bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Binge Eating Disorder Treatments
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the long-term effectiveness of interpersonal psychotherapy,
      behavioral weight loss interventions, and guided self help treatments in treating binge
      eating disorder (BED).
    

Detailed description: 
      BED is a serious condition that is associated with psychiatric comorbidity, psychosocial
      impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL)
      interventions, and guided self help (GSH) treatments for BED have been evaluated, but the
      safest and most effective treatment has not yet been identified. This study will determine
      which of these three treatments is most effective in treating BED.

      Participants are stratified by negative affect subtype and are randomly assigned for 6 months
      to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal
      problems which are hypothesized to increase negative affect and lead to binge eating. BWL
      interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened
      version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL
      patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are
      made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is
      complete.
    

Intervention name(s): Interpersonal Therapy; Behavioral Weight Loss Treatment; Guided Self Help
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 20 sessions of interpersonal therapy were provided over a 6-month period; 20 sessions of behavioral weight loss treatment were provided over a 6-month period; 10 sessions of guided self help were provided over a 6-month period
Other intervention name(s): IPT; BWL; Weight loss treatment; GSH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight Loss
Study on Anti-inflammatory Effects of Topical R115866 Gel
Condition: Cutaneous Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical
      R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.
    


Intervention name(s): Talarozole; Differin™, 0.1% adapalene gel
Intervention type(s): Drug; Drug
Intervention description(s): Topical Application (20 mg); Topical Application (20 mg)
Other intervention name(s): Rambazole, R115866; adapalene gel
Intervention MeSH terms: Adapalene; R 115866
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      The American Diabetes Association (ADA), among other medical societies, is strongly
      recommending medical nutrition therapy (MNT) for prevention and management of type 2
      diabetes. However, the ADA recognized that there is no "one size fits all" diet and thus
      recommends that MNT should be conducted through a consultation with registered dietitians
      (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an
      integral part of the MNT, lowers postprandial blood glucose levels. Through our experience
      from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying
      MNT within a structured dietary intervention protocol has the best impact on blood glucose
      values and body weight. Meanwhile, the frequent use of health coaching during dietary
      intervention proved to be effective in managing diabetes and inducing weight loss. However,
      no study compared those three intervention methods in a randomized clinical study.

      The aim of this study is to evaluate the effect of different models of conducting medical
      nutrition therapy on the glycemic control in patients with type 2 diabetes.
    


Intervention name(s): Traditional MNT; Structured MNT; Structured MNT plus Weekly Support
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Will follow the nutritional recommendations set by the American Diabetes Association in 2013.; Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.; Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula; in addition to receiving weekly coaching from a registered dietitian
Other intervention name(s): Medical Nutritional Therapy Plan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Obesity; Nutrition; Medical Nutrition Therapy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40
      mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (oxycodone HCl); Original OxyContin® (OXY) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 40-mg tablet x 1 dose taken without food; Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid; Healthy volunteers
Succinate Salt Version of GSK961081 for Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Salt Bridging study for GSK961081
    


Intervention name(s): GSK961081; GSK961081 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.; GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: succinate; anti-muscarinic; b-agonist
HIV, Immune Activation and Salt Sensitive Hypertension
Condition: HIV-1-infection; Hypertension,Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      High dietary salt is associated with immune activation, elevated levels of inflammatory
      cytokines and hypertension in murine models. Hypertension is independently associated with
      inflammation in both murine studies and studies in humans. In people living with HIV, these
      interactions are not well established. The aim of this study is to determine the effect of
      excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood
      pressure between individuals with and without hypertension among people living with HIV and
      HIV negative persons.
    


Intervention name(s): Dietary salt (Sodium chloride)
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are instructed on salt deprivation for a week followed by a low salt (4 grams) diet for one week and switched to high salt (9 grams) for the following one week
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Inflammation; Human immunodeficiency virus (HIV); Salt; Interleukin 6; Interleukin 17A; Hypertension
A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)
Condition: Relative Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the systemic exposure of budesonide delivered by the combination
      inhaler (budesonide/albuterol sulfate pressurized inhalation suspension [BDA metered dose
      inhaler {BDA MDI}]) with Pulmicort Flexhaler dry-powder inhaler (DPI).
    

Detailed description: 
      This study will be an open-label, randomized, 2-way cross-over study in healthy adult male or
      female participants, performed at a single study center.Participants will receive single
      doses of BDA MDI or Pulmicort Flexhaler on 2 occasions, under fasted conditions. There will
      be a minimum washout period of 3 days between each dose administration. A total of 66
      participants will be randomized in this study to ensure that at least 62 participants are
      evaluable. The study will comprise of screening period of maximum 27 days; Two treatment
      periods during which participants will be resident from the day prior to administration of
      budesonide/albuterol sulfate pressurized inhalation suspension metered dose inhaler (BDA MDI)
      or Pulmicort Flexhaler (Day -1) until at least 24 hours after dosing. Participants will be
      discharged on the morning of Day 2; and a final follow-up visit within 5 to 7 days after the
      last administration of BDA MDI or Pulmicort Flexhaler.
    

Intervention name(s): BDA MDI 160/180 mcg; Pulmicort Flexhaler 180 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg.; Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg.
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Inhaled corticosteroid
Investigating the Effects of Glucodia™ on Glucose Parameters, Triglycerides and Body Weight
Condition: Glucose Parameters; Triglycerides; Body Weight
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on
      glucose parameters, triglycerides and body weight as compared to a placebo. Half of the
      subjects will be administered Glucodia™, while the other half will receive placebo.
    


Intervention name(s): Glucodia™; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Protein; mung bean; glucose; triglycerides; insulin; body weight,; DXA scan
Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device
Condition: Disorder of Soft Tissue
Study type: Interventional

Summary: 
      The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as
      determined by clinical assessment of treatment sites and routine tracking of adverse events.
    

Detailed description: 
      A multi-center, open-label, prospective study of implanted cross-linked HA device, Aline HA,
      for soft tissue augmentation, to treat only one anatomic feature in up to 100 subjects for 6
      months.
    

Intervention name(s): Aline HA
Intervention type(s): Device
Intervention description(s): Implantable dermal filler
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: soft tissue; augmentation; correction; wrinkles
A Randomized Exercise Trial for Wheelchair Users
Condition: Spinal Cord Injury; Multiple Sclerosis; Muscular Dystrophy; Cerebral Palsy; Spina Bifida; Amputation; Arthritis; Stroke
MeSH terms: Arthritis; Muscular Dystrophies; Multiple Sclerosis; Spinal Cord Injuries; Cerebral Palsy; Spinal Dysraphism; Sclerosis
Study type: Interventional

Summary: 
      People with mobility disabilities are at greater risk than the general population for
      incurring health problems. Many of these conditions are preventable through behavior and
      lifestyle changes such as exercise and physical activity. Recent evidence suggests that
      people with disabilities experience the same physiologic response to exercise as the general
      population. Nonetheless, nearly three-fourths of those with disabilities report being
      entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of
      issues that limit physical activity among this population, few studies have investigated
      methods for promoting physical activity adoption among people with disabilities, including
      wheelchair users. The purpose of this study is to test the effectiveness of a behavioral
      intervention to promote physical activity adoption over 6 months and maintenance of physical
      activity over another 6 months by community-dwelling manual wheelchair users.
    


Intervention name(s): Educational session to promote physical activity; Minimal contact
Intervention type(s): Other; Other
Intervention description(s): Educational session, goal setting, self monitoring of daily engagement in physical activity; Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Wheelchair use; Spinal cord injury; Multiple sclerosis; Muscular dystrophy; Cerebral palsy; Spina bifida; Amputation; Arthritis; Stroke
CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE® Inhaler With An Adjustable Maintenance Dose Of SYMBICORT® Inhaler. SERETIDE® Inhaler is a Trademark of GSK Group of Companies. SYMBICORT® Inhaler is a Trademark of Astra Zeneca.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of
      formoterol/budesonide where the dose is adjusted according to a physician-guided
      self-management plan
    

Detailed description: 
      A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing
      regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the
      DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with
      formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir
      inhaler)in adults asthmatics
    

Intervention name(s): Salmeterol/fluticasone propionate or formoterol/budesonide
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: formoterol/budesonide; exacerbations; Salmeterol/fluticasone propionate; adjustable maintenance dosing; asthma control
Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a chronic dose of a tryptophan-rich protein
      drink (lumiVida™) can improve cognitive function, emotional processing and sleep in
      middle-aged women. In addition, also genetic predictors of susceptibility to an increase of
      Trp levels will be investigated.

      lumiVida™ is considered a dietary supplement, and therefore it is not an approved drug by the
      Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
      Administration does not strictly regulate herbs and dietary supplements. The investigators do
      not claim that this supplement is meant to treat any ailment
    

Detailed description: 
      The treatment conditions are either placebo or lumiVida™ (N=30 per group) 0.5 g twice a day
      (total 1 g/ day). The first testing took place on the screening day (baseline). Subsequently,
      participants were supplied with supplements for 19 days intervention (sachets which had to be
      dissolved in 200-ml water). After 19 days, participants were tested again (same tests as on
      the baseline day). An additional facet was the completion of a 'sleep diary', which asks
      questions about sleep quality and latency, and bed-time mood, as well as allowing recording
      of timing of supplement taking.
    

Intervention name(s): lumiVida™; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: lumiVida™, cognition, mood, sleep, tryptophane
Trama-Code (Two Analgesics-comparative Study)
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®,
      Dafalgan-Codeine®) in the emergency unit.

      The efficacy (relief of pain) would be assessed 2 hours after administration of one of the
      two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain
      assessment score).
    


Intervention name(s): Ixprim®; Dafalgan-Codeine®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Is Intralymphatic Allergen Immunotherapy Effective and Safe?
Condition: Allergic Rhinitis Due to Grass Pollen
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      15 patients with moderate to severe allergic rhinitis against grass were recruited and
      enrolled in the study. They received three open label intralympatic grass allergen injections
      with the dose 1000 SQ-U each and with one month interval. The next year the patients were
      randomized double blind to an active or placebo booster injection of 1000 SQ-U before the
      pollen season. Grass specific IgG4 levels were measured before and at various time ponts
      after treatment.
    

Detailed description: 
      The purpose of the study is to evaluate whether intralymphatic administration of AIT is a
      safe and effective treatment for patients with pollen-induced allergic rhinitis. The long
      term goal is to provide a base for a more efficient administration of ASIT, which will reduce
      both the dose necessary and the number of clinic visits associated with the conventional
      subcutaneous ASIT.

      The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster,
      after three open label ILIT injections, can increase the allergen specific IgG4 antibodies,
      and if the IgG4 increase can be correlated to clinical effect characterized with seasonal
      questionnaires.

      The first part of the study is completed and published (PMID: 23374268)
    

Intervention name(s): ALK Alutard 5-grasses; ALK Diluent
Intervention type(s): Drug; Drug
Intervention description(s): 0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection; 0.1 mL of ALK Diluent as an intralymphatic injection
Other intervention name(s): Grass allergen with aluminum adjuvant; Human albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying
Condition: Gastric Emptying
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of either elemental liquid diet or
      standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients
      receiving gastrostomy feeding.
    

Detailed description: 
      A randomized, crossover trial using elemental liquid diet or standard semi-solid diet
      containing 13C sodium acetate as a tracer is performed in both healthy subjects and bedridden
      gastrostomy-fed patients. 13C breath tests is performed to estimate gastric emptying.
    

Intervention name(s): Elemental liquid diet; Standard semi-solid diet
Intervention type(s): Other; Other
Intervention description(s): This is a randomized, crossover trial. Two types of test meals (200 kcal/200 mL of either the elemental diet or the semi-solid diet) are labeled with 100 mg [13C]sodium acetate and administered within 5 min in healthy subjects or within 15 min in gastrostomy-fed patients.; This is a randomized, crossover trial. Two types of test meals (200 kcal/200 mL of either the elemental diet or the semi-solid diet) are labeled with 100 mg [13C]sodium acetate and administered within 5 min in healthy subjects or within 15 min in gastrostomy-fed patients.
Other intervention name(s): Elental®; Racol NF semi-liquid®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment