bioihbjkbjnl/mcl2 huggingface dataset:
Nutrigenomics Investigation of the Body's Metabolic Response to 2 Different Meal Challenges
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the biological response to a metabolic stress,
      given in the form of a high carbohydrate or fat meal in normal weight, overweight and obese
      individuals and to further explore these responses using novel metabolomic, proteomic,
      transcriptomic and genotyping techniques.
    

Detailed description: 
      The most recent statistics from the Department of Health in Ireland (2005) indicate that the
      leading causes of death are those in which nutrition can play a key preventative role. The
      proposed study will provide information on the metabolic stress from varying body weight
      overlaid by the additional metabolic stress of a test-meal challenge, in this case being
      delivered in the form of an oral glucose tolerance test (OGTT) and oral lipid tolerance test
      (OLTT), standard metabolic challenges in post-prandial research. Previous studies assessing
      metabolic risk factors associated with a disease have typically focused on information
      collected from individuals in a fasting state only. However, it is equally important to
      assess how the body responds when stressed. Employing an acute high fat or carbohydrate
      intake is sufficient to induce a mild stress in which time an individual's unique
      post-prandial response can be monitored. This study will combine traditional markers
      (dietary, anthropometric, lifestyle, clinical and physical activity) with nutrigenomics, a
      tool that attempts to describe the genome-wide influences of nutrition by examining the
      impact of diet on genes (genomics), mRNA (transcriptomics), proteins (proteomics) and
      metabolites (metabolomics).
    

Intervention name(s): Oral glucose tolerance test; Oral lipid tolerance test
Intervention type(s): Other; Other
Intervention description(s): 75g anhydrous glucose powder mixed with 100mls water; 150ml drink composed of 2 commercially available high fat products
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Post-prandial; Nutrigenomic; Test meal; Oral glucose tolerance test; Oral lipid tolerance test
An ACT Manual-based, Guided Self-help Intervention Pilot
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of a guided self-help intervention using
      Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help
      manual whilst on a waiting list for individual therapy, while the other half will remain on a
      waiting list and not receive the manual. This study is looking specifically at individuals
      with mild to moderate anxiety and/or depression.
    

Detailed description: 
      Many patients are offered written self-help material as a stage 1 (low intensity)
      intervention for anxiety and/or depression, as recommended by the United Kingdom's National
      Institute for Clinical Excellence's pathways framework (http://pathways.nice.org.uk/).

      Acceptance and Commitment Therapy (ACT) is an emerging therapy that has been shown to help
      patients with mild to moderate anxiety and/or depression in therapist-led individual and
      group treatments. However, few studies have shown how effective ACT is in the form of a
      low-intensity, guided self-help intervention.

      This study seeks to find out whether an ACT-based manual, sent to patients with anxiety
      and/or depression, increases their ability to effectively manage their difficulties and
      improve their quality of life. Participants on a primary care mental health waiting list will
      be invited to take part in this study.

      Eligible participants will be randomly allocated to one of two groups: the ACT intervention
      or waiting list as usual. Participants receiving the ACT intervention will be posted a manual
      and will be asked to read a chapter each week for six weeks. A member of the research team
      will also phone them on two occasions to support their use of the manual, trouble shoot any
      difficulties and provide encouragement. All participants will be asked to complete nine,
      short questionnaires sent through the post prior to and after six weeks of self-help.

      By comparing the results the study will demonstrate whether the ACT intervention is effective
      compared to wait list as usual.
    

Intervention name(s): ACT Intervention Group
Intervention type(s): Behavioral
Intervention description(s): A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluation of Acacia Gum on Microbiome and Bowel Function in Participants With Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Proof of concept study to investigate the impact of a food supplement consisting of Acacia
      gum on changes of gut microbiota and production of short chain fatty acids. Additionally,
      safety, tolerability and parameters of bowel function (stool frequency, stool consistency and
      gastrointestinal symptoms) will be assessed during the study.
    


Intervention name(s): acacia gum
Intervention type(s): Dietary Supplement
Intervention description(s): Two sachets (à 5 g) in the morning and two sachets in the evening, reconstituted in 120 ml water and stirred until fully dissolved to be taken 10 minutes before meals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acacia gum; gummi arabicum; microbiome; short chain fatty acids; SCFA; stool frequency; stool consitency
A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether or not the drug Nabilone significantly
      reduces pain and improves quality of life in patients with fibromyalgia.
    

Detailed description: 
      Fibromyalgia is a disease of unknown cause. People with fibromyalgia experience diffuse body
      pain, fatigue, sleep disturbance, and a generalized stiffness and swollen feeling.
      Fibromyalgia affects 2-6% of the general population, affecting females more commonly than
      males. Symptoms usually start between 20 and 55 years of age.

      No medical treatment has been specifically approved for the management of fibromyalgia,
      however, there is strong evidence that some antidepressants, exercise, and patient education
      are effective in reducing the pain experienced by fibromyalgia patients. A recent study of
      four patients has suggested the possible benefit of Nabilone, a synthetic cannabinoid, in the
      treatment of fibromyalgia, however more studies are needed.

      Marijuana is the common name for cannabis. Nabilone (brand name, CESAMET®), is a synthetic
      cannabinoid (form of cannabis). Cannabinoid receptors exist naturally in the human body and
      respond to naturally occurring cannabinoids produced by the body, as well as marijuana and
      synthetic cannabinoids like Nabilone.

      In Canada, Nabilone is approved for the treatment and management of severe nausea and
      vomiting associated with cancer chemotherapy and may be prescribed by physicians.

      Research has shown that activating the cannabinoid receptors also has an effect on reducing
      acute and chronic pain.

      Our hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the pain
      experienced by patients with fibromyalgia and improve quality of life, compared to the
      placebo controlled group. This will be evident by finding significant differences in Visual
      Analogue Scale pain scores, number of tender points, average pain threshold, and scores on
      the Fibromyalgia Impact Questionaire.
    

Intervention name(s): Nabilone
Intervention type(s): Drug
Intervention description(s): Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.
Other intervention name(s): Cesamet
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Cannabinoids; Nabilone; Cesamet; Pain
Safety and PK/PD of RTA 1701 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD)
      and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this
      study will be conducted in approximately 56 healthy participants in up to 7 groups. Each
      group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a
      single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available
      pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to
      dose escalation.

      Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up
      to 3 groups and will commence after safety data for the highest dose in the SAD phase has
      been evaluated. Each group will consist of up to 10 participants who will be randomized in a
      4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety,
      tolerability, and available pharmacokinetics will be assessed in each dosing group prior to
      dose escalation
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Placebo oral capsule; RTA 1701 capsules
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsule matched to an RTA 1701 capsule; Capsule containing RTA 1701, multiple dosages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RTA 1701; RTA 1701 capsules
Health Beneficial Effects of Krill Oil and Lean and Fatty Fish
Condition: Healthy
Study type: Interventional

Summary: 
      Intake of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) from fish oil and fish are
      associated with significant health benefits in risk of cardiovascular disease. However, both
      lean and fatty fish have been shown to have beneficial effects suggesting that not all
      effects are mediated by n-3 PUFAs. Krill oil is an n-3 PUFA supplement on the marked. The n-3
      PUFAs from krill oil is in the form of phospholipids, and these fatty acids may be more
      readily and effectively absorbed after ingestion than n-3 PUFAs in the form of
      triacylglycerols from fish oil. Fish also contain many other potential health components than
      n-3 PUFAs such as taurine and vitamin D, iodine, selenium and more unspecified components
      such as bioactive peptides which can mediate the health beneficial effects observed after
      intake of fish.

      The present study aims to elucidate the cardiovascular health beneficial effects after
      consumption of fish (lean and fatty) and krill oil, with regard to effects on plasma lipids
      and other markers of cardiovascular health such as inflammatory, haemostatic and endothelial
      dysfunction markers. The investigators will perform whole genome transcriptome analyses in
      peripheral blood mononuclear cells (PBMCs) in order to further understand the cardiovascular
      health benefits and elucidate the mechanisms of action.
    


Intervention name(s): Krill oil; Lean and fatty fish; Placebo capsules
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): The krill group and the control group will be double blinded. The krill oil and placebo capsules will be administered in equal amounts and are of equal size and have the same color.; The fish group will be open labeled.; The krill group and the control group will be double blinded. The krill oil and placebo capsules will be administered in equal amounts and are of equal size and have the same color.
Other intervention name(s): Rimfrost Sublime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Triacylglycerols; Omega-3 fatty acids; Krill oil; Fish; Healthy Volunteers
Impact of Lower Body Weight Support Treadmill on Cardiopulmonary Exercise Capacity and Trainability
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The AlterG®-anti-gravity treadmill provides lower body weight support which enables
      individuals to exercise without feeling their full body weight. How this body weight support
      influences cardiovascular, respiratory, vascular and metabolic parameters is currently
      unclear. Further, whether body weight support influences the trainability in response to
      moderate continuous exercise is unknown. This investigation has two main goals. First, we
      explore the direct influence of lower body weight support on cardiometabolic parameters
      during maximal exercise testing. Second, we aim to compare changes in cardiorespiratory
      fitness in response to a structured exercise protocol using moderate intensity with and
      without lower body weight support.
    


Intervention name(s): AlterG Anti-gravity treadmill
Intervention type(s): Other
Intervention description(s): Participants in this group will complete a 12 week aerobic exercise training protocol with 40% lower body weight support on an AlterG Anti-gravity treadmill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Diets Enriched With Pecans
Condition: Hypercholesterolemia; Obesity
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Background: Previous studies report that daily pecan consumption reduces cholesterol in
      healthy adults while promoting weight maintenance.

      Purpose: To examine the impact of daily pecan consumption with and without dietary
      substitution instructions for an 8-week period on markers of health in adults at risk for
      cardiovascular disease.
    

Detailed description: 
      This was a single-blind, randomized controlled trial. The investigators recruited subjects
      with hypercholesterolemia (high blood cholesterol levels) or at higher risk for
      cardiovascular disease (CVD) (BMI > 28 kg/m2). Subjects were randomized into one of three
      groups: (1) the no nut group (CON), (2) pecan ADD (no diet instructions), and (3) pecan SUB
      (instructions to substitute pecans with isocaloric foods in habitual diet).

      There was a screening visit and 3 testing visits: Baseline (visit 1), mid-visit at week 4
      (visit 2), and post-visit at week 8 (visit 3). Anthropometrics, questionnaires, and a fasting
      blood sample were collected at each visit. A subset of participants participated in a
      saturated fatty acid meal challenge in which additional blood and metabolism measurements
      were collected.

      Hypothesis: The investigators hypothesized that daily pecan consumption would result in
      significantly greater improvements in blood lipids, metabolism, and appetite compared to the
      control group. The investigators also hypothesized that pecan ADD group will result in a
      larger increase in body weight compared to the pecan SUB and control groups.
    

Intervention name(s): Pecan ADD; Pecan SUB
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Raw pecan halves without dietary substitution instructions; Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet
Other intervention name(s): Pecan; Pecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
IMPAACT P1073: Study of IRIS for Infants and Children Initiating HAART at Int'l Sites
Condition: IRIS; HIV
Study type: Observational

Summary: 
      Your child is able to participate in this study, if your child's doctor is planning to start
      your child on HAART (which is a combination of at least 3 anti HIV drugs). When your child is
      treated with HAART, the way your child's body is able to fight infection may change. The
      immune system is the body's defense against infection. Your child's immune system may respond
      in a stronger way to some types of infections that your child may already have. This immune
      response may cause your child to become sick and the condition is then called "immune
      reconstitution inflammatory syndrome" or IRIS.
    

Detailed description: 
      IMPAACT P1073 is a prospective clinical, observational and pathogenesis study of HIV-infected
      infants and children who are ART-naïve and will be initiating a HAART regimen at an IMPAACT
      study site. Where possible, infants and children co-enrolled in IMPAACT studies will be given
      preference for enrollment in P1073.

      The plan is to enroll subjects in P1073 at a timepoint ≤ 1 week prior to starting HAART. For
      DMC purposes, this is Step 1 for P1073, and subjects are designated as a Non-case, according
      to the Study Flow Chart
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is a prospective, clinical observational and pathogenesis study of HIV-infected
        infants and children stratified into 2 age groups: ≥ 4 weeks to ≤ 12 months of age; and >
        12 to < 72 months of age who will enroll into P1073 at a timepoint ≤ 1 week prior to
        initiating HAART
      
Keywords: IRIS; HIV; Immune; Reconstitution; Inflammatory; Syndrome
Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block
Condition: Analgesia; Pain, Postoperative; Thoracic; Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Objective: The authors hypothesized that combined deep and superficial serratus anterior
      plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative
      and postoperative analgesia for video-assisted thoracoscopic surgery.

      Design: A prospective randomized controlled study. Participants: Adult patients undergoing
      elective video-assisted thoracoscopic surgery.

      Interventions: Preoperative SAPB or ESPB implementation.
    

Detailed description: 
      Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative
      Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic
      consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side
      effects, complications related to plane blocks, mobilization time and length of hospital stay
      was recorded and measured.
    

Intervention name(s): erector spinae plane block; combined deep and superficial serratus anterior plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): Erector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.; Combined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, controlled
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: serratus anterior plane block; video-assisted thoracoscopic surgery; erector spinae block; postoperative analgesia
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of this study is to assess the efficacy of the co-administration of lanreotide
      Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant
      (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a
      week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the
      percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the
      end of the co-treatment period.
    


Intervention name(s): lanreotide (Autogel formulation); Pegvisomant
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.; Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
Intervention MeSH terms: Lanreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment