bioihbjkbjnl/mcl2 huggingface dataset:
Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the effects of plasticity-based, adaptive
      cognitive remediation on the cognitive abilities, functional status and quality of life of
      soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a
      mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as
      compared to a computer-based control.
    

Detailed description: 
      This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled
      clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized
      cognitive remediation treatment versus a computer-based control. Both the study and the
      cognitive remediation treatments meet the criteria of Non-Significant Risk.
    

Intervention name(s): Computerized Plasticity-based Adaptive Cognitive Training; Commercially available computerized training
Intervention type(s): Other; Other
Intervention description(s): Computerized plasticity-based adaptive cognitive training, up to 65 hours; Commercially available computerized training, up to 65 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild Traumatic Brain Injury; Cognitive remediation; computer
Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effectiveness of a wearable therapeutic
      ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of
      the device to reduce pain, increase mobility, increase range of motion and muscle strength of
      the affected leg, and improve quality of life in patients with knee osteoarthritis will be
      evaluated.
    

Detailed description: 
      This is an eight week study to clinically evaluate the effect of the low intensity long
      duration ultrasound (LITUS) device on symptoms of patients suffering from knee
      osteoarthritis. The device, sam® has been FDA-cleared for use. For the first two weeks of the
      study, baseline data will be collected as patients report pain scores (NRS) three times per
      day. During the following 6 weeks, patients will self-apply the wearable LITUS device to
      their affected knee for 4 hours daily. Each day of the study, pain scores (NRS) will be
      recorded immediately before application of LITUS device as well as 30 minutes, 2-hours and
      4-hours after applying the device. A quality of life assessment (WOMAC), muscle strength and
      range of motion assessment (JTech) will be performed prior to the patient beginning the
      protocol and at the conclusion of the protocol.

      Up to 93 subjects will be recruited from neighboring communities to the study site. The study
      is designed to reach a target patient population which includes rural citizens and
      socioeconomic disadvantaged individuals where non-pharmacotherapies do not exist to manage
      pain. Subjects will be randomly assigned to active (60%) and placebo groups (40%). The
      sponsor and investigators are blinded as to which type of device each patient is assigned.

      The study will be monitored by an external monitor and a data safety monitoring board (DSMB).
    

Intervention name(s): Sam Ultrasonic Diathermy Device
Intervention type(s): Device
Intervention description(s): Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Other intervention name(s): ZetrOZ ultrasound device; wearable ultrasound device; long duration ultrasound; LITUS device; long duration low intensity device
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; arthritis; musculoskeletal; connective tissue disease; ultrasound; pain; mobility; heat; strength; ZetrOZ; LITUS; Sam; grade 1; grade 2
Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled
      in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations
      with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the
      immune system's response to the vaccine. The safety and immune system's response will be
      studied throughout the trial.
    


Intervention name(s): VCL-IPM1; VCL-IPM1; VCL-IPT1; PBS
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): IM, 0.5 mg/mL, 2 injections, 0 and 21 days; IM, 1 mg/mL, 2 injections, 0 and 21 days; IM, 1 mg/mL, 2 injections, 0 and 21 days; IM, 1 mL, 2 injections, 0 and 21 days
Other intervention name(s): Phosphate Buffered Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pandemic Influenza; Avian Influenza; DNA Vaccines; Antibody; T Cells; HA/NP/M2; Biojector
Modified Diet Trial: A Study of SMT C1100 in Paediatric Patients With DMD Who Follow a Balanced Diet
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is
      to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with
      Duchenne Muscular Dystrophy (DMD) who follow a balanced diet.
    

Detailed description: 
      Primary Objective:

      To determine the plasma concentration of SMT C1100 calculated at each time point for each
      subject (sample size (n), mean, standard deviation (SD), percentage of coefficient of
      variation (%CV), geometric mean, median, minimum, and maximum for the parent and the major
      metabolites).

      Secondary Objectives:

        1. To determine the safety and tolerability of single and multiple oral doses of SMT C1100
           in patients with Duchenne Muscular Dystrophy (DMD) by assessing the participants adverse
           events, ECG results, vital signs and laboratory tests.

        2. To evaluate the diurnal variability in the steady state PK of SMT C1100 calculated at
           each time point for each subject (sample size (n), mean, standard deviation (SD),
           percentage of coefficient of variation (%CV), geometric mean, median, minimum, and
           maximum for the parent and the major metabolites).

        3. To evaluate reductions in creatine phosphokinase as a potential pharmacodynamic (PD)
           marker of SMT C1100 activity and clinical benefit.
    

Intervention name(s): SMT C1100; SMT C1100; SMT C1100
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Period 1, SMT C1100 1250 mg BID; Period 2, Placebo BID; Period 3, SMT C1100 2500 mg BID; Period 1, SMT C1100 1250 mg BID; Period 2, SMT C1100 2500 mg BID; Period 3, Placebo BID; Period 1, Placebo BID; Period 2, SMT C1100 1250 mg BID; Period 3, SMT C1100 2500 mg BID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamics Effect of Calcipotriol/Betamethasone Dipropionate in a New Administration Form in Subjects With Chronic Plaque Psoriasis.
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety, tolerability and pharmacodynamics effect of treatment with microarray
      patches containing calcipotriol and betamethasone dipropionate.
    


Intervention name(s): Microarray patch A; Microarray patch B; Placebo; Daivobet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Microarray patch; Microarray patch; Microarray patch vehicle; Daivobet Gel
Other intervention name(s): Calcipotriol; Betamethasone dipropionate; Calcipotriol; Betamethasone dipropionate; Calcipotriol; Betamethasone dipropionate
Intervention MeSH terms: Calcitriol; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intra-individual comparison of all treatments
Masking: Single (Investigator)
Primary purpose: Treatment
Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This double-blind, placebo-controlled study will be conducted at 5 study centers in the
      United States. Approximately 30 subjects with moderate to severe plaque-type psoriasis will
      take part. The study will consist of a screening period of up to 21 days, a 12-week treatment
      period with 7 on-treatment clinic visits (approximately one every 2 weeks) and a post-dosing
      follow-up clinic visit approximately 30 days after the last dose of study drug is taken.

      Subjects will be randomized to receive either 250mg, 500mg or 1000mg of study drug or
      placebo. Study drug will be taken by mouth on a full stomach, every day for 84 days.

      Vital signs, clinical laboratory results (hematology, chemistry, and urinalysis), ECGs and
      physical examinations will be assessed at periodic intervals from Day 1 through Day 84.

      A skin biopsy will be taken at the beginning and the end of the dosing period to evaluate any
      effects of the study drug on psoriasis. Investigators will perform other psoriasis
      evaluations (including the Psoriasis Area and Severity Index [PASI] and the Physician's
      Global Assessment [PGA] at 5 different times throughout the study to quantify the effects of
      SRT2104 on psoriasis activity.

      Subjects will complete questionnaires throughout the study, to document their sense of
      well-being and mood at 4 different times during the study.

      Five blood samples will be obtained at different timepoints during the study, to measure the
      amount of SRT2104 in the body.
    


Intervention name(s): Placebo; SRT2104
Intervention type(s): Drug; Drug
Intervention description(s): For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.; SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule, packaged in dosing bottles containing a single daily dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in
      single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in
      healthy subjects
    


Intervention name(s): BIRT 2584 XX; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers
Condition: Endothelial Dysfunction
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is
      much higher than previously assumed, with approximately 10 % of patients undergoing
      non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study
      furthermore showed that patients treated with a high inspiratory oxygen fraction during
      surgery had a higher 1 year mortality compared with patients treated with a low inspiratory
      fraction. This was especially significant among patients undergoing cancer surgery. A
      possible explanation, is that a high oxygen fraction results in oxidative stress and
      endothelial dysfunction.

      With this randomized cross-over study we wish to investigate the effect of a high inspiratory
      oxygen fraction on the endothelial function among healthy male volunteers. The primary
      outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are
      changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a
      measure for the effect of oxygen on the autonomic nervous system.
    


Intervention name(s): 80% oxygen; 30% oxygen
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxidative stress; Nitrogen oxide; Reactive oxygen species
P3 Ghana Cookstove Study
Condition: Household Air Pollution; Behavior, Social
Study type: Interventional

Summary: 
      Background:

      Despite their potential health and social benefits, adoption and use of improved cookstoves
      has been low throughout much of the world. Explanations for low adoption rates of these
      technologies include prices that are not affordable for the target populations, limited
      opportunities for households to learn about cookstoves through peers, and perceptions that
      these technologies are not appropriate for local cooking needs. The P3 project employs a
      novel experimental design to explore each of these factors and their interactive effects on
      cookstove demand, adoption, use and exposure outcomes.

      Methods:

      The P3 study is being conducted in the Kassena-Nankana Districts of Northern Ghana.
      Leveraging an earlier improved cookstove study that was conducted in this area, the central
      design of the P3 biomass stove experiment involves offering stoves at randomly varying prices
      to peers and non-peers of households that had previously received stoves for free. Using
      household surveys, electronic stove use monitors, and low-cost, portable monitoring
      equipment, we measure how prices and peers' experience affect perceptions of stove quality,
      the decision to purchase a stove, use of improved and traditional stoves over time, and
      personal exposure to air pollutants from the stoves.

      Discussion:

      The challenges that public health and development communities have faced in spreading
      adoption of potentially welfare-enhancing technologies, like improved cookstoves, have
      highlighted the need for interdisciplinary, multisectoral approaches. The design of the P3
      project draws on economic theory, public health practice, engineering, and environmental
      sciences, to more fully grasp the drivers and barriers to expanding access to and uptake of
      cleaner stoves. Our partnership between academic institutions, in the US and Ghana, and a
      local environmental non-governmental organization creates unique opportunities to disseminate
      and scale up lessons learned.
    


Intervention name(s): P3 Bio Intervention
Intervention type(s): Behavioral
Intervention description(s): Two types of improved biomass burning cookstoves (ACE1 and Greenway Jumbo) are offered to participants in both arms at varying prices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cookstoves; Household Air Pollution; Behavior Change; Global Health
Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
Condition: Chronic Myeloid Leukaemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the complete cytogenetic response rate in patients with newly-diagnosed
      chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with
      interferon at low doses
    

Detailed description: 
      Open, prospective, multicentre, phase IV, comparative and randomised study
    

Intervention name(s): Glivec; Interferon
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic myeloid leukaemia; Glivec; Interferon
A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing
Condition: Mucogingival Deformity - Insufficient Keratinized Tissue
MeSH terms: Congenital Abnormalities
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate Omega-3 Wound™ as an alternative to autogenous free
      gingival grafts harvested from the palate to treat human subjects with insufficient KT (< 2
      mm)
    

Detailed description: 
      Primary objective:

      The primary aim will be to see if Omega-3 Wound™ is clinically superior to tissue harvested
      from the palate (Autogenous Free Gingival Graft) when comparing before and after measurements
      of: keratinized tissue. Change in KT width from time of surgery to 6 months post-surgery
      (22).

      Secondary objectives:

        1. Measures of periodontal health (probing depth, recession levels, bleeding on probing,
           plaque score, clinical attachment level, resistance to muscle pull, vestibular depth,
           healing time) over 3 months (at study entry, 4 weeks, 3 months and 6 months)

        2. Time of surgery

        3. Subject Discomfort Survey during healing and at 1 week and 4 weeks

        4. Subject Preference Questionnaire at month 6

        5. Safety endpoints assessed by monitoring adverse events
    

Intervention name(s): Kerecis Oral™; Free Gingival Graft
Intervention type(s): Device; Other
Intervention description(s): A free gingival autograft from patient palate placed and secured on wound bed
Other intervention name(s): Acellular Fish Skin Graft; FGG
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized controlled, split mouth (within subject) non-inferiority, single-center trial.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Is There a Risk of Perioperative Stroke Due to the Retraction Used During Anterior Cervical Discectomy?
Condition: Cervical Disc Disease; Cervical Stenosis; Cervical Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Observational [Patient Registry]

Summary: 
      In anterior cervical disc surgery, head and neck extansion position and, surgical retraction
      used while reaching the anterior surface of the cervical vertebra can be affect the carotid
      blood flow and constituting a risk for cerebral ischaemia. In this study, we planned to
      investigate the relationship between head position and retraction, cerebral oxygenation and
      postoperative cognitive functions in patients undergoing anterior cervical disc surgery.
    


Intervention name(s): Near infrared spectroscopy
Intervention type(s): Device
Intervention description(s): The Near Infrared Spectroscopy (NIRS) is the method used for monitorize the risk of the development of cerebral ischaemia while providing information about brain tissue oxygenation.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing cervical disc surgery
      
Keywords: Cerebral blood oxygenation; Near infrared spectroscopy; Cervical disc disease; Cervical microsurgery
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
Condition: Retinal Detachment
MeSH terms: Retinal Detachment
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the feasibility, primary safety and efficacy of
      foldable capsular vitreous body (FCVB) in the treatment of retinal detachment.
    

Detailed description: 
      Pars plana vitrectomy (PPV) has been one of the most important ophthalmic surgeries for
      treating a number of blinding diseases by removing and replacing the diseased vitreous body.
      Current clinic vitreous substitute cannot mimic the natural vitreous which is unable to
      regenerate after surgery. We have devised a novel foldable capsular vitreous body (FCVB)
      consisting of a vitreous-like capsule with a tube-valve system, and demonstrated it could
      finely mimic the morphology and restore main physiological function of the natural vitreous
      body in our previous study.
    

Intervention name(s): foldable capsular vitreous body(FCVB)
Intervention type(s): Device
Intervention description(s): the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV
Other intervention name(s): FCVB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: retinal detachment, vitreous body substitute
Evaluation of an Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects.
Condition: Healthy
Study type: Interventional

Summary: 
      The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the
      lean body mass (LBM) loss that occurs after bed rest.
    


Intervention name(s): ONS without AN777; ONS containing AN777
Intervention type(s): Other; Other
Intervention description(s): 2 servings a day; 2 servings a day
Other intervention name(s): Commercially available ONS; Investigational ONS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Immune Dysfunction in Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.
    

Detailed description: 
      Subjects with mild allergic asthma are examined before, immediately after and 2 months after
      a course of treatment with anti-IgE. The following are examined: Allergen skin tests,
      allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.
    

Intervention name(s): Xolair
Intervention type(s): Drug
Intervention description(s): Patients are administered Xolair
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science