bioihbjkbjnl/mcl2 huggingface dataset:
Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Condition: Endotoxemia
MeSH terms: Endotoxemia; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate putative ethnic differences in the
      proinflammatory response in human endotoxemia.
    

Detailed description: 
      Recent data show that there are significant disparities among genders and races in the
      incidence of sepsis. While men are consistently more likely to have sepsis than women, the
      apparent racial disparities are even more striking, approaching a doubling of the risk for
      sepsis among Afro-Americans. Most prominent is the risk among black men, the group in which
      sepsis occurs at the youngest age and results in the most deaths. Potential mechanisms for
      heterogeneous susceptibility to sepsis include genetic differences, which have been explored
      according to sex but not according to race, and other social and clinical factors.

      The goal of this study is to explore whether proinflammatory and procoagulant responses in a
      well standardised inflammation model are comparable in healthy Caucasian and African
      volunteers.
    

Intervention name(s): LPS
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: LPS; ethnicity; neutrophils; TNF
Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults
Condition: Diabetes
Study type: Observational

Summary: 
      The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid
      going through the tubing) and leakage (observation of fluid on and around the device) during
      and after subcutaneous infusion using two types of infusion sets. One infusion set is
      investigational, developed by BD, and the other is the Quick-set (Medtronic), which is
      commercially available. These infusion sets will be used with a commercially available
      insulin pump to deliver insulin diluent (an inactive liquid with no medication) for
      approximately 4 1/2 hours. During this time pressure and leakage will be continuously
      monitored.
    

Detailed description: 
      This is a single center, open label study.

      Each subject is to receive up to 4 basal/bolus diluent infusions in the abdomen with the BD
      Scarlett and the Medtronic Quick-set®; 2 Scarlett infusion sets and 2 Quick-set infusion
      sets. The order of device placement will be randomized.

      After insertion, insulin diluent will be delivered at a rate of 0.01 mL/hour (equivalent in
      volume and rate to 1.0 unit/hour of U-100 insulin) via the insulin pump for a minimum of 3
      hours. After 3 hours of basal infusion, a bolus of 0.1 mL (equivalent to 10 units) will be
      delivered via the insulin pump and basal infusion continued for a minimum of 1 additional
      hour.

      At the end of the final basal infusion period, the infusion set tubing will be clamped to
      mimic an occlusion event and allowed to run until either an occlusion alert ("no delivery")
      is signaled by the pump, or a minimum of 30 minutes, whichever comes first. Infusion pressure
      data will be collected during the entire infusion period, including the time the tubing is
      clamped. After removal of the device from the body, the presence of fluid on the application
      site skin (Leakage) will be determined by visual assessment then measured using gravimetric
      analysis, if applicable.
    

Intervention name(s): BD Scarlett Infusion set; Medtronic QuickSet Infusion Set
Intervention type(s): Device; Device
Intervention description(s): Each subject will receive subcutaneous infusion from two investigational BD Scarlet infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.; Each subject will receive subcutaneous infusion from two Medtronic infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.
Keywords: Diabetes; Insulin therapy; insulin pump; Infusion sets
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets
      manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
    


Intervention name(s): Lorcaserin manufactured at Zofingen; Lorcaserin manufactured at Kawashima
Intervention type(s): Drug; Drug
Intervention description(s): Lorcaserin XR tablets manufactured at Zofingen.; Lorcaserin XR tablets manufactured at Kawashima.
Other intervention name(s): BELVIQ XR; APD356; BELVIQ XR; APD356
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lorcaserin; Bioequivalence; Extended release; Tablets; Phase 1; Healthy
Genotypic and Phenotypic Correlates of Resistance to Aspirin
Condition: Platelet Dysfunction Due to Aspirin
Study type: Interventional

Summary: 
      The study seeks to identify genomic markers associated with aspirin resistance.
    

Detailed description: 
      Not desired
    

Intervention name(s): aspirin
Intervention type(s): Drug
Intervention description(s): aspirin 81mg, 7-10 days
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: genomic markers; aspirin resistance
Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics
      parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following
      administration of single subcutaneous dose. The objective of this randomized, crossover,
      clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T
      produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by
      Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),
      as surrogate markers for their circulating concentrations of the drug.
    

Detailed description: 
      In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI)
      activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as
      secondary objectives.
    

Intervention name(s): Heparin, Low-Molecular-Weight
Intervention type(s): Drug
Intervention description(s): single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
Other intervention name(s): Clexane; Enoxalow
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: subjects
Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges
Condition: Surgical Technique; Implant Surface
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The aim is to clinically and radiographically assess a novel wedge implant placed in narrow
      ridges.

        -  60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery®
           following either a bone consumption (n=30) or bone expansion technique (n=30). Each
           group (bone consumption and bone expansion) will be divided into 2 surface treatments:
           machined transcortical portion (n=15) and roughened transcortical portion (n=15).

        -  Record the time needed to place each implant.

        -  ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after
           implant placement.

        -  Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5
           years after loading to assess marginal bone stability.

        -  Buccal bone height and lingual and buccal bone thickness will be recorded
           post-intervention, at the time of functional loading, and at 12, 36, and 60 months after
           loading with CBCT.

        -  Digital impressions will be taken post-operatively, at loading and at 12 months after
           loading to monitor gingival profile.
    


Intervention name(s): Bone Consumption; Bone expansion
Intervention type(s): Procedure; Procedure
Intervention description(s): The surgery will be done using a bone consumption protocol; implants will be placed after a bone expansion protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Glenohumeral Cortisone Injection
Condition: Humeral Fractures
MeSH terms: Humeral Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this project is to determine if giving a cortisone injection to patients
      with proximal humerus fractures who have stiff shoulders recover their range of motion.
    

Detailed description: 
      THis is a randomized control trial to determine if giving a cortisone injection to patients
      with proximal humerus fractures who have stiff shoulders recover their range of motion.
    

Intervention name(s): kenalog; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Cortisone injection into shoulder; Lidocaine injection into shoulder
Intervention MeSH terms: Triamcinolone Acetonide; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a
      fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the
      respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this
      study will complement lung function data obtained in the pivotal QVM149 phase 3 program by
      assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing
      interval of 24 hours.
    


Intervention name(s): QVM149 150/50/80 μg o.d.; QVM149 150/50/160 μg o.d.; salmeterol/fluticasone FDC 50/500 μg b.i.d.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A; B; C
Intervention MeSH terms: Fluticasone; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:
      2-sachets for oral solution in two divided doses given a night before (first dose - sachet)
      and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral
      solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its
      effectiveness, tolerability and safety.
    


Intervention name(s): PicoPrep; HalfLytely; bisacodyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids.; HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.; Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
Other intervention name(s): PicoPrep™; Prepopik™
Intervention MeSH terms: Bisacodyl; Picosulfate sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bowel Preparation; Colonoscopy
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Condition: Pseudomonas Aeruginosa
MeSH terms: Pneumonia; Pseudomonas Infections; Healthcare-Associated Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically
      ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas
      aeruginosa.
    


Intervention name(s): MEDI3902; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.; Participants will receive a single IV dose of placebo matched to MEDI3902.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pseudomonas aeruginosa, Pneumonia
Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      An emerging body of epidemiological evidence suggests that various forms of sedentary
      behavior, including TV viewing, occupational sitting, and total daily sitting, may be
      associated with all-cause and cardiovascular mortality, overweight and obesity, type 2
      diabetes, depression and psychological well-being. Importantly, many of these associations
      were independent of participation in moderate to vigorous intensity physical activity. We
      propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of
      two interventions targeting sedentary behavior. Since it is currently unknown what component
      of sedentary behavior exposure presents the greatest risk to health, we propose separate
      interventions to reduce overall sedentary time and to promote breaks in sedentary time.
    

Detailed description: 
      Primary aim: To determine the acceptability and feasibility of selected personal, social and
      environmental strategies to reduce overall sitting time and increase the number of times
      participants stand up in a day.

      Secondary aim: To assess whether existing and new measurement approaches can detect specific
      changes in sedentary behavior.

      Exploratory aim: To establish whether specified intervention strategies were efficacious in
      reducing sedentary behavior and whether intervention effects were specific to the targeted
      sedentary behavior construct (e.g. decreased overall sitting time or increased number of
      breaks in sitting).
    

Intervention name(s): Sedentary behavior
Intervention type(s): Behavioral
Intervention description(s): Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions. Information was provided in person, through written materials and by emails and phone calls in both conditions. Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day. During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Influence of Diesel Exhaust Particles (DEP) With and Without Organic Compounds on the Allergic Inflammation in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional

Summary: 
      The primary objective of this study is to elucidate the effects of Diesel particles on the
      allergic inflammation in the airways of asthmatic patients.
    

Detailed description: 
      A first bronchoscopy will be performed with a baseline bronchoalveolar lavage (BAL) and
      epithelial brushes followed by a segmental instillation of allergen (grass mix or house dust
      mite) alone, in combination with Diesel particles, further in combination with Diesel
      particles without organic compounds and saline as control into four different lung segments.
      After 24 hours, during a second bronchoscopy, BAL samples will be collected in these
      challenged segments in order to obtain cells and lavage fluid for cell biological and
      immunological analysis.
    

Intervention name(s): Bonchoscopy
Intervention type(s): Other
Intervention description(s): Segmental instillation of allergen/Diesel particles; bronchoalveolar lavage
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma GINA 1; Mild intermittant asthma
Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)
Condition: Desaturation of Blood
Study type: Interventional

Summary: 
      A clinical study designed to determine the accuracy of the peripheral capillary oxygen
      saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood
      saturation level.
    

Detailed description: 
      The clinical study protocol was designed for determining the accuracy of the SpO2 function of
      the Vital Signs Patch device for measuring blood oxygen saturation level, according to the
      guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in
      Annex EE of ISO 80601-2-61. Section 4.
    

Intervention name(s): Vital Signs Patch (VSP)
Intervention type(s): Device
Intervention description(s): Infrared and red absorbance measurement
Other intervention name(s): Vital signs Patch; VSP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers
Condition: HIV INFECTIONS
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this research is to check whether the test drug (lamivudine in the form of
      coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in
      the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres
      under fasting condition.
    

Detailed description: 
      It is an open, randomized, crossover 2x2, single dose, with the administration of medicine
      with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14
      females). Of the 28 volunteers planned in the study protocol to start, gave up one (woman)
      before the start of Phase I. So the study was initiated and completed with the participation
      of 27 volunteers. The volunteers were in hospital for a period of approximately 36 hours in
      each stage.
    

Intervention name(s): Epivir ® tablet 150-mg single dose (drug reference); Lamivudine 150-mg tablet single dose (drug test)
Intervention type(s): Drug; Drug
Intervention description(s): Bioequivalence lamivudine 150 mg tablets fasting condition; Bioequivalence lamivudine 150 mg tablets fasting condition
Other intervention name(s): lamivudine; 3TC; 3TC
Intervention MeSH terms: Lamivudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lamivudine; bioequivalence test; pharmacokinetics; high-performance liquid chromatography; 3TC; LC-MS/MS; mass spectrometry
Duloxetine in the Treatment of Melancholic Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the optimal treatment strategy for MDD patients
      with melancholic features who do not respond to a standard daily dose. This study will allow
      investigators to mimic standard clinical practice. During the first 2 weeks of treatment,
      clinical evaluation of individual patient tolerability and efficacy will enable the dose of
      duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of
      duloxetine adjusted in the attempt to elicit a clinical response.
    


Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in
      patients with knee osteoarthritis

      Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3
      per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and
      VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.
    


Intervention name(s): Exercise; Control
Intervention type(s): Other; Other
Intervention description(s): Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.; Patients randomized to the control arm were instructed not to change their baseline exercise programs
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; exercise; cycling