markers and prevention of problems related to
      hypovitaminosis D.
    

Intervention name(s): fortified bread; supplement; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50 g of fortified bread + placebo daily; vitamin D supplement+ plain bread; plain bread+placebo
Other intervention name(s): FB; SP; PP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: vitamin D; fortified bread; efficacy; Vitamin D Deficiency
Sulforadex in Healthy Human Males MAD
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male
      volunteers over 7 days with qd or bid dosing
    

Detailed description: 
      This study will be conducted in a randomised, double-blind, placebo-controlled design with
      multiple ascending doses of Sulforadex® administered qd [once daily] or bid [twice daily]) to
      healthy male subjects between 18 to 45 years of age.
    

Intervention name(s): Sulforadex; alpha-cyclodextrin
Intervention type(s): Drug; Drug
Other intervention name(s): Stabilised sulforaphane
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Condition: Rhinovirus
MeSH terms: Infections; Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on

        -  shortening the length and reducing the symptoms of human rhinovirus infection (also
           known as the common cold),

        -  controlling asthma symptoms, and

        -  lowering the risk of asthma symptoms worsening in subjects with asthma.
    

Detailed description: 
      Subjects with a previous diagnosis of asthma will be pre screened within 90 days prior to
      enrolment. If a subject develops symptoms of human rhinovirus (HRV) infection they will visit
      the site for assessment. Symptomatic subjects meeting all eligibility criteria will be
      invited to enroll.
    

Intervention name(s): BTA798; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BTA798 twice daily; Placebo twice daily
Other intervention name(s): Glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human rhinovirus; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study
Condition: Nasal Congestion Due to Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The researchers in this study want to find out whether participants with a history of stuffy
      nose due to allergic reactions in the nose would intend to buy drug Phenylephrine
      Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the
      drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl
      is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used
      to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and
      throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without
      special rate controlling) was already approved to be used for adults and children and the
      recommended dose for adults and children 12 years or older is 10mg every 4 hours.
      Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but
      under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want
      to find out if participants have any medical problems during the trial.

      Participants in this study will be asked to record their stuffy nose symptoms in a diary
      before and after drug intake. At 8 hours after drug intake, participants need to assess
      whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose
      relief. At the end the participants will complete a questionnaire about their job, learning
      background, income and medical history of stuffy nose.
    


Intervention name(s): Phenylephrine HCl (Sinus Comfort, BAY112476)
Intervention type(s): Drug
Intervention description(s): 30 mg Extended Release Tablets, single oral dose
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic Rhinitis with Nasal congestion
Serum Nesfatin-1 and Human Cartilage glycoproteın-39 (YKL-40) Levels in Knee Osteoarthritis
Condition: Osteoarthritis of Knee; Degenerative Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this study, our objective was to assess the correlation between serum YKL-40 and
      nesfatin-1 values, the patient's clinical condition, ultrasonographic cartilage thickness
      measurements, and the response to PRP treatment in knee osteoarthritis (OA)
    

Detailed description: 
      The objective of this study is to assess the correlation between serum YKL-40 and nesfatin-1
      values, clinical condition, ultrasonographic cartilage thickness measurements, and response
      to PRP treatment in Knee Osteoarthritis (OA).

      Thirty patients diagnosed with grade 2 and 3 knee osteoarthritis (OA) according to ACR
      diagnostic criteria, and scheduled for leukocyte-poor platelet-rich plasma (LP-PRP)
      injections, were enrolled in the study. Patients were assessed at three time points: before
      treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment
      combined with exercise treatment once a week (day 28). The evaluation included the Numeric
      Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC),
      cartilage thickness measurement by ultrasonography (USG), 6-minute walk test (6MWT)
      parameters, and measurements of serum YKL-40 and nesfatin-1 levels.
    

