bioihbjkbjnl/mcl2 huggingface dataset:
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Condition: Cardiovascular Disease; HIV Infection
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether fish oil supplementation with Lovaza,
      formally known as Omacor will result in a significant reduction in serum triglyceride (TG),
      an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
    

Detailed description: 
      This is a randomized, double blind, placebo controlled, cross-over, clinical trial to
      determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in
      HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40
      subjects. The total duration of the study is 28 weeks, with 12-week treatment periods
      separated by a 4-week washout. This study will be conducted at the Clinical Research Center
      at Tufts Medical Center.
    

Intervention name(s): Lovaza; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.; 2 capsules given twice daily
Other intervention name(s): Omacor (omega-3-acid ethyl esters) capsules; corn oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV; cardiovascular risk; atherogenic lipid profile; brachial artery reactivity; omega three fatty acids
The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity
Condition: Exploratory Behavior
Study type: Interventional

Summary: 
      Our objective is to investigate neuro-anatomical correlates of the regulation of energy
      intake by means of functional MRI. Administration of glucose with and without lactisole and
      exendin as well as fructose is followed by functional brain MRI, and findings are correlated
      with serum GLP-1 levels as an endogenous satiety signal in humans.
    


Intervention name(s): tap water; Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube; Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole; 25g Fructose in 300ml tap water; 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39; 300ml tap water with 450ppm lactisole
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients
Condition: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether either a peripheral nerve block under
      ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided
      block of the nerve followed by continuous catheter infusion of local anesthetic, offers
      better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery,
      than the current analgesic regimen of subcutaneous local anesthetic infiltration.

      Eligible subject, pediatric patients having reconstructive surgery for burns, having skin
      graft donor sites of the lateral thighs, will be randomized into three groups: control
      (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided
      nerve block with catheter placement --fascia iliac.

      Post-operative comfort will be assessed over the next 48 hours.
    


Intervention name(s): Regional nerve block; Catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): a block of the lateral femoral cutaneous nerve is performed under ultrasound guidance. For LFCN block, ropivacaine 0.2% will be used. Dose will be 20 ml, unless patient weighs less than 20 kg, in which case volume will be equal to patient's weight in kilograms.; After an ultrasound guided nerve block is performed a catheter is placed under the fascia iliaca and an infusion of ropivacaine 0.2% running at 0.15 ml/kg/hour is administered for 48 hours.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: burn; skin graft donor site; analgesia for donor site
Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT
Condition: Compare Image Quality Between SDCT and Conventional CT Images of Any Tissue Lesion, Determine Optimal Monochromatic Energy Level for a Coronary Artery Image
Study type: Observational

Summary: 
      Study hypothesis: Post-processed SDCT images provide additional diagnostic value over
      conventional CT datasets.

      The CT examination would be a clinically-necessary, standard-of-care CT performed as per the
      clinical indication. The protocol and scan parameters for the CT exam will be similar to that
      of an equivalent scan performed with any other CT scanner. There would be no additional
      scanner of injection of any drug specifically for the study. The conventional CT images
      generated by the scanner will be used for clinical purposes as routinely practiced.
    


Intervention name(s): Computed Tomography scan
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients requiring a clinically-necessary CT scan
Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation
Condition: Lacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Interventional

Summary: 
      Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction.
      As a result of the lacrimal duct obstruction, tears are retained over the obstacle and
      repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the
      obliterated lacrimal duct and subsequently drained into the nasal cavity. The most common
      cause of unsuccessful surgery is intranasal stoma scarring. One of the methods that can
      increase the success rate of surgery is the introduction of silicone stent into the lacrimal
      duct during DCR, so-called bicanalicular intubation of the lacrimal system. The aim of the
      study is to compare long term effectiveness of DCR with and without bicanalicular intubation.
    

Detailed description: 
      Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction.
      Lacrimal duct obstruction can be caused by inflamation and trauma or might be the consequence
      of previous surgery in the lacrimal duct region. As a result of the lacrimal duct
      obstruction, tears are retained over the obstacle and repeated lacrimal infections occur.
      During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently
      drained into the nasal cavity. The results of DCR are generally excellent and the success
      rate (regression of complaints) varies between 85-95% depending on the condition of the
      lacrimal pathways before surgery. Yet there is a constant effort to improve the results of
      operations. The most common cause of unsuccessful surgery is intranasal stoma scarring. It is
      caused by an inadequately formed bone window, an individual tendency to healing and scar
      formation, but a frequent cause is the insufficient opening of the tear bag or the formation
      of scars between the nasal septum and the lateral nasal wall. One of the methods that can
      increase the success rate of surgery is the introduction of silicone stent into the lacrimal
      duct during DCR, so-called bicanalicular intubation of the lacrimal system. Silicone stent
      remains in the lacrimal system for 12 weeks and prevents scarring. Results of previous
      studies are not clear whether bicanalicular intubation is beneficial. The aim of the study is
      to compare long term effectiveness of DCR with and without bicanalicular intubation.
    

Intervention name(s): dacryocystorinostomy
Intervention type(s): Procedure
Intervention description(s): Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomized into two parallel groups.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: lacrimal duct obstruction; bicanalicular intubation; dacryocystorinostomy; silicone stent
Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      To determine the immediate effects on the abdominal musculature, assessed by ultrasound
      (RUSI), due to the application of electrostimulation using whole body electrostimulation
      together with physical exercise in healthy people and to compare with the application of
      local EMS in the abdominal area and the same physical exercise session. The same intervention
      is carried out for the control group as the WB-EMS group but simulated.
    

Detailed description: 
      Evaluation of the immediate changes in the thickness of the abdominal muscles (Transversus
      abdominis, Internal and External Oblique and Rectus abdominis) and in the Interrectus
      distance after the physical exercise session together with whole body electrostimulation or
      local electrostimulation assessed by ultrasound (RUSI) in healthy people.
    

Intervention name(s): WB-EMS (Whole body electrostimulation); EMS; WB-EMS off
Intervention type(s): Device; Device; Device
Intervention description(s): Application of physical exercise and electrical stimulation on the abdominal muscles through the WB-EMS during 20 minutes training session with specific exercise (CORE); Application of physical exercise and electrical stimulation on the abdominal muscles through the EMS during 20 minutes training session with specific exercise (CORE); Application of physical exercise without electrical stimulation on the abdominal muscles through the WB-EMS off during a 20 minutes training session with specific exercise (CORE).
Other intervention name(s): Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Whole body electrostimulation; healthy; abdominal muscles; ultrasound; RUSI; WB-EMS
Investigating the Role of Resistance Exercise Frequency in the Regulation of Skeletal Muscle Mass
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study will investigate whether manipulating resistance exercise frequency impacts muscle
      protein synthesis rates. The investigators will test the hypothesise that a higher resistance
      exercise frequency will result in greater muscle protein synthesis rates than a lower
      resistance exercise frequency.
    

Detailed description: 
      Resistance exercise is currently the most effective means of building or maintaining muscle
      mass. Resistance exercise guidelines generally suggest that those looking to increase muscle
      mass should train each muscle group once to twice per week. However, it has been proposed
      that it may be of greater benefit to train a muscle group with a higher frequency (i.e., four
      to six times per week) than currently suggested. If true, completing the same total volume of
      resistance exercise in more frequent, smaller bouts could prove to be a more beneficial
      strategy to optimally build or maintain muscle mass.

      Therefore, this study will investigate whether manipulating resistance exercise frequency
      impacts cumulative muscle protein synthesis rates in young individuals. Participants will
      undergo a 7 day period of habitual activity before completing the same total volume of
      resistance exercise as either; i) one isolated bout (low frequency) or ii) five smaller bouts
      (high frequency) over a period of 7 days.
    

Intervention name(s): Low Frequency Condition; High Frequency Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.; Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
Condition: Placenta; Implantation
Study type: Interventional

Summary: 
      The successful hatching process is a prerequisite for implantation. Freezing/thawing cycles
      can impair the hatching process by introducing changes in the composition of the zona
      pellucida. The purpose of this study is to test the hypothesis that the implantation rate per
      embryo and the clinical pregnancy rate per embryo transfer is higher after embryo transfer of
      frozen-thawed embryos with opened or thinned ZP after assisted hatching when compared to
      embryo transfer of frozen-thawed embryos without assisted hatching.

      All patients starting a thawing cycle (with frozen embryos on d1-d2-d3-d5) can be included in
      this RTC study. Assisted hatching will be performed with a non-contact 1.48 diode laser
      system (MTG, Germany).
    

Detailed description: 
      In view of insufficient clinical evidence demonstrating the value of AH at the start of our
      study and in view of the need for higher implantation and LBRs in our ART programme within a
      series of reimbursed cycles, a prospective randomized controlled trial was performed to
      evaluate the effect of AH, by modified quarter laser-assisted zona thinning (mQLAZT), in our
      cryopreservation program. The primary aim was to test the hypothesis that the IR per embryo
      transferred is higher after transfer of frozen/vitrified-thawed/warmed embryos with thinned
      ZP after mQLAZT when compared with the transfer of frozen/vitrified-thawed/warmed embryos
      without mQLAZT.
    

Intervention name(s): assisted hatching
Intervention type(s): Procedure
Intervention description(s): assisted hatching with laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: implantation rate
Effect of Texting and Writing on Grip and Pinch Strength
Condition: Muscle Weakness Condition; Hand Grasp
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      Texting and writing are common hand activities among college students. Students tend to spend
      increasing hours of texting and writing for every day activities in addition to the academic
      assignments that are mainly on line and through distance education. The effect of such daily
      activities on hand grip and key pinch strength has not been studied among college students.
    

Detailed description: 
      Students will be recruited from physical therapy department of college of medical
      rehabilitation sciences after satisfying the inclusion and exclusion criteria. Participants
      will be randomly assigned to one of the four groups (texting 10 minutes, texting 15 minutes,
      writing 10 minutes and writing 15 minutes). Participants will be blinded to the outcome
      measures and the evaluator will be blinded to the participants assigned group. Hand grip
      strength and key pinch strength will be the main outcome measures. Participants demographics
      will be gathered in addition to recreational status, risk factors, pain body diagram and
      number of hours spent for texting and writing in every day life.
    

Intervention name(s): Texting- 10 minutes; Writing- 10 minutes; Texting- 15 minutes; Writing- 15 minutes
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will practice texting for 10 minutes using smart phone.; Participants will practice writing on notebook for 10 minutes.; Participants will practice texting for 15 minutes using smart phone.; Participants will practice writing on notebook for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of the parallel four groups
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hand grip strength, key pinch, risk factors, students; Key pinch; Risk factors; Students
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2
      mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
    


Intervention name(s): ABT-089; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks; Subjects will take placebo QD, BID for 4-6 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when
      compared to sticky bone (control).
    

Detailed description: 
      It was done in 40 subjects who were evaluated for a period of 6 months. the results were
      evaluated clinically (CAL, PPD) and radiographically (bone fill) and after 6 months.
    

Intervention name(s): BMP-2; PRF
Intervention type(s): Drug; Procedure
Intervention description(s): lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.; For the preparation of sticky bone, the patient's venous blood is collected and centrifuged at 2400rpm for 2min which leads to two different layers in the vacutainer the upper autologous fibrin glue (AFG) and the lower RBC portion, the upper AFG is mixed with a particulate bone graft (hydroxyapatite). Within 5-10 min fibrin meshwork was formed
Other intervention name(s): Experimental group; Sticky bone group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization involved the computerized generation of the allocation sequence in random permuted blocks (block randomization) and blinding was ensured by assigning the block of sites to study groups according to the specified sequence by a second operator who coded the two treatment sites selected from every patient by the first operator into the following groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sticky bone; Intrabony defects; Regeneration
A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study will provide data on two systems for assigning point values to food choices in a
      diet plan. The primary purpose of this study is to compare the effectiveness of the two
      systems with regard to changes in body weight.
    


Intervention name(s): Existing diet plan; New diet plan
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Diet; Obesity
Obalon in Children With Severe Obesity
Condition: Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-); Altered Liver Function Tests; Glycemic Intolerance
MeSH terms: Obesity; Pediatric Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      The ongoing global rise in the prevalence of overweight and obesity among all ages and among
      all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher
      incidence in serious health risks, already present at an early age, "switching-on" the engine
      towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to
      avoid systemic and cardiovascular complications of obesity.

      Weight loss devices have been recently introduced in bariatric surgery, also in children.
      They mostly require invasive procedures to be applied. Mini-invasive devices would be needed
      to obtain weight loss in the pediatric population, since the early age of involved patients.

      Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air,
      and have been used to induce weight loss in obese adults. The investigators aimed to perform
      a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters
      modifications, after up-to-3 Obalon® Gastric Balloons placement.
    


Intervention name(s): Swallowable Obalon® Gastric Balloon
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obalon swallowable intragastric balloons; Severe obesity; Children