bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage
      strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
    

Detailed description: 
      The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase
      will consist of 2 periods that taken together, will last up to a maximum of 21 days: a
      Screening Period and a Baseline Period. The Randomization Phase will comprise 4 treatment
      periods (Treatment 1, Treatment 2, Treatment 3, Treatment 4) with intervening washout periods
      between treatment periods (Washout 1, Washout 2, Washout 3). A single dose of study drug will
      be administered in a randomized, 3-way double-blind crossover manner at Treatment Periods
      1-3; flurazepam 30 mg will be administered in an open-label manner at Treatment Period 4.
    

Intervention name(s): Lemborexant 5 mg; Lemborexant 10 mg; Lemborexant-matched placebo.; Flurazepam 30 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lemborexant 5 mg tablet.; Lemborexant 10 mg tablet.; Lemborexant-matched placebo tablet.; Flurazepam 30 mg capsule.
Other intervention name(s): E2006; E2006; E2006
Intervention MeSH terms: Lemborexant; Flurazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia Disorder; E2006; Multiple Sleep Latency Test; Lemborexant
Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the clinical response to autologous bone marrow
      aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis
      with respect to pain, function, and quality of life at up to 1 year following the
      intervention. Specifically, the clinical response will be compared to baseline and a control
      group treated with a Gel-One® hyaluronate injection to the target knee.
    


Intervention name(s): BMAC injection; PRP injection; Gel-One® hyaluronate injection
Intervention type(s): Biological; Biological; Device
Intervention description(s): 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.; 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.; Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; regenerative medicine; orthobiologics; cellular therapy
Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Condition: Angina Pectoris; Unstable Angina; Myocardial Infarction
MeSH terms: Myocardial Infarction; Angina Pectoris; Angina, Unstable; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and feasibility of a novel oxygen carrying
      solution, HBOC-201, in the setting of PCI for Acute Coronary Syndromes from randomization til
      hospital discharge.
    

Detailed description: 
      Acute coronary syndromes are due to an acute or subacute primary reduction of myocardial
      oxygen supply provoked by disruption of an atherosclerotic plaque associated with
      inflammation, thrombosis, vasoconstriction and microembolization. Occlusive thrombosis
      superimposed on a ruptured atheroma in an epicardial coronary artery is firmly established as
      the immediate cause of an acute ST-segment Elevation Myocardial Infarction (STEMI). Rapid
      restoration of blood flow (oxygen supply) to jeopardized myocardium limits necrosis and
      reduces mortality. This can be accomplished medically with a thrombolytic agent, or
      mechanically, with so-called primary balloon angioplasty or stenting. Primary percutaneous
      coronary intervention (PCI) has become the preferred therapy for STEMI in most developed
      countries.

      HBOC-201 is a solution belonging to a new class of biologic oxygen therapeutics, hemoglobin
      based oxygen carriers. HBOC-201 is a crosslinked and glutaraldehyde-polymerized hemoglobin
      (Hb) extracted from isolated bovine red blood cells. On a gram-for-gram basis, HBOC-201 was
      calculated to be approximately three times more potent than stored fresh red blood cell
      hemoglobin at restoring baseline tissue oxygenation following severe acute anemia. Evaluation
      of this Hemoglobin Based Oxygen Carrier has been undertaken in 57 preclinical studies and 21
      human clinical trials. The compound is under review by the US FDA and has been approved in
      the Republic of South Africa. However, HBOC-201 has not yet been evaluated in the setting of
      this disease (narrowing of a coronary artery).

      Biopure will be studying the safety and feasibility of HBOC-201 in patients with typical
      symptoms of Unstable Angina or Non ST-segment Elevation Myocardial Infarction eligible to
      undergo invasive revascularization through a PCI procedure.
    

Intervention name(s): Percutaneous Coronary Revascularization; Hemoglobin-Based Oxygen Carrier-201 (HBOC-201); Voluven
Intervention type(s): Procedure; Drug; Drug
Intervention MeSH terms: Chrysarobin; HBOC 201
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemoglobin Based Oxygen carrier; HBOC 201; Percutaneous Revascularization; Percutaneous Coronary Intervention; Non ST-segment Elevation Myocardial Infarction; Tissue Oxygenation; Transluminal Percutaneous Coronary Angioplasty
Investigating the Impact of Ex Vivo Ozone Injection on Synovial Fluids in Patients Diagnosed With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objective of this study is to examine the effect of varying ozone doses on the levels of
      pro-inflammatory cytokines in synovial fluid collected from individuals with knee
      osteoarthritis.
    

