bioihbjkbjnl/mcl2 huggingface dataset:
Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults
Condition: Dual-task; Functional Test
Study type: Observational

Summary: 
      In this study, reference values for the five basic functional tests that are commonly used,
      with and without the addition of dual-task activity, will be determined. It will be ensured
      that healthy normative data that researchers and clinicians can compare in determining the
      effects in different pathologies by using easy-to-perform evaluations. The aim of this study
      is to determine the reference values performed with and without dual-task of the five
      functional tests for young adults according to age and gender by considering the interaction
      between both mobility and cognitive tasks.
    


Intervention name(s): Assessment study
Intervention type(s): Other
Intervention description(s): Assessment of functional tests with and without dual tasks
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy young people
      
Keywords: dual-task; functional test; healthy young; reference value
Study to Determine the Effects of Multiple-dose Omeprazole on the Single-dose Pharmacokinetics of Tipranavir (TPV) Coadministered With Ritonavir (RTV) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effects of multiple-dose omeprazole on the single-dose
      pharmacokinetics of tipranavir and ritonavir
    


Intervention name(s): Tipranavir (TPV); Ritonavir; Omeprazole
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): (Aptivus ®); (Norvir-SEC®); (Antra®)
Intervention MeSH terms: Ritonavir; Tipranavir; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY900014 in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and
      the effect of LY900014 on blood sugar levels. For each participant, the study will consist of
      3 periods and will last about 51 days.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Lactose, Sucrose & Corn Syrup Tolerance
Condition: Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose
Study type: Interventional

Summary: 
      Lactose, one of the key nutrients in human milk may be critically important to infants for
      more reasons than being a source of energy. We are interested in understanding how lactose
      when compared to other sugars influences how nutrients, specifically macronutrients are
      handled after digestion and absorption. To date, there have been no studies looking at how
      fat and protein varies when lactose compared to other sugars is ingested. There may be
      metabolic advantages to considering lactose for nutrition support of premature infants rather
      than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in
      lactose-free formulas. We hope the information from this study will provide new information
      on the unique aspects of lactose.

      Hypothesis: The hypothesis is that providing carbohydrate as lactose:

        1. minimizes the amount of carbohydrate that is converted into fat

        2. enables a relatively constant metabolic state throughout feeding interval that avoids
           swings of high to low insulin, glucose, and fats.
    


Intervention name(s): corn syrup solids; sucrose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oral ingestion 50 grams, 2 doses; oral ingestion 50 grams, 2 doses
Other intervention name(s): corn syrup
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      This is a study of the safety and efficacy of a new surgical procedure using endoscopic
      instruments and a tunneling technique to reach the LES for dissection. We hypothesize that
      this technique provides an incisionless, less invasive option with similar functional outcome
      compared to standard Heller myotomy.
    

Detailed description: 
      By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer
      can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only
      the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact.
      Thereby, post-interventional reflux disease should be avoided.
    

Intervention name(s): Endoscopic Myotomy; Endoscopic Myotomy for treatment of achalasia
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive the surgical procedure described in the summary (POEM).; Surgical procedure
Other intervention name(s): POEM; POEM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Achalasia
Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
Condition: Stress Urinary Incontinence; Sexual Dysfunction; Vulvovaginal Atrophy
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This is an open label, prospective study aimed to evaluate safety and efficacy of the Silk'n
      Tightra device for improvement of sexual functioning, vulvovaginal appearance and reduction
      of SUI.
    

Detailed description: 
      This is an open label, prospective study aimed to evaluate safety and efficacy of the Silk'n
      Tightra device.

      The study includes 12 treatment sessions 3 times a week, over a period of 4 weeks. Each
      subject will serve as her own control, while comparing results before and after treatment.
      Treatment will be performed on the internal volva for 20 min according to the device
      instructions, .

      Subjects that are interested in improving their labial appearance, and are willing to perform
      the external treatment twice a week in addition to the internal treatments, will be offered
      to conduct both treatments. The study will include one follow-up visit conducted one month
      following treatment end. During the second month of the study subjects will perform
      mainte-nance treatments and will gradually reduce the frequency of the treat-ments as
      follows:

        -  Week 5: 2 treatments

        -  Weeks 6-8: 1 treatment per week.
    

Intervention name(s): Tightra vaginal device
Intervention type(s): Device
Intervention description(s): Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children
Condition: Food Intake Regulation
Study type: Interventional

Summary: 
      No studies have reported the effect of pre-meal snacking on raisins compared to other
      commonly consumed snacks on energy intake in children. Therefore, the objective of the
      current study was to examine appetite and energy intake following consumption of ad libitum
      snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on
      appetite and food intake 30 min later in 8 - 11 y old normal weight children. The
      investigators hypothesized that raisins would lower subsequent energy intake in children and
      reduce hunger.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: raisins, grapes, snacks, appetite, food intake
Exercise and Low Back Pain
Condition: Healthy Volunteers With and Without Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of an individually educated exercise program for the lower
      back at home in employees over a period of 20 weeks.

      We hypothesize that regular exercise for the lower back results in greater improvements of
      low back strengths compared to controls.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Educated exercise training for the trunk 3 times per week, each for 20 min. Recommendation of additional fitness courses as offered by the local healthy insurance company.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of food on the pharmacokinetics of a
      single 800 mg oral dose of BIA 2-093 in healthy volunteers.
    

Detailed description: 
      Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers.
      The study consisted of 2 periods separated by a washout period of 14 days or more. On each of
      the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following
      either a standard high fat content breakfast or 10 hours of fasting.
    

Intervention name(s): BIA 2-093
Intervention type(s): Drug
Other intervention name(s): ESL, Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BIA 2-093; Eslicarbazepine acetate
Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors
Condition: Food Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      In this research project, the effect of different polyphenol-containing beverages with
      varying alcohol content of < 0.4 vol% on immune function as well as muscular growth factors
      will be investigated
    


Intervention name(s): non-alcoholic Pilsner; non-alcoholic wheat beer; apple spritzer; lemonade
Intervention type(s): Other; Other; Other; Other
Intervention description(s): intake of 1 L non-alcoholic Pilsner per day for 2 weeks; intake of 1 L non-alcoholic wheat beer per day for 2 weeks; intake of 1 L apple spritzer per day for 2 weeks; intake of 1 L lemonade per day for 2 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Nicotine Vaccination and Nicotinic Receptor Occupancy
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a molecular imaging research study designed to examine how much nicotine gets into
      the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi
      Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine
      designed as an aid to smoking cessation and long-term abstinence, as well as an aid to
      prevent relapses of a treated smoker.

      In this project we want to understand the degree to which NicVAX administration changes how
      much nicotine enters the brain in smokers.
    

Detailed description: 
      The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic
      acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration
      of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both
      before and after vaccination will be measured using the nicotinic agonist [123I]5-IA-85380
      ([123I]5-IA) and single photon emission computed tomography (SPECT). [123I]5-IA will be
      administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9
      days (time period necessary for nicotine and pharmacological active metabolites to clear from
      brain). Three baseline SPECT images will be obtained after equilibrium has been reached (~6
      hours into the [123I]5-IA infusion). Then, IV nicotine will be administered (0.5-1.5 mg/70 kg
      will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same
      procedure will be repeated for a second [123I]5-IA scan day. We hypothesize that occupancy of
      β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine
      administration.
    

Intervention name(s): NicVAX; [123I]5-IA-85380; Nicotine bitartrate
Intervention type(s): Biological; Radiation; Drug
Intervention description(s): 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies; up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days; 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
Other intervention name(s): Nicotine Conjugate Vaccine; 5-IA; IV nicotine
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Nicotine, SPECT, vaccine, receptor
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core
      features of autism in autistic children aged 2-6 years as measured by the change from
      baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared
      to placebo at 6 months.
    

Detailed description: 
      This is a multi-center, randomized, placebo-controlled, double-masked study of 166 evaluable
      participants taking buspirone twice daily for 6 months. Children aged 2-6 years with autism
      will be randomized to receive one of three treatments: 2.5mg, 5.0mg, or matched placebo. The
      placebo controlled trial will be followed by an optional follow-up trial to assess the long
      term safety of buspirone. In addition, a PET scan of serotonin synthesis and plasma serotonin
      will be measured at baseline to determine whether these measures are predictors of drug
      response. This trial is aimed at the core features of autism. The outcome measures for
      efficacy will be examiner and parent ratings on psychological tests and questionnaires. The
      outcome measure for the primary objective will be the Autism Diagnostic Observation Scale
      (ADOS) Composite Total score. The behavioral outcomes for the secondary aims are delineated
      in the study design.
    

Intervention name(s): Buspirone; Buspirone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buspirone liquid, 2.5 mg in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study; Buspirone liquid, 5.0 mg in 1 ml , once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study; Placebo liquid, in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism
Differences Between Coffee and Non-coffee Drinkers in the Gut Microbiome and Microbiota-Gut-Brain Axis
Condition: Healthy
Study type: Observational

Summary: 
      The aim of this study is to investigate the potential of coffee to act as a prebiotic to
      alter gut microbiota and improve mood, memory and cognitive performance.
    

Detailed description: 
      The aim of this study is to investigate the potential of coffee to act as a prebiotic to
      alter gut microbiota and improve mood, memory and cognitive performance in moderate coffee
      drinkers compared to non-coffee drinkers healthy adults. Reaction time, socioemotional
      processing, visual and episodic memory, learning, and an attentional task were administered
      to measure cognitive performance. Self-report questionnaires on mood, behavior and lifestyle
      were administered and response to an acute stressor was assessed. Biological samples of
      saliva, urine, blood, and stool were collected to investigate microbiome-gut-brain-axis
      signaling such as inflammation, short chain fatty acids and other metabolites production and
      physiological stress.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers between 30 and 50 years old.
      
Biospecimen description: 
      Urine, stool, blood and saliva samples
    
Keywords: Coffee; Microbiome-gut-brain-axis; Stress; Polyphenols; Cognition; Microbiota; Mood; Behaviour; Inflammation
Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Posttraumatic stress disorder (PTSD) is a major public health problem in this country. It is
      estimated that at least one out of every seven women in our society have been the victim of
      childhood sexual abuse at least once before their 18th birthday. Previous studies have shown
      that stress is associated with damage to neurons of the hippocampus, a brain area involved in
      learning and memory. Also, imaging studies of brain function are consistent with dysfunction
      of the medial prefrontal cortex during presentation of traumatic cues. We have previously
      shown that serotonin reuptake inhibitor medications (paroxetine; Paxil) can change memory
      function and hippocampal structure in PTSD. We now propose to perform a placebo controlled
      study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought
      as paroxetine with less side-effects. The main purpose of this study is to determine the
      effects of Paxil CR on memory deficits measured with neuropsychological testing, hippocampal
      volume measured with a magnetic resonance imaging (MRI), medial prefrontal lobe cortical
      function estimated with PET, and cortisol response (reflecting the intensity of stress) in
      men and women with PTSD. We plan to recruit 40 subjects. After completing physical
      examination and evaluating neuropsychiatric history, patients will undergo an initial group
      of tests which includes memory testing, MRI and PET brain scan, and measurement of cortisol
      in their saliva. Afterwards, half will receive Paxil CR 12.5 to 62.5 mg and half will receive
      a placebo (sugar pill) in the beginning of the first 12 weeks as "Double Blind Phase". After
      12 weeks, they will be administered memory tests, PET and MRI scan for the post-treatment
      phase. After this period, Paxil CR will be offered to the placebo group and followed for an
      additional 12 weeks. They will have final memory tests, and a MRI scan. We hypothesize that
      Paxil CR exerts its efficacy by acting on abnormal neural circuits, including hippocampus and
      prefrontal cortex, in PTSD.
    


Intervention name(s): paroxetine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: hippocampus; paroxetine; stress; PTSD
Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Bioequivalence study of two formulations containing a fixed dose combination of 600 mg
      Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets
      under a single-dose, two-way crossover design.
    


Intervention name(s): Efavirenz, tenofovir disoproxil fumarate and emtricitabine
Intervention type(s): Drug
Intervention description(s): Two period administration of a formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, two-way crossover.
Masking: None (Open Label)
Primary purpose: Other
1-1-8 Wash-in for Sevoflurane Low Flow Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with
      fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%.

      The objective of this study is to identify time to achieve alveolar concentration of
      sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%
    

Detailed description: 
      The benefits of low flow anesthesia are economic, less pollution, more heat and humidity
      preservation but it requires appropriate wash-in phase. The current wash-in protocols for
      sevoflurane are complicated and time consuming. The investigators propose a new 1-1-8
      sevoflurane wash-in protocol which is more simple and predictable.

      The objective of this study is to identify time to achieve alveolar concentration of
      sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% with 1-1-8 wash-in protocol.

      All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5
      mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35
      mmHg with O2:N2O or O2:air 1:1 L/min with sevoflurane 8%. Time to achieve alveolar
      concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% will be recorded and analyzed.
      After that, the concentration of sevoflurane and anesthetic technique will be adjusted to
      requirement of anesthesiologist.
    

Intervention name(s): 1-1-8 wash-in; Sevoflurane
Intervention type(s): Procedure; Drug
Intervention description(s): wash-in phase during start of low flow anesthesia; Drug used for wash-in protocol
Other intervention name(s): Inhalation anesthetic
Intervention MeSH terms: Anesthetics; Sevoflurane; Anesthetics, Inhalation
Intervention model: Single Group Assignment
Intervention model description: All participants will receive sevoflurane 8% with O2:N2O or O2:air 1:1 L/min under controlled ventilation. Time to achieve alveolar concentration of sevoflurane of 1%, 1.5%, 2%, 2.5%, 3% and 3.5% will be recorded.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low flow anesthesia; wash-in; sevoflurane