bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
Condition: Tobacco Use Disorder; Tobacco Dependence; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the
      effects of study product on a smoker's desire to smoke, measured by changes in scores on
      questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will
      self-administer the study product and visit the study site for assessment of desire to smoke
      and collection of samples for the evaluation of smoking-related biomarkers.
    


Intervention name(s): Anatabloc(TM); CigRx(R)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): one dissolvable bit, one time, after a period of abstinence from smoking; one dissolvable bit, one time, after a period of abstinence from smoking
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: dietary supplement; nutraceutical
Safety and Exploratory Efficacy Study of NEUROSTEM® Versus Placebo in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity
      (DLT), and exploratory efficacy of three repeated intraventricular administrations of
      NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an
      Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.
    

Detailed description: 
      The study is divided into the 2 stages: dose-escalation in stage 1 and randomized and
      multiple-dose cohort parallel design in stage 2.The target population for enrollment in this
      study is patients with mild to moderate Alzheimer's disease.
    

Intervention name(s): human umbilical cord blood derived mesenchymal stem cells; Normal saline 2mL
Intervention type(s): Biological; Other
Intervention description(s): Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals; Intraventricular administrations of 2mL Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
Other intervention name(s): NEUROSTEM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stage 1: 9 subjects (3 subjects for low dose and 6 subjects for high dose) Stage 2: 36 subjects ( 24 subjects for high dose and 12 subjects for placebo) A total of 45 subjects to be enrolled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: human umbilical cord blood derived mesenchymal stem cells; stem cells; alzheimer's disease; cognitive ability; mesenchymal stem cells; cord blood
The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will assess the effects of colesevelam, alone or in combination with sitagliptin,
      on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise
    

Detailed description: 
      The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater
      reduction in HbA1c compared to colesevelam HCl treatment by

        1. improving the effects of colesevelam on fasting glucose metabolism

        2. improving the effects of colsevelam on postprandial glucose metabolism
    

Intervention name(s): Colesevelam HCl; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.; Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
Other intervention name(s): Welchol; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colesevelam; type 2 diabetes; sitagliptin; glucose metabolism
The Effect of Compression Stockings During Training on Running Performance
Condition: Healthy Runners. Compression Stocking and Performance
Study type: Interventional

Summary: 
      Studies that have examined the effects of compression stocking on athlete's performance have
      been carried out in a single test, i.e., the athlete's was examined during
      running/riding/jumping with and without the compression stocking.

      Yet, using the stocking during all training session and for longer period of time might
      further enhance the performance. Compression stocking were found to have a positive effect on
      the athlete' recovery. We hypotheses that if the athlete will train with the stocking on a
      regular basis and his/her recovery will improve, it will also improve the performance. In
      addition, the athlete's body may need an adjustment period to use the compression stocking.
      As such, the advantages of using compression stocking might only be revealed after training
      with the socks during a period of time and not just performing the tests/competitions with
      it.
    

Detailed description: 
      All runners will be examined for: demographical parameters, time of 5 Km run, distance of
      forward jumping with two leg.

      The sample will be divided into 2 research group: research group - all training with
      compression stocking and control group -training without compression stocking. Both groups
      will continue their training program for 8 weeks according to their coach. A second
      examination for the same tests at the end of the 8 weeks.
    

Intervention name(s): compression stocking; control
Intervention type(s): Device; Other
Intervention description(s): participants will continue their training program as prepared by their coach with compression stocking; participants will continue their training program as prepared by their coach without compression stocking
Other intervention name(s): compression garments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: research group and control group
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: running; performance; compression
Cerebral Microstructural Changes Following Mild Traumatic Brain Injury
Condition: Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study examine the possible microstructural changes in the middle brain after mTBI using
      diffusion MRI
    

Detailed description: 
      There is a need for clinical and biological markers at 2-3 month to screen people in risk of
      getting chronic post-concussion symptoms (PCS) but also biomarkers in the brain to find out
      if this group with prolonged symptoms has measurable changes in the brain which could explain
      the persisting symptoms.

      Several biomarkers and brain areas have been investigated as possible sites of injury after