Detailed description: 
      In this study, synovial fluid samples will be collected from patients diagnosed with knee
      osteoarthritis for in vitro studies. The synovial fluid will be collected under sterile
      conditions by a joint puncture, and ultrasonography will be performed before sample
      collection. The synovial fluid samples will then be transferred to sterile urine culture
      tubes, with one containing only synovial fluid and the others containing synovial fluid and
      ozone gas. Afterward, the synovial fluid samples will be centrifuged, and the upper portion
      will be stored at -80°C for biochemical analyses. The total protein content will be measured
      using a commercial kit based on the Bradford method, and the total antioxidant level and
      Total oxidant levels will be measured using commercially purchased kits according to the
      manufacturer's instructions. The oxidative stress index will be calculated using the formula
      (TOS/TAS) and will be normalized to the total protein content measured in the synovial fluid.
    

Intervention name(s): Ozone injection
Intervention type(s): Other
Intervention description(s): Ozone injection is a process where ozone gas is injected into a substance or system for various purposes. Ozone gas (O3) is a highly reactive form of oxygen that can be generated through the use of specialized ozone generators. Ozone injection can be used in a variety of applications, including water treatment, air purification, and medical therapy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Synovial fluid samples taken from patients will be prepared to form 3 separate groups, one fluid will not be treated, one will be injected with 10 gamma and the other with 30 gamma ozone.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Dose-dependent effect; knee osteoarthritis; ozone therapy; pro-inflammatory cytokines; synovial fluid
Adults With SMA Treated With Nusinersen
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Observational

Summary: 
      This is a single center, 22-month observational study of nusinersen treatment in adult
      patients with spinal muscular atrophy (SMA). There will be a total of seven visits.
      Nusinersen is provided as standard of care and not considered research in this study.
      Information will be collected regarding the general health, and function including muscle
      strength of, as well as any positive and/or adverse events experienced by the study
      participants.
    

Detailed description: 
      This is a single center, 22-month observational study of nusinersen treatment in adult
      patients with SMA. There will be a total of five visits. All subjects will be evaluated at a
      screening visit no more than four weeks before starting their standard of care nusinersen
      treatment to determine their eligibility for participation. Eligible patients will complete
      their standard induction intrathecal nusinersen treatment on day 1, 15, 29 and 60 followed by
      maintenance doses every four months. Subjects will be reevaluated after completing the
      loading doses at 2 months followed by every four-month evaluations for the total duration of
      the treatment of 22 months.

      Currently, there is no data published on patients receiving this treatment over the age of
      18. Without published data collected from research, it is difficult for adult patients to get
      approval from their insurance companies to receive this treatment. This study hopes to
      collect data, in order to make this treatment option easier for patients with SMA to access
      and in general learn how well nusinersen is working in adult patients with SMA overtime.
    

Intervention name(s): nusinersen
Intervention type(s): Drug
Intervention description(s): SPINRAZA (nusinersen) is FDA approved to treat spinal muscular atrophy (SMA) through intrathecal injection.
Other intervention name(s): SPINRAZA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with spinal muscular atrophy (SMA) as confirmed by clinical and genetic assessments.
      
Biospecimen description: 
      blood/serum
    
Keywords: nusinersen; Spinraza
Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation
Condition: Amputation, Traumatic; Low Back Pain
MeSH terms: Low Back Pain; Amputation, Traumatic
Study type: Observational

Summary: 
      The aim of this study is to investigate the relationship between sagittal spinopelvic
      parameters and low back pain and quality of life in individuals with lower extremity
      amputation.
    

Detailed description: 
      Low back pain is one of the secondary health problems that negatively affect functionality,
      independence and quality of life in individuals with lower extremity amputation. The
      prevalence of low back pain was reported to be higher in individuals with lower extremity
      amputation (52-89%) than in the non-amputee population (12-45%). Although the etiology of low
      back pain is multifactorial, changing anatomy and biomechanics after lower extremity
      amputation and maintaining daily activities are often associated with the development of low
      back pain. Postural imbalance, which is one of the musculoskeletal disorders of the spine
      that contributes to low back pain, is considered to cause additional load on the spinal
      structures.
    

Intervention name(s): Measurements of sagittal spinopelvic parameters
Intervention type(s): Other
Intervention description(s): Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Lower extremity amputation
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children
Condition: Laryngeal Mask Airway Removal; Respiratory Complication
Study type: Interventional

Summary: 
      The purpose of this prospective, randomized study was to compare the incidence of adverse
      events associated with removal of the LMA either in deeply anesthetised or awake patients.
    

Detailed description: 
      Written informed consent was obtained from parents for this prospective, randomized study
      conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane,
      supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4%
      in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were
      randomized into 2 groups:

        -  Awake: the LMA was left in place until the patient fully regained consciousness

        -  Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic
           turned off, and ventilation using facial mask was carried until spontaneous ventilation
           recovery.

      Respiratory complications that occurred during LMA removal until 20 minutes afterwards were
      recorded. Children with respiratory history and those for whom peripheral nerve blocks
      failed, were excluded.
    

Intervention name(s): LMA removal
Intervention type(s): Other
Intervention description(s): According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Efficacy Evaluation of Dai Dai Flower on Body Weight
Condition: Gastroenterology
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      To assess the Dai Dai flower extract on body weight control
    


Intervention name(s): Placebo drink; Dai Dai flower drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 1 bottle (50 mL) per day for 8 weeks; consume 1 bottle (50 mL) per day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Obesity; Weight control; Dai Dai flower
Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain
Condition: Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      This Clinical trial study for the effect of a product E-PR-01 will be studied for its ability
      to attain rapid pain relief in the individuals suffering from exercise-induced knee joint
      pain, as well as determine its sustained effect on pain reduction over a treatment period of
      five days.
    

Detailed description: 
      The study is a randomized, double-blind, placebo controlled, cross-over study to explore the
      effect of a product E-PR-01 on joint pain. Approximately 50 participants aged between ≥ 20
      and ≤ 60 years will be screened. At least 40 participants will be randomized, and the
      participants will be crossed over both the IP and placebo arms. A minimum of 32 participants
      must complete the study, after accounting for the screening failure and dropout /withdrawal
      rate of 20% each. The duration of each treatment for all the study participants will be 5
      days, the washout period between each treatment period being 5 ± 2 days.

      The total study period from the first start of treatment visit, inclusive of the washout and
      treatment periods, is estimated to be 15 days.
    

Intervention name(s): E-PR-01; E- PR-02
Intervention type(s): Other; Other
Intervention description(s): Active arm; Placebo arm
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Placebo-controlled, Double-blind, Cross-Over Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
Condition: Keloid
MeSH terms: Keloid; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot study will assess the safety and efficacy of Apligraf in the healing and
      recurrence of keloids post surgical shave excision in patients with clinically diagnosed
      keloids.
    


Intervention name(s): Apligraf; Standard dressing regimen
Intervention type(s): Device; Other
Intervention description(s): Application at Day 0, potential re-application at Week 4; A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
Condition: Postoperative Pain; Breast Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative analgesia in breast surgery is a difficult and overworked issue due to
      extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is
      a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study
      was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast
      surgery.
    


Intervention name(s): Erector Spinae Plane Block; Intravenous Morphine patient controlled analgesia device
Intervention type(s): Other; Device
Intervention description(s): erector spinae plane block with double level injection will be administered before the surgery; 24 hour morphine consumption will be recorded
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: erector spinae plane block; breast surgery; postoperative pain
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Condition: Current or Recent History of Atrial Fibrillation
MeSH terms: Heart Failure; Atrial Fibrillation; Atrial Flutter
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to
      metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial
      flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic
      receptor.
    

Detailed description: 
      The goal of the GENETIC-AF trial is to demonstrate the superiority of pharmacogenetically
      targeted bucindolol compared to metoprolol for the prevention of symptomatic atrial
      fibrillation or atrial flutter in a genotype-defined population with heart failure and/or
      reduced left ventricular ejection fraction at high risk of atrial fibrillation/atrial flutter
      recurrence.
    

Intervention name(s): bucindolol hydrochloride; metoprolol succinate; Placebo oral capsule
Intervention type(s): Drug; Drug; Other
Other intervention name(s): bucindolol; Toprol-XL; metoprolol; placebo
Intervention MeSH terms: Metoprolol; Bucindolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial fibrillation; atrial flutter; heart failure; reduced left ventricle ejection fraction; electrical cardioversion; GENETIC-AF; Medtronic; bucindolol; pharmacogenetic; ARCA; Toprol; Toprol-XL; Metoprolol; Metoprolol succinate
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of
      'GC1107' administered intramuscularly in healthy children
    

Detailed description: 
      Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study
    

Intervention name(s): GC1107; TD_PUR INJ / SK Td vaccine
Intervention type(s): Biological; Biological
Intervention description(s): GC1107-T5.0: low dose, GC1107-T7.5: high dose; step 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      5 Day study to assess how quickly a topical acne product begins to work.
    


Intervention name(s): 3% Benzoyl Peroxide; 3% Benzoyl Peroxide Placebo; Neutrogena Rapid Clear®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.; The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.; A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment