bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
Condition: Depressive Episode; Bipolar 1 Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study to test the effectiveness of an investigational drug to treat people that
      have major depressive episodes when they have Bipolar 1 Depression
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study
      designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199
      monotherapy given as 200 mg/day or 400 mg/day compared with placebo for the treatment of
      major depressive episodes associated with bipolar I disorder (bipolar I depression).
    

Intervention name(s): SEP-4199 200 mg; SEP-4199 400 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-4199 200 mg/day (supplied in two 100mg tablets); SEP-4199 400 mg/day (supplied in two 200mg tablets; Placebo (supplied in two tablets/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression
Ready to Use Supplementary Food in Moderate Childhood Malnutrition
Condition: Moderate Acute Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe
      malnutrition. Their efficacy and effectiveness were proven in community therapeutic care
      programs. Recently, the question rose if RUTF would be more effective than enriched flours to
      treat moderate malnutrition.

      The purpose of this study is to compare the effectiveness of Ready to Use Food
      Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain,
      duration of treatment, morbidity and mortality in the treatment of moderate acute
      malnutrition.

      Compare the longer term effect on nutritional status and morbidity (relapse?).
    


Intervention name(s): Ready to Use Supplementary Food; Premix CSB-oil treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.; Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines
Other intervention name(s): Supplementary-plumpy®; Corn Soy Blend; Fortified Blended Flours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate; Wasting; Malnutrition; Ready to Use Food; Fortified Blended Flour
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients
      diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study
      will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind,
      placebo-controlled study. In Part B, patients who safely complete participation in part A may
      be enrolled in an open-label extension.
    


Intervention name(s): ITI-007 (Lumateperone); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Minocycline in Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral
      hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for (1)
      safety/ tolerability and (2) evaluate for clinical efficacy
    

Detailed description: 
      Intracerebral hemorrhage (ICH) remains a devastating neurological disorder with high
      mortality and poor prognosis with unchanged mortality rates (53-59%). Acute treatment options
      for ICH remain supportive with no available effective drug or surgical therapy. All trials so
      far have failed to improve clinical outcome in randomized, double-blinded trials. However,
      one area of interest has been maintaining the integrity of the blood-brain-barrier (BBB) and
      preventing the growth of vasogenic edema. Matrix metalloproteinases (MMP) are a family of
      ubiquitous zinc-dependent endopeptidase enzymes whose primary function is the digestion of
      collagen type IV, laminin, and fibronectin for the purpose of remodeling extracellular basal
      lamina. Elevated MMP-9 as a pathological process associated with larger hematoma volume,
      larger perihematomal edema, and poorer clinical outcome in intracerebral hemorrhage is well
      documented in animal models and patients. One particular MMP-9 inhibitor gaining usage in
      cerebrovascular disease is minocycline. Normally FDA-approved for bacterial infection and
      acne vulgaris, minocycline has also been found to be both a safe and effective treatment in
      ischemic stroke; its potential role as a neuroprotectant in ischemic stroke is currently
      being tested in a large, randomized, double-blinded trial. Minocycline's beneficial role as a
      neuroprotectant may also extend to ICH. By inhibiting MMP-9, minocycline may decrease BBB
      permeability, resulting in less perihematomal edema and decreased mass effect. Although
      numerous animal ICH models support minocycline's role as an inhibitor of MMP-9 and
      neuroprotectant, its use has never been studied in humans with ICH.
    

Intervention name(s): Minocycline; normal saline infusion
Intervention type(s): Drug; Other
Intervention description(s): high-dose, intravenous minocycline
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus
Condition: Hearing Disorders; Hearing Loss; Hyperacusis; Tinnitus
MeSH terms: Hearing Loss; Deafness; Tinnitus; Hearing Disorders; Hyperacusis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether chronic electrical stimulation of the
      primary auditory cortex is effective in the treatment of chronic, severe and intractable
      tinnitus
    

Detailed description: 
      Severe and chronic tinnitus - the perception of sound in one or both ears or in the head when
      non-external sound is present - can be disabling and difficult to treat. Physiopathology of
      tinnitus can be considered as similar to neuropathic pain. Neuropathic and central pain are
      treated since ten years by chronic electrical motor cortex stimulation. The hypothesis of
      this study is that it will be possible to treat severe tinnitus by this stimulation as
      neuropathic pains are treated by motor cortical stimulation.

        -  Principal Objective : to evaluate the efficacy of chronic electrical stimulation of the
           auditory cortex for intractable tinnitus

        -  Secondary Objective : to evaluate the tolerability and the safety of chronic electrical
           stimulation of the auditory cortex for intractable tinnitus

        -  Study design : randomized, cross over, double blind, study to evaluate the efficacy of
           the chronic electrical stimulation versus sham in severe and chronic tinnitus

        -  Inclusion criteria :

      Patient >18 years of age and < 70 years of age Permanent and chronic tinnitus during more
      than 2 years. A score over 19 at the STI (Quality of life index for tinnitus) Unilateral
      tinnitus

      • Exclusion criteria : Deaf person Surgical or anesthetic contraindication History of
      psychiatric disorder or suicide Epilepsia

      • Number of subjects : 10
    

Intervention name(s): significant chronic primary auditory cortex stimulation during the first two weeks; non significant chronic primary auditory cortex stimulation during the first two weeks
Intervention type(s): Procedure; Procedure
Intervention description(s): significant chronic primary auditory cortex stimulation during the first two weeks of the follow up than wash out period followed by two weeks of non significant stimulation; non significant stimulation during the first two weeks of the follow up than wash out period followed by two weeks of significant chronic primary auditory cortex stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging
Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      Children with cerebral palsy (CP) have postural control problems due to the lack of motor and
      sensory development. Trunk control which has an important role in ensuring postural control,
      is the basis for sitting, mobility, development of the upper extremity, pulmonary function
      and activities of daily living. Poor postural control restricts upper extremity functions
      which also affects the quality of movements. For this reason, it is important to assess the
      relationship between trunk control and upper extremity functions. This study is planned to
      investigate the effect of balance and trunk control on upper extremity functions in children
      with CP.
    

Detailed description: 
      30 hemiparetic and 32 diparetic CP, in total 62 children, aged between 5-12 years, were
      included in this study. Trunk Control Measurement Scale (TCMS) was used to assess trunk
      control, Pediatric Balance Scale (PBS) was used to assess balance, and Quality of Upper
      Extremity Skills Test was used to assess upper extremity functions (QUEST).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cerebral palsy (CP) describes a group of permanent disorders in movement and posture that
        limit activity and participation and are attributed to non-progressive disturbances in the
        developing fetal or infant brain
      
Keywords: cerebral palsy; trunk control; upper extremity
China ATTUNE® Study
Condition: Osteoarthritis; Post-traumatic Arthritis
MeSH terms: Osteoarthritis
Study type: Observational [Patient Registry]

Summary: 
      The study was designed as prospective, single-arm, multi-center which was intended to broadly
      capture all patients as the technology is adopted.
    

Detailed description: 
      The primary objective is to evaluate the implant survivorship of ATTUNE primary, cemented
      Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs. The subject
      population is male and female subjects who are candidates for primary, total knee
      arthroplasty between 18 and 80 years of age, inclusive, willing to consent with indications
      consistent with the Instructions for Use. A total of 120 subjects will be enrolled in this
      study.
    

Intervention name(s): Cemented ATTUNE® Knee System
Intervention type(s): Device
Intervention description(s): This product is for total knee arthroplasty. Four implant configurations are permitted: Cruciate Retaining Fixed Bearing (CR FB), Cruciate Retaining Rotating Platform (CR RP), Posterior Stabilizing Fixed Bearing (PS FB) and Posterior Stabilizing Rotating Platform (PS RP)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female Subjects who are candidates for primary, total knee arthroplasty between 18
        and 80 years of age, inclusive, willing to consent with indications consistent with the
        Instructions for Use.
Food Effect Study of D-0502 Tablet in Healthy Volunteers
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting),
      two-period, two-sequence crossover study of postmenopausal female healthy subjects.
    


Intervention name(s): D-0502
Intervention type(s): Drug
Intervention description(s): D-0502 oral tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, placebo-controlled parallel-group study, comparing the
      bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of
      Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of
      seasonal allergic rhinitis.
    


Intervention name(s): triamcinolone acetonide aqueous nasal spray (Apotex Inc.); triamcinolone acetonide aqueous nasal spray (Nasacort® AQ); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.; It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.; It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated and optimized settings for, and evaluated the performance of,
      AI-700-enhanced echocardiographic imaging on several ultrasound imaging platforms, as well as
      collected additional safety data for AI-700 in healthy volunteers and stable cardiac
      patients.
    

