bioihbjkbjnl/mcl2 huggingface dataset:
A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, placebo-controlled, double-blind study will assess the
      safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two
      parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to
      placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of
      RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants
      will subsequently receive a single IV dose of RO6836191 for further analysis.
    


Intervention name(s): LS followed by NS diet condition; NS followed by LS diet condition; Placebo; Placebo; RO6836191; RO6836191; RO6836191
Intervention type(s): Other; Other; Drug; Drug; Drug; Drug; Drug
Intervention description(s): LS diet period followed by NS diet period; NS diet period followed by LS diet period; Single oral administrations; 2 single oral administrations; Orally administered, single ascending doses; 2 single oral doses; Intravenous administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Incretin Effect in Patients With Chronic Pancreatitis
Condition: Chronic Pancreatitis; Type 2 Diabetes Mellitus
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv)
      glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin
      effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly
      reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a
      primary event leading to T2DM or if it is merely a consequence of the diabetic state. To
      answer this question the investigators plan to estimate the incretin effect in 8 patients
      with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the
      incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with
      T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is
      measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose
      infusion.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic pancreatitis with and without secondary diabetes mellitus
      
Biospecimen description: 
      Blood samples
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
Condition: Acute Kidney Insufficiency; Acute Renal Insufficiency; Acute Kidney Injury; Ischemic Preconditioning
MeSH terms: Acute Kidney Injury; Renal Insufficiency; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its
      pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic
      preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing
      coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the
      incidence of acute kidney injury associated with cardiopulmonary bypass.
    


Intervention name(s): Remote Ischemic Preconditioning
Intervention type(s): Procedure
Intervention description(s): Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Acute Kidney Insufficiency; Acute Renal Insufficiency; Acute Kidney Injury; Cardiac Surgical Procedures; Ischemic Preconditioning
Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery
Condition: Pediatric Anesthesia; Tracheal Intubation
Study type: Observational

Summary: 
      This study evaluates the effect of head and neck movement in children on endotracheal tube
      (ETT) tip displacement undergoing head-and-neck surgeries. The tube-tip displacement will be
      measured using flexible fiberoptic bronchoscope.
    

Detailed description: 
      In clinical application, especially in head-and-neck surgeries, the operators often change
      the position of children's head-neck for easy operating. Flexing the head resulted in the ETT
      moving towards the carina, and extension resulted in the tube being displaced in the opposite
      direction. Head and neck movement change the length of trachea as well: extending the head
      resulted in the extension of trachea, while flexing resulted in the opposite. Serious
      complications following from head and neck movement, such as accidental extubation and
      endobronchial intubation, threat children's life.

      In pediatric anesthesia, insertion depth (cm) of orotracheal intubation equals to age/2+12,
      according to classic intubation formulae. The ETT will be put in the depth calculated by the
      classic formulae under general anesthesia. The distance of ETT-tip displacement and the
      length change of trachea will be measured as the head and neck placed as follows: fully
      extended, neutral position, or fully flexed. These three head and neck positions imitate the
      head-neck movement during those head-and-neck surgeries.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who schedul to undergo elective head-and-neck surgeries under general anesthesia
        with orotracheal intubation will be enrolled.
      
Keywords: pediatric; intubation; neck movement
Strengthening Exercises for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in
      patients with fibromyalgia (FM).

      Material and Method: Sixty FM patients were randomized into two groups: an intervention group
      (IG), in which patients performed muscle strength exercises using the Swiss ball, and a
      stretching group (SG), in which patients performed stretching exercises. All patients
      participated in 40-minute training sessions three times per week for 12 weeks. The IG
      performed the following eight strengthening exercises using a Swiss ball: lateral rise,
      simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row,
      reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups
      trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1
      repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to
      evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All
      participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The
      assessor was blind to patient allocation.
    


Intervention name(s): strengthening exercises using a Swiss ball; strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): This group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads.
Each training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM).; The stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Muscle strength exercises; Pain; Quality of life
Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)
Condition: Head and Neck Neoplasms
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study Objectives:

        -  To determine the MTD (maximal tolerated dose) and recommended dose of a weekly docetaxel
           and cisplatin combination regimen for locoregional recurrent/metastatic Squamous Cell
           Carcinoma of the Head and Neck (SCCHN)

        -  To determine the response rate of the recommended dose

        -  To determine the safety and tolerability of the recommended dose
    


Intervention name(s): Docetaxel
Intervention type(s): Drug
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Into Pain in Subacromial Shoulder Pain
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The aim of the randomized clinical trial is to investigate if "exercising into pain" gives
      better results in term of clinical outcomes compared to a non-painful exercise program.
    

Detailed description: 
      Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder
      pain (SSP). Guidelines suggest exercise therapy for at least three months and research
      underlines the importance of progressive loaded exercise therapy at high dosage. However, it
      is not clear which is the best type of exercise and if pain should be provoked or avoided
      during exercise. Recent research found that painful exercises are beneficial in short term on
      pain and function in patients with different kinds of chronic musculoskeletal pain. The aim
      is to investigate if one painful exercise can give better and faster results in the
      management of SSP than non-painful program.
    

Intervention name(s): exercising into pain; exercising with no/slight pain
Intervention type(s): Other; Other
Intervention description(s): the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale; the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder pain; subacromial impingement syndrome; exercise therapy
Blackberry Polyphenol Intake and Fuel Management
Condition: Fuel Management
Study type: Interventional

Summary: 
      Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts
      can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid
      class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation,
      and this may be the mechanism by which body fatness is influenced by anthocyanin intake.
      Well-controlled studies in humans are lacking.
    


Intervention name(s): Blackberry; Jello
Intervention type(s): Other; Other
Intervention description(s): Participants will be fed a higher fat, typical American diet for two 1-week periods. Participants must consume only and all food provided during the intervention periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the
      tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for
      treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO)
      and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of Avastin® is added to
      standard-of-care high dose steroids and an additional dose of Avastin® is added to plasma
      exchange (if necessary). The primary outcomes are clinical changes in the Expanded Disability
      Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters and safety.
    

Detailed description: 
      Study Objective: The overall objective is to evaluate the tolerability/safety and efficacy of
      adding bevacizumab (Avastin®) to standard of care therapy in improving clinical and
      radiologic outcomes of acute optic neuritis and/or transverse myelitis in neuromyelitis
      optica and neuromyelitis optica spectrum disorders.

      Primary Objective: To compare the clinical and radiographic outcome following acute optic
      neuritis and/or transverse myelitis in NMO/NMOSD in patients who receive 1-2 doses of 10
      mg/kg dose of bevacizumab (Avastin®) in addition to standard medical therapy.

      Secondary Objectives:

        -  To determine the effect of Avastin on NMO clinical scores (Expanded Disability Status
           Scale, Timed 25-foot Walk and Low Contrast Visual Acuity [LCVA]).

        -  To evaluate the safety and tolerability of a 10 mg/kg dose of intravenous Avastin.

        -  To determine the frequency of adverse events with Avastin in this patient population.

        -  To determine the effect of Avastin on MRI lesion size and extent.

      The duration of the investigation is 1-2 years.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NMO; NMOSD; NMO-IgG; Aquaporin-4; AQP4; anti-AQP4
Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot
      ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived
      mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release
      growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor
      (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an
      new option in treating a diabetic foot ulcer.
    


Intervention name(s): ALLO-ASC-DFU
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
mHealth Intervention in Increasing HPV Vaccinations in College Students
Condition: Healthy Subject
Study type: Interventional

Summary: 
      This randomized pilot trial studies how well a mobile health (mHealth) intervention works in
      increasing human papillomavirus (HPV) vaccination among college students at the Ohio State
      University. mHealth educational intervention may communicate information about HPV
      vaccination and increase HPV vaccine uptake in college students.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Pilot test an mHealth HPV vaccine intervention for college students to establish
      feasibility and acceptability.

      II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention
      increases HPV vaccine initiation compared to the control group.

      SECONDARY OBJECTIVES:

      I. Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared
      to the control group.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I: Participants receive targeted HPV vaccine narrative-style video via the
      mobile-friendly website. Participants also receive monthly HPV vaccination reminders via
      email or by text message.

      ARM II: Participants receive standard information about HPV and then HPV vaccine information
      statement (VIS) via the mobile-friendly website.

      After completion of study, participants are followed up at 3 and 7 months.
    

Intervention name(s): Informational Intervention; Media Intervention; Survey Administration
Intervention type(s): Other; Other; Other
Intervention description(s): Receive standard HPV vaccine information (HPV VIS); Receive targeted HPV vaccine narrative-style video; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cancer prevention; HPV; Human papillomavirus vaccine
Effect of Relora Supplement on Anxiety, Cognitive Performance & Mood Tested After Induced Stress
Condition: Mood (Psychological Function)
Study type: Interventional

Summary: 
      The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the
      effects of Relora supplementation on responses to induced stress produced by a combination of
      cognitive and physiologic stressors in healthy men and women. The effects of the supplement,
      compared with a placebo, will be evaluated using measures to assess anxiety [State-Trait
      Anxiety Inventory-Part 1 (STAI-Part 1), mood [Bond-Lader Visual Analog Scale (VAS)],
      hypothalamic-pituitary-adrenal axis activation (salivary cortisol) and cognitive function
      (cognitive flexibility, reaction time, processing speed, attention, sustained attention,
      working memory, and executive function). Testing will be completed at the beginning and end
      of 7-d supplementation periods with the active and placebo products to assess both the acute
      effects and the "acute-on-chronic" effects following one week of daily use.
    


Intervention name(s): Relora; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 750 mg/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Healthy mood; Stress management; Relora; Healthy subjects
Clinical Trials of Two Non-drug Treatments for Chronic Depression
Condition: Mood Disorders; Depressive Disorders; Depression; Chronic Depression
MeSH terms: Depression; Depressive Disorder; Mood Disorders
Study type: Interventional

Summary: 
      This study investigates the potential efficacy of two nonpharmacologic treatments for
      nonseasonal depression, bright light exposure or high-density negative air ion exposure.
      Treatments are self-administered at home by the patient under close clinical supervision.
    

Detailed description: 
      Bright light exposure and high-density negative ion exposure have been designed to mimic
      outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter)
      depression, but their effectiveness in treating chronic depression has not been explored.

      Participants in this 10-week study will have an interview, a complete physical exam, and six
      one-hour appointments for progress evaluations. They will be randomly assigned to either
      light or high- or low-dose negative ions. Each treatment must be taken consistently for five
      weeks at the same time every day, after which treatment is temporarily suspended to determine
      whether symptoms return. Participants will then have the opportunity to try the alternate
      active treatment to determine which works best for them. On two occasions, participants will
      provide saliva samples, used to determine the level of melatonin, a hormone that becomes
      active at night and indicates whether a person's internal circadian clock is "in sync" with
      the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet
      readily available in medical practice, provides our research participants with unique
      information that can be used to optimize the timing of future treatment.
    

Intervention name(s): Bright light box; High-output negative ion generator; Low-output negative ion generator
Intervention type(s): Device; Device; Device
Intervention description(s): 60-min light therapy shortly after awakening; 60-min high-density ion exposure shortly after awakening; 60-min low-density ion exposure shortly after awakening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antidepressive Agents; Chronobiology; Chronotherapy; Circadian rhythms; Depressive Disorder; Ions; Light; Lighting; Mood disorders; Phototherapy.
Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Improvement exercise tolerance
    

Detailed description: 
      This study allows improved exercise tolerance in patients undergoing rehabilitation effort
    

Intervention name(s): custom work endurance; dietary management adapted to the nutritional status
Intervention type(s): Other; Behavioral
Intervention description(s): Experimental: Rehabilitation effort; dietary management adapted to the nutritional status
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents
Condition: Influenza, Avian
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune
      response, immunogenicity of two different doses, antibody persistence 360 days after the
      first vaccination, immune response to a heterologous booster given on Day 360) of a Vero
      cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents
      aged 6 months to 17 years.
    


Intervention name(s): H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Intervention type(s): Biological
Intervention description(s): Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention