bioihbjkbjnl/mcl2 huggingface dataset:
Emotional and Cognitive Control in Late-Onset Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study may help identify how abnormalities in brain systems that control the ability to
      ignore irrelevant information may contribute to the development of depression in older
      adults.
    

Detailed description: 
      Approximately half of those who develop depression in late life never had depression before.
      The classic view is that changes taking place in our brains as we age contribute to the
      development of late-onset depression. This view is supported by the relative absence of
      family history for those with late onset depression. This research study will recruit 70
      older adults with late life depression and 70 older adults without depression. All
      participants will receive a sub-clinical, non-contrast (magnetic resonance imaging (MRI) scan
      at the beginning of the study and then again 12 weeks later at the completion of the study.
      The depressed older participants will also receive a Food and Drug Administration
      (FDA)-approved antidepressant, escitalopram (Lexapro), as treatment for their depressive
      symptoms over 12 weeks. This MRI study may help the researchers identify how abnormalities in
      brain systems that control our ability to ignore distractions, control our emotions, and
      anticipate reward may contribute to the development of depression in older adults. The
      investigators hope that the findings promote the development of tests that may improve the
      detection of older adults at risk for poor treatment outcomes and eventually guide the
      development of novel treatments for depression.
    

Intervention name(s): Escitalopram; Magnetic Resonance Imaging
Intervention type(s): Drug; Other
Intervention description(s): 20 mg target dose for 12 weeks; Structural and functional MRI of the brain for research purposes.
Other intervention name(s): Lexapro; 76184942; MRI
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Escitalopram; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Physiological Effects of Drugs; Muscarinic Antagonists; Antidepressive Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Magnetic Resonance Imaging, Functional; fMRI; Magnetic Resonance Imaging
Scapular Stabilization During Manual Horizontal Adduction Stretches and Its Effect on Increasing Posterior Shoulder Flexibility
Condition: Posterior Shoulder Tightness
Study type: Interventional

Summary: 
      The purpose of this study is to determine if stabilizing the scapula (shoulder blade) during
      a common shoulder stretch is more effective at improving shoulder range of motion than not
      stabilizing the scapula. Investigators hypothesize that scapular stabilization during
      horizontal adduction stretching will demonstrate greater gains in shoulder range of motion
      than stretching without scapular stabilization.
    


Intervention name(s): horizontal adduction stretch with scapular stabilization; Horizontal adduction stretch without scapular stabilization
Intervention type(s): Other; Other
Intervention description(s): Scapular is stabilized during manual horizontal adduction stretch; Scapula stabilization is not performed during horizontal adduction stretch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: glenohumeral internal rotation deficit; overhead athlete; shoulder exercise; posterior glenohumeral capsule; posteroinferior glenohumeral ligament; posterior rotator cuff
Utilization of the Mirror During Pelvic Exams
Condition: Pelvic Exam
Study type: Observational

Summary: 
      This is a prospective cohort study to determine if using a birthing mirror during the
      patient's pelvic examination decreases patients's degree of vulnerability and discomfort.
    

Detailed description: 
      In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is
      routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate
      nature, pelvic examinations may result in loss of control, embarrassment, discomfort and
      anxiety.

      The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve
      comfort during an already uncomfortable examination. However, little research has focused on
      this modality to date.

      The purpose of this study is to investigate whether the mirror pelvic exam decreases the
      level of vulnerability and discomfort experienced during the pelvic examination.
    

Intervention name(s): Usage of a mirror
Intervention type(s): Other
Intervention description(s): using a mirror during the pelvic examination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All women 18 years of age to 80, who undergo pelvic exam by a physician at Cincinnati
        Urogynecology Associates, TriHealth will be approached for recruitment.
Effectiveness of Virtual Reality in Patients With Chronic Neck Pain
Condition: Pain, Neck; Virtual Reality; Proprioception; Balance
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Virtual reality application has been increasing in recent years for pain control, distraction
      in wound care, treatment of anxiety disorders and support for physical rehabilitation. For
      example, it has been found to be effective in reducing pain when used in addition to medical
      treatment during bandaging of severe burns. The studies related with chronic pain patients
      were stated that virtual reality application was found to be interactive and fun by patients.
      Therefore, The aim of this study was to investigate the effects of virtual reality on pain
      threshold, disability, balance, proprioception, exercise sustainability, muscular performance
      in neck region, quality of life and anxiety / depression in addition to the exercise program
      that includes stabilization exercises in patients with chronic neck pain.
    


Intervention name(s): Virtual Reality
Intervention type(s): Other
Intervention description(s): Virtual reality group will have virtual reality for 20 minutes in addition to motor control exercises for 20 minutes. Virtual reality will apply using Oculus Go. On the other hand control group will have only exercise for 40 minutes. Exercises will include same exercises in both groups, but exercise group will perform exercises twice compared to virtual reality group.
Other intervention name(s): Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Virtual Reality
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; virtual reality; proprioception; balance
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
Condition: Influenza
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus
      Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of
      age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days
      post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or
      medically-attended adverse events.
    

Detailed description: 
      As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the
      intention of offering broader protection to include both lineages of influenza B strains, it
      is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The
      demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI)
      Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to
      those of the matching antigens in a US - approved IIV4 is intended to support licensure of
      Flublok Quadrivalent for the adult population for which Flublok trivalent is currently
      approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4
      is expected to confirm a similar safety profile.
    

Intervention name(s): Flublok Quadrivalent; Inactivated Influenza Vaccine (IIV4)
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection of study vaccine; Intramuscular injection of study vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Physical Therapy and Neuroactive Steroids Therapy Does Not Modulate Serum Level of Neuroactive Steroids
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study describes modulation of neuroproprioceptive facilitation and inhibition physical
      therapy on serum level of neuroactive steroids in multiple sclerosis.
    

Detailed description: 
      In the parallel group, single blind, randomized controlled trial, participant underwent two
      kinds of neuroproprioceptive PT (MPAT and VRL). At baseline and after the end of the two
      months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from
      serum level.
    

Intervention name(s): Neuroproprioceptive facilitation and inhibition physical therapy
Intervention type(s): Behavioral
Intervention description(s): All groups underwent two months' therapy, 16 face-to-face sessions (1 hour, twice a week for two months).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuroactive steroids; physical therapy; dehydroepiandrosterone; cortisol; multiple sclerosis
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics
      and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin
      aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.
    


Intervention name(s): biphasic insulin aspart 30; biphasic insulin aspart 50; biphasic insulin aspart 70; insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between; A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between; A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between; A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of ATx201 as a Topical Antibiotic Agent
Condition: Infection, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      AntibioTx is developping ATx201 as a topical product for treatment of skin infections,
      including infected atopic dermatitis.
    

Detailed description: 
      Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity
      of or resistance towards the main topical antibiotics. Accordingly, the infections are either
      not effectively treated or harsher systemic antibiotics with side effects are needed.

      Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various
      species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms.
      ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus
      aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all
      topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the
      onset of de novo resistance compared to currently marketed antibiotics.

      The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients.

      The primary objective is to demonstrate the safety and tolerability of new topical
      formulations of ATx201 in healthy volunteers, and in a population of patients with infected
      atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4
      and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of
      ATx201 including the respective Placebos will be applied to healthy volunteers. One
      formulation will advance into Phase II, where patients will be treated with the respective
      formulation or Placebo.
    

Intervention name(s): ATx201 dermal formulations 2%
Intervention type(s): Drug
Intervention description(s): Topical application of ATx201 dermal formulations 2%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
Condition: Chronic Total Occlusion
Study type: Interventional

Summary: 
      Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to
      providing additional guidewire support that is expected to allow easier crossing of
      femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will
      be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires
      revascularization.
    

Detailed description: 
      This is an open label, single center, prospective, first in man pilot study in which the
      investigational device, NitiLoop micro-catheter, will be tested in up to 15 patients with
      symptomatic peripheral arterial occlusive disease scheduled to undergo CTO in an anterograde
      approach.
    

Intervention name(s): NovaCross™ microcatheter
Intervention type(s): Device
Intervention description(s): successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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 Kansas City
        metropolitan area, Vince & Associates Clinical Research's database and from referrals.
      
Keywords: Healthy; Control
Effect of External Electrical Stimulation and Pelvic Floor Muscle Training
Condition: Urinary Incontinence, Stress; Electrical Stimulation; Pelvic Floor Disorders; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Pelvic Floor Disorders; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      In this study, the effects of the external electrical stimulation (EES) added to pelvic floor
      muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.
    

Detailed description: 
      Fifty one women with mild and moderate SUI symptoms were included in the study. The patients
      were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block
      randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week
      for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective
      perception of improvement, severity of incontinence, quality of life, pelvic floor
      dysfunction (PTD) and urinary parameters were assessed as outcome variables. All
      measurements, except subjective perception of improvement were investigated before and after
      treatment.
    

Intervention name(s): External electrical stimulation (EES) added to pelvic floor muscle training (PFMT); External electrical stimulation; Pelvic floor muscle training (PFMT)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.; Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.; While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an
      impact on morbidity and mortality. Regular aerobic exercise training is a proven effective
      therapy to improve exercise capacity in healthy and clinical populations. The effect of this
      training has not yet been evaluated in the decompensated cirrhosis patient population. The
      safety of this intervention also requires further study. Using a randomized controlled
      design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic
      exercise training on aerobic capacity, functional performance, and muscle mass in
      decompensated cirrhosis patients.
    


Intervention name(s): Aerobic Exercise; No Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic exercise; No Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment