bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
Condition: Hypoglycemia; Cognitive Impairment
MeSH terms: Hypoglycemia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the cerebral blood flow in subjects with high and
      low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone
      system which is involved in the regulation of the blood pressure. Earlier studies have shown
      that high RAS activity is associated with a more pronounced cognitive impairment during
      hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy
      volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning
      during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers
      with high and low RAS activity, respectively
    

Detailed description: 
      The purpose of this study is to evaluate the regional cerebral blood flow in subjects with
      high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that
      high RAS activity is associated with a more pronounced cognitive impairment during
      hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy
      volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning
      during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers
      with high and low RAS activity, respectively.
    

Intervention name(s): Human insulin
Intervention type(s): Drug
Intervention description(s): Hyperinsulinaemic induced hypoglycaemia
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypoglycemia; Cognitive impairment; PET; CalCAP
Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC "
Condition: Healthy
Study type: Interventional

Summary: 
      Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one
      side of the body that accompany controlateral voluntary movements. Congenital mirror
      movements (CMM) are characterized by childhood onset and the absence of additional
      manifestations. The aim of this study is to unravel the pathophysiology of the CMM that
      remains poorly elucidated. The combination of imaging studies and neurophysiological studies
      using transcranial magnetic stimulation in a homogeneous and relatively large group of
      patient is likely to allow us to better understand the underlying pathophysiology of the
      disorder. Using a linkage analysis approach we will try to identify a locus associated with
      CMM and related candidate genes.
    


Intervention name(s): healthy volunteers; Kallmann; Congenital Mirror Movement
Intervention type(s): Other; Other; Other
Intervention description(s): morphological and functional brain MRI; transcranial magnetic stimulation; morphological and functional brain MRI; transcranial magnetic stimulation; morphological and functional brain MRI; transcranial magnetic stimulation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Congenital mirror movement, physiopathology, imaging, transcranial magnetic stimulation, candidate gene
Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment
      response to pharmacological interventions has been modest for these patients. Chronic
      elevated anxiety and associated psychophysiological parameters including increased heart rate
      and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin
      reuptake inhibitors (SRIs) are considered treatment of first choice for these patients,
      however a substantial portion of patients treated with SRIs do not respond sufficiently.
      Therefore, there is a need to establish novel and effective treatment strategies for these
      patients. Recently, duloxetine has received considerable attention since it was shown in
      multiple controlled trials to be an effective treatment for people with major depressive
      disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the
      psychophysiological responses at baseline and in response to treatment with duloxetine have
      been inadequately studied and may provide novel insight into antidepressant and anxiolytic
      mechanisms of this compound.

      Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients
      with chronic PTSD.

      Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological
      responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat
      interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Dosage given according to the following schedule:
Week 1: 30mg QD, Week 2: 60mg QD, Week 3: 60mg QD, Week 4-6: Flexible dosing according to clinical situation, dose range between 60-120mg QD, Weeks 7 + 8: fixed dose
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PTSD
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the absorption, metabolic pathways of
      lazertinib, and the excretion of the parent lazertinib and its metabolites, after a single
      oral dose of 14C-lazertinib in healthy adult male participants.
    


Intervention name(s): 14C-lazertinib
Intervention type(s): Drug
Intervention description(s): A single oral dose of 14C-lazertinib will be administered.
Other intervention name(s): JNJ-73841937
Intervention MeSH terms: Lazertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
3D Analysis of the Effects of tDCS (Transcranial Direct Current Stimulation) on a Functional Task in High Level Athletes
Condition: Healthy; Athlete
Study type: Interventional

Summary: 
      Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions
      of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome
      is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles
      after each session
    

Detailed description: 
      Recruitment :

      Relatively high level athletes will be recruited through social media and advertisements.

      Each subject came twice to the Liege University Hospitals' Human Movement Analysis
      Laboratory.

      After placing the different infrared emitters and placing and calibrating the surface EMG
      electrodes, subjects underwent 3 maximal squat jumps (without upper limb implication). They
      were then familiarized with the fatigue protocol (8 jumps at a 33 jumps per minute pace).

      Then each subject received either bi-anodal tDCS of sham tDCS. Neither the evaluator or the
      subject knew which they were receiving. Immediately following tDCS, subjects underwent
      another warmup 3 maximal squat jumps, and then the fatigue protocol (comprised of 30 maximal
      jumps at a rate of 33 per minute).
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): 20 minutes of anodal tDCS (C3 & C4/FPZ) 2mA or sham
Other intervention name(s): Non invasive brain stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, triple-blind, sham-controlled, crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: tDCS; Athlete; Endurance; Fatigue; 3D
Muscle Response to High Intensity Interval Resistance Training (HIIRT)
Condition: Exercise; Resistance Training
Study type: Interventional

Summary: 
      Resistance training (RT) is one of the most important stimuli for muscle hypertrophy and it
      plays an important role on weight loss and fatty acid oxidation increase. RT affects anabolic
      pathways but the differences among various training techniques has been till now were poorly
      investigated. The aim of this study was to compare the effect of two different intensity of
      training, high-intensity interval resistance training (HIIRT) and traditional resistance
      training (TRT), on muscle signalling pathway.
    

Detailed description: 
      Nine young healthy subjects performed HIIRT and TRT protocol in two different moments and
      with different legs. HIIRT technique consisted of three sets of: 6 repetitions at 6RM (6
      repetitions maximum) and then 20 seconds of rest and 2/3 repetitions (until exhaustion)
      repeated for 3 times with 2'30" rest between sets; while TRT consisted of 3 sets of 15 reps
      with 75 sec of rest between sets. Biopsies from the vastus lateralis were taken at baseline
      (pre), immediately (0h) at the end of training, 6 hours (6h) and 24 hours (24h) after
      training. Western blot and RT-PCR mRNA (Reverse transcriptase-polymerase chain reaction)
      analysis were performed to assess muscle signalling pathway activation
    

Intervention name(s): High Intensity Interval Resistance Training; Traditional Resistance Training
Intervention type(s): Other; Other
Intervention description(s): Subjects trained one leg with HIIRT; Subjects trained the other leg with HIIRT
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Same subjects serve as both the test and control arms which allows for within-subject comparison. Using a within-person design, participants trained each lower limb on separate days under two different training stimulus (HIIRT) and traditional training (TRT)
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: resistance training; recovery; muscle hypertrophy; muscle signalling
Clinical Trial to Assess the Efficacy of µSmin® Plus
Condition: Chronic Venous Disease
Study type: Interventional

Summary: 
      This study evaluates treatment with the dietary supplement µSmin® Plus in a group of patients
      suffering from chronic venous insufficiency in comparison with a similarly-sized group of
      patients receiving placebo evaluated by quality of life questionnaires, VAS pain scale, CVI
      symptomatology, and change in the circumference of the affected leg at calf level
    

Detailed description: 
      In this study we use a dietary supplement - µSmin® Plus - for symptomatic treatment of CVI
      and we will monitor its impact on CVI symptoms, features, and consequences (item) of the
      disease listed below: limb edema, walking, daily tasks performance, pain/burning symptoms,
      pruritus/paresthesis, sensation of heaviness/fatigue, time wasted in the management of the
      disease, social burden, disease impact on self-confidence, and its impact on physical
      exercise/recreational activities. Results of related clinical trials were published before
      showing that this is an active field in clinical reasearch.
    

Intervention name(s): µSmin® Plus; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): µSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day.; It will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Diosmin is a naturally occurring flavonoid present in citrus fruits and other plants belonging to the Rutaceae family. It is used for the treatment of chronic venous insufficiency (CVI) for its pheblotonic and vaso-active properties, safety and tolerability as well.
µSmin® Plus is a proprietary flavonoid complex with enhanced bio-efficacy. It contains highly concentrated micronized and standardized Diosmin. Highly improved bioavailability and improved oral absorption by micronization of the particles.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Performances of a H. Pylori Stool PCR Test
Condition: Helicobacter Pylori
Study type: Interventional

Summary: 
      Performance of a non-invasive test for the detection of Helicobacter pylori and its
      resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR
      (Mobidiag).
    


Intervention name(s): Stool specimen collection
Intervention type(s): Diagnostic Test
Intervention description(s): The stool specimen collection was performed at the hospital or at home using a disposable device to be placed on the toilet seat and an E-nat Tube sent by postal to the lab.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      A multi-year clinical study to improve tools for measuring the function of insulin-producing
      beta cells in people with type 2 diabetes mellitus.
    

Detailed description: 
      A three-year observational study to standardize the meal tolerance and maximum stimulational
      tests for measuring beta cell function in the clinical setting. It also aims to improve
      methods for the early prediction of the long-term response to an intervention and for
      identification of patients at risk for rapid beta cell function deterioration, thereby
      enabling future clinical studies that examine diabetes progression.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        obese individuals with type 2 diabetes mellitus
      
Keywords: type 2 diabetes; beta cell function; meal tolerance test; maximum stimulation test; method standardization; insulin secretion; prediabetes; insulin sensitivity
Mediators and Moderators of Exercise Behavior Change
Condition: Validate STRIDE Exercise Intervention in Sedentary Individuals; Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions; Increase Self-reported Physical Activity
Study type: Interventional

Summary: 
      Rates of cancer and cardiovascular disease have shown very little improvement over the past
      two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming
      rate. Recent reports estimate that approximately 30% of total cancer deaths are related to
      poor exercise and nutrition, and other reports have suggested that, when taking into
      consideration both cardiovascular disease and cancer, inactivity contributes to as many as
      250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular
      physical activity in the prevention of cancer and other debilitating illnesses, 75% of the
      U.S. population do not get the recommended amount of physical activity as defined by 30
      minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40%
      of the population is completely sedentary (USDHHS, 19960. The objective of the proposed
      research is to understand the mediators and moderators of a well-tested individually
      tailored, print-based intervention to increase exercise behavior among sedentary adults.
      Using a randomized, controlled intervention ton trial, the proposed study will address three
      primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion
      intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals
      initiate and maintain a moderate intensity physical activity regimen, as compared to a health
      and wellness control intervention, 2) Increases in positive attitudes, perceived normative
      support, self-efficacy, and intentions to exercise will mediate the effectiveness of the
      intervention, 3) That increased positive mood, and better temperature, stress, and lactate
      regulation immediately after exercise challenge (assessed in the laboratory) will moderate
      the effectiveness of the intervention, and 4) Secondarily, we will test whether gender,
      race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the
      effectiveness of the intervention. The rigorous assessment of how and for whom an exercise
      promotion intervention is effective will provide information for future development of
      intervention strategies and content, as well as allow the targeting of exercise content to
      individuals for whom it is most likely to be effective.
    


Intervention name(s): STRIDE
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Exercise; Transdisciplinary; Physiology; Mood; Motivation
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
Condition: Candidiasis
MeSH terms: Candidiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole
      loading dose in infants and toddlers.
    

Detailed description: 
      This is an open label study to investigative the pharmacokinetics and safety of a fluconazole
      loading dose in infants and toddlers < 2 years of age with suspected sepsis. There will be
      two treatment groups: single fluconazole loading dose 25 mg/kg; fluconazole loading dose
      25mg/kg followed by 12 mg/kg daily for total of 5 days. There will be three age cohorts
      within each group: pre-term < 30 week EGA infants > 48 hours and < 31 days; > 30 weeks EGA
      infants > 48 hours and < 31 days; infants ≥ 31 days and < 2 years of age. The study requires
      administration of fluconazole over 1-5 days depending on treatment group followed by 1 week
      of safety monitoring. Six to eight 100 µL PK samples will be obtained over the 5 days of drug
      administration. The risks are reasonable vs. the benefits and have been minimized
      appropriately. There may be benefit to the subjects (administration of empirical antifungal
      therapy), and information from the study may benefit a large number of other infants and
      toddlers with suspected or proven fungal sepsis. There is a data analysis plan.
    

Intervention name(s): Fluconazole Loading Dose; Fluconazole Loading Dose & High Dose
Intervention type(s): Drug; Drug
Intervention description(s): Single Fluconazole loading dose 25 mg/kg; Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days
Other intervention name(s): Diflucan; Diflucan
Intervention MeSH terms: Fluconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluconazole; pharmacokinetic; candidiasis; sepsis; pediatric; infants; antifungal; candidemia; fungemia; loading dose
Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers
Condition: DNA Damage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH)
      and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral
      blood lymphocytes of cigarette smokers.
    


Intervention name(s): Noni juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of noni juice, a source of iridoids, daily for 30 days.
Other intervention name(s): Tahitian Noni® Juice; Tahitian Noni® Original Bioactive; Thrive Adaptogenics Original
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the effects of wearable vibration devices
      for children with cerebral palsy and impaired arm function.
    

Detailed description: 
      Vibration devices have been used by some patients with cerebral palsy during therapy
      sessions. Researchers believe they have the potential to be even more useful for everyday
      use, and are doing this study to learn more about what they can do.

      Participate in this study will be asked to complete assessments that test arm motion, muscle
      tone, motor control, and sensory function. They will then be asked to wear a wristband on
      each wrist and on their shoulder. These wristbands contain vibrators that can vibrate at
      different levels. The vibrations are caused by a low-level of sound waves that people may
      barely be able to hear. While wearing the vibration devices on the wrist and shoulder,
      participants will be asked to perform two tasks. The first task is called the box and blocks
      test, which consists of transferring wooden blocks from one box to another. The second test
      is called the Shriners upper extremity evaluation (SHUEE). In this test participants will
      perform a series of fine motor tasks with their hands. The SHUEE test will be video recorded
      for scoring by a study therapist at a later time on how much and how well participants use
      their impaired arm to perform the tasks. Participants will be asked to complete the box and
      blocks test and the SHUEE test 3 times. Participation in this study will be one single visit
      and last approximately an hour to an hour and a half.
    

Intervention name(s): Stochastic resonance (SR) wraps
Intervention type(s): Device
Intervention description(s): SR wraps will be applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators will be secured around the shoulder. The threshold for detection of SR will be determined by the examiner prior to initiating the test condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant reports being able to feel it. This will set the participant's detection threshold.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care