Detailed description: 
      Because the quality of AI-700-enhanced images is in part determined by the ultrasound (US)
      settings selection, the continuing study of different imaging modes and/or techniques is
      required in order to provide US settings recommendations for the many available systems.
      Therefore AI-700-enhanced imaging was performed in this study using imaging platforms and
      modes not previously tested and the AI-700 dose and administration methods employed in
      previous Phase 3 studies.

      Two cohorts of subjects were studied at each site. Enrollment commenced with Cohort A and
      included normal (healthy) volunteers and stable cardiac patients. Settings optimization was
      performed in Cohort A using a single platform and real-time imaging. If the Sponsor agreed
      that the images and settings acquired in Cohort A were acceptable, the site was authorized to
      begin enrollment in Cohort B using the platform and settings that were defined in Cohort A.
      Authorized sites enrolled stable cardiac patients in Cohort B; no healthy volunteers were
      studied. For Cohort B subjects, the first 0.04 mL/kg dose of AI 700 was used to evaluate
      real-time imaging with the settings defined in Cohort A. The second dose of AI-700 for Cohort
      B subjects may have been used to confirm the data obtained with the first dose, or to explore
      imaging in a second mode (e.g. 3D/4D) and/or using real-time, high mechanical index triggered
      imaging on a second platform.
    

Intervention name(s): AI-700
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; echocardiography; cardiac imaging; heart disease; ultrasound contrast agent; myocardial contrast enhancement; myocardial perfusion
Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population
Condition: Acute Aortic Dissection; Sex Role
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      The study evaluated the prevalence, presentation, management, and prognosis of coronary heart
      disease differ according to sex.
    

Detailed description: 
      The study included 884 patients enrolled in our institute between June 2002 and May 2016.
      Considering psychosocial factors, treatments, and the outcomes in men versus those in women
      with acute aortic dissection, explored the association of sex with psychosocial
      characteristics and mortality risk. Of 884 patients, 211 (23.9%) were women. The median
      duration of follow-up was 2.9 years (25th -75th percentiles: 1-4 years ).
    

Intervention name(s): drug; Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Application bracket; Surgery
Other intervention name(s): thoracic endovascular aortic repair
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Chinese
      
Biospecimen description: 
      patients
    
Keywords: aortic dissection; sex; treatment
Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in
      treatment of chinese patients with acne.
    


Intervention name(s): Adapalene + Clindamycin Hydrochloride; Adapalene + Clindamycin Hydrochloride; Adapalene + Clindamycin Hydrochloride; Adapalene + Clindamycin Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.1% Adapalene + 1% Clindamycin Hydrochloride; 0.1% Adapalene + 2% Clindamycin Hydrochloride; 0.05% Adapalene + 0.5% Clindamycin Hydrochloride; 0.05% Adapalene + 1% Clindamycin Hydrochloride
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; efficacy
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Due to the complexity of orally inhaled products (combination of a formulation and a
      device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo
      correlation(IVIVC) for inhaled dosage forms is not generally known.

      The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH
      product variants under development and compare pulmonary deposition (administration with
      charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.
    

Detailed description: 
      In order to reduce variability, a crossover design is chosen. An open study design is
      regarded appropriate because the study is a pilot and the primary study variables are
      pharmacokinetic(PK) parameters derived from drug concentrations in plasma. Wash-out period of
      at least 3 days between the study treatment administration days is considered sufficient for
      the elimination of budesonide and formoterol.

      The single dose study is suitable for this kind of study, where the aim is to compare
      products and the therapeutic response is not measured.

      The dose level selected is 2 inhalations (single dose) for all products. The administration
      of 2 inhalations enables the determination of budesonide and formoterol concentrations in
      plasma.

      In this study the investigational products are administered concomitantly with oral charcoal
      to block the GI absorption and to assess the pulmonary deposition of the active substances.

      Comparison of pulmonary deposition between the products is considered more relevant than
      systemic exposure at this point of product development. In the pivotal PK study total
      systemic exposure will also be assessed.

      Blood samples for formoterol analysis will be collected up to 24 hours and for budesonide
      analysis up to 12 hours after dosing to cover at least 80% of the total area under the
      concentration-time curve from time zero extrapolated to infinity (AUC∞).
    

Intervention name(s): Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Intervention type(s): Drug
Intervention description(s): Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product
Other intervention name(s): Symbicort 320/9 μg inhaler
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Easyhaler