bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers
Condition: Thermogenesis by Different-dosage Ginger Flour Footbaths
Study type: Interventional

Summary: 
      A study to explore whether different dosages of ginger flour in footbaths cause different
      effects on warmth development as well as on general well-being and the autonomic nervous
      system.
    

Detailed description: 
      This is a four-arm randomized controlled trial with crossover design to explore the
      dose-response relationship of footbaths with different dosages of ginger flour in healthy
      volunteers, compared to a placebo control (footbath with warm water only). The main focus is
      on thermogenesis and warmth distribution, as assessed by high-resolution infrared
      thermography and questionnaire data before, during and after the intervention. In addition,
      effects on the autonomic nervous system are assessed by measuring various parameters of heart
      rate variability and pulse wave analysis.
    

Intervention name(s): 3-g footbath; 6-g footbath; 12-g footbath; Warm water footbath
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g ginger flour (3 g per l), followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g ginger flour (6 g per l), followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g ginger flour (12 g per l), followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ginger flour footbaths; Dose-response relationship; Thermogenesis; Infrared thermography; Heart rate variability; Healthy volunteers
Physiotherapy in Postpartum After a Cesarean
Condition: Postpartum Period
Study type: Interventional

Summary: 
      The purpose of this study is to promote a prevention of the complications using an elaborate
      guide effective and easy to understand.
    

Detailed description: 
      The puerperium consists the period of pregnancy and postpartum cycle that the alterations
      provoked for pregnancy and delivery on the women organism return to your state before
      pregnancy. The physiotherapist can follow the puerperium since hospital phase until women has
      been recovered of pregnancy physiologist alterations.
    

Intervention name(s): Avolition; Orientation; Guide
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): - avolition for cesarean discomforts; avolition of cesarean discomfort
physiotherapy orientation; avolition of cesarean discomfort
physiotherapy orientation
guide orientation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Immediate puerperium; physiotherapy in postpartum; cesarean complications
The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Aerobic exercise is a promising treatment modality for cognition in persons with TBI, but
      effects are consistently small. This study aims to investigate the effect of difference
      environments during moderate intensity cycling sessions on cognition.
    

Detailed description: 
      The proposed research study would be the first to investigate the acute effects of aerobic
      exercise with different environments relative to control and comparison conditions on several
      domains of cognition in people with TBI. This critical investigation will be a first step
      toward systematically identifying an optimal exercise training intervention for managing
      common cognitive consequences of TBI.
    

Intervention name(s): Exercise Only; Exercise + Non-Immersive Virtual Reality; Exercise + Immersive Virtual Reality
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Cycling in a lab environment; Cycling with an environment simulated by non-immersive virtual reality; Cycling with an environment simulated by immersive virtual reality
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain Injuries, Traumatic; Aerobic Exercise; Leg Cycling; Virtual Reality
A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the amount of mirikizumab that gets into the
      blood stream and how long it takes the body to get rid of it, when given as a solution
      formulation via manual prefilled syringe or autoinjector. The information about any adverse
      effects experienced will be collected and the tolerability of mirikizumab will also be
      evaluated.

      Screening is required within 28 days prior to the enrolment. For each participant, the total
      duration of the clinical trial will be about 17 weeks including screening.
    


Intervention name(s): Mirikizumab Prefilled Syringe; Mirikizumab Autoinjector
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC by prefilled syringe; Administered SC by autoinjector
Other intervention name(s): LY3074828; LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study Comparing Two Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical
      coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as
      part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS),
      except that it can provide much higher resolution of coronary cross sectional images than
      IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained
      full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has been
      shown to be safe in clinical settings and has been used in over 300 patients without
      complication at Queen Mary Hospital.

      In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents (ZES)
      and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and specific
      post-intervention re-study intervals.

      The investigators objective is to investigate the clinical impact and OCT difference on early
      stent healing and late lumen loss between the two new-generation limus-eluting-stents -
      Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating
      polymer.
    

Detailed description: 
      This is a prospective, randomised, assessor-blinded, single centre study. Patients with
      symptomatic coronary artery diseases in 2 or 3 coronary vessels requiring PCI are eligible
      for the study. PCI will be performed in the usual manner to all the study lesions in the same
      procedure. In a randomized fashion, each patient will have one artery with critical
      disease(s) treated by the Resolute Integrity Stent(s) and the other artery treated by the
      Biomatrix Stent(s).

      Baseline OCT data will be obtained right after stenting. The remaining coronary artery, if
      diseased and required PCI treatment, will be treated during the angiographic and OCT
      follow-up as a staged procedure. Patients will be randomly assigned into 5 groups with equal
      number, receiving a follow-up coronary angiogram with OCT from 2, 3, 4, 5 and 6 months
      interval post-intervention. Each patient will serve as his/her own control comparing the 2
      types of stents. At 9-month post-intervention, all patients will receive a second follow-up
      coronary angiogram with OCT. All OCT data analyses will be performed in a blinded fashion by
      a core laboratory. Phone follow up will be carried out for cardiac events at 1 year and 2
      year of post intervention.
    

Intervention name(s): Resolute Integrity Stent; Biomatrix stent
Intervention type(s): Device; Device
Intervention description(s): Resolute Integrity Stent; Biomatrix stent
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stent, OCT
Temporal Genomics Mechanisms Underlying Disease and Aging
Condition: Gene Expression in Response to Acute Stress
Study type: Interventional

Summary: 
      Given the salient role of early-life adversity and the resulting biological embedding in
      disease risk, there is a critical need to understand the mechanisms operating at multiple
      levels of analysis in order to promote effective clinical treatments and intervention efforts
      for survivors. An example for such an effort could be to utilize models of dynamic cellular
      markers as individual-level factors to account for variation in intervention response and
      clinical outcomes. Results of this study will lead to new knowledge about specific gene
      expression pathways in response to stress, and whether the response is moderated by previous
      exposure to early adversity, shorter telomere length (a marker of cellular aging) and
      self-report mental-health measures. Thus, the long-term effects of this study will advance
      our understanding on stress-related transcriptomic changes that play a downstream role in
      disease susceptibility and accelerated aging, with the goal of targeting specific pathways
      and genes for potential intervention studies and pharmacological treatments to reverse the
      effects of exposure to early adversity. For example, considering high failure rates for
      depression treatments, and in order to tailor individual interventions, identifying objective
      changes in stress-induced gene expression may help to predict intervention efficacy in
      clinical and non-clinical settings, as seen, for example, in breast and leukemia cancers.
      Thus, findings will have a range of impacts for basic science, intervention studies and
      clinical practice that will influence treatments to match the specific cellular processes
      operating within an individual.
    


Intervention name(s): Behavioral; Control condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trier Social Stress Test; In the no-stress control condition, participants will be instructed to sit in a room, read magazines, and to refrain from any stressful activities (e.g., cell-phone use will be restricted).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Sensory Study: Taste and Tongue Biology
Condition: Healthy Adults
Study type: Observational

Summary: 
      Researchers will investigate the correlation between a) self-reported dietary intake of foods
      and beverages, b) intensity of sucrose stimuli, and c) liking rating of sweet stimuli, with
      the relative expression of the taste receptor genes from human fungiform papillae (TAS1R2 and
      TAS1R3).

      * This research will provide new information on how sweet taste perception is regulated.

        -  The hypothesis: Greater dietary consumption of sugar and sweet foods is associated with
           reduced expression of the sweet taste receptors.

        -  The results of this study could help to identify pathways to help modify sweet taste
           perception by uncovering this mechanism.

      Participants will sample solutions prepared with sweet ingredients, provide salivary DNA, and
      collect fungiform papillae. This will allow researchers and investigators to compare the
      relationship between the sweetness of stimuli, genetic differences in sweet taste receptors,
      and expression levels of sweet taste receptor genes.
    


Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Healthy adults, over the age of 18, able to provide consent in English, able to complete
        survey on an electronic device
      
Biospecimen description: 
      saliva, tissue
    
Keywords: sweet; genetics; gene expression; dietary intake; psychophysics
Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Condition: Neuropsychiatric Systemic Lupus Erythematosus
MeSH terms: Lupus Vasculitis, Central Nervous System; Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      The purpose of this study is to determine if three functional Magnetic Resonance brain
      imaging techniques: Magnetic Resonance Spectroscopy(MRS),Magnetic Resonance perfusion, and
      Diffusion Tensor Imaging(DTI) can detect brain alterations distinctive for neuropsychiatric
      systemic lupus erythematosus (NPSLE)and systemic lupus erythematosus(SLE).
    

Detailed description: 
      Purpose of the Study:

      We plan with this study to obtain pilot data to support a larger grant application which will
      evaluate whether any of three types of functional Magnetic Resonance Imaging (known as MR
      Spectroscopy [MRS], MR Perfusion Imaging, and MR Diffusion Tensor Imaging [DTI]) can detect
      alterations in brain function distinctive for Neuropsychiatric Systemic Lupus Erythematosus
      (NPSLE), Systemic Lupus Erythematosus (SLE), and compare our findings to those found in an
      existing cohort of 20 normal healthy controls. Because this study is being done on a
      3T(tesla)scanner (3T(tesla) Achieva(Model name), Philips Medical Systems) and our previous
      group of healthy controls was assessed using a 1.5 T(tesla) scanner (LX EchoSpeed, General
      Electric(GE) Medical Systems), we propose to re-consent 10 of the previous 20 healthy
      controls and re-collect imaging data on the 3T(tesla) scanner in order to confirm that our
      previously-collected data from the group of 20 healthy controls is still valid. This will
      confirm that the change of field strength and manufacturer does not affect data validity.

      Recruiting Update as of March/2009: Enrollment is completed for Study Arms 1 and 2.

      This study is only being conducted in Ann Arbor, Michigan. Travel reimbursement does not
      include hotel accommodations or air fare to and from Ann arbor, Michigan.
    

Intervention name(s): Magnetic Resonance Angiography (MRA); Magnetic resonance imaging; MRA; MRA; diffusion Imaging; perfusion imaging.
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): As part of the Magnetic Resonance(MR) scan, you will need to lie still on a padded MR table inside the MR machine for about 15 minutes at a time while MR studies are being performed on you. The total time for the clinical portion of the MR study is approximately 35-40 minutes and there will be an additional 30 minutes for the research related MR studies. The total time you will spend on the MR table for this research will seldom be more than one hour.; MR spectroscopy; MRA of the brain; MRA of the Brain; MRA of the brain
Other intervention name(s): Magnetic resonance imaging; MRA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lupus
Non-invasive Detection of Anastomotic Leakage
Condition: Anastomotic Leak
MeSH terms: Anastomotic Leak
Study type: Observational [Patient Registry]

Summary: 
      Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with
      malignant tumors of the esophagus or pancreatic head. These procedures are associated with
      high morbidity rates, which are strongly correlated with the occurrence of anastomotic
      leakage. Current diagnostic methods, including clinical, biochemical and radiological
      techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which
      ratifies the need for development of novel and accurate non-invasive diagnostic tests for
      detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic
      status of an individual, which is associated with a systemic immunological response. The aim
      of this study was to determine the diagnostic accuracy of urinary volatile organic compounds
      to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early
      phase.
    


Intervention name(s): Urinary volatile organic compound analysis
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible participants had suspected malignancies of the esophagus, pancreas, distal bile
        duct, ampulla Vateri or duodenum and were scheduled for surgery (i.e. esophagectomy or
        pancreaticoduodenectomy).
      
Biospecimen description: 
      Urine samples
    
Keywords: Pancreatic cancer; Esophageal cancer; volatile organic compounds; Field asymmetric ion mobility spectrometry
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
Condition: Healthy; Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
    


Intervention name(s): TD-1211; TD-1211; TD-1211; TD-1211; TD-1211; TD-1211; TD-1211; TD-1211; TD-1211; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose level 1; Dose level 2; Dose level 3; Dose Level 4; Ascending doses; Ascending doses; Ascending doses; Ascending doses; Ascending doses; Ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy subjects
Repetitive Transcranial Magnetic Stimulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The study is a prospective, randomized, double-blind sham-controlled study.
    

Detailed description: 
      The principal objective of this trial is to investigate the effect of left prefrontal high
      frequency rTMS on negative symptoms in schizophrenia.
    

Intervention name(s): rTMS, "repetitive transcranial magnetic stimulation"; rTMS
Intervention type(s): Procedure; Other
Intervention description(s): 10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex; repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia, rTMS
Out-of-Hospital Resuscitation in Winterthur - an Outcome Study
Condition: Resuscitation
Study type: Observational

Summary: 
      The investigators will retrospectively examine all patients with out-of-hospital
      resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the
      year 2013 with a two year follow-up and a structured interview about Quality of life.
      Furthermore, the costs generated by the local health system are analysed.
    

Detailed description: 
      The Primary objective of this study is to evaluate the Quality of out-of-Hospital
      resuscitation by the ambulance Service from the Kantonsspital Winterthur including a 2-year
      follow-up of the survivors. In this follow-up we evaluate the Quality of life by a validated
      questionnaire.

      The following endpoints will be retrospectively analysed:

      time-to-Response Interval; Initial cardiac rhythm; medications given; number of
      Defibrillations; return of spontaneous circulation, Overall costs for the local health System

      Furthermore length of hospital-stay, survival until Hospital discharge, one-year survival,
      Quality of life two years after resuscitation and total costs will be analysed.
    

Intervention name(s): Interview
Intervention type(s): Other
Intervention description(s): Interview by validated Quality-of-life-questionnaire
Other intervention name(s): patient interviews
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that were resuscitated out-of-hospital in the year 2013 by the emergency medical
        team from the Kantonsspital Winterthur.
      
Keywords: Resuscitation, quality of life
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool
      for the evaluation of both new and existing pharmacological treatments for type 2 diabetes,
      using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a
      probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin,
      twice daily will lead to a statistically significant decrease in 24 hour weighted-mean
      glucose (WMG) relative to placebo.
    


Intervention name(s): Vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic