bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic
      Obstructive Pulmonary Disease (COPD)
    


Intervention name(s): GW642444 6.25; GW642444 3mcg; GW642444 12.5mcg; GW642444 25mcg; GW642444 50mcg; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): GW642444 6.25; once daily; GW642444 12.5mcg; GW642444 25mcg; GW642444 50mcg; placebo
Other intervention name(s): GW642444
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); COPD; GW642444
Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome
Condition: Moyamoya Disease; Remote Ischemic Preconditioning
MeSH terms: Moyamoya Disease; Ischemia
Study type: Interventional

Summary: 
      In the present study, we evaluated whether RIPC with RIPostC reduce the major
      neurocomplication in patients undergoing STA-MCA anastomosis.
    


Intervention name(s): RIPC with RIPostC
Intervention type(s): Procedure
Intervention description(s): The sphygmomanometer is closed to the lower limb and the cuff is inflated and the pressure is increased by 30 mmHg higher than the systolic blood pressure of each patient for 5 minutes. The loss of the distal pulse is confirmed by Doppler in the dorsalis pedis pulse. If there is a pulse, increase the pressure until it disappears. After 5 minutes of ischemia time, the cuff is deflated to confirm that the pulse has returned and has a reperfusion time of 5 minutes. A total of 4 cycles of 5 cycles of ischemic time and 5 minutes of reperfusion time are performed. (Estimated total 40 minutes) When the skull is started to close, RIpc with RIPostC group performs RpostC and the method is the same as the above RIPC method. (Estimated total 40 minutes)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate the Effect of PH-797804 on QTc Interval
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24
      mg oral tablet on the QTc interval
    


Intervention name(s): PH-797804; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, 24 mg, single dose; Tablet, 400 mg, single dose; Tablet, PH-797804 matched placebo, single dose
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Vitamin D in Periodontal and Cardiovascular Disease Progression
Condition: Vitamin D Deficiency
MeSH terms: Cardiovascular Diseases; Vitamin D Deficiency; Disease Progression
Study type: Observational

Summary: 
      Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which
      may be a link for the known interaction of periodontitis (CP) and coronary heart disease
      (CHD). This study investigated the association between serum vitamin D levels and
      periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine
      if periodontitis and CHD had an impact on serum vitamin D levels.
    

Detailed description: 
      Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38
      patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.
    

Intervention name(s): Evaluation of periodontal status
Intervention type(s): Other
Intervention description(s): Clinical examination
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thus, for this study, at least of 39 patients with CP, 38 patients with CHD, 38 patients
        with both CP and CHD, and 37 healthy subjects will finally enrolled.
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
Condition: Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis); Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Unilateral; Hearing Loss, Mixed Conductive-Sensorineural
Study type: Interventional

Summary: 
      To study the initial experience with implanting and fitting a new Bone Conduction system in
      pediatric patient population with conductive, mixed or single-sided deafness.
    

Detailed description: 
      Experimental: Bone-conduction hearing device The bone-conduction hearing device Osia system
      allows a direct bone-conduction through an osseointegrated implant. A magnet allows the
      external Sound Processor to be placed in the correct position over the implanted system
      including an inner magnet.

      Device: Osia System An external Sound Processor captures and digitize the sound which is
      transferred to the internal implant where it is converted to an electrical signal. The
      electrical signal is further transferred as a vibration through an osseointegrated implant to
      the mastoid bone and eventually to the cochlea
    

Intervention name(s): Osseointegrated Steady State Implant
Intervention type(s): Device
Intervention description(s): Bone anchored, bone conduction hearing system
Other intervention name(s): Bone anchored, bone conduction hearing system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Condition: Mental Fatigue
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to determine which substances in cocoa produces changes in
      mental energy. This is a double blind study. The primary outcome measures are performance on
      tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at
      pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of
      mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions
      are the following:
    

Detailed description: 
      Only one prior study has examined the acute influence of cocoa on mental energy. The purpose
      of this research is to replicate the previous observations and extend research in four ways:
      1) start to determine which substance in cocoa responsible for the effect by including
      several comparison groups, 2) focus on individuals with average or below average symptoms of
      mental energy and who are not high consumers of fruits, vegetables and other products
      containing high amounts of flavonoids in order to learn whether people with low energy accrue
      a greater benefit, and 3) include additional measures of mental energy plausibly influenced
      by cocoa to better understand the health consequences of cocoa.
    

Intervention name(s): Caffeinated cocoa; Cocoa; Caffeine; Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener; 21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener; 473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener; 473 ml of brewed water, caramel coloring and one packet Truvia sweetener
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cacao; theobromine; flavanols; caffeine; sustained attention; vigilance; vigor; vitality; energy; fatigue
CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients
Condition: Protruded Disk
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a
      tissue barrier when used as an annular patch in discectomy patients with low back & leg pain
      when compared to traditional discectomy patient outcomes. This will be a 120 patient,
      prospective randomized study model over a 5 year post-operative period.
    


Intervention name(s): CLARIX™100; CLARIX CORD 1K
Intervention type(s): Other; Other
Intervention description(s): CLARIX™100 is Amniox's processed and cryopreserved human amniotic membrane tissue retrieved from donated placental tissue after elective Cesarean Section delivery. Amniox's Amniotic Membrane is designated by the FDA as a tissue product under PHS 361 HCT/P (human cells, tissues and cellular and tissue-based products).; CLARIX CORD 1K is made from cryopreserved human umbilical cord, utilizing the patented CRYOTEK™ process. CLARIX CORD 1K is considered a Human Cells, Tissues & Cellular and Tissue-based product (HCT/P) by U.S. FDA standards.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Discectomy; Lumbar discectomy; Protruding disc
Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the rate and extent of absorption of three oral
      formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy
      volunteers.
    


Intervention name(s): Ertugliflozin 10 mg tablet; Ertugliflozin OC Fast; Ertugliflozin OC Slow
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets.; Formulation B) Ertugliflozin 10 mg OC Fast; Formulation C) Ertugliflozin 10 mg OC Slow
Intervention MeSH terms: Ertugliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Relative Bioavailability; Pharmacokinetics; Pharmacodynamics
A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
Condition: HIV Infections
MeSH terms: Pneumonia; Acquired Immunodeficiency Syndrome; Pneumonia, Pneumocystis
Study type: Interventional

Summary: 
      The objectives of this study are:

      To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent
      as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia
      (PCP). To compare the effects of the two lipid emulsions on immunologic function in AIDS
      patients. To compare the effect of the two lipid emulsions on HIV load in AIDS patients as
      measured by reverse transcriptase (RT) in culture. To determine whether a decrease in HIV
      infectivity is greater in patients given a parenteral feeding regimen containing Liposyn II
      20 percent or Liposyn III 2 percent.
    


Intervention name(s): Fat Emulsion 2%; Fat Emulsion 20%
Intervention type(s): Drug; Drug
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Primary purpose: Treatment
Keywords: Weight Loss; Pneumonia, Pneumocystis carinii; Parenteral Nutrition; Liposyn; Acquired Immunodeficiency Syndrome
Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      This is uncontrolled, interventional feasibility study for determining the effects medical
      music on anxiety levels in subjects with ILD. Enrolled subjects will be asked to complete
      questionnaires and undergo physiologic measurements prior to listening to medical music. The
      music intervention will be for approximately 30 minutes. Post intervention questionnaires and
      physiologic measurements will be done.
    

Detailed description: 
      The Medical Music intervention includes playlists that contains songs specifically designed,
      recorded, and optimized through the provisionally-patented methods, to treat their co-morbid
      anxiety. The duration of the medical music playlist is 30 minutes.

      Enrolled subjects will be asked to complete questionnaires to assess anxiety, a questionnaire
      related to their music preferences, and undergo physiological measurements (vital signs,
      galvanic skin response, and heart rate variability) before and after the intervention.
    

Intervention name(s): Medical Music
Intervention type(s): Other
Intervention description(s): Enrolled subjects will undergo 30 minutes of medical music listening
Intervention model: Single Group Assignment
Intervention model description: This is an uncontrolled, interventional pilot study to determine feasibility
Masking: None (Open Label)
Primary purpose: Treatment
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Condition: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design
      that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high
      risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once
      daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
    


Intervention name(s): Epanova® (omega-3 carboxylic acids); corn oil control
Intervention type(s): Drug; Drug
Intervention description(s): Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE); corn oil control arm
Other intervention name(s): omega-3 carboxylic acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: omega-3 carboxylic acid
Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
Condition: Hepatitis B; Vaccination
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province
      of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs
      between age 15 and 35; the proportion of vaccinated children who will still be protected at
      this age is currently unknown. This study is designed to determine:

        -  persistence of immunity until age 25

        -  persistence of immunological memory as demonstrated by an anamnestic response following
           a booster dose

        -  the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the
           primary vaccination course (at age (15, 20 or 25).
    

Detailed description: 
      Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month
      schedule to 1126 9-10 year-old children.

      The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B
      in all subjects at age 25 and to compare the levels obtained in those given a booster
      injection at age 15 or 20 with those receiving no booster injection.

      Secondary objectives

        -  To determine the antibody levels obtained following primary vaccination and the
           proportion of children who seroconvert

        -  To determine the antibody levels of one third of subjects at age 15, 5 years after
           primary vaccination (Group A)

        -  To determine the effect on antibody levels of a booster injection at age 15 years given
           to one third of the subjects (Group A)

        -  To determine the antibody levels of subjects in groups A and B at age 20, 5 years after
           booster (Group A), 10 years after primary vaccination (Group B)

        -  To determine the effect on antibody levels of a booster injection at age 20 years given
           to one third of the subjects (Group B)

        -  To determine the effect on antibody levels of a booster injection at age 25 years given
           to one third of the subjects (Group C)

        -  To determine the antibody levels of subjects in Group A and Group B one year after their
           5 or 10 year booster

        -  To evaluate safety
    

Intervention name(s): Engerix-B
Intervention type(s): Biological
Intervention description(s): 10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Vaccination; Engerix-B; Immunogenicity; Long-term immunity; Booster dose; Safety
Magnetic Resonance Imaging and Acute Low Back Pain
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This is a behavioral observational study aimed at understanding the limit of tolerance (in
      days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back
      pain. It consists of a short self-administered questionnaire. Relationships between low back
      pain intensity, maladaptive thoughts and awaited days before ideally requesting a MRI will be
      evaluated.
    

Detailed description: 
      This is a behavioral observational study aimed at understanding the limit of tolerance (in
      days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back
      pain (LBP) and by general practitioners (GP).

      Literature pointed out that LBP is a common occurrence in people, with high rates of
      self-resolution in the absence of red flags (i.e. possible indicators of serious spinal
      pathology).

      In Italy there is an over-prescription of MRI despite international guidelines go the
      opposite way.

      The study consists of a short self-administered questionnaire which will be given to people
      and GP to complete. In more details, the survey is made of 3 questions collecting information
      on the limit of tolerance (in days) before requesting (people) and prescribing (GP) a MRI for
      the lumbar tract of the spinal column.

      Further, participants will have to complete a self-administered pain intensity numerical
      rating scale, along with catastrophizing and anxiety self-administered questionnaires.

      Descriptive statistics will be presented by taking into account the socio-demographic
      characteristics of the sample being investigated. Statistical correlations between
      participants' answers and the scores from the questionnaires will be also evaluated.

      This study investigates the relationships among acute low back pain, the intention of
      persons/GP to request/prescribe a MRI despite the absence of red flags, mood disorders and
      maladaptive thoughts.
    

Intervention name(s): The present study does not contain any intervention
Intervention type(s): Other
Intervention description(s): The present study does not contain any intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult people with acute low back pain (i.e., a pain lasting no more than 6 weeks).

        General practitioners who are involved in the managment of people with acute low back pain.
      
Keywords: Low back pain; Magnetic Resonance Imaging; Catastrophizing; Anxiety; Red flags
Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
Condition: DVT; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to prevent blood clots from forming during surgery and a few days
      after total knee replacement surgery. This study will help us identify whether using a blood
      thinner in the operating room will stop blood clots from forming during the operation.
    

Detailed description: 
      Venous thromboembolism is a major cause of morbidity and mortality after lower limb
      orthopaedic surgery in the adult patient. If, as suggested, DVT formation begins
      intra-operatively then targeting this period to prevent clot formation could substantially
      reduce DVT rates in the TKA population. The present study aims to determine whether this
      intra-operative regional heparinization technique is effective in preventing the
      intra-operative formation of DVT following TKA, as evidenced by venography in the early
      post-operative period.
    

Intervention name(s): unfractionated heparin
Intervention type(s): Drug
Intervention description(s): Five minutes prior to tourniquet inflation, patients will receive 0.1 ml/kg/minute of intravenous (IV) unfractionated heparin (1000 units/ml) or placebo (normal saline solution). Five minutes will be allowed to elapse to ensure complete systemic heparinization. The operated limb will then be elevated and exsanguinated using an Esmarch bandage. Following cuff inflation, the contents of a second syringe will be administered IV over a 5 minute period. The second syringe will contain either protamine sulfate (1.0 mg/kg) to reverse the systemic heparin for patients in the treatment group, or normal saline for the control group. Study drugs will be administered by the anaesthesiologist via a peripheral IV. This new method of intraoperative regional heparinization has been used in two previous studies (Giachino et al., 2001; Giachino et al., 1985) with no adverse effects noted.
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: DVT; Osteoarthritis; Total Knee Arthroplasty
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects
Condition: Healthy Volunteers; Pharmacokinetics of ASP3700
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
      of single ascending oral doses of ASP3700 in healthy male subjects. This study will also
      explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to
      evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in
      healthy male subjects.
    

Detailed description: 
      This study consists of 2 parts: Part 1 is a single ascending dose study where subjects will
      receive either ASP3700 or matching placebo; Part 2 is a drug-drug interaction (DDI)
      open-label, crossover study comprised of 1 sequence with 2 investigational periods where
      subjects will receive ASP3700 alone and in combination with itraconazole.
    

Intervention name(s): ASP3700; itraconazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Pharmacokinetics; ASP3700; Itraconazole; Drug-drug interaction