bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A three part study to demonstrate the bioequivalence of a single dose of the Final Market
      Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination
      (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as
      individual tablets. Subject will only participate in one part, receiving treatment A and B
      (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).
    


Intervention name(s): sitagliptin phosphate (+) metformin hydrochloride; Comparator: metformin 500mg; Comparator: sitagliptin; Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet; Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet; Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet; Comparator: metformin 1000 mg; Comparator: metformin 850 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): place holder - do not post; A single dose of metformin 500 mg tablet; A single dose of 50 mg sitagliptin tablet; A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet; A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet; A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet; A single dose of metformin 1000 mg tablet; A single dose of metformin 850 mg tablet
Other intervention name(s): Glucophage; Januvia; Glucophage; Glucophage
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Condition: Graft vs Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional

Summary: 
      The addition of rituximab to prednisone for the initial treatment of chronic GVHD will
      increase the overall response rate, enable a more rapid and effective steroid taper.
    

Detailed description: 
      To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy
      will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months
      without clinical or GVHD relapse/ recurrence.
    

Intervention name(s): Rituximab; Prednisone; Cyclosporine A; tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9; 1 mg/kg; po per day with taper; trough 200-300 or lower; po; trough 5-10 or lower; po
Other intervention name(s): Rituxan; Deltasone; Liquid Pred; Meticorten; Orasone; cyclosporine; Ciclosporin; FK-506; Fujimycin
Intervention MeSH terms: Cyclosporine; Prednisone; Rituximab; Tacrolimus; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty. A Prospective Randomized Study
Condition: Postoperative Analgesia
Study type: Interventional

Summary: 
      Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the
      Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient
      Undergoing Total Knee Arthroplasty.
    


Intervention name(s): Adductor canal block with Ipack block or selective tibial nerve block
Intervention type(s): Procedure
Intervention description(s): Ultrasound guided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell
      glucagon release.
    


Intervention name(s): Dapagliflozin; Saxagliptin; Glucose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions
Condition: Metastatic Cancer
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may
      help to control fluid in the chest caused by cancer. It is not yet known if bleomycin,
      doxycycline, or talc is more effective in treating patients with malignant pleural effusions.

      PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline,
      or talc in treating patients with malignant pleural effusions.
    

Detailed description: 
      OBJECTIVES: I. Compare intrapleural bleomycin vs. doxycycline vs. talc in the treatment of
      malignant pleural effusion with respect to time to recurrence of the effusion. II. Compare
      these treatments with respect to the necessity for further treatment of recurrent effusions.
      III. Compare these treatments with respect to the extent of postinfusion complications,
      including pain and dyspnea. IV. Compare these treatments with respect to duration of chest
      tube or soft catheter drainage required following pleurodesis. V. Compare these treatments
      with respect to duration of hospitalization for retreatment of malignant pleural effusion
      following recurrence. VI. Compare these treatments with respect to survival. VII. Compare
      these treatments with respect to the impact of the procedure on pain and dyspnea.

      OUTLINE: This is a randomized trial. Patients are stratified by type of drainage device and
      participating institution. All patients are randomized to undergo pleurodesis with bleomycin,
      doxycycline, or talc by indwelling pleural catheter. A second procedure is undertaken 72
      hours later if pleural drainage is persistently large. Patients are followed monthly for
      survival.

      PROJECTED ACCRUAL: A total of 480 patients will be entered over 48 months.
    

Intervention name(s): bleomycin sulfate; doxycycline; talc
Intervention type(s): Biological; Drug; Other
Intervention MeSH terms: Doxycycline; Bleomycin
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: malignant pleural effusion
A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the overall safety and efficacy of TRV027 when administered in addition to
      standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients
      hospitalized with Acute Decompensated Heart Failure (ADHF).
    


Intervention name(s): TRV027 Dose #1; TRV027 Dose #2; TRV027 Dose #3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TRV027 continuous intravenous infusion Dose #1; TRV027 continuous intravenous infusion Dose #2; TRV027 continuous intravenous infusion Dose #3; Placebo continuous intravenous infusion
Other intervention name(s): Formerly known as TRV120027; Formerly known as TRV120027; Formerly known as TRV120027
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans
Condition: Aged; Healthy
MeSH terms: Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part
      of the aging process, including immunosenescence, is explained by an imbalance between
      inflammatory and anti-inflammatory networks, wich results in the low grade chronic
      pro-inflammatory status termed inflammaging. It can contribute to a number of age-related
      chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis).
      Prevention or delay in onset of chronic diseases can potentially benefit a large segment of
      the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade
      inflammation through improvement of the gut barrier function and gut microbiota composition
      in elderly people with low-grade inflammation.
    

Detailed description: 
      Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part
      of the aging process, including immunosenescence, is explained by an imbalance between
      inflammatory and anti-inflammatory networks, wich results in the low grade chronic
      pro-inflammatory status termed inflammaging. It can contribute to a number of age-related
      chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis).
      Prevention or delay in onset of chronic diseases can potentially benefit a large segment of
      the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade
      inflammation through improvement of the gut barrier function and gut microbiota composition
      in elderly people with low-grade inflammation.
    

Intervention name(s): Probiotic drink; Control Group
Intervention type(s): Dietary Supplement; Other
Intervention description(s): This group receives a probiotic drink daily for 6 week.; without intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Eldery People
Efficacy and Safety Study of MT10109L in the Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
Condition: Glabella Line Severity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study design is multi-center, randomized, double-blind, parallel group, active
      controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active
      controlled, preliminary study). Subjects who voluntarily signed the informed consent and are
      judged to be eligible for this study will be intramuscularly injected with the study drug or
      the comparator at a total of 20U(4U/0.1ml each)in five sites of the glabella line.
      Thereafter, follow-up visits will be made 4 weeks, 10weeks, 16weeks and efficacy and safety
      assessments will be conducted for total 16 weeks.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Intervention description(s): 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glabella line; Glabella lines; Botulinum Toxin
Improved Training Program for Fall Prevention of War Fighters
Condition: Limb Injury
Study type: Observational

Summary: 
      This study will train War Fighters with lower extremity trauma to decrease fall risk.
    

Detailed description: 
      Eligible active duty service members, retired or veterans who participated in rehabilitation
      programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National
      Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or
      the Naval Medical Center San Diego) will be considered for enrollment in this study. This
      study will look at service members who have undergone transfemoral, transtibial or bilateral
      lower extremity amputation or limb salvage procedures. Participants will receive fall
      prevention training on an instrumented treadmill (6, training sessions). Participants will
      receive three performance assessments:-immediately following completion of the treadmill
      training and at three and six months following the completion of the training. Post training,
      twice per month subjects will receive an email containing a follow up fall questionnaire
      monitoring if they have fallen and the circumstances surrounding their fall. If they do not
      have access to email, or if a timely response is not received from the email questionnaire
      which was sent out, subjects will be contacted by phone.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study plans to recruit both male and female military beneficiaries with a unilateral
        or bilateral transtibial or transfemoral amputation or salvaged and preserved limbs. The
        subjects will be present or past patients in the Naval Medical Center San Diego, C5
        Rehabilitation Program, Center for the Intrepid Rehabilitation Program or Walter Reed
        National Military Medical Center Rehabilitation Program. Subjects will be contacted by the
        respective site study coordinator and asked to participate in the study.
      
Keywords: transfemoral amputation; limb salvage; bilateral amputation; Department of Defense; orthosis; prosthesis; rehabilitation; military treatment facilities; military; injured lower extremity; prevent falls; trauma lower extremity; service members; retired service members; active service members; unilateral lower extremity trauma; limb amputation; limb preservation; preserved limb; trips; slips; transtibial amputation
A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult
      subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg
      intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This
      study will evaluate LAP formulations of GSK1265744 with different particle sizes.

      Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400
      mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by
      intramuscular injection. Samples for determination of GSK1265744 concentrations will be
      collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording
      and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects
      will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last
      day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A
      enzymes.

      The subjects will undergo follow-up evaluations for a minimum of 12 weeks.
    


Intervention name(s): GSK1265744 30 mg oral; Midazolam 3 mg oral + GSK1265744 30mg oral; GSK1265744 400 mg (200 nm); GSK1265744 400 mg (1 micro m); GSK1265744 400 mg (5 micro m)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK1265744B 30 mg Tablet taken orally, once a day in the morning with or without a meal; Midazolam Syrup 3mg each mL Oral/single dose administer by oral syringe on Day -29 and Day -14; A single dose of GSK1265744 400 mg Intra Muscular (IM) injection (Nanomilled 200 nm); A single dose of GSK1265744 400 mg IM injection (Nanomilled 1 micrometer); A single dose of GSK1265744 400 mg IM injection (Dry milling and homogenization 5 micrometer)
Intervention MeSH terms: Cabotegravir; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy subjects; GSK1265744 LAP; integrase inhibitor; HIV-1 infection; long acting retroviral; relative bioavailability
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Losartan
      Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.
    


Intervention name(s): losartan potassium / hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): 100 mg / 25 mg tablet
Other intervention name(s): Hyzaar
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Therapeutic Options for Treatment of Burning Mouth Syndrome
Condition: Burning Mouth Syndrome
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of
      life and does not have an adequate therapeutic option. The purpose of this study is to
      determine the most effective treatment option for burning mouth syndrome, among oral
      probiotics, low-level laser, B-vitamin injections and informative treatment only.
    


Intervention name(s): BioGaia Prodentis lozenges; low level laser treatment with Ga-Al-As laser; B vitamin injections (Neurobion, Merck, Darmstadt, Germany)
Intervention type(s): Dietary Supplement; Procedure; Dietary Supplement
Intervention description(s): oral probiotics; low level laser treatment; intra muscular vitamin injections
Intervention MeSH terms: Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: burning mouth syndrome; treatment
Reduction of Immunization Discomfort in Children
Condition: Pain
Study type: Interventional

Summary: 
      A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic
      suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged
      children.
    

Detailed description: 
      Randomization of 42 children evaluated the method described above against an office routine
      control group.
    

Intervention name(s): Topical anesthetic and hypnotic distraction; Office routine
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.; Standard vaccine administration
Other intervention name(s): Wahl vibrator
Intervention MeSH terms: Anesthetics; Hypnotics and Sedatives; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Immunizations; Children; Injections; aged 4-6 Years; Hypnosis
Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The use of PRP has dramatically increased in the fields of orthopedics, spine surgery,
      reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological
      indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other
      fields. In this experimental study, the treatment outcome of autologous PRP was assessed in
      comparison to conventional therapy among patients with chronic venous leg ulcers.
    

Detailed description: 
      Venous ulcers are the most common form of leg ulcers which have a significant impact on
      quality of life and work productivity. In addition, the costs associated with the long-term
      care of these chronic wounds are substantial. Conventional therapies such as dressings,
      surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory
      healing since these treatments are not able to provide necessary growth factors that can
      modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple,
      affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly
      good results. Since it is an autologous method, it is biocompatible and safe. Data from this
      would help in establishing it as a treatment of choice, thereby leading to a reduction in
      cost and benefiting the patient both financially and psychologically.

      PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e.,
      five times more than normal platelet counts. PRP enhances wound healing by promoting the
      healing process by seven growth factors present in it. They are platelet-derived growth
      factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal
      growth factor, and transforming growth factor. These growth factors are important in
      modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis
      during the healing process.
    

Intervention name(s): PRP; Conventional therapy
Intervention type(s): Biological; Other
Intervention description(s): PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.; Conventional therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment