bioihbjkbjnl/mcl2 huggingface dataset:
The SleepTrackTXT2 Randomized Trial With Air-medical Personnel
Condition: Poor Quality Sleep; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The overarching goal of this proposal is to address the MedEvac foundation priority of
      educational techniques and technologies and improve Helicopter Emergency Medical Services
      (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS
      clinicians can be improved with real-time assessment and intervention.

      Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS
      clinician fatigue reported in real-time during and at the end of shift work.

      Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality
      and sleep health indicators including hours of sleep and recovery between shift work.
    

Detailed description: 
      The investigators will examine short term impact by examining self-reported fatigue captured
      at the start, during, and end of scheduled shifts.

      The investigators will determine longer-term impact on sleep quality by comparing scores on
      the Pittsburgh Sleep Quality Index (PSQI) taken at baseline and then again at 4 months.
    

Intervention name(s): SleepTrackTXT2
Intervention type(s): Behavioral
Intervention description(s): Participants that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness during shift work. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pediatric Pain Optimization After Tonsillectomy
Condition: Obstructive Sleep Apnea; Tonsillitis; Pain, Procedural
MeSH terms: Tonsillitis; Sleep Apnea, Obstructive; Pain, Procedural
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the use of short acting opioids
      (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following
      tonsillectomy surgery.
    

Detailed description: 
      This is a single center, randomized, double blind, parallel-group dose escalation
      investigation which will compare post operative pain control indices for patients receiving
      short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia
      care, except for intraoperative opioid management, are not altered for study purposes.
      Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid
      (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be
      collected for up to 30 days post-operatively.
    

Intervention name(s): Fentanyl/Hydromorphone; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): Per routine care; Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis
Intervention MeSH terms: Fentanyl; Methadone; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Dietary Sugar Consumption on Sweet Taste Perception
Condition: Sweet Taste Perception
Study type: Interventional

Summary: 
      The purpose of the study is to determine how reducing the amount of simple sugars in the diet
      affects sweet taste perception. Healthy adult subjects will be assigned to either follow
      their usual diet, or to replace sugar calories with fats or starch.

      The investigators hypothesize that eating less sugar will:

        1. cause foods and drinks with a given amount of sugar to taste sweeter

        2. cause people to prefer lower levels of sugar in foods and drinks
    


Intervention name(s): Low sugar diet; Sham diet manipulation
Intervention type(s): Other; Other
Intervention description(s): All subjects followed their usual diet during month 1. For months 2-4: sham diet intervention for the control group, 40% reduction in sugar calories for the experimental group. All subjects were allowed to chose any diet they wished during month 5.; Subjects in the control group will meet with a dietician and discuss diet records, but the dietician will not instruct the control subjects to reduce the number of calories from simple sugars in the diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Youth PHP Pilot Transdiagnostic Treatment Implementation and Effectiveness Study
Condition: Emotional Disorder
MeSH terms: Mood Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine patient effectiveness outcomes of a transdiagnostic
      treatment for youth emotional disorders, implemented in a partial hospitalization program
      (PHP). Participants will be youth between ages 6 to 17 and their families, as well as
      clinicians, participating in the PHP program at Children's Hospital Colorado. Additionally,
      the research team will study modifications to the transdiagnostic intervention that are
      required to feasibly and effectively deliver it in a PHP setting.
    


Intervention name(s): Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
Intervention type(s): Behavioral
Intervention description(s): The Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C and UP-A) are transdiagnostic, behavioral interventions for youth with emotional disorders, including anxiety, depression, obsessive-compulsive disorders, and irritability.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be youth and parents recruited from the partial hospitalization program
        at Children's Hospital Colorado.
Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Raisins contain a significant amount of dietary fiber and polyphenolic compounds that
      represent an important substrate for microbiota fermentation which generates potentially
      beneficial end products, such as short-chain fatty acids. The mammalian gut contains a
      phylogenetically as well as functionally diverse microbiota that contributes to host
      physiology. To date, little is known about how increased raisin intake affects human gut
      microbiota composition.

      This research study will assess the effects of adding raisins to the diet of healthy adults
      on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well
      as markers of immune function. The hypothesis is that by adding raisins to the diet this will
      result in changes in gut microbiota. Furthermore, the changes in microbiota will largely be
      beneficial, as evaluated by an increase in butyrate producers and bacteria associated with
      anti-inflammatory properties.
    

Detailed description: 
      The research study design is a 14 day international focus on increasing raising intake.
      Participants will be provided with a commercial raisin product for a 14 day period.
      Participants will consume 2 servings/day (84g of raisins). While participants will be told to
      substitute raisins for other diet ingredients, they will be free to choose what to substitute
      according to their preferences. Participants will keep daily food records and will be told
      that raisin consumption will be monitored in their fecal samples (qPCR). Fecal samples will
      be collected before the start (Day1), during (Day5-7) and at the end (Day 12-14) of the
      intervention using a stool collection kit (Sigma). Participants will complete a GI health
      questionnaire on a weekly basis to determine tolerance to increased raisin intake.
    

Intervention name(s): Raisins
Intervention type(s): Other
Intervention description(s): Participants will consume 84g of raisins per day for 14 days.
Other intervention name(s): Sun-Maid California Raisins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gut Microbiota
Intra-discal Steroid Injection for MODIC I Discopathy
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the
      inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on
      magnetic resonance imaging.

      Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients
      with inflammatory discopathy
    

Detailed description: 
      Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral
      disc for patients with chronic back pain and MODIC I discopathy on MRI

      Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care
      hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved
      by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention:
      Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography
      (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome
      measures: The primary outcome measure is pain level assessed on a 11-point numeric scale
      (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month.
      Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire),
      quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and
      anti-inflammatories during the last week, return to work, assessment of the disabilities at 1
      and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will
      be recorded.

      Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits:
      at 1, 3, 6, and 12 months Statistical analysis: intention to treat
    

Intervention name(s): Visipaque - Hydrocortancyl; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route; Visipaque - 320 mg I/ml - 1 ml in intra-discal route
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low back pain; steroid injection; inter-vertebral disc; randomized trial; Lack of efficacy of usual recommended treatments; More than 40 on the pain numeric scale (0-100); Inflammatory discopathy (MODIC I) on MRI
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. The primary aim of this clinical trial is to locate and
      compare simulated insulin injections (injections of sterile atmospheric air) in normal weight
      and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles
      with and without lifting of skin fold at different injection sites.
    


Intervention name(s): NovoFine® needle 6 mm; NovoFine® needle 12 mm
Intervention type(s): Device; Device
Other intervention name(s): NEEDLEN; NEEDLEN
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of the Rosacea Prevalence in the General Population
Condition: Rosacea
MeSH terms: Rosacea
Study type: Observational

Summary: 
      Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea
      Prevalence in the General Population.
    

Detailed description: 
      Primary objective:

      Assessment of the prevalence of rosacea in the general population per country using subject
      questionnaire and dermatologist diagnosis
    

Intervention name(s): Prevalence assessment
Intervention type(s): Other
Intervention description(s): Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Part I:

        Subjects will be screened from the general population by questionnaires mainly focusing on
        detection of signs and symptoms of rosacea.

        Subjects' answers will be submitted to a pre-defined algorithm to identify the potential
        subjects with rosacea (screened positive for rosacea, Screened R+).

        Part II:

        A subgroup of subjects (100 maximum per country) will be randomly selected among those who
        screened positive for rosacea and will be referred to the closest investigational site
        (dermatologist practice).
Efficacy of Olibra: A 12 Week Controlled Trial
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Today's obesogenic environment, favors behavioral choices that lead to an excess of energy
      intake over expenditure, and consequently weight gain. Intervention strategies that harness
      the body's own appetite and satiety regulating signals could provide an effective means of
      countering excessive energy intake. The purpose of this study was to investigate whether a
      vegetable oil emulsion (Olibra) would result in weight loss that was associated with a
      reduction in food intake.
    

Detailed description: 
      71 healthy subjects were enrolled (60 females, 11 males; Age: 18 - 60 years, BMI 25 - 40
      kg/m2) in a two-phased, randomized, placebo-controlled, double-blind, parallel trial. During
      a 12-week period, Olibra was compared with a placebo (milk fat). Food intake testing was
      conducted on three days and anthropometric data was collected on 7 days. Key outcome measures
      were, body weight, body composition, energy intake, and appetite ratings.
    

Intervention name(s): Olibra; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Fractionated palm oil and fractionated oat oil in the proportion of 95:5; 100% milk fat
Other intervention name(s): Fabuless
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Malnutrition in Gastroenterology Patients
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Malnutrition is frequently occurring in sick patients and is associated with a
      higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which
      leads to a reduced functional status and quality of life.

      Specific aims: The purpose of the study is to evaluate the effect of a three month
      nutritional intervention with oral supplements on nutritional status, muscle function and
      quality of life.
    


Intervention name(s): Fresubin protein energy Drink (CAVE! nutritional intervention)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Metformin and Longevity Genes in Prediabetes
Condition: Insulin Resistance; Prediabetes; Aging; Inflammation
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Pre-diabetes, a condition characterized by hyperglycaemia, is associated with increased
      cardiovascular risk and reduced life expectancy, as compared to the general population.
      AMP-activated protein kinase (AMPK) is an enzyme that plays a key role in cellular energy
      homeostasis and metabolism, and recently it has been demonstrated that AMPK regulates aging
      pathways, as well. AMPK is susceptible to modulation through pharmacologic (e.g. metformin)
      and non-pharmacologic (e.g. physical exercise) interventions. This clinical trial aims to
      describe the effects of the AMPK pathway on longevity genes and inflammation in the setting
      of pre-diabetes in vivo and in vitro. To this end, the investigators will compare treatment
      with metformin (500 mg t.i.d) for 2 months, versus placebo in pre-diabetic subjects. The
      investigators will assess expression of longevity genes SIRT1, p66Shc, p53 and mTOR in
      peripheral blood mononuclear cells (PBMCs) ex vivo. The investigators will evaluate monocyte
      polarization by flow cytometry, according to the expression of surface antigens (CD68, CCR2,
      CD163, CD206, CX3CR1) to determine the prevalence of pro- or anti-inflammatory cells.
      Inflammatory cytokines (TNF-alpha, MCP-1, IL-1, IL-6, IL-10, CCL12) will also be determined.
      In the in vitro study the investigators will evaluate the effects of AMPK activation or
      inhibition on longevity gene and protein expression.
    


Intervention name(s): Metformin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin tablets 500 mg tris in die (tid)
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insulin resistance; Prediabetes; Longevity genes; Inflammation; Metformin
Effects of Montelukast in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO)
      concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung
      function is unknown. We will aim to study the effect of treatment and withdrawal of
      montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in
      children with asthma.

      A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18
      atopic children with mild persistent asthma who will be treated with oral montelukast (5
      mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive
      matching placebo.

      A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.
    


Intervention name(s): montelukast sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): one tablet 5 mg once/day for 4 weeks; one tablet 5 mg once/day for 4 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: airway inflammation; childhood asthma; fractional exhaled nitric oxide; leukotriene receptor antagonists; lung function
Analgesia and Pancreatic Cancer Surgery
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      Long-term survival for patients with pancreatic carcinoma is low, even following resection,
      the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to
      local recurrence, distant metastasis or both within one to two years after surgery2-4.

      Surgery has been suggested to accelerate the development of preexisting micro metastases and
      to promote the establishment of new metastases5. Release of catecholamine and proinflammatory
      products secondary to surgical stress is believed to promote cancer progression6. Maintenance
      of proper anesthetic depth is beneficial to attenuate surgical stress. However, general
      anesthesia including numerous induction agents, volatile anesthetics and opioids, is
      associated with immunosuppression especially on the cell-mediated immunity which has a
      crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and
      analgesia which effectively attenuating surgical stress while efficiently reducing general
      anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer
      progression. Currently, most studies available in humans are retrospective and observational
      to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related
      outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is
      available13. However, it is not specific to an individual cancer type and perioperative
      cell-mediated immunity is not evaluated.

      In this study, we aimed to identify whether epidural block beneficial to early surgical and
      late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative
      cell-mediated immunity functions including natural killer cells, helper and cytotoxic
      T-lymphocytes were also investigated.
    


Intervention name(s): Epidural patient controlled analgesia; Intravenous patient controlled analgesia
Intervention type(s): Procedure; Drug
Intervention description(s): Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control; Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control
Other intervention name(s): Fentanyl; marcaine(bupivacaine hydrochloride); morphine
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.
Condition: Irritable Bowel Syndrome Predominant Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional

Summary: 
      This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel
      syndrome predominant constipation. one-third of patients will receive Ficus carica, another
      one-third will receive Descurainia Sophia and remained patients only will follow their
      regular diet for 4 months.
    


Intervention name(s): Descurainia Sophia; Ficus carica
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral
      administration of single rising doses and multiple doses.
    


Intervention name(s): BI 1291583; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1291583; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment