bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Free Air Portable Air Powered Respirator
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR)
      system versus a N95 mask in preventing nasal detection of influenza following an exposure.
      The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95
      respirator at interrupting the exposure of the study participants to aerosolized influenza
      virus particles.
    

Detailed description: 
      Airborne transmission represents one of the most rapidly spreading and least understood
      dissemination mechanisms for pathogens. Public health strategies to prevent and control the
      often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment,
      if available, 2) decontamination of the exposed areas and surfaces, and 3) isolation and
      barrier precautions such as face masks. Unfortunately, evidence of the efficacy of currently
      recommended barrier precautions is currently lacking.

      Attempts to validate the effectiveness of personal protective equipment are limited to in
      vitro experiments with mannequin heads. This human exposure study will provide a much more
      accurate life-like exposure scenario. The use of live attenuated influenza virus vaccine has
      been proven to be safe.

      Objectives: Evaluate the Free Air Portable Air Powered Respirator (PAPR) versus an N95 face
      mask for preventing the airborne cross-transmission of aerosolized influenza in human
      participants.

      Methods: Participants will be randomized to one of two arms: a) N95 respirator, or b) Free
      Air PAPR System. The primary outcome will be the rate of the transmission for the 2 study
      groups, so a nasal and nasopharyngeal swab will be performed immediately following the
      exposure.
    

Intervention name(s): Free Air Portable Air Powered Respirator; N95 Respirator
Intervention type(s): Other; Other
Intervention description(s): The Free Air PAPR is a portable air powered respirator that you will wear like a backpack with a mask and tubing attached.; The N95 respirator is a mask that is standardly used clinically at Wake Forest Baptist Health.
Other intervention name(s): Free Air PAPR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Live Attenuated Influenza Vaccine (FluMist); Free Air Portable Air Powered Respirator; N95 Respirator; Personal Protective Equipment; Viral Transmission
Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long
      duration of action of GSK233705 when administered via inhalation in animal models supports
      the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary
      disease.

      GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long
      duration of action of GSK233705 when administered via inhalation in animal models supports
      the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary
      disease.
    


Intervention name(s): GSK233705; Tiotropium; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.; Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.; Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK233705; Chronic Obstructive Pulmonary Disease (COPD); COPD
Mealtime Interactions and Risk of Toddler Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with
      mother-toddler dyads who participated in a study that is testing the effects of a
      multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain
      in obese women. Specifically, dyads will be invited to participate in home-based assessments
      to videotape an evening meal, have anthropometric measures taken, and complete study
      questionnaires. The overall goal is to understand factors related prospectively to responsive
      feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18
      and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which
      factors are most strongly predictive of child zBMI change from birth to 36 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934
        will be invited to participate in this observational study.
      
Keywords: toddler obesity; responsive feeding; behavioral weight control; pregnancy weight gain; early life risk factors
Impact of Behavioral Economic Strategies on Low-Income Older Adults' Food Choices in Online Retail Settings
Condition: Diet Habit
Study type: Interventional

Summary: 
      The specific aims of this proposal are to 1) develop the components of a behavioral economics
      strategy (i.e., healthy bundle defaults) to influence diet behaviors; 2) characterize the
      online grocery shopping behaviors and attitudes of low-income adults nationally; and 3)
      examine the extent to which "healthy bundles defaults" and other behavioral economic
      strategies increase fruit and vegetable purchases among low-income adults in an online
      randomized controlled experiment.
    


Intervention name(s): Simulated Grocery Shopping Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants will click a link and simulate a shopping experience by selecting a week's worth of Supplemental Nutrition Assistance Program (SNAP)-eligible groceries for their household in a web-based supermarket platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Exercise on Mood After Traumatic Brain Injury
Condition: Traumatic Brain Injury; Depression
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Depression
Study type: Interventional

Summary: 
      We proposed to examine the effect of an aerobic exercise intervention on depression in
      persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury
      who are assigned to receive the exercise intervention with those in the control group to
      determine the effect of exercise on levels of depression and specific symptoms related to
      depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise
      on activity, participation level, and quality of life will be examined.

      HYPOTHESES:

        1. Participation in an aerobic exercise intervention will decrease the severity of
           depression in persons with chronic TBI.

        2. Participation in an aerobic exercise intervention will lead to improvements in negative
           symptoms associated with depression including anxiety, insomnia, pain, and impaired
           cognitive functioning.

        3. Participation in an aerobic exercise intervention will be related to improvements in
           activity and participation for patients with TBI.

        4. Participation in an aerobic exercise intervention will lead to improvements in
           perceptions of quality of life.
    


Intervention name(s): Aerobic exercise; No exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down. A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.; Controls were wait-listed for the exercise program during the 10 week study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic brain injury; Depression; Exercise
A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A safety study to compare the effect of two different formulations of PrEP-001 nasal powder
      when dosed in healthy subjects
    

Detailed description: 
      A single centre, randomised, partially blinded placebo-controlled repeat dose study in
      healthy male subjects to compare the effect of two different formulations of PrEP-001 nasal
      powder on nasal mucosal and serum cytokine profiles when dosed for up to five days in health
      subjects and provide additional safety and tolerability information on active PrEP-001 nasal
      powder.
    

Intervention name(s): PrEP-001 6.4 mg; PrEP-001 6.4 mg; PrEP-001 3.2 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6.4 mg as 4 sprays per nostril (ie total of 8 sprays for a single dose) using Aptar unit dose strength powder (UDSP) device; 6.4 mg as 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device; 3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device; 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
Other intervention name(s): Poly-IC; Poly-IC; Poly-IC
Intervention MeSH terms: Poly I-C
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomised partially blinded, partially placebo controlled, repeat dose
Masking: Single (Participant)
Primary purpose: Diagnostic
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
Condition: Anesthesia, Local; Analgesia; Arthropathy of Hip
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Total hip replacement surgery is one of the most common orthopedic interventions. Proper
      anaesthesia and adequate analgesia is one of the key interests of attending anaesthetist.
      Recent studies show that ultrasound guided suprainguinal fascia iliaca compartment block may
      play a significant role in proper management of pain after these procedures. The aim of this
      study was to assess the clinical usefulness and compare different methods of anaesthesia for
      total hip replacement surgery via posterolateral approach.
    


Intervention name(s): Opioid and non opioid postoperative analgesia.; Fascia iliaca compartment block; Dexamethasone
Intervention type(s): Other; Other; Drug
Intervention description(s): Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.; Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.; Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.
Intervention MeSH terms: Dexamethasone; Analgesics, Non-Narcotic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of ziprasidone 20
      mg capsules versus Geodon 20 mg capsules under fasting conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of Ziprasidone 20 mg capsules and Geodon 20
      mg capsules in healthy subjects under fasting conditions.
    

Intervention name(s): Ziprasidone Hydrochloride
Intervention type(s): Drug
Intervention description(s): Ziprasidone HCL Capsules, 20 mg
Other intervention name(s): Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ziprasidone hydrochloride; crossover
Ability of Beta-glucan Supplementation to Augment Immune Function
Condition: Cold; Cold Symptom; Flu; Flu Symptom; Supplement; Stress; Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      This proposed study is designed to assess the efficacy of a capsule containing beta-glucan
      taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune
      response change in marathon runners
    

Detailed description: 
      At screening, an informed consent form will be given to the potential volunteer. They will be
      required to read the information and will be given the opportunity to seek more information
      if needed or provided with the option of taking the consent form home to review prior to
      making their decision. If agreeable, the volunteer will sign the consent form and receive a
      duplicate of the signed copy. Once consent has been obtained, the screening visit will
      proceed. Each volunteer will be sequentially assigned a screening number to be entered in the
      screening and enrollment log. Screening assessments include: review medical history, assess
      inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel
      diary, and GI symptom questionnaire.

      The next visit will be scheduled 14 days prior to their marathon date (baseline).
      Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI
      symptoms and bowel diary in advance of this baseline visit. At baseline participants will
      begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI
      tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires,
      and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the
      marathon the participant will be instructed to complete a muscle soreness assessment.

      Two and four weeks post-marathon participants will return to the clinic for with unused
      investigational product, completed study diaries, daily URTI questionnaires, daily bowel
      diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress
      questionnaires, and blood sample for the analysis of CRP and NK cell activity.
    

Intervention name(s): Beta-Glucan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 95% beta-glucan sourced from whole cell Euglena Gracilis; microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, randomized, double-blind, placebo-controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Telemedical Coaching for Weight Loss
Condition: Overweight; Obesity; Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome; Weight Loss
Study type: Interventional

Summary: 
      Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching
      have the potential to support lifestyle change and weight loss. Therefore, the aim of our
      randomized controlled trial is to examine the effect of telemedicine with and without
      coaching in comparison to a control group on weight loss in overweight participants.
    

Detailed description: 
      In an occupational health care setting employees with overweight and/or metabolic syndrome
      will be randomized into a three arm 12-week trial. Participants in the telemedical (TM) and
      telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic
      transfer into a personalized online portal, which could be monitored from both, the
      participant and the study centre. The TMC group weekly will get care calls from the study
      centre aiming to discuss measured data and to fix target agreements. The control group will
      remain in routine care.
    

Intervention name(s): telemedical (TM) group; telemedical coaching (TMC) group
Intervention type(s): Device; Behavioral
Intervention description(s): telemedical devices (weighing machine and step counter); care calls once per week for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: telemedicine; overweight; obesity
Constitution of a Standardized Neural Imaging Database in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric
      study, tissue study, study of connectivity).

      Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission
      Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG
      PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).

      These examinations routinely contribute to the clinical diagnosis and surveillance of many
      neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular
      pathology, brain tumors, etc.).

      As a result of the original morphological and functional information they provide, these
      examinations are being increasingly included in clinical research protocols involving the
      brain.

      The absolute or relative quantification of anomalies observed, however, can be obtained only
      after comparison to a database of normal subjects.

      The creation of these databases is currently limited by their cost and strictly single center
      nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).

      The aim of this multidisciplinary study is to constitute a standardized database of multimode
      neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in
      patients, at the scale of a group or an individual, for the diagnosis and surveillance of
      neurological diseases.

      Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men
      and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days
      (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).

      The strictly single center character of this study is explained by the variability of the
      physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to
      each center.
    


Intervention name(s): SPET, PET and MRI
Intervention type(s): Procedure
Intervention description(s): 60 healthy subjects after a a consultation with a neurologist for wich 4 examinations will be programmed in two days ( 1 cerebral MRI, 1pet scan, 1 spet, 1 datascan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: To constitute a standardized database of multimode neural imaging.
Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy
      rate. This study aims to compare IVF pregnancy between two groups of patients that received
      either acupuncture or sham acupuncture (placebo)around embryo transfer
    

Detailed description: 
      Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study
      aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi
      treatment. The patients are randomized to receive either acupuncture or sham acupuncture
      (placebo)around embryo transfer
    

Intervention name(s): Acupuncture (Carbo®); Placebo acupuncture (Strietberger®)
Intervention type(s): Device; Device
Intervention description(s): The acupuncture points were chosen according to traditional Chinese medicine and included DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.; The acupuncture points were the same as in the true acupuncture group, namely DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
Sham acupuncture needles used were the validated Strietberger® placebo-needle from the company, Asia Med. The needle is not fixed inside the copper handle and its tip is blunt. When the needle touches the skin it moves inside the handle and appears to be shortened. A pricking sensation is felt by the patient, simulating the puncturing of the skin. Developed by dr. Konrad Streitberger.
Other intervention name(s): Acupuncture needles: Carbo® needle,Acupharma A/S.; Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: infertility; ivf; acupuncture
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      The objective of the current study is to investigate the effects of repetitive transcranial
      magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and
      alcohol use outcomes in alcohol use disorder (AUD).
    

Detailed description: 
      To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local
      intensive outpatient (IOP) treatment programs and randomized to treatment with either
      inhibitory 1Hz rTMS to cerebellar vermis given daily for 2 weeks (total of 10 sessions) or
      sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at
      baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop
      task will be obtained at baseline and 1 day after the final rTMS session.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS); Sham transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): Repetitive transcranial magnetic stimulation (rTMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of 1Hz stimulation, for a total of 1800 pulses delivered.; Sham transcranial magnetic stimulation (TMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of sham stimulation. Sham stimulation will imitate the active rTMS but does not have active stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS