bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
Condition: Cervical Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis
MeSH terms: Spinal Stenosis; Intervertebral Disc Degeneration; Spondylolisthesis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in
      subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical
      vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level
      anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.
    

Detailed description: 
      This is a prospective, multicenter, randomized, single-blinded, controlled study evaluating
      safety and preliminary efficacy of immunoselected, culture-expanded, nucleated, allogeneic
      MPCs (NeoFuse) combined with MasterGraft Matrix in a commercially available PEEK cervical
      Spacer compared to an active control in subjects undergoing 2 or 3 level anterior cervical
      discectomy and fusion with anterior cervical plate fixation.

      After the screening and surgical visits, each subject will be evaluated clinically and
      radiographically within 3 days and 30 days after surgery, and at 3, 6, 12, and 24 months
      after surgery.

      Subjects will be evaluated at the same time points for safety.
    

Intervention name(s): NeoFuse; MasterGraft Granules
Intervention type(s): Biological; Device
Intervention description(s): Single Dose NeoFuse Surgical Implantation; Single Dose MaterGraft Granules Surgical Implantation
Other intervention name(s): Anterior Cervical Discectomy and Fusion with NeoFuse; Cervical Spinal Fusion; Adult Stem Cells; Anterior Cervical Discectomy and Fusion with Granules; Cervical Spinal Fusion; Active Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects received treatment in one of two parallel arms.
Treatment Arm 1; NeoFuse (a biologic, consisting of STRO-3 immunological selected allogeneic Mesenchymal Precursor Cells, derived from adult bone marrow mononucleated cells) with Mastergraft Matrix (a medical device that is compression resistant and embedded with Mastergraft Granules). Subjects received 10 million Neufuse cells per treated cervical interbody level involved in the fusion. Either 2 or 3 levels were involved for a total of either 20 million or 30 million Neofuse cells.
Treatment Arm 2; Mastergraft Granules (medical device made of medical grade combination of hydroxyapatite and beta-tricalcium phosphate).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cervical Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis; Stem cells; Adult Stem Cells; Anterior cervical discectomy and Fusion (ACDF); Anterior Cervical Plate Fixation
Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study aims to evaluate safety, tolerability and immunogenicity of three lots of
      Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a
      conventional egg-derived control vaccine licensed in Europe.
    


Intervention name(s): Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV); Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV); Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV); Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1; One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2; One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3; One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; Flu; Cell-Derived; Egg-Derived; Healthy Adults; Safety; Immunogenicity; Vaccination
The Effect of Plant Sterol Supplement on Blood Cholesterol
Condition: High Blood Cholesterol Level
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether supplement of plant sterol could lower
      blood cholesterol.
    


Intervention name(s): Intake of plant sterols
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Condition: Hyperinsulinism
MeSH terms: Hyperinsulinism
Study type: Interventional

Summary: 
      OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor
      I (IGF-I) on insulin secretion in children with hyperinsulinism.

      II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this
      patient population.

      III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other
      insulin dependent parameters, in this patient population.
    

Detailed description: 
      PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood
      glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are
      assessed for insulin response.

      Beginning on day 5, patients are given recombinant human insulin-like growth factor I
      subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30
      minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the
      third dose (on day 6) is followed by a supervised fast.
    

Intervention name(s): recombinant human insulin-like growth factor I
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Mitogens; Mecasermin
Primary purpose: Treatment
Keywords: endocrine disorders; hyperinsulinism; rare disease
A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole
Condition: Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized two-way crossover study to determine whether concomitant administration of CYP
      P450 3A4 inhibitor ketoconazole and fluticasone furoate/GW642444M combination significantly
      increases the systemic effects and exposure to repeat dose fluticasone furoate and/or
      GW642444 in healthy subjects. Key assessments will include blood potassium, heart rate, blood
      pressure, QTc, serum cortisol and pharmacokinetic parameters, and safety including vital
      signs, ECGs, adverse event monitoring and laboratory safety tests, including blood glucose.
    

Detailed description: 
      This will be a single centre, randomized, double-blind (with respect to ketoconazole),
      two-way cross-over study in healthy male and female subjects. Subjects will attend for a
      screening visit within 28 days prior to the first treatment period. There will be two study
      periods, each consisting of 14 days. Ketoconazole or matching placebo will be administered
      for 11 days with fluticasone furoate/GW642444M inhalation powder co-administered on Days
      5-11. During each period subjects will be required to report to the unit on Day -1 and will
      remain there until 1 hour post-dosing with ketoconazole or placebo on Day 1. Subjects will
      return to the unit on the mornings of Day 2 to Day 4 for dosing with ketoconazole or placebo.
      Subjects will then return on the evening of Day 4 and leave the unit on the morning of Day 6
      (2 nights). Subjects will return to the unit on the mornings of Day 7 to Day 10 for dosing
      and pre-fluticasone furoate/GW642444M dose safety assessments. Subjects will return on the
      evening of Day 10 and leave the unit on the morning of Day 12 (2 nights). Subjects will make
      two outpatient visits, one in the evening on Day 12 and one in the morning on Day 13, to
      complete a few study related procedures. The two treatment periods will be separated by a
      washout of at least 7 days and no more than 14 days. Pharmacodynamic profiles for potassium,
      heart rate, QTc, blood pressure and serum cortisol will be taken on Day 11 with fluticasone
      furoate and GW642444 pharmacokinetic profiles on Days 5 and 11. Safety assessments will
      include vital signs, ECGs, adverse event monitoring and laboratory safety tests, plus blood
      glucose and blood potassium profiles on Day 5.
    

Intervention name(s): FF / GW642444; ketoconazole; ketoconazole (placebo to match)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200mcg/25mcg Novel DPI; 400mcg overencapsulated tablets; placebo to match overencapsulated tablets
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: pharmacodynamics; drug interaction; ketoconazole; pharmacokinetics; Fluticasone furoate; GW642444
Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The aim of this study is to find out how well iron is absorbed when a newly developed form of
      ferric pyrophosphate is added to a commercial apple juice drink.
    

Detailed description: 
      Micronized dispersible ferric pyrophosphate (MDFP) is an iron compound that has been reported
      to be highly bioavailable and likely to cause few sensory problems when added to food. It is
      therefore a potentially effective iron additive for the food industry and is particularly
      formulated for adding to liquids. A randomized cross-over trial will be undertaken to compare
      the absorption of iron added to a commercial apple juice drink as MDFP with iron added as
      ferrous sulphate. The null hypothesis is that absorption of iron added as MDFP is not
      different to absorption from iron added as ferrous sulphate.

      The study population will consist of 16 women (age 18-65) with iron stores at the lower end
      of the normal range. This group will efficiently absorb bioavailable iron and will be
      sensitive to differences in bioavailability between different forms of iron. Test drinks
      containing added iron, labelled with stable isotopes of iron (Fe-57 or Fe-58), will be
      consumed on two consecutive days. Iron absorption from the drinks will be determined using
      the erythrocyte incorporation technique. A baseline blood sample will be taken prior to
      consuming the test drinks and then a second blood sample will be taken 14 days after the last
      test drink. Iron absorption will be calculated from the isotopic enrichment of the final
      blood sample, assuming that 80% of absorbed iron is incorporated into red blood cells. The
      order in which the volunteers will be given the MDFP or ferrous sulphate will be randomised.
    

Intervention name(s): Micronized dispersible ferric pyrophosphate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Basic Science
Keywords: ferric pyrophosphate, iron bioavailability, fortification,
To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers
Condition: Diseases of the Circulatory System; Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having
      2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days
      between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a
      day for 6 days.
    


Intervention name(s): Telmisartan; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
Condition: Leiomyoma
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian
      function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD
      (pharmacokinetic/pharmacodynamic) relationship
    


Intervention name(s): BAY1002670; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: PK/PD; BAY1002670
A Study Comparing the Safety and Tolerability of Two Doses of Fipamezole in Adult Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this clinical trial is to compare the safety and tolerability of two dose
      regimens of fipamezole in adult patients with Parkinson's Disease who are receiving levodopa.
    

Detailed description: 
      Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While
      treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in
      the early phases of the disease, their benefits decrease with disease progression, and
      problems such as dyskinesia and on-off phenomenon begin to manifest. This study investigates
      the safety and tolerability of fipamezole at two dose levels in patients with Parkinson's
      Disease.

      The sampling method used was simple random sampling.
    

Intervention name(s): Fipamezole ODT; Fipamezole ODT Cohort 2
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive fipamezole ODT 15 mg three times daily for 1 week followed by fipamezole ODT 30 mg three times daily for 1 week, followed by a 2-week washout period. Beginning at Visit 5, subjects will receive fipamezole ODT 30 mg three times daily for 2 weeks.; Subjects will receive fipamezole ODT 30 mg three times daily for 2 weeks, followed by a 2-week washout period. Beginning at Visit 5, subjects will receive fipamezole ODT 15 mg three times daily for 1 week followed by fipamezole ODT 30 mg three times daily for 1 week.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Parkinson's Disease on stable regimen of levodopa
      
Keywords: Dyskinesia
A Clinical Trial to Assess the Effect of HC-SVT-1001 and HC-SVT-1002 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones (Bonecure)
Condition: Pseudoarthrosis
MeSH terms: Pseudarthrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and
      HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.
    


Intervention name(s): HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
Intervention type(s): Other
Intervention description(s): A single application in the context of a single surgical intervention.
Intervention model: Single Group Assignment
Intervention model description: Cell therapy
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Due to metabolic disorders and dietary restrictions, patients with diabetes may have
      different degrees of malnutrition. The primary objective of this study is to investigate
      whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve
      metabolic parameters in patients with type 2 diabetes.
    


Intervention name(s): LEHEL multi-nutrients supplement
Intervention type(s): Dietary Supplement
Intervention description(s): The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malnutrition; Metabolic disorders
Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery
Condition: Brain Surgery With Motor Evoked Potential Monitoring; Spine Surgery With Motor Evoked Potential Monitoring
Study type: Interventional

Summary: 
      The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery
      is essential for intraoperative motor-evoked potential monitoring. However, the precise
      strategy of administering neuromuscular blocking agent for obtaining that goal has not been
      established. Therefore, the investigators tried to find the optimal initial dose of
      vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by
      neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).
    

Detailed description: 
      The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery
      is essential for intraoperative motor-evoked potential monitoring. However, the precise
      strategy of administering neuromuscular blocking agent for obtaining that goal has not been
      established. Therefore, the investigators tried to find the optimal initial dose of
      vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by
      neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).
      Previously, one to two counts of response to TOF stimulation has been considered to be
      primary goal of partial neuromuscular blocking needed for intraoperative motor evoked
      potential monitoring. However, the visualization of twitch height of response to TOF
      stimulation has been possible with the help of NMT module. For adequate motor evoked
      potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF
      stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by
      not only count of TOF stimulation but also twitch height of T1 or T2.
    

Intervention name(s): TOF count guided adjustment; T1/ T0 guided adjustment; T2/ T0 guided adjustment
Intervention type(s): Other; Other; Other
Intervention description(s): adjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module.; adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.; adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: infusion dose; vecuronium; motor evoked potential; neuromuscular blocking agent
Accuracy of Pulse Oximeters With Profound Hypoxia
Condition: SpO2
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe
      hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will
      include at least ten subjects (at least 200 necessary data points to meet the ISO
      80601-2-61:2017).
    

Detailed description: 
      After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse
      oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable
      semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of
      oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is
      breath-by-breath by breath respiratory gas analysis and a computer program that permits the
      inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve
      the desired degree of saturation.
    

Intervention name(s): A-line
Intervention type(s): Procedure
Intervention description(s): Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.
Other intervention name(s): Hypoxemia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
Condition: Elevated Blood Lead Levels
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The toxic nature of lead has been recognized ubiquitous for than 2,000 years and today it is
      a persistent and common environmental contaminant in most parts of the world. Vitamin C is a
      strong antioxidant and a metabolic co factor playing an important role in many biological
      processes and biochemical functions (hydroxylation reactions). The research objective is to
      assess the effect of oral ascorbic acid supplementation 500mg and 250 mg once a day for 4
      weeks on Blood Lead level among school going urban adolescents, using a cluster randomized
      trial study design. Ascorbic Acid (vitamin C) 250 and 500 mg will be administered in two
      study arms.
    


Intervention name(s): Ascorbic Acid
Intervention type(s): Drug
Intervention description(s): Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.
Other intervention name(s): Vitamin C
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Reinforcement Approach to Improve Diabetes Management
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this project is to evaluate the efficacy of a behavioral economic intervention
      to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D.
      The intervention will reinforce patients for conducting SMBG, with escalating reinforcers
      provided when patients achieved sustained periods of testing at least 4 times/day at
      appropriate intervals. A 6-month trial will be conducted in which 60 patients will be
      randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.
    


Intervention name(s): Reinforcement for BG testing; Standard of care
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects will receive reinforcement for BG tests. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.; Subjects receive standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment