bioihbjkbjnl/mcl2 huggingface dataset:
Meals and Grazing Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effects of low vs. high eating frequency (EF)
      on biomarkers of health and subjective appetite.
    

Detailed description: 
      Observational studies have demonstrated an inverse relationship between eating frequency
      (EF), obesity, and other markers for disease risk. It has been suggested that consumption of
      several small, frequent meals may influence physiological mechanisms, reducing the risk for
      disease and lowering appetite. Participants in this randomized crossover study completed two
      intervention phases lasting three weeks each: one of low eating frequency ("low-EF"; 3 eating
      occasions/day) and one of high eating frequency ("high-EF"; 8 eating occasions/day). Fasting
      C-reactive protein, insulin-like growth factor, and leptin were measured at baseline and
      endpoint of each phase and an optional subjective appetite testing session lasting four hours
      was offered at the endpoint of each phase. During appetite testing sessions, participants
      consumed an amount of food equal in total energy and macronutrient content at either one
      occasion at 8:00 am ("low-EF" condition) or spread evenly over two smaller eating occasions
      at 8:00 am and 10:30 am ("high-EF" condition). Ratings of hunger, desire to eat, fullness,
      thirst, and nausea were made every 30 minutes using paper-and-pencil semi-anchored 100-mm
      Visual Analog Scales. A composite appetite score was calculated as the mean of hunger, desire
      to eat, and 100-fullness. The generalized estimating equation modification of linear
      regression was used to compare fasting plasma biomarkers and mean ratings of subjective
      appetite.
    

Intervention name(s): High Eating Frequency (High EF); Low Eating Frequency (Low EF)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Free-living participants complete a 21-day high eating frequency (high EF) Phase in which they consume all daily energy at 8 eating occasions.; Free-living participants complete a 21-day low eating frequency (low EF) Phase in which they consume all daily energy at 3 eating occasions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meal frequency; eating frequency; ingestive frequency; positive energy balance; satiety; appetite; hunger
Chronic Pain, Life Style Factors and Quality of Life
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that
      aims to analyze life style factors, socioeconomic and psychometric properties, metabolic
      problems, drug use, quality of life and biochemical variables in chronic non-cancer pain
      patients. The life style factors will be compared to those of normal population. At baseline,
      the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and
      blood pressure are measured, pain-related factors are recorded and blood samples taken.
      Changes in the quality of life of the study patients will be evaluated by questionnaires
      during follow-up at 2 years and 5 years.
    

Detailed description: 
      Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and
      sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain
      information on the life style factors of adult chronic pain patients referred to university
      hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the
      study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use
      of health services, physical activity, smoking, use of alcohol or other substances, sleep,
      quality of life, nutrition and psychological factors at their first visit to the pain clinic.
      Height, weight, waist circumference, blood pressure and pulse are measured by the study
      nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL),
      triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician
      records the pain diagnosis, medication and other methods of pain management chosen. The
      patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for
        multidisciplinary pain treatment.
      
Biospecimen description: 
      Blood samples frozen for possible further biochemical analysis (vitamin D, S-PTH, S-TSH,
      cytokines, P-Ca++)
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions
Condition: Migraine
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride
      Tablet under fasted conditions.
    


Intervention name(s): naratriptan hydrochloride
Intervention type(s): Drug
Intervention description(s): 2.5 mg tablet
Other intervention name(s): AMERGE
Intervention MeSH terms: Naratriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
General or Spinal Anesthesia for Cesarean Delivery
Condition: Anesthesia for Cesarean Delivery
Study type: Observational

Summary: 
      During the cesarean deliveries, one of the anesthesia techniques, regional anesthesia or
      general anesthesia (GA) is prefered. Spinal anesthesia (SA) is preferred among the regional
      anesthesia methods because the onset of anesthesia is faster and muscle relaxation is more
      suitable for cesarean section anesthesia. Although both methods have advantages and
      disadvantages, the anesthesia method to be chosen may vary depending on the condition of the
      mother and fetus.

      The goal of this retrospective clinical trial is to compare general and spinal anesthesia in
      cesarean deliveries. The main questions it aims to answer are:

        -  Are the anesthesia techniques effect maternal outcome?

        -  Are the anesthesia techniques effect fetal outcome?
    


Intervention name(s): General Anesthesia; Spinal Anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): General Anesthesia was intruduced for Cesarean Delivery; Spinal Anesthesia was intraduced for Cesarean Delivery
Intervention MeSH terms: Anesthetics
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The pregnant women and their babies in 01.01.2019 - 31.12.2019.
Tracheal Anatomy After Thyroidectomy
Condition: Goiter, Nodular
MeSH terms: Goiter; Goiter, Nodular
Study type: Observational

Summary: 
      The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and
      airflow in patients with benign nodular goiter, employing a prospective observational study.

      Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior
      to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional
      area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement
      by the thyroid were evaluated. Through flow-volume curves respiratory function, including
      both in- and expiration, was evaluated.
    


Intervention name(s): Thyroidectomy
Intervention type(s): Procedure
Intervention description(s): Remove the nodular goiter on the neck by thyroidectomy (standard procedure)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred for thyroidectomy for symptomatic benign nodular goiter
Modulating the Vaginal Microbiome After Implantation Failure
Condition: Implantation Failure; Infertility, Female; Vaginal Flora Imbalance
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The
      investigators wish to determine if it is possible to change an unfavorable vaginal microbiome
      using lactobacilli loaded vaginal supplements.
    


Intervention name(s): Vivag Plus; Placebo - Cap
Intervention type(s): Drug; Drug
Intervention description(s): Contains two lactobacilli strains; l. gasseri and l. rhamnosus; Vaginal supplements
Other intervention name(s): Placebo vaginal capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised placebo controlled, double blinded study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infertility, female; Vaginal microbiome
Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the safety of CC-1088 to patients with
      myelodysplastic syndromes (MDS).
    


Intervention name(s): CC-1088
Intervention type(s): Drug
Intervention description(s): 400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myelodysplastic syndrome
Fentanyl Patch Pharmacokinetics in Healthy Adults
Condition: Peer Review, Research
Study type: Interventional
Phase: Phase 4

Summary: 
      The study to be performed will utilize already FDA-approved marketed products in healthy
      adults for the purpose to generate data for establishing rate of drug delivery comparisons
      between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and
      Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these
      types of products.
    

Detailed description: 
      Transdermal drug delivery systems (TDDS) available in the form of patches are convenient,
      attractive, and easy to use systems. Fentanyl patches are very popular TDDS available on the
      United States market today. Accurate determination of the rate and extent of drug release and
      absorption is crucial to ensure the safety of individuals using these and other types of
      patches. Delivery rate can be determined early in the development process by using in vitro
      skin flux permeation studies, and later in humans by accurately quantifying residual drug
      from patches post-wear and in pharmacokinetic studies. In this proposal, we will employ two
      types of evaluation to determine the rate and extent of drug release and absorption from RLD
      (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic
      Fentanyl TDDS, namely residual drug analysis post-wear and pharmacokinetic analysis in
      healthy adult volunteers. In addition, we will compare the plasma drug concentrations
      following patch and intravenous administration of Fentanyl, in order to determine the
      absolute bioavailability of these patches. We will conduct residual drug analysis of TDDS
      following in vivo wear using highly sensitive validated quantification methods. Positive
      outcome of this project will identify appropriate methods to determine the rate and extent of
      drug release and absorption from TDDS, and will help regulatory agencies in the development
      of Guidances for Industry regarding the characterization of drug release and absorption
      kinetics to ensure the safety of individuals utilizing these types of products
    

Intervention name(s): Intravenous fentanyl citrate; Duragesic®; Mylan generic fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 micrograms (2 millilitres) via intravenous injection; TDDS dosage is 25 micrograms/hour (worn for 72 h); TDDS dosage is 25 micrograms/hour (worn for 72 h)
Other intervention name(s): Duragesic® fentanyl skin patch; Mylan generic fentanyl skin patch
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Therapeutic Equivalency
Computer Aided Detection of Polyps During Colonoscopy Procedures
Condition: Colo-rectal Cancer; Polyp of Colon; Adenomatous Polyps
MeSH terms: Adenomatous Polyps; Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a
      Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy
      procedure.
    

Detailed description: 
      The details of the proposed study are as follows:

        1. Colonoscopy will be performed in the same standard of care manner as if no study was
           taking place. The video signal from the colonoscope will be fed into a computer running
           the EndoVigilant CAD software in addition to the standard video output to the procedure
           monitor. The EndoVigilant CAD software will display an annotated video on an additional
           monitor that includes both the colonoscopy picture and annotation by the software
           indicating the location of any polyps on the screen.

        2. The endoscopist performing the procedure will therefore be able to observe a standard
           colonoscopy video on the primary monitor and the annotated video on the second monitor.

        3. The endoscopist will primarily rely on the second monitor (augmented with annotation
           from EndoVigilant ColonCAD software) but the standard procedure monitor will be always
           operational and available for maneuvers such as fast insertion, polypectomy etc.
    

Intervention name(s): EndoVigilant CAD Software
Intervention type(s): Device
Intervention description(s): The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Pertussis (Tdap) Vaccination in Pregnancy
Condition: Pertussis; Pregnancy
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite good vaccination coverage, included in national immunization programs in developed
      countries, the number of reported pertussis cases is rising, also in very young infants.
      Current immunization strategies fail to protect infants too young to be immunized with the
      licensed vaccine. Different strategies are possible to close the gap of susceptibility
      between the loss of maternal antibodies and protection by vaccination. The main aim of the
      present study is to measure the influence of an adult pertussis booster in pregnant women, on
      the titer and duration of maternal antibodies in their infants. Early humoral immunity will
      be assessed and the influence on vaccine response of the infant measured. The present study
      offers the opportunity to have new insights in neonatal immunological mechanisms against
      pertussis and a better understanding in strategies to protect infants against pertussis.
    


Intervention name(s): Pertussis vaccine
Intervention type(s): Biological
Intervention description(s): Vaccination during pregnancy with a pertussis containing vaccine
Other intervention name(s): Boostrix®, GSK Biologicals, Rixensart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Infants; Vaccination; Pregnancy
Emergent Therapies in OBP. Pilot Study
Condition: Neonatal Brachial Plexus Palsy
MeSH terms: Neonatal Brachial Plexus Palsy
Study type: Interventional

Summary: 
      Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the
      affected upper limb within the child's natural environment. The therapeutic interventions of
      Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the
      rehabilitation of the affected upper limb and the quality life improvement.

      To quantify the increase in the affected upper limb spontaneous use and the quality of life
      of children with upper OBP from 6-12 years, when They are treated with Conventional MT or
      Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.
    

Detailed description: 
      The intervention protocol was permorfed for four weeks, three days per week applying
      Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4
      weeks. Designed to be done at home.

      Two measurements of the affected upper limb spontaneous use and quality of life were
      performed, a pre-treatment assessment corresponding to the baseline situation, and another
      post-treatment Assessment to observe the results after the therapy.
    

Intervention name(s): Conventional Mirror Therapy
Intervention type(s): Other
Intervention description(s): The Conventional Mirror Therapy was carried out with a mirror box and the Mirror Therapy Virtual Reality was carried out with virtual reality glasses and mobile application: Mirror Therapy VR.
Other intervention name(s): Mirror Therapy Virtual Reality
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality.; family; Mirror Therapy; Obstetrical Brachial Palsy; Upper extremity
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Condition: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and tolerability of pancrelipase delayed release capsules
      in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic
      Fibrosis.
    


Intervention name(s): Pancrelipase Delayed Release
Intervention type(s): Drug
Intervention description(s): 3,000, 6,000 and 12,000 unit Lipase Capsules
Intervention MeSH terms: Pancrelipase; Pancreatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
Microcirculation & ASICs
Condition: Physiological Conditions
Study type: Interventional

Summary: 
      Pressure ulcers are a common and costly problem. Advancing the understanding regarding the
      basic pathophysiological mechanisms mediating the development of pressure ulcers will allow
      for better delineation of populations at risk.

      Healthy skin is protected from pressure-induced ischemic damage because of the presence of
      pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic
      patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous
      ischemia, which could lead to pressure ulcer formation.

      Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous
      mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments
      that block ASICs.
    


Intervention name(s): Diclofenac; Amiloride
Intervention type(s): Drug; Drug
Intervention description(s): diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler; amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler
Intervention MeSH terms: Diclofenac; Amiloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Skin, microcirculation; ASIC, pressure ulcer
Normative Data of Brain Network Activation in Adolescents and Young Adults
Condition: Healthy Controls
Study type: Observational

Summary: 
      Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in
      two age groups: adolescents and young adults.
    

Detailed description: 
      Currently, there is no reliable, practical, and non-invasive method for assessing changes in
      electrophysiological activity of the brain associated with brain-related pathologies, e.g.,
      concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs),
      which are temporal reflections of the neural mass electrical activity of cells in specific
      regions of the brain that occur in response to stimuli, may offer such a method, as they
      provide both a noninvasive and portable measure of brain function. The ERPs provide excellent
      temporal information, but spatial resolution for ERPs has traditionally been limited.
      However, by using high-density electroencephalograph (EEG) recording spatial resolution for
      ERPs is improved significantly. The paradigm for the current study will combine
      neurophysiological knowledge with mathematical signal processing and pattern recognition
      methods (BNA) to temporally and spatially map brain function, connectivity and
      synchronization.

      The need of objective measures that will help the clinician in its decision making in
      brain-related pathologies is recognized. BNA is a new imaging modality that has been
      developed to fill this gap.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Experimental subjects will include males and females recruited from the New York City
        metropolitan area, Clinilabs Ltd. Clinical Research's database and from referrals.
      
Keywords: Healthy; Control
Olive Oil Polyphenols, Vitamin D, Docosahexaenoic Acid (DHA) and Locomotor Function (PolivD3)
Condition: Osteopenia; Sarcopenia
MeSH terms: Bone Diseases, Metabolic; Sarcopenia
Study type: Interventional

Summary: 
      The present project hypothesizes that the potential protective effect of olive oil relies on
      its polyphenols profile (quality and quantity) and that it may be synergistic to other food
      components. Among the nutrients that may be of interest for bone and muscle tissues,
      unsaturated fatty acids and vitamins are the most described.

      Consequently, based on the promising available preliminary data, the present project aims to
      investigate the possible preventive effect of olive oil polyphenols and eventually the
      synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order
      to prevent any locomotor dysfunction.

      Volunteers will be supplemented during 9 months. The primary and secondary outcome measures
      will be performed at baseline, 3 and 9 months.
    


Intervention name(s): olive oil
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; bone loss