bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults
Condition: Immune System; Innate Inflammatory Response
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      In this study, the purpose was to describe and compare the modulator effects on the immune
      system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective,
      randomized, double-blind, parallel group nutritional study for 8 weeks was carried out
      comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A
      complete battery of in vitro tests on the activity of immune system, processes and phenomena
      was performed.
    


Intervention name(s): Pasteurised yoghurt; Fresh yoghurt; Sterilised yoghurt
Intervention type(s): Other; Other; Other
Intervention description(s): Pasteurised (heat treated) natural yoghurt containing <15 CFU/g of Lactobacillus delbrueckii bulgacirus and <15 CFU/g of Streptococcus thermophilus.; containing ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus; Not containing viable bacteria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Qvar Therapy in Smoking Asthmatics
Condition: Asthma; Smoking
MeSH terms: Asthma
Study type: Observational

Summary: 
      To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF
      HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically
      fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care
      asthma population of current smokers.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are all current smokers ages between 16-70 years with evidence of asthma
      
Keywords: Primary Care; Particle size; beclomethasone dipropionate; Asthma Management; Maintenance Therapy; Metered-Dose Inhaler; Smoking
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
Condition: Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The main purpose of this study is to determine the degree to which Mindfulness-Based Stress
      Reduction, a group-based psychological therapy that includes mindfulness meditation
      exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with
      daily life among adult chronic pain patients.

      The second purpose is to examine the role of attention in improving psychological and
      physical health for chronic pain patients.
    


Intervention name(s): Mindfulness-Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): An 8-week structured group program that was developed to improve psychological and physical symptoms associated with pain. It incorporates a variety of mindfulness meditation exercises including mindful yoga, sitting meditation, and body scan to facilitate attention, acceptance, and awareness of one's experiences.
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Meditation; Mindfulness; Attention; Chronic Pain; Depression; Anxiety; Stress; Acceptance; Pain intensity; Pain disability
The Effect of Supervised Exercise on Physical Fitness and Energy Expenditure in Post Bariatric Surgery Patients
Condition: Post-bariatric Surgery
Study type: Interventional

Summary: 
      It is hypothesized that the patients in the EXDA group will be able to complete a structured
      exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that
      the structured endurance activity will increase their physical fitness and total daily energy
      expenditure compared to the DA group.
    


Intervention name(s): supervised exercise; Diet advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): supervised exercise; Diet Advice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss
Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia
Condition: Deglutition Disorders
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      The aim of this research study is to determine the effectiveness of: 1) a traditional therapy
      regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box)
      musculature and 2) a new therapeutic exercise, the Shaker exercise.

      The primary objective of this 5-year project is to identify which of two therapy programs,
      the Shaker exercise versus traditional therapy, results in the largest number of stable,
      non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6
      weeks of intervention. The study is powered adequately so that this aim can be tested
      separately for head and neck cancer and stroke patients. Our primary outcome measure is
      return to oral feeding, i.e., 100% of nutrition and hydration by mouth.
    

Detailed description: 
      Secondary aims of this research are:

        1. Determine in a descriptive manner whether patients with residue in the pyriform sinuses
           who aspirate the residue after the swallow respond better, i.e., a higher percentage of
           them can return to 100% oral intake, than patients with residue in the valleculae who
           aspirate after the swallow or patients with residue in both locations who aspirate after
           the swallow and thus to define the spectrum of indications for the proposed exercise
           programs in the two groups of dysphagic patients (stroke and post-chemo radiation
           treatment for head and neck cancer) and whether postures enable each patient type to
           swallow more bolus types without aspiration at pre- and post

        2. Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic
           elements which change as a result of each therapy program including changes in -

             1. anteroposterior and lateral diameter of maximum deglutitive UES opening

             2. maximum deglutitive laryngeal anterior and superior excursions
    

Intervention name(s): Shaker Exercise vs. Traditional Dysphagia Therapy Regime
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Keywords: UES; Dysphagia
Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance
Condition: Knee Osteoarthritis; Total Knee Arthroplasty; Remimazolam
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The investigators hypothesized that intraoperative opioid consumption would be different
      between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was
      adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or
      propofol under total intravenous anesthesia. The purpose of this study is to compare the
      intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when
      the intraoperative remifentanil dose adjustment was performed under the ANI guidance while
      maintaining a similar depth of anesthesia with remimazolam or propofol.
    


Intervention name(s): remimazolam group; propofol group
Intervention type(s): Drug; Drug
Intervention description(s): Remimazolam 6 mg/kg/hr is administered as an intravenous infusion until the patient loses consciousness. Anesthesia is maintained at 1 mg/kg/hr of remimazolam. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.; Propofol intravenous infusion is initiated by the application of a target concentration infusion (TCI) pump to cause the patient to lose consciousness. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Probiotics to Treat "Inflammatory Depression"
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The main aims of this project are to test if: i) Specific probiotic lactobacilli (added to
      stabilized ongoing treatment) are efficacious in treating depressive symptoms in individuals
      with low-grade inflammation, defined using high sensitivity C-reactive protein (hs-CRP) and
      BMI. ii) This effect is mediated through decrease of inflammation, estimated by
      treatment-associated changes in blood and faeces biomarkers. Secondary aims are to
      investigate the relationship between specific depressive symptoms and inflammation and if
      there is a correlation between certain pro-inflammatory or metabolic markers and depression.
    


Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Specific probiotic lactobacilli (added to stabilized ongoing treatment); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention will be add-on specific probiotic to ongoing treatment with antidepressant medication or Cognitive Behavioral Therapy (CBT). Subjects will be randomized to placebo or probiotic. To assure a balanced subject recruitment, block randomization within strata (ongoing treatment with CBT, antidepressant or both) will be performed. Blood sampling and symptom rating scales will be completed at baseline, at weeks 4 and 8 (end of study). Feces will be collected at baseline and end of study. Biomarkers (from baseline, week 4 and week 8) will be analyzed after the study. Subjects will be recruited from outpatient or inpatient settings, Psychiatry Skåne or primary care clinics in Skåne, Sweden. Subjects will be recruited via clinical referrals, but also via ads.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation
Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis
Condition: Bursitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with
      trochanteric bursitis experience chronic intermittent or continuous hip pain at and around
      the greater trochanter.

      The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa,
      though this has not been confirmed. Accordingly, the use of corticosteroid injections has
      been shown to provide considerable relief. However, routine "blind" injections, those
      performed without the aid of imaging, such as fluoroscopy, have shown limited success in the
      appropriate needle placement. Fortunately, blind injections have yielded positive results in
      majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical
      outcome for trochanter bursa injections.

      Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such
      as ultrasound have not been studied and may be more useful. Fluoroscopy allows for
      bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue
      structures such as the bursa and has gained significant support for use in musculoskeletal
      injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an
      ultrasound guided injection and whether ultrasound should be routinely used during trochanter
      bursa injections.
    


Intervention name(s): Trochanter bursa injections; Ultrasound
Intervention type(s): Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of HNC042 in Healthy Chinese Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after
      multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.
    


Intervention name(s): HNC042 for Injection; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg; Placebo , Intravenous route , multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neuraminidase inhibitor
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and
      tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.
    

Detailed description: 
      Pharmacokinetics and safety and tolerability data will be collected.
    

Intervention name(s): tecovirimat; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study is based on Animal Regulatory Rule; Does not apply
Other intervention name(s): ST-246
Intervention MeSH terms: Tecovirimat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment; orthopoxvirus; smallpox
Efficacy of Rifaximin in Preventing Campylobacteriosis
Condition: Dysentery; Diarrhea; Enteric Campylobacteriosis
MeSH terms: Campylobacter Infections; Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating
      the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C.
      jejuni.
    

Detailed description: 
      30 healthy volunteers (2 of these were planned alternates) gave informed consent and were
      enrolled to participate in a study to determine the efficacy of prophylactic rifaximin in
      preventing diarrheal illness following challenge with C. jejuni, strain CG8421. Volunteers
      were screened for inclusion and exclusion criteria and were admitted to the inpatient unit of
      the Center for Immunization Research at Johns Hopkins University. Volunteers were treated
      with rifaximin or placebo in a double blind manner for four days, beginning the day prior to
      challenge. On the day of challenge, the volunteers were given 5x10(5) C. jejuni with
      bicarbonate buffer and were then monitored and treated for any symptoms. Stools were cultured
      daily for the excretion of C. jejuni and all subjects were treated with antibiotics to insure
      that the challenge strain has cleared prior to to discharge. Subjects were followed for six
      months following the inpatient phase to detect adverse events following the study.
    

Intervention name(s): Rifaximin intervention; Placebo intervention
Intervention type(s): Biological; Biological
Intervention description(s): Rifaximin administered then Challenge with C jejuni; Placebo administered then Challenge with C jejuni
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Campylobacter jejuni; rifaximin; antibiotic prophylaxis; dysentery; diarrhea
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Condition: Skin Laxity of the décolleté
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using
      the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days
      post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and
      tighten the skin of the décolleté region.
    

Detailed description: 
      This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale
      scores and chest measurements will be assessed prior to study treatment. Study images will be
      obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
    

Intervention name(s): Ulthera® System
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy™ treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Pain Processing in Anxiety and Depression
Condition: Pain; Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      The purpose of the study is to investigate pain, anxiety and depression in patients with
      panic anxiety disorders without pain or depression without pain compared with healthy
      volunteers
    


Intervention name(s): Observation
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatient clinic Primary care clinic Community sample
      
Keywords: Neuropathic pain; Chronic pain; Depression; Anxiety
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with
      evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2).

      The primary purpose of this study is to evaluate the safety and tolerability of single
      ascending oral doses in Part 1 (SAD Including Evaluation of Food Effect) and multiple
      ascending oral doses in Part 2 (MAD) of MA-0211 in healthy adult participants.

      This study will also evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of single
      ascending and multiple ascending oral doses of MA-0211 in healthy adult participants. In
      addition, this study will evaluate the effect of a single oral dose of MA-0211 on the QT
      interval using Fridericia's Correction (QTcF); determine the effect of food on the PK of a
      single oral dose of MA-0211 as well as evaluate the effect of multiple oral doses of MA-0211
      on the QTcF.
    

Detailed description: 
      After a screening period of up to 29 days prior to study drug administration, eligible
      participants will be residential for a single period of 6 days/5 nights in Part 1 and 19
      days/18 nights in Part 2 . Participants will be admitted to the clinical unit on day 2.
    

Intervention name(s): MA-0211; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ASP0367
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; MA-0211; Single Ascending Dose; Healthy Volunteer; Multiple Ascending Dose; Pharmacodynamics
The Effects of Ultrasonic Noise Exposure on Human Hearing
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The aim of this research is to investigate the effects of ultrasonic noise exposure on the
      human auditory system (how it effects hearing). Current international regulations concerning
      ultrasound exposure differs significantly and are based on scarce and outdated scientific
      data; hence the motivation for this research. A cohort of 20 audiometrically healthy
      volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity,
      at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A
      subgroup of 10 subjects will be used as a control group. The resulting audiograms will
      establish the extent of any recoverable loss in hearing sensitivity known as temporary
      threshold shifts (TTS).
    


Intervention name(s): Ultrasonic noise exposure; Pure Tone Audiometry
Intervention type(s): Other; Diagnostic Test
Intervention description(s): Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.; Participants will undergo 2 (pre and post exposure) hearing tests
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Ultrasound, Hearing
Phone Coaching for Weight Loss Maintenance
Condition: Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether weight loss maintenance can be improved by
      providing individuals with 4 consecutive weeks of phone coaching during the maintenance
      period. Individuals who previously achieved and maintained a >=5% weight loss in a 1-year
      behavioral weight loss program will be provided with a low-intensity maintenance
      intervention. Some individuals will be selected to receive phone coaching. Assessments of
      weight, physical activity, and other weight-related behaviors will occur at baseline, 6
      months, and 1 year.
    


Intervention name(s): Maintenance program; Phone coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1-year weight loss maintenance program, consisting of monthly newsletters; Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phone coaching; diet; exercise