bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg
      clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet
      dose under fed conditions
    

Detailed description: 
      The study was conducted as an open-label, randomized, 2-way crossover study to compare the
      single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin® 40o mg)
      amoxicillin (as the trihydrate)/57 mg clavulanic acid (as the potassium salt) chewable
      tablet, following administration of 2 tablet dose under fed conditions A total of 40
      Subjects, 20 males and 20 females; were enrolled in the study, and 39 subjects, 20 males and
      19 females, completed the study.
    

Intervention name(s): Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets
Intervention type(s): Drug
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Safety Study of BLS-M22 in Healthy Volunteers
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      BLS-M22 is being developed as an anti-myostatin agent for the treatment of Duchenne Muscular
      Dystrophy (Muscular Dystrophy). A total of 37 subjects participated in this study to confirm
      the safety of BLS-M22.
    

Detailed description: 
      This study is a dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation
      Phase I Clinical Trial to Evaluate Safety of BLS-M22.

      The single ascending dose group participated in 9 patients in each group(500mg, 1,000mg,
      2000mg/BLS-M22 or Placebo(n=7:2)). The multiple ascending dose group participated in 10
      patients(determined dose in SAD/BLS-M22 or Placebo(n=8:2)).
    

Intervention name(s): BLS-M22; Placebo
Intervention type(s): Biological; Other
Intervention description(s): BLS-M22 250mg/capsule; BLS-M22 placebo 250mg/capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The study is a single-center, randomized and double-blinded trial to evaluate the
      immunobridging between different manufacture scales, lot-to-lot consistency of the
      Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59
      years of age. The immunobridging between different manufacture scales will be evaluated
      first, the immunobridging between different age groups will be evaluated second, the
      lot-to-lot consistency will be evaluated at last.
    


Intervention name(s): Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml; Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml
Intervention type(s): Biological; Biological
Intervention description(s): Containing 0.5E10vp; Containing 0.3E10vp
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: COVID-19; Vaccine; Ad5; Immunobridging; Lot-to-lot consistency
Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      the purpose of this study is to compare the effect of physical therapy (PT) program and oral
      appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).
    

Detailed description: 
      The details of each intervention are listed as following:

        -  physical therapy program group (PT): manual myofascial release over craniomandibular
           system, chin-in exercise and self-care education

        -  oral appliance group (splint): custom-made stabilization splint and self-care education
    

Intervention name(s): PT program; oral appliance
Intervention type(s): Other; Device
Intervention description(s): manual myofascial release for craniomandibular system for 30~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks; custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporomandibular joint disorder; myofascial pain; manual myofascial release; physical therapy; oral appliance
Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV
Condition: Degenerative Lesion of Articular Cartilage of Knee
Study type: Observational

Summary: 
      The purpose of the study is to evaluate prospectively the outcome of treatment interventions
      of knee osteochondral lesions Outerbridge grade III and IV.
    

Detailed description: 
      The main purpose of the study is to prospectively evaluate the outcome of treatment
      interventions with replacement, repair and regenerative approaches, of osteochondral
      articular lesions or defects, Outerbridge grade III and IV, in terms of symptomatic and
      functional recovery 12 months after surgery.
    

Intervention name(s): knee surgery
Intervention type(s): Procedure
Intervention description(s): Reparative, replacement or regenerative techniques, with or without associated osteotomy.
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients referred to the participating centers for the treatment of symptomatic
        degenerative lesions of the knee, which meet the following inclusion criteria
      
Keywords: osteochondral defect of the knee
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
Condition: Anal Intraepithelial Neoplasia (AIN); High-grade Squamous Intraepithelial Lesions (HSIL)
MeSH terms: Neoplasms; Carcinoma in Situ
Study type: Interventional

Summary: 
      Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency
      ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).
      Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA
      will be applied using the Barrx™ Ablation System.
    


Intervention name(s): Radiofrequency Ablation (Barrx™)
Intervention type(s): Device
Intervention description(s): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.
Other intervention name(s): Barrx™ Ablation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anal intraepithelial neoplasia; AIN; Radiofrequency Ablation; RFA
Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants
Condition: Graft Versus Host Disease; Bone Marrow Transplantation
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Graft versus host disease (GVHD) is one of the common complications after stem cell
      transplant. This is a complication, which happens when the new stem cells from the donor
      attack other cells in the body of the transplant recipient.

      Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective
      in the prevention of Graft vs. Host Disease.

      Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease
      recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of
      this study is:

        -  To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without
           increasing the risk of relapse (your condition getting worse).

        -  To find whether low dose of alemtuzumab in combination with cyclosporine can prevent
           GVHD more effectively when compared to current standard of care and does not increase
           the risk of recurrence.
    


Intervention name(s): Alemtuzumab; mycophenolate or cyclosporine and methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.; One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate
Intervention MeSH terms: Cyclosporine; Methotrexate; Alemtuzumab; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graft Versus Host Disease; Alemtuzumab; Campath; Bone Marrow Transplants
Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Condition: Sleep Disorder, Shift-Work
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting
      drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight
      shifts will significantly improve both objective (total sleep time, sleep efficiency, wake
      after sleep onset) and subjective (sleep quality) measures of daytime sleep.
    


Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Belsomra
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Kinesiotaping in Treatment of Pes Anserinus Tendino-bursitis
Condition: Pes Anserinus Tendinobursitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs
      and physical therapy in treatment of pes anserinus tendino-bursitis.
    

Detailed description: 
      The treatment of pes anserinus tendino-bursitis includes refraining from aggravating
      activities, local modalities such as heat, ice, ultrasound (US), iontophoresis,
      phonophoresis, electrical stimulation (ES), nonsteroidal anti-inflammatory drugs (NSAIDs) and
      injections with either corticosteroids or local anesthetics. Another treatment that seems to
      have a significant effect on the improvement of the disease is kinesiotaping. Kinesiotaping
      is a cotton strip with an acrylic adhesive that is used for treating athletic injuries and a
      variety of physical conditions. The therapeutic effects of the tape is to relax the overused
      muscles and in rehabilitation to facilitate the underused muscles. Advocates claim that the
      wave pattern found on the kinesiotaping has a lifting effect on the skin which can diminish
      swelling and inflammation via improving circulation and reduce pain by removing pressure from
      pain receptors.
    

Intervention name(s): Kinesiotaping; NSAIDs/Physical therapy
Intervention type(s): Device; Procedure
Intervention description(s): Use of kinesiotaping on the painful area in the form of "space correction". Kinesiotaping was repeated for 3 weeks with 1week interval; Use of non-steroidal anti-inflammatory drugs and 10 sessions of daily physical therapy.
Other intervention name(s): taping; non-steroidal anti-inflammatory drugs; physical therapy
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesiotaping; pes anserinus tendino-bursitis; nonsteroidal anti-inflammatory drugs; physical therapy
Epiduo Pediatric Acne Study
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and
      benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to
      11 years of age with acne vulgaris.
    


Intervention name(s): adapalene/benzoyl peroxide; Topical Gel Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): daily topical application for 12 weeks; daily topical application for 12 weeks
Other intervention name(s): Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses
Condition: Vision Disorders
MeSH terms: Vision Disorders
Study type: Interventional

Summary: 
      The purpose of this investigation is to evaluate the short-term, clinical performance of two
      silicone hydrogel daily disposable contact lenses.
    


Intervention name(s): JJVC Marketed Contact Lens (Test); Competitor Marketed Contact Lens (Control)
Intervention type(s): Device; Device
Other intervention name(s): senofilcon A; delefilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Traveler's Diarrhea (TD) Automated Process
Condition: Prevention of Travelers' Diarrhea
MeSH terms: Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate and compare the immune responses and safety following a two vaccination regimen
      by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or
      placebo patches.
    


Intervention name(s): heat-labile enterotoxin of E. coli (LT); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Travelers' Diarrhea Vaccine System; Travelers' Diarrhea Vaccine System
Other intervention name(s): TD Vaccine System; TD Vaccine System
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Remote Ischemic Preconditioning in Elective Percutaneous Interventions
Condition: Myocardial Ischemia; Ischemic Reperfusion Injury
MeSH terms: Myocardial Ischemia; Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      Myocardial injury occurs after percutaneous coronary intervention due to micro emboli,
      ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning
      has been shown to be useful in preventing myocardial injury but it is not suitable to perform
      it especially in ad hoc interventions. In this study the investigators aim is to show whether
      one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during
      percutaneous coronary intervention.
    

Detailed description: 
      About in one third of elective percutaneous coronary interventions (PCI) troponin release
      occurs showing myocardial necrosis. And it has been shown that myocardial necrosis due to
      coronary interventions has also adverse effects on long term prognosis.

      Beneficial effects of of ischemic preconditioning in elective PCI and in coronary artery
      bypass surgery has been shown in several studies. In most of the trials 3 cycles of ischemia
      was performed, but this is time consuming and it's not suitable to apply it, in ad-hoc
      interventions. The investigators found one study showing that one cycle will also be enough
      to prevent troponin elevation after elective PCI.

      The investigators aim was also to show that one cycle preconditioning performed just before
      coronary intervention will also be useful in preventing myocardial necrosis due to elective
      PCI.
    

Intervention name(s): remote ischemic preconditioning
Intervention type(s): Other
Intervention description(s): Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemic preconditioning; myocardial injury; percutaneous coronary intervention
Aprepitant Effects on Oxycodone Response
Condition: Narcotic Abuse
MeSH terms: Narcotic-Related Disorders
Study type: Interventional

Summary: 
      Addressing the issue of opioid dependence and tolerance has public health implications for
      the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the
      treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in
      modulating both the acute and chronic response to opioids. The objective of this study is to
      determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist
      can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse
      liability and reinforcing effects.
    

Detailed description: 
      Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral
      routes will be admitted to this 6-week inpatient, crossover study. They will participate in
      15 experimental test sessions, each lasting approximately 6.5 hours, during which they will
      receive a range of acute doses of aprepitant, including placebo, followed by challenge with
      oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including
      physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires
      related to mood, abuse liability) and observer ratings will be collected repeatedly
      throughout each session. Data will be analyzed using parametric approaches to within-subject
      designs.
    

Intervention name(s): Aprepitant 0mg; Aprepitant 40mg; Aprepitant 200mg; Oxycodone 0mg, p.o.; Oxycodone 20mg, p.o.; Oxycodone 40mg, p.o.; Oxycodone 0mg, IN; Oxycodone 15mg, IN; Oxycodone 30mg, IN
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Aprepitant 0mg, p.o. pretreatment; Aprepitant 40mg, p.o. pretreatment; Aprepitant 200mg, p.o. pretreatment; Oxycodone 0mg, p.o.; Oxycodone 20mg, p.o.; Oxycodone 40mg, p.o.; Oxycodone 0mg, IN; Oxycodone 15mg, IN; Oxycodone 30mg, IN
Intervention MeSH terms: Oxycodone; Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within subject crossover designed that examined 15 experimental conditions within a single group of participants
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: opioid; oxycodone; NK1 antagonist; aprepitant; intranasal; abuse
A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Four-drug combo yielded a statistically significant improvement in progression-free survival
      and overall survival compared to gemcitabine in patients with advanced pancreatic
      adenocarcinoma. Nab-Paclitaxel showed promising antitumor activity in patients with
      pancreatic cancer. Given the synergism of taxanes with gemcitabine, fluoropyrimidines and
      platinating agents the role of nab-Paclitaxel in a 4-drug regimen will be explored.

      The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination
      with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the
      feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic
      cancer.
    

Detailed description: 
      OBJECTIVES: PHASE I: to determine the recommended phase 2 dose of nab-paclitaxel in
      combination with cisplatin, capecitabine, and gemcitabine.

      PHASE II: to evaluate the feasibility and the activity of the PAXG regimen in terms of
      6-months progression-free survival in patients with stage III and IV pancreatic cancer.

      OUTLINE Phase I - dose finding single institution trial, followed by a randomized open label
      multicenter phase II trial.

      Phase II: Patients will be stratified by stage (III vs IV) and CA19.9 level (< 10 x ULN
      versus >10 x ULN); Patients will be randomly assigned to receive PAXG (arm A) or
      gemcitabine-nab-paclitaxel regimen (arm B).

      Treatment plan (phase II):

      Arm A: PAXG every 4 weeks (1 cycle): cisplatin at 30 mg/m2 on days 1 and 15, nab-paclitaxel
      at the RP2D on days 1 and 15, capecitabine at 1250 mg/ m2 days 1-28, gemcitabine at 800 mg/
      m2 on days 1 and 15.

      Arm B: Gemcitabine + nab-paclitaxel every 4 weeks (1 cycle): gemcitabine at 1000 mg/m2 on
      days 1, 8 and 15; nab-paclitaxel at 125 mg/mq on days 1, 8 and 15.

      Treatment will be administered for a maximum of 6 cycles or until there is a clinical
      benefit.
    

Intervention name(s): cisplatin; capecitabine; gemcitabine; nab-paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): cisplatin at 30 mg/m2 on days 1 and 15; capecitabine at 1250 mg/ m2 days 1-28; gemcitabine at 800 mg/ m2 on days 1 and 15 in arm A; at 1000 mg/m2 on days 1, 8 and 15 in arm B; nab-paclitaxel at the recommended phase II dose day 1 and 15 in arm A; at 125 mg/m2 on days 1, 8 and 15 in arm B
Other intervention name(s): cisplatino TEVA; XELODA; Gemzar; abraxane
Intervention MeSH terms: Paclitaxel; Gemcitabine; Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic adenocarcinoma; stage III disease; stage IV disease; chemotherapy