bioihbjkbjnl/mcl2 huggingface dataset:
Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects
Condition: Acne
Study type: Observational

Summary: 
      The aim of this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110
      after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess
      anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against
      recurrence of acne lesions post-sun exposure.
    

Detailed description: 
      This is a monocentric study on adults and adolescents with acne prone skin on the face. This
      open-labelled study aim first to assess the dermatological and ophthalmological tolerance of
      the investigational sunscreen product RV4857A formula CD2110 after 28 days and,
      dermatological tolerance after 57 days of at least a twice daily on the study areas, under
      normal conditions of use, on 40 subjects intending to have a minimum of 10 days per month of
      sun exposure duration ≥ 1h, in the time slot 11am-4pm and intending to have a minimum of 4
      swimming sessions (sea or swimming pool) during at least the first month of the study.

      Secondary objectives :

        -  To assess the anti-imperfection efficacy of the product during the summer

        -  To assess the "non" rebound effect (non recurrence of acne) one month after stopping the
           application of the sunscreen and without any sun exposure at D85 (difference between D85
           and D0)

        -  To evaluate the impact on Quality of Life of subjects through CADI and DLQI
           questionnaires (or CDLQI questionnaire for adolescent from 12 to 16 years-old) completed
           at baseline, D29 and D57

      The study includes 4 visits :

        -  Visit 1: Inclusion visit (D1)

        -  Visit 2: Intermediate visit (D29)

        -  Visit 3: Intermediate visit "end of summer" (D57), a Stop the application of the
           sunscreen product (and stop sun exposure) between Visit 3 and the end of the study Visit
           4: End of study visit in autumn (D85)

      The theoretical study duration for each subject will be 85 days with at least 57 days of
      product use. The study interest areas are Face and Neck.
    

Intervention name(s): RV4857A
Intervention type(s): Other
Intervention description(s): RV4857A formula CD2110 is a sunscreen product
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects will be recruited from the investigation centre's panel. The participants will be
        selected on the basis of inclusion and non-inclusion criteria specific to the study and on
        their ability to comply with the constraints required by the protocol. The participants
        will be definitely included in the study after a specific interview and a clinical
        examination
      
Keywords: Sunscreen; Lesions post sun exposure; Anti-imperfections
Study With GW274150 In Patients With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect
      on a model of asthma type inflammation called the allergen-induced late asthmatic response.
      This will be compared with the response after treatment with a dummy (placebo) and a tablet
      treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3
      treatments in a random order. The study is double-blind so subjects will not know which
      treatment they are taking at any given time.
    


Intervention name(s): GW274150; Singulair; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GW274150 will be available as 30 mg white oval tablets.; Singulair will be available as over encapsulated 10 mg orange tablets.; Matching placebo for Singulair and GW274150 will be available.
Other intervention name(s): GW274150
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: asthma; allergen challenge
EEG Characteristics in ECT
Condition: Electroconvulsive Therapy; Direct Current Electroencephalogram; Ketamine; Spreadind Depression
MeSH terms: Depression
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators will be examining slow-wave characteristics in depressed patients receiving
      electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by
      anesthesia induction agent.
    

Detailed description: 
      This is a pilot project using dcEEG to look at infra-slow waves in depressed patients
      receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow
      waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT,
      which could lead to decreased morbidity and mortality with the procedure and lessen the
      burden of depression in our patient population.
    

Intervention name(s): Ketamine; Methohexital
Intervention type(s): Drug; Drug
Intervention description(s): Induction agent that suppresses infra-slow waves; Induction agent that does not suppress infra-slow waves
Intervention MeSH terms: Ketamine; Methohexital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on pilot patient observations, and experience from the prior study KTS-1-2008, the
      investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell
      depletion therapy using Rituximab induction with maintenance treatment.

      The hypothesis is that at least a subset of CFS patients have an activated immune system
      involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.
Approved amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic fatigue syndrome; CFS; Myalgic encephalomyelitis; Rituximab; B-cell depletion
Ciprofloxacin BioThrax Co-Administration Study
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to determine whether there is any effect on the
      antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of
      BioThrax® (Anthrax Vaccine Adsorbed or AVA).

      This study will be conducted in the United States (US) in 154 healthy male and female
      volunteer subjects ages 18 to 45.

      The duration of study participation for each subject will be approximately 76 days
      (approximately 2.5 months)
    

Detailed description: 
      BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a
      randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions
      of ciprofloxacin and BioThrax.
    

Intervention name(s): BioThrax; Ciprofloxacin
Intervention type(s): Biological; Drug
Intervention description(s): route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule; 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
Other intervention name(s): Anthrax Vaccine Adsorbed; AVA
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post-exposure prophylaxis; toxin neutralization assay
Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis
Condition: Bacterial Meningitis
MeSH terms: Meningitis, Bacterial; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this trial is to test if mortality of childhood bacterial meningitis can
      be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional
      bolus administration four times daily (qid), combined with high-dose paracetamol orally, when
      both treatments are executed for the first 4 days. The series will be collected at Hospital
      Pediátrico David Bernardino, Luanda, Angola.

      The recruitment of patients begins, the conditions permitting, in early 2012. The criteria
      for patient participation is a child at the age of 2 months to 15 years who presents with the
      symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is
      performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.
    

Detailed description: 
      The principal objective of the study is to examine if mortality of childhood bacterial
      meningitis can be reduced by slow continuous infusion of cefotaxime combined with high-dose
      paracetamol orally for the first 4 days (instead of the traditional qid administration of
      cefotaxime without concomitant paracetamol). Children qualifying for entry (see criteria
      below), whose guardian has given informed consent,will be randomized into 2 treatment arms
      (see details below)and receive the treatments in a double blind fashion (see details below).
      Primary and secondary outcomes (detailed below) will be evaluated according to predefined
      criteria and time points (see below).

      Results will be analyzed for all patients in ITT datasets and in prespecified subgroups
      (etiology, nutritional status, etc.) in both crude and adjusted analysis. The efficacy
      results will be expressed as OR with 95% confidence intervals.
    

Intervention name(s): Infusion with paracetamol; Bolus without paracetamol
Intervention type(s): Drug; Drug
Intervention description(s): The administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days.; The control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days.
Other intervention name(s): paracetamol=acetaminophen; Paracetamol=acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bacterial meningitis; infusion; bolus; paracetamol
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
Condition: Hearing Loss, Bilateral Sensorineural, Progressive
MeSH terms: Hearing Loss; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted
      on hard of participants with a hearing loss to grant quality control prior to product launch.
      The aim of the investigation series is to ensure zero-defect overall performance of the new
      hearing systems as well as maximum benefit for the participant with the devices in comparison
      to previously outstanding Phonak Hearing Systems.
    

Detailed description: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials in the way as planned for
      this study ("phase of final inspection"). This will be a controlled, single blinded and
      randomised active comparator clinical evaluation which will be conducted mono centric at
      Sonova AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Hearing Aid (Successor of Phonak Virto V); Hearing Aid (Phonak Virto V)
Intervention type(s): Device; Device
Intervention description(s): The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.; Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
Masking: Single (Participant)
Primary purpose: Treatment
Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Background: There is evidence linking conditioned pain modulation (CPM) deficiency with
      musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical
      therapies could activation situations of chronic pain there is no activation of CPM.

      Objectives: The purpose of this study is to measure the CPM response and determine whether
      Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the
      improvement of CPM, TS, pain intensity, disability.

      Design: Double-blind, randomized placebo clinical trial. Methods: Patients with fibromyalgia
      will be randomly allocated into two groups: the Electro Neuro Adaptative Regulator group
      (SCENAR) or the sham technique (ST) group.

      Main outcomes measures: Pain intensity (with visual analogue scale, Conditioned Pain
      Modulation (CPM), Temporal Summation (TS) and Pressure Pain Thresholds (PPT´s) were the
      primary outcomes and will be assessed at baseline and at 3-months follow-up. Secondary
      outcome measures were the Fibromyalgia Impact Questionnaire to measure disability, Pain
      Catastrophizing Scale and the Pain Anxiety Symptoms Scale, Beck Depression Inventory, Jenkins
      Sleep Scale. Questionnaire of quality of life SF36.

      Participants will be selected if they met the following inclusion criteria: (a) fulfilled the
      1990 and 2010 American College of Rheumatology classification criteria for FM; (b) reported
      an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week
      to study commencement; (c) were on stable doses of medication for FM ≥ 4 weeks; and (d) were
      aged between 18 and 65 years.
    


Intervention name(s): Electro Neuro adaptative Regulator
Intervention type(s): Other
Intervention description(s): The SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance
Other intervention name(s): InterX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: visual analogue scale; conditioned pain modulation; disability; pressure pain threshold; temporal summation
Influence of Music on 6 Minutes Walking Distance in Healthy Children
Condition: Healthy Children
Study type: Interventional

Summary: 
      To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred)
      on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen
      saturation) in healthy children.
    


Intervention name(s): Listening to fast music; Listening to preferred music; Listening to slow music
Intervention type(s): Behavioral; Behavioral; Behavioral
Other intervention name(s): Listening to fast music during the test; Listening to preferred music during the 6MWT; Listening to preferred music during the 6MWT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: exercise tolerance; 6MWT
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to describe the safety, tolerability, and immunogenicity of V114 in
      children with sickle cell disease.
    


Intervention name(s): V114; Prevnar 13™
Intervention type(s): Biological; Biological
Intervention description(s): V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.
Condition: COVID-19 Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Observational

Summary: 
      PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study
      of ventilation practice and adjunctive therapies in critically ill, invasively ventilated
      COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and
        October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.
Electro-Neuro-Muscular Stimulation in ICU
Condition: Myopathy; Neuropathy
MeSH terms: Muscular Diseases
Study type: Interventional

Summary: 
      We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in
      critical care patients, can decrease the impact or severity of the critical illness myopathy
      (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect
      the incidence density rate of nosocomial pneumonia in the ICU.

      Patients will be divided into two groups, Group A and Group B chosen at random. In Group A
      conventional physiotherapy will be applied while in Group B, ENMS will also be applied
      additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will
      be 1 hour, it will be applied before the start of the physiotherapy per day of
      hospitalization and for 10 days in each patient.

      The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will
      undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori
      Trichrome will be used to determine the existence or absence of myopathy. In addition the
      ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3),
      thus achieving a separation of myopathy and neuropathy.

      The primary outcome of the study will be the incidence of myopathy in both groups, at day
      12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing
      this rate by 50% in the intervention group using statistical power equal to 0.80 up to a
      level of p <0.05, 12 number of patients will be required in each group.
    


Intervention name(s): Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ICU,; MYOPATHY,; NEUROPATHY,; PNEUMONIA
The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
Condition: Crohn's Disease; Perianal Fistulas
MeSH terms: Crohn Disease; Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on
      patient suffering from residual Crohn's disease related perianal fistulas already treated
      with TNF alpha blockers
    

Detailed description: 
      This study is a prospective open-label study that consists three periods: screening,
      treatment and follow-up. After signing an informed consent, subjects will be assessed by a
      gastroenterologist, a surgeon (for the diagnosing the perianal disease and assessing the need
      for surgery) and a HBOT specialist for assessing the capability of the subject to undergo
      HBOT treatment.After the screening period, eligible subjects will enter an 8 weeks HBOT
      treatment period, combined with TNFalpha blocker treatment. This period will be followed by a
      4 months follow-up period in which treatment with TNFalpha blocker will continue.

      All patients will have an MRI and TRUS examinations to assess the fistulas and also blood
      tests for CBC, chemistry, inflammatory markers and cytokine analysis. Same evaluation will be
      repeated at the end of the study.
    

Intervention name(s): Hyperbaric oxygen
Intervention type(s): Other
Intervention description(s): HBOT will be given for 40 sessions of 2 atmospheres for 90 minutes each session, 5 times a week (2 months). TNF alpha blocker therapy will remain the treatment received before recruitment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: crohn's disease; perianal fistulas; TNF alpha blockers; hyperbaric oxygen therapy