Intervention name(s): exercise; intraarticular knee PRP injections
Intervention type(s): Behavioral; Biological
Intervention description(s): 2 weeks of home exercise; 2 doses of intra-articular platelet rich plasma (PRP) injection, 1 week apart
Other intervention name(s): PRP
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Thirty patients were evaluated at three different time points: before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). The assessment included the Numeric Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), cartilage thickness measurement by ultrasonography (USG), 6-minute walk test (6MWT) parameters, and measurements of serum YKL-40 and nesfatin-1 levels.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Rotator cuff tears are a common injury that lead to pain and loss of function for those who
      suffer from it. Treatment includes the use of arthroscopic surgery to return function to the
      patient and reduce their pain. This study is interested in a technique that has the potential
      to improve patient outcomes in terms of less pain and better function after their surgery.
      Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of
      interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a
      high concentration of cells called platelets. Platelets release growth factors important for
      healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected
      into the shoulder at the time of surgery and again at 4 weeks. It has been shown to
      accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but
      there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff
      tears. It is on this basis that the study is being performed. Participating patients will
      receive either a PRP injection or a placebo (normal saline) and the effects will be compared
      at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires.
      The primary hypothesis for this study is that ACP compared with placebo is effective in
      reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It
      is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week
      pain scores compared to the placebo group.
    


Intervention name(s): Autologous conditioned plasma (ACP); Normal saline
Intervention type(s): Biological; Other
Intervention description(s): ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.; Normal saline injection
Other intervention name(s): Platelet rich plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroscopic repair; Rotator cuff; Platelet rich plasma; Randomized; Pilot
Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Observational

Summary: 
      The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has
      had in the community both on the number of rotavirus-associated hospitalizations and on the
      strains of rotavirus circulating in the community. The investigators will use cases of
      rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the
      2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine
      effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to
      assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to
      examine whether and to what extent rotavirus vaccine was used outside the recommended age
      limits (off label) during the first 2 years of its implementation in Rhode Island. Finally
      using the state child health database, KIDSNET the investigators plan to investigate the
      reasons that children may not have received rotavirus vaccine in order to better target
      educational efforts for parents and health care providers.
    

Detailed description: 
      The goals of this study, conducted after the introduction of RV5 (RotaTeq) vaccine in the
      community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in
      preventing rotavirus-associated hospitalizations under field conditions, 2) to assess
      rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was
      used outside the recommended age limits (off label) during the first 2 years of its
      implementation in Rhode Island and 3) to investigate risk factors for non-receipt of
      rotavirus vaccine to inform educational efforts for parents and providers, and 4) to
      characterize the strains of rotavirus circulating in the community both prior to and after
      introduction of vaccine to determine if serotype replacement is occurring.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Residents of Rhode Island
      
Biospecimen description: 
      Stools
    
Keywords: rotavirus; gastroenteritis; vaccine; case-control study; serotype
Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Recurrence; Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to
      a healthy level, but high percentage of patients relapse during the first year following the
      discharge. The development of strategies to overcome this problem represents a priority for
      clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program
      based on cognitive dissonance theory developed for hospitalized patients.
    

Detailed description: 
      Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a
      high percentage of patients relapse following discharge. The aim of the study was to assess
      the effect of a relapse prevention program during the last phase of inpatient treatment.
      Patients, when they achieve a BMI of 18.5, are randomly allocated to complete the standard
      cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight
      relapse prevention groups based on the cognitive dissonance. The intervention has been
      derived by the selective and indicated prevention programs using a dissonance-based approach.
      This intervention showed to be effective in reducing the risk for eating pathology onset. The
      primary outcome of the study is to assess the number of patients allocated to the two
      condition with a BMI equal or greater than 18.5 at 12-months after discharge.
    

Intervention name(s): RePAN
Intervention type(s): Behavioral
Intervention description(s): The dissonance relapse prevention intervention consists of eight groups conducted by a psychologist who involves participants in interactive activities aimed to prevent relapse after discharge from the inpatient treatment
Other intervention name(s): Dissonance relapse prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anorexia Nervosa; Relapse prevention; Cognitive Dissonance; Inpatient treatment; Cognitive behavior therapy
Study of Telaprevir in Subjects With Hepatic Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir
      following administration of multiple oral doses to subjects with moderate and severe hepatic
      impairment.
    


Intervention name(s): telaprevir (VX-950)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Liver Disease