bioihbjkbjnl/mcl2 huggingface dataset:
Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age
Condition: Infant Immunizations
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the safety and immunogenicity of two mixed primary immunization schedules:
      Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of
      age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of
      age.
    

Detailed description: 
      Immunogenicity will be evaluated using the following:

      Serological outcome measures will be assessed on day 0 (visit 1) and 28-42 days after the 3rd
      dose of the primary series for both groups:

        -  Seroprotection rates for antibodies against PRP (anti-PRP), defined as percentage of
           subjects with antibody concentrations ≥ 0.15 µg/ml and ≥ 1.0 µg/ml.

        -  Geometric mean concentration (GMC) for antibodies against PT, FHA, PRN, and FIM.

        -  Anti-pertussis antibody concentrations ≥4-fold rise (post-Dose 3/pre-Dose 1).

      Safety will be evaluated using the following:

        -  Occurrence, time to onset, number of days of occurrence, severity and seriousness of
           solicited injection site reactions (tenderness, erythema, swelling) and systemic
           symptoms (fever, vomiting, crying abnormal, drowsiness, appetite decreased,
           irritability) within 8 days (Day 0 - Day 7) after each vaccination and across all
           vaccinations.

        -  Occurrence, nature, time to onset, duration, severity, and relationship to vaccination
           of unsolicited adverse events (AE) occurring within 31 days (Day 0 -Day 30) of each
           vaccination.

        -  Occurrence, nature, time to onset, duration, and relationship to vaccination of any
           serious adverse events (SAE) during the entire study period for all groups.
    

Intervention name(s): Pediacel® and Infanrix™-IPV/Hib
Intervention type(s): Biological
Intervention description(s): 0.5 mL IM at 2,4 and 6 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations
Condition: Opioid Intoxication
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the tolerance and safety of naltrexone while
      performing military specific tasks, and to assess plasma concentrations following naltrexone,
      administered orally at 50 mg per day for 7 days. The physical and mental/cognitive
      performance assessments will be conducted at various times prior, during and following drug
      administration. Daily blood draws will also be taken to assess blood levels of naltrexone and
      active metabolites for correlation to performance parameters associated with the Military
      Skill & Tasked Based Fitness Test.
    


Intervention name(s): Naltrexone Hydrochloride
Intervention type(s): Drug
Intervention description(s): 50 mg per os naltrexone hydrochloride
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Intervention model description: Open label safety assessment
Masking: None (Open Label)
Primary purpose: Prevention
Fecal Microbiota Transplantation for Constipation
Condition: Gut Microbiota; Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Difficult defecation is a common symptom involving with patients'life quality. The stool
      pattern of these patients might be related to the contribution of gut microbiota. This pilot
      study proposed hypothesis that stool pattern could be used as a simple index to screen the
      potential candidates of fecal microbiota transplantation in patients with difficult
      defecation.
    

Detailed description: 
      Difficult defecation is a common symptom involving with patients'life quality. The stool
      pattern of these patients might be related to the contribution of gut microbiota. This pilot
      study proposed hypothesis that stool pattern could be used as a simple index to screen the
      potential candidates of fecal microbiota transplantation in patients with difficult
      defecation. Patients underwent single FMT in this study were divided into hard-stool group
      and loose-stool group. All patients were assessed before FMT and during 12-week follow-up
      after FMT.
    

Intervention name(s): Fecal Microbiota suspension
Intervention type(s): Drug
Intervention description(s): The prepared microbiota suspension was infused into mid-gut.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: difficult defecation; fecal microbiota transplantation; stool pattern
Remediation of Working Memory in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The primary aim of the study is to test the efficacy of a novel cognitive remediation
      intervention that targets working memory-related functions. To accomplish this goal, 80
      volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive
      remediation condition that targets working memory or a computer skills training intervention
      that teaches computer applications. In both conditions participants will receive computer
      training three times a week for 4 months. The investigators hypothesize that patients who
      receive the cognitive remediation intervention will demonstrate significantly greater change
      on neuropsychological measures of working memory and executive abilities than patients who
      receive the computer skills course. In addition, the investigators hypothesize that the
      intervention-induced cognitive change will be associated with concurrent improvements in
      functional capacity and psychosocial functioning in the community. A second study goal is to
      examine the stability of the intervention-induced changes in cognition. Cognition and
      psychosocial functioning will be reassessed 4 and 8 months after treatment termination to
      examine the stability of treatment effects and to assess whether a less intense maintenance
      training (once a week sessions) provides any additional benefit to participants. Lastly, this
      study will examine in an exploratory manner whether there are individual differences in
      treatment response. The Val158Met polymorphism of the COMT gene has been found to be
      associated with working memory and prefrontal dysfunction in schizophrenia. The study will
      test whether the COMT polymorphism is predictive of response to cognitive remediation.
    


Intervention name(s): Cognitive Remediation; Computer Skills
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months.; This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Fish Oil (Omega 3), Immune Function, and Mood
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to examine the effects of fish oil on immune function and mood.
    

Detailed description: 
      The beneficial effects of fish oil (or eating fish more frequently) include reductions in
      triglycerides, blood pressure, and heart rate, as well as increases in HDL cholesterol, the
      "good" type of cholesterol. In addition, certain aspects of immune function also appear to
      show favorable responses to fish oil supplementation, and some studies suggest that fish oil
      helps to improve mood and decrease depression.

      This study is designed to examine how supplementation with omega-3 polyunsaturated fatty
      acids (key fish oil components) affects aspects of your immune response, and your mood;
      because some research suggests that people who eat more fish may do better during stressful
      times, the study will also examine how fish oil affects your immune response to stress,
      certain stress hormone responses, and your psychological response to stress.

      For detailed information about the study, please visit our website at
      http://www.stressandhealth.org
    

Intervention name(s): Omega 3 (Fish Oil) Supplementation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.25 g or 2.496 g daily for 4 months; matching placebo capsule daily for 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: affect; inflammation
Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)
Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a
      alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"). The investigators hypothesize that
      doxazosin will attenuate the cardiovascular and subjective response to MDMA.
    

Detailed description: 
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its
      euphoric effects. MDMA releases serotonin (5-HT), dopamine, and norepinephrine (NE). NE
      release is thought to mediate the cardiovascular effects of MDMA and may also contribute to
      its psychostimulant effects. However, the functional role of adrenergic postsynaptic
      receptors in the cardiovascular and subjective effects of MDMA in humans is largely unclear.
      To determine the role of alpha-adrenergic receptors in the response to MDMA in humans the
      investigators test the effects of the alpha1-receptor blocker doxazosin on the physiological
      and subjective effects of MDMA. The investigators use a randomized double-blind
      placebo-controlled cross-over design with four experimental sessions. doxazosin or placebo
      will be administered before MDMA or placebo to 16 healthy volunteers. Subjective and
      cardiovascular responses will be repeatedly assessed throughout the experiments and plasma
      samples are collected for pharmacokinetics. The primary hypothesis is that doxazosin will
      significantly reduce the blood pressure response to MDMA.
    

Intervention name(s): 3,4-Methylenedioxymethamphetamine; Doxazosin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg per os, single dose; 3 days (-64h) before MDMA: 4 mg doxazosin per os. 2 days (-40h) before MDMA: 8 mg doxazosin per os.
1 day (-16h) before MDMA: 8 mg doxazosin per os.; capsules identical to MDMA or doxazosin
Other intervention name(s): MDMA; ecstasy; Cardura
Intervention MeSH terms: Doxazosin; N-Methyl-3,4-methylenedioxyamphetamine
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MDMA; doxazosin; norepinephrine; alpha1- receptor; ecstasy; stimulants
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent
      subjects who completed study V59P6 in which they received either Novartis Meningococcal
      (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The
      study will also enroll age-matched subjects who have never received any other meningococcal
      vaccine (naïve subjects) to serve as an additional control group.
    

Detailed description: 
      Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
    

Intervention name(s): Novartis Meningococcal (MenACWY-CRM) vaccine
Intervention type(s): Biological
Intervention description(s): All subjects will have blood draws at Day 1, Day 8, and Day 29.
Intervention MeSH terms: Lactitol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Adolescents; Persistence
Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional

Summary: 
      Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for
      chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing,
      limits mucositis severity and associated pain. As its use is recommended in the treatment of
      radio induced mucositis in adults, the level of evidence in pediatric studies does not allow
      a precise treatment protocol. The investigators present here the protocol of a feasibility
      study in the haemato-oncology department of the Children University Hospital of Toulouse,
      with the view to a future efficacy study.
    

Detailed description: 
      This study aims to evaluate the feasibility of using low level laser therapy (LLLT) in the
      haemato-oncology department of the Children University Hospital of Toulouse. The feasibility
      will be considered as acceptable if 60% of patients hospitalized for oral mucositis had
      successfully benefit from the procedure. The secondary objectives are the evaluation of
      efficacy of LLLT on pain and mucositis grade, the evaluation of tolerance of this treatment
      and the medical time needed for this supportive care. The athermic phototherapy laser diode
      will be used by scanning the entire oral mucosa area. It will be applied uniformly every two
      days as long as grade of mucositis is 2 or more, with a fluence of 4J/cm², under two
      wavelengths (635 nm and 815 nm).
    

Intervention name(s): "Oncolase Digi" therapy laser diode
Intervention type(s): Device
Intervention description(s): The athermic phototherapy laser diode will be used by scanning the entire oral mucosa, including cheek and lip mucosa, gums, palate, tongue and floor of the mouth. It will be applied uniformly every two days as long as the grade of mucositis is 2 or more, with a fluence of 4J/cm², under two wavelengths (635 nm and 815 nm).
Cheeks will be scanned extra-orally with laser fiber during 50 seconds, at the fluence of 4J/cm², associating two wavelengths : infra-red (815 nm, 3850mW) and red (635 nm, 150mW).
Intra-orally, the fiber will be used to scan each area of mucositis during 30 seconds per area of 2 cm2, at 1cm from the mucosa; the power at 635 nm will be 150 milliwatts and 150 milliwatts at 815 nm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: low level laser therapy; oral mucositis; child
Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax
Condition: Sjogren's Disease
MeSH terms: Sjogren's Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®)
      on the surface of the eye and tear film (a film that coats the eye which is made up of oil
      and water).
    


Intervention name(s): Administration of Lotemax
Intervention type(s): Drug
Intervention description(s): An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.
Intervention MeSH terms: Loteprednol Etabonate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Non-invasive instruments; Environment; Wavefront; Placido Disk; Ellipsometer; Thermal Imaging
Laryngeal Handshake for Identifying the Cricothyroid Membrane
Condition: Emergent Cricothyrodotomy
Study type: Interventional

Summary: 
      The cricothyroid membrane is the most common position that the invasive airway secure is
      performed, but it is not easy to identify the cricothyroid membrane by tactile perception.
      Although it is recommended to use the laryngeal handshake method for identifying the
      cricothyroid membrane in difficult airway society 2015 guidelines for management of
      unanticipated difficult intubation in adults, there is only suggestion without clinical data
      about how much the laryngeal handshake method improves the accuracy of identification of the
      cricothyroid membrane So we made the hypothesis that the cricothyroid membrane is identified
      more correctly when the laryngeal handshake method is used than when that method is not used.
      And we try to find out whether there is actual difference about identification of the
      cricothyroid membrane between using the laryngeal handshake method and not using that method.
      By identifying the difference between them, we are going to support the recommendation of
      guidelines and make the evidence for educating the doctors who have any possibility to
      perform the criocthyroidotomy to use the laryngeal handshake method skillfully in the 'cannot
      intubate, cannot oxygenate' situation.
    


Intervention name(s): laryngeal handshake; simple palpation
Intervention type(s): Procedure; Other
Intervention description(s): palpate for the cricothyroid membrane using the laryngeal handshake technique; conventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cricothyroid membrane
Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux
Condition: Gastro-esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specific airway clearance technique,
      l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in
      infants under the age of one year. Infants referred to hospital for a multichannel
      intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is
      only possible after signing the informal consent by one of the parents.
    


Intervention name(s): expiration lente prolongée
Intervention type(s): Other
Intervention description(s): l'Expiration Lente Prolongée (ELPr) is a passive technique to enhance the expiration used in infants, obtained by a slow and increasing manual thoraco-abdominal pression applied at the end of a spontaneous expiration till the residual volume. The aim is to obtain a bigger expired volume compared to a normal expiration and drain the mucus out of the airways (Postiaux 2003). This technique has been invented by Guy Postiaux and is used in the Chest Physiotherapy (CPT).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Pneumonia, Diarrhoea and Fever in Children by Community Health Workers
Condition: Pneumonia, Diarrhea, Fever
MeSH terms: Pneumonia; Diarrhea; Fever
Study type: Observational

Summary: 
      The investigators propose to test the feasibility and acceptability of community health
      workers (ASHAs and ANMs) being able to treat sick children in the community. There is a
      national policy for treatment for children aged 2-59 months with illnesses such as pneumonia,
      diarrhea and fever by community health workers (CHWs), this policy has not been implemented
      as yet in Haryana. This research will identify barriers and opportunities for use of CHWs as
      treatment sources.
    

Detailed description: 
      Using indepth interviews, focus group discussions and other qualitative research methods
      barriers and opportunities for promoting use of ASHAs as a treatment source for diarrhea,
      pneumonia and fever will be identified. An intervention package which includes training of
      ASHAs and ANMs to treat uncomplicated cases of pneumonia, diarrhea and fever, ensuring they
      have required supplies, creating awareness in community and monitoring and supervising the
      treatment provided by them will be implemented in primary health centre areas in Haryana,
      India. ASHAs will treat cases of fast breathing pneumonia with amoxicillin and refer children
      with danger signs or chest indrawing pneumonia. Three rounds of cross sectional surveys will
      be conducted to ascertain prevalence of morbidity, careseeking and hospitalizations in
      children aged 2 to 59 months.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted in 2 primary health centres. These include 6 sub centres in
        Rasoolpur PHC (population ~57000) and 7 sub centres in Mandkola PHC (population ~57000).
      
Keywords: Pneumonia; Fever; Diarrhoea
Study to Evaluate the Safety and Efficacy of PAZ320 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Treated With Insulin
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions
      measured via continuous glucose monitoring and its adverse effect profile in humans.
    

Detailed description: 
      In this study, the investigators seek to evaluate the effect that PAZ320 has on post-prandial
      glucose excursions measured via continuous glucose monitoring and its adverse effect profile
      in humans. Continuous glucose monitors (CGM) are minimally invasive devices that measure
      glucose levels in interstitial fluid. A small wire is inserted subcutaneously which transmits
      the ambient subcutaneous glucose concentration every 5 minutes to a wireless recorder. In
      usual use, the patient can see these data and graph the previous 1, 3 or 9 hours to identify
      trends or look back over time (ie over night). In our study, the patient will be blinded to
      the data so as not to confound results, as it has been noted in another study that patient's
      blood sugar control was better when they were able to see CGM results and modified their
      diet. CGM's have been shown to have clinical accuracies of 95.5-98.9% and have been used in
      clinical trials and found to be safe. Having the patient do a finger-stick glucose
      intermittently during the time they are wearing the CGM improves accuracy.
    

Intervention name(s): PAZ320
Intervention type(s): Drug
Intervention description(s): Single-center pilot study, open label dose escalation design
Intervention MeSH terms: PAZ320
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment