bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
Condition: Mechanical Insufflation-exsufflation Session ( With Cough Assist)
Study type: Interventional

Summary: 
      A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve
      airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to
      confirm the beneficial effects of this treatment in a larger neuromuscular population, to
      study its mechanisms of action and to assess whether the effects observed persist over time.
      A better knowledge of this treatment should help to define its position in the respiratory
      management of neuromuscular patients.
    

Detailed description: 
      30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive
      care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches,
      France).

      Respiratory parameters and comfort will be evaluated before and after (5min,

      1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax
      and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern
      will be recorded allowing the measurements of respiratory frequency, tidal volume,
      Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of
      tension-time index (TT0.1).

      Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse
      oxymetry.

      Respiratory comfort will be assessed with a visual analog scale. Optoelectronic
      plethysmography will be use to perform regional ventilation evaluation. Using chest wall
      motion analysis we will compute respiratory participation of upper, lower thorax and abdomen,
      right and left side.

      Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms
      of action of MI-E on respiration and chest-wall motion will be analysed and the persistence
      of the beneficial effect of MI-E will be assessed.
    

Intervention name(s): Plethysmography opto electronic; respiratory parameters
Intervention type(s): Device; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuromuscular disorders; mechanical insufflation-exsufflation; respiratory parameters; plethysmography opto electronic; Vital capacity
Oxygenation Test During General Anesthesia
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The study investigates if applying a special ventilatory strategy during anesthesia for
      laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of
      using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates
      oxygenation with blood gas samples but also with a new method that might give more
      information without the use of blood gas samples.

      Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction
      and maintenance of anesthesia is performed with either a continuous positive airway pressure
      (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in
      comparison to a technique without CPAP but with a PEEP of 10 cm H2O.

      Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative
      period if emergence from anesthesia is performed without high levels of oxygen.
    


Intervention name(s): CPAP and 100% oxygen; CPAP and 31% oxygen; No CPAP and 100% oxygen
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cmH2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal carbon dioxide (CO2) level of 5 %. During emergence from anesthesia 100 % oxygen is used.; During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cm H2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal CO2 level of 5 %. During emergence from anesthesia 31 % inspiratory oxygen or the inspiratory oxygen level needed to achieve a SpO2 of at least 96 % (if 31 % oxygen is not enough), is used.; This intervention follows a standard protocol without the use CPAP during induction of anesthesia.
Other intervention name(s): Preventive ventilation; Preventive ventilation; Standard protocol.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese
      populations to support future clinical development of BIIB023 in China and Japan.

      Study Design: This is a single-dose study to assess the PK, safety, and tolerability of
      BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy
      volunteers. The Caucasian group is included to allow comparison of PK data from different
      groups using data from the same study under the same controlled conditions.

      Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up
      to 100 days.
    

Detailed description: 
      Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese
      populations to support future clinical development of BIIB023 in China and Japan.

      Study Design: This is a single-dose, Randomized, Double-Blind, parallel-group study to
      evaluate the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult
      Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow
      comparison of PK data from different groups using data from the same study under the same
      controlled conditions.
    

Intervention name(s): BIIB023 - low dose IV Dose; BIIB023 - high dose IV Dose
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment
Condition: Deep Caries
Study type: Interventional

Summary: 
      The management of deep carious lesions approaching a healthy pulp is considered a challenge
      to the dental practitioner. The conventional treatment of deep carious lesions requires the
      removal of all infected and affected dentin to avoid more cariogenic activity.
    

Detailed description: 
      This study is designed to assess the clinical and radiographic effectivness of nano silver
      fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second
      primary molars. This clinical study is important because World Health Organization (WHO) has
      reported that school children experience to dental caries was 60-90% of worldwide (P. D.
      Garkoti et al., 2015).

      This clinical trial has potential benefits to patients where indirect pulp treatment
      preserves pulp vitality by partial caries removal without exposing pulp. Several materials
      have been used for indirect pulp technique including calcium hydroxide (Metalita M et al.,
      2016).
    

Intervention name(s): Nano Silver Fluoride; Calcium hydroxide
Intervention type(s): Drug; Drug
Intervention description(s): Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.; Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.
Other intervention name(s): NSF; CaoH
Intervention MeSH terms: Calcium; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Pivotal Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Test Product; Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test and Reference product in each study period; 2 inhalations of Test and Reference product in each study period
Other intervention name(s): Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals; ADVAIR DISKUS 250/50
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
Condition: Joint Dysfunction
MeSH terms: Joint Diseases
Study type: Observational

Summary: 
      The objective of this study is to gather clinical data on SI-LOK® for the treatment of
      sacroiliac joint dysfunction.

      The purpose of this prospective study is to evaluate clinical and radiographic outcomes,
      intra-operative parameters, patient satisfaction and work status following a procedure using
      SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
    

Detailed description: 
      Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by
      either the surgeon, clinical coordinator or patient.

      Forms completed by patients will be checked, initialed and dated by the site coordinator.

      Data collected will be presented as mean +/- standard deviation. Statistical significance
      will be evaluated at the P < 0.05 significance level.
    

Intervention name(s): SI-LOK
Intervention type(s): Device
Intervention description(s): Sacro-iliac joint fusion
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be screened according to inclusion/exclusion criteria and will be selected
        for the treatment using the SI-LOK® system
      
Keywords: Sacro-iliac Joint
A Study on Safety of tDCS One-shot in UCP
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The study aims to evaluate the safety and the feasibility of transcranial Direct Current
      Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP).
      Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short
      term, Upper Limb (UL) functions.
    

Detailed description: 
      Unilateral Cerebral Palsy (UCP) represents the most frequent form of CP; the upper limb (UL)
      is generally more affected than the lower limb with an impact in "activity" and
      "participation" areas. The non-invasive brain stimulation techniques (NIBS), such as
      transcranial Direct Current Stimulation (tDCS), appear able to modulate neuronal plasticity
      processes even more late in age attracting great interest for their potential fallout in the
      field of rehabilitation. The effects of tDCS in recovery of motor function has more
      investigated in adults, while in the pediatric population studies on safety and efficacy are
      still few and not conclusive. This study aims to evaluate the safety and the feasibility of
      tDCS session in children and young adults with UCP both in short term and in follow up (up to
      24 hrs after the tDCS session). Secondarily it aims to test the effects of tDCS (real vs
      sham) in improving, in short term, UL functions. For the study 6 children (aged 10-17 years)
      and 6 young adults (aged 18-28 years) with UCP will be recruited. Each subject receives,
      randomly, a real session and a sham session of tDCS with BrainStim Stimulator. Before (T0),
      immediately after (T1) and after 1 hour and half (T2) to each tDCS session (real or sham)
      heart rate, blood pressure and UL functions will be measured. Moreover the subject fills in
      an ad hoc questionnaire on safety at T1 and T2 and, on call, at 24 hours after the sessions
      (T3).
    

Intervention name(s): real tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator.; one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Unilateral Cerebral Palsy; tDCS; Safety; Upper Limb functions
Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the trial are:

      To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant
      to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma
      multiforme.

      To describe the possible effect of nelfinavir on functional imaging To describe the activity
      of nelfinavir in vivo on blocking the AKT pathway.
    

Detailed description: 
      Glioblastoma multiforme is the most malignant and common, about 50%, variant of all primary
      brain tumours. The treatment strategies for this disease have not changed appreciably for
      many years consisting of a surgical intervention (biopsy or tumour resection) and
      post-operative local radiotherapy until several years ago. Combined chemoradiotherapy with
      temozolomide is at the moment the standard medical practice after results of the joint
      EORTC-NCIC phase III study randomizing between radiotherapy alone and combined
      chemoradiotherapy with temozolomide showed a significant improvement in 2-years survival from
      8% to 24% for the combined treatment arm (Stupp 2005). Given the poor prognosis of these
      patients and the still poor treatment response, further therapeutic improvement will remain
      the most challenging topic for the future. The next step to further improve survival for this
      patient group would be the addition of biological modifying and/or antiangiogenic therapies.
      These strategies are motivated by the fact that glioblastomas often express very high levels
      of vascular endothelial growth factor which is a key mediator of blood vessel growth as high
      expression of EGFR, which upregulates the downstream PI3K-AKTpathway. (Fischer I, Carmeliet
      P, Koul D) One possible candidate is nelfinavir, a protease inhibitor interfering with Akt
      activity downstream of EGFR and upstream of VEGF. (Geng L, Gorski D, HLu B)
    

Intervention name(s): nelfinavir
Intervention type(s): Drug
Intervention description(s): The start dose of nelfinavir in phase 1 is 1000mg BID. The maximum administered dose, if no DLT occurs, will be1250 mg BID (2500mg). Nelfinavir will be administered 1 week before start of the chemoradiotherapy until the last day of chemoradiotherapy.
Intervention MeSH terms: Nelfinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma; nelfinavir; functional imaging; AKT pathway
Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne
Condition: Inflammatory Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in
      patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate
      clinical profile for further clinical development.
    

Detailed description: 
      This was a randomized, placebo-controlled, subject- and investigator-blinded, multicenter,
      nonconfirmatory, parallel group, and proof-of-concept study in adult patients with moderate
      to severe inflammatory acne. After an initial screening period (up to 4 weeks), subjects were
      treated with LYS006 or matching placebo for 12 consecutive weeks to assess preliminary
      clinical efficacy, safety, and tolerability in the targeted subject population. At the
      beginning of the treatment period, subjects were randomized to one of three treatment groups,
      i.e., LYS006 20 mg twice daily (BID), LYS006 2 mg BID or matching placebo in a 3:1:3 ratio.

      After treatment period completion, all subjects entered a post-treatment safety follow-up
      period of 4 weeks without study drug administration. The maximum duration of study
      participation was 20 weeks. Study completion was defined as when the last subject completed
      his/her study completion visit, and any repeat assessments associated with this visit were
      documented and followed-up appropriately by the investigator, or in the event of an early
      study termination decision, the date of that decision.
    

Intervention name(s): LYS006 20 mg; LYS006 2 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LYS006 20 mg, capsules, oral administration, BID, for 12 weeks; LYS006 2 mg, capsules, oral administration, BID, for 12 weeks; Matching placebo, capsules, oral administration, BID, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne, efficacy, safety
Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint Dysfunction.
Condition: Temporomandibular Joint Dysfunction
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle
      activation as a result of symptoms such as pain and limitation of movement. The aim of this
      study is to examine the efficacy of manual therapy electromyographically in patients with
      TMD.
    

Detailed description: 
      TMD is a common condition in the community. It may occur due to factors such as trauma,
      stress, occlusal disorders. Symptoms include pain, limitation in mouth opening, joint voice,
      postural and psychosocial disorders. TMD/RDC diagnostic criteria are used in the
      classification of TMD, and accordingly, it is stated that it may originate from the joint,
      disc and chewing muscles. In the treatment, conservative treatments such as patient
      education, manual therapy and exercises are applied first.

      Manual therapy is an effective physiotherapy method on pain and muscle dysfunctions in
      musculoskeletal problems. In our study, electromyographic changes of masticatory muscles will
      be examined by applying manual treatment to the masticatory muscles and cervical region in
      myofascial TMD patients according to TMD/RC.
    

Intervention name(s): Manual Therapy
Intervention type(s): Other
Intervention description(s): Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporomandibular joint dysfunction; manual therapy; EMG; maximal mouth opening
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Condition: Arthritis, Gouty
MeSH terms: Arthritis; Arthritis, Gouty
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory proof-of-concept study to evaluate the safety and efficacy of
      canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
    


Intervention name(s): canakinumab; dexamethasone; placebo matching canakinumab; placebo matching dexamethasone
Intervention type(s): Biological; Drug; Other; Other
Intervention description(s): 10 mg/kg intravenous infusion 250 mL over 2 hours.; 12 mg intravenous infusion 50 mL over 30 minutes.; 5% glucose in water intravenous infusion.; Placebo intravenous infusion.
Other intervention name(s): ACZ885; Ilaris®
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Arthritis Gouty; ACZ885; IL1B protein; Pain