bioihbjkbjnl/mcl2 huggingface dataset:
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
Condition: Stable Coronary Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
Study type: Interventional

Summary: 
      The aim of the present study is to investigate whether the ingestion of a cocoa
      flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and
      platelet function in patients with overt coronary artery disease acutely (after 2 hours)
    


Intervention name(s): flavanol-rich drink vs flavanol-free drink
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Fields in Mild and Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of weak extremely low frequency
      electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.
    


Intervention name(s): Magnetic field generator; Placebo magnetic field generator
Intervention type(s): Device; Device
Intervention description(s): dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month; Placebo device with no magnetic fields
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      This study looked at parenteral administration of selenium to septic patients and
      subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the
      development of clinical status.
    

Detailed description: 
      Patients will be divided into two groups. Se-group who received selenium supplementation
      during hospitalization in the form of sodium selenite pentahydrate at 750 mg/day for 6 days
      immediately after admission to our department (1000 mg of sodium selenite pentahydrate = 333
      micrograms of selenium) (Selenase, Vivax; selenium hereinafter).

      The placebo group will receive continuous saline NaCl 50 ml/day for 6 days as a continuous
      infusion (excluding additional infusion therapy). Patients will be further divided into
      subgroups according to OI on the day of admission to ICU. The oxygenation index (OI)
      PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) ratio
      in patients will be calculated daily.

      The determination of biochemical and hematological parameters of blood samples will be as a
      part of the routine diagnostic methods. Data collection for the Se-AOX study will be
      performed at two-day intervals: T1 (1st-2nd day), T2 (3rd-4th day) and T3 (5th-6th day).
      Kinetic methods for estimating the activities of glutathione peroxidase (GPx, E.C. 1.11.1.9),
      glutathione reductase (GR, E.C.1.6.4.2) will be performed using a kit (Sigma-Aldrich,
      Germany) and that of superoxide dismutase (SOD, E.C. 1.15.1.1) by means of the SOD-Assay
      Kit-WST (Fluka, Japan) following the user manual provided.
    

Intervention name(s): sodium selenite pentahydrate; placebo - continuous saline NaCl 50 ml
Intervention type(s): Drug; Other
Intervention MeSH terms: Selenious Acid; Sodium Selenite
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill patients with APACHE II score between 19 and 24 points after admission with
        sepsis, severe sepsis or septic shock during hospitalization as defined by the
        International Sepsis Definitions Conference
      
Keywords: oxidative stress, sepsis, selenium
Reading Fluency and Accommodative Lag
Condition: Ocular Accommodation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether special reading glasses improve children's
      ability to learn to read.
    

Detailed description: 
      Many children are believed to under accommodate (have a lag of accommodation) when looking at
      near targets. If this occurs, the retinal image is out of focus. Children who have a lag of
      accommodation may have difficulty in focusing their eyes at near for long periods of time.
      This difficulty could reduce their ability to read fluently. Children with above average lags
      of accommodation will be randomly assigned to a group which receives special reading glasses
      or a group which does not. The groups will be assessed using a standard test for reading
      fluency.
    

Intervention name(s): Autorefractor, standard clinical instrument
Intervention type(s): Other
Intervention description(s): Autorefractor, standard clinical instrument was used to assess the children's focusing power at near.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ocular Accommodation; Reading
Virtual Reality Analgesia During Pediatric Physical Therapy
Condition: Burn
Study type: Interventional

Summary: 
      We would like to determine whether Virtual Reality (VR) analgesia continues to be effective
      for reducing pain when administered for a clinically relevant treatment duration over
      multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).
    

Detailed description: 
      This study is done in a hospital for inpatients pediatrics. By randomization some subjects
      will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days
      to see whether this will reduce the pain and anxiety.
    

Intervention name(s): VR during Physical Therapy; VR Background Pain; NO VR
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Virtual Reality will be performed during a painful physical therapy procedure.; Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.; The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Virtual Reality Peds
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
Condition: Muscle Damage
Study type: Interventional

Summary: 
      To examine the influence of compression garments manufactured with Far-Infrared technology on
      exercise performance during and after repeated eccentric isokinetic muscle actions of the leg
      extensors.
    

Detailed description: 
      Participants: Eighty recreationally active (1-5 hrs per week) healthy participants between
      the ages of 18 - 35 will visit the Neuromuscular Research Laboratory on 6 separate occasions,
      with 4 of those occasions also requiring a visit to Health services for a blood draw.

      Procedures (methods): During pre-screening, each participant will complete an informed
      consent document, a health history questionnaire, and have their stature and body mass
      assessed. A familiarization session will then be conducted on a separate day where all
      participants will practice the strength assessment, eccentric isokinetic protocol, and
      ultrasound assessments. Participants will be assigned to 1 of the 4 treatment groups based on
      their initial maximal isometric strength values using a matched-participants design. The
      first experimental session will then begin 2-10 days later, where the participants will
      perform the repeated eccentric exercise protocol (10 sets of 15 eccentric contractions 210
      deg/sec with 3 min of rest between sets) with the non-dominant leg following a 60 min rest
      period where they will wear the apparel and perform a 5 min warm-up on a cycle ergometer.
      Follow-up blood draws and strength and ultrasound assessments will be obtained at 24 and 48
      hours post-exercise. Each participant will also complete a visual analog scale at baseline,
      24, 48, and 72 hours post-exercise to examine perceived muscle soreness.
    

Intervention name(s): Far Infrared Fabric; Spandex
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: compression, isokinetic, far-infrared
Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce
      growth hormone. Growth hormone is important for muscle tissue as well as many other tissues
      in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with
      SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving
      long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I
      levels. IGF-I levels will be determined before and after treatment with baclofen. In this
      study, the investigators will determine the minimum dose of baclofen at which improvements in
      GH and IGF-1 levels occur.
    


Intervention name(s): Baclofen
Intervention type(s): Drug
Intervention description(s): Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.
Intervention MeSH terms: Baclofen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Baclofen; Growth Hormone, Pituitary; Insulin-Like Growth Factor I
Paracervical Block During II-trimester Abortion
Condition: Second Trimester Medical Abortion
Study type: Interventional

Summary: 
      Paracervical blockage can reduce severe pain during second trimester induced medical
      abortion.
    


Intervention name(s): bipuvacain; NaCl
Intervention type(s): Drug; Other
Intervention description(s): PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).; PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator
Other intervention name(s): (Marcain® 2,5mg/ml)
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: medical abortion; second trimester; para cervical blockage; pain management
Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for
      which there are no existing therapies that alter the disease course. This research will
      utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal
      of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling
      will improve walking in subjects with SPMS.
    

Detailed description: 
      Individuals with secondary progressive multiple sclerosis (SPMS) experience significant
      impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs.
      Treatment attempts for progressive MS have been disappointing. No therapeutic intervention
      has been shown to modulate disability in patients with SPMS. FES cycling has been shown to
      have multiple primary medical benefits including: increased muscle mass, improvements in bone
      density, enhanced cardiovascular function, improved bowel function, decreased spasticity and
      reductions in bladder infection rate. More importantly FES may modulate the inflammatory
      central nervous system (CNS) environment in progressive MS. The investigators are proposing a
      novel, and easy to implement intervention strategy of FES cycling to help improve gait
      function in individuals with SPMS. A successful outcome on a larger SPMS population would
      have significant impact towards changing MS clinical care. FES is easily transferable to
      clinical practice and could potentially ameliorate other complications associated with SPMS
      such as spasticity, mood and fatigue reducing the burden of health care cost. In addition,
      the investigators will gain a better understanding of the mechanisms underlying these changes
      that could be used to design new therapeutic strategies.
    

Intervention name(s): Active cycling; Passive cycling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.; The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
Other intervention name(s): cycling; endurance training; letting the functional electrical stimulation move the legs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: SPMS
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
Condition: Healthy Volunteers
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the cellular immune responses following 2 doses given
      3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy
      participants.
    

Detailed description: 
      The vaccine tested in this study was TDV. This study assessed cellular immune responses and
      safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years
      and in dengue endemic regions.

      The study enrolled 200 participants. Participants received:

      • TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90
      (Month 3).

      This multi-center trial was conducted in Panama and Philippines. 198 participants received
      the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1).
      Participants made multiple visits to the clinic and were contacted at least every week for
      the entire study duration post first injection.
    

Intervention name(s): TDV
Intervention type(s): Biological
Intervention description(s): TDV SC injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Drug therapy
Soft Tissue Integration of Different Abutment Surfaces
Condition: Edentulous Alveolar Ridge; Soft Tissue Healing
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Objective of the present study was to assess the peri-implant soft tissue profiles between
      argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and
      histological parameters 2 months after abutment placement.
    

Detailed description: 
      Patients that need implant supported restoration were recruited for this study. At baseline a
      specific abutment was screwed at 20 N.Two months following healing abutment placement
      clinical measurements were evaluated.

      Endopoints of the study:

      Histological outcomes at 2 using traditional histological staining (ematossilin/eosin)
      Immunohistological outcomes at 2 using different stainings. Postoperative complications.
      Comparison between the histological outcomes and the preoperative clinical evaluation of the
      sites
    

Intervention name(s): Argon plasma pre-treated abutment insertion; abutment insertion
Intervention type(s): Procedure; Procedure
Intervention description(s): abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min.; the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants received either abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um (surface roughness: Ra=0.2 and Sa=0.11) or abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm (surface roughness: Ra=0.62 and Sa=0.60) abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. in control group were allocated argon plasma non-treated abutmentsParticipants underwent 2-level randomization for allocation of abutments with different surface configurations and experimental treatment using permuted block technique to limit any selection bias. Allocation concealment was preserved by sealing the tested abutments in sterile envelopes sealed in opaque sleeves opened at the time of the second surgical step.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Oral Mucositis; Hematopoietic Stem Cell Transplantation
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem
      cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition
      and intravenous narcotics for pain control. Palifermin (Kepivance[TM]) is a human
      keratinocyte growth factor that is produced by recombinant DNA technology in E. coli.
      Palifermin is a FDA-approved, commercially available pharmacologic agent that is manufactured
      by Amgen. As keratinocyte growth factor receptors have been found within the epithelium of
      gastric mucosa, the use of palifermin has been proven to decrease the frequency and duration
      of severe mucositis in adult studies. Whereas the appropriate dosing regimen has been
      determined for adults at 60mcg/kg/day, the dosing of palifermin has not been established in
      the pediatric setting. This initial pediatric study of palifermin will determine the maximum
      tolerated dose, evaluating the use of this agent at three dose levels, below, at, and above
      the recommended adult dose. Non-hematologic, life-threatening NCI grade IV or grade V
      toxicities definitely related to the administration of palifermin from the first infusion
      until day +6 after HSCT (post palifermin administration day +3) will comprise the safety
      endpoints of the study.

      The study is designed to evaluate palifermin at 3 dose levels. The study population will be
      recipients of either a matched family member donor or matched unrelated donor HSCT. The
      pharmacokinetics of palifermin at each dose level will be described to help determine the
      appropriate dose for future studies, which will evaluate efficacy
    

Detailed description: 
      Secondary objectives of this study include exploring the pharmacoeconomics of palifermin in
      this particular patient population through an assessment of inpatient days, intravenous
      nutrition, and analgesia requirements within 100 days post-transplantation. We will also
      explore the research participants' rates of immune reconstitution, specifically T and
      B-lymphocytes and NK cells, within the first year of HSCT.
    

Intervention name(s): Palifermin
Intervention type(s): Drug
Intervention description(s): Dose level 1 40 mcg/kg/day intravenous Dose level 2 60 mcg/kg/day intravenous Dose level 3 90 mcg/kg/day intravenous
Other intervention name(s): Kepivance®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mucositis, Oral; Hematopoietic Stem Cell Transplantation; Allogeneic Transplantation; Pharmacokinetics; Maximum Tolerated Dose
PRETERM DELİVERY and MYOCINE BINDING PROTEIN C LEVELs
Condition: Preterm
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST
      TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE
      SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.

      SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.
    

Detailed description: 
      IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST
      TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE
      SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.

      SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.A TOTAL OF 90 WOMEN WERE PLANNED TO INCLUDE 45
      STUDY 45 CONTROL GROUP IN THE STUDY.
    

Intervention name(s): level of myosin binding protein c in serum
Intervention type(s): Diagnostic Test
Intervention description(s): Serum samples will be taken from the participants in the first trimester, transferred to eppendorf tubes after appropriate procedures, and stored at -80 degrees until the time of deliveryParticipants will be divided into two groups according to the timing of birthThe first group is those who gave birth earlier than 37 weeks those who gave birth on time in the other group The mbpc levels will be looked at and compared.
Intervention MeSH terms: Protein C
Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Includes participants whose serum samples were collected in the first trimester, stored,
        and then divided into two according to timing of delivery fırst grup ıs preterm group, and
        second one ıs those who gave birth on time
      
Keywords: PRETERM DELİVERY, MBPC,
A Study of Experimental Medication BMS-986278 Given to Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate experimental medication BMS-986278 given to
      healthy participants.
    


Intervention name(s): BMS-986278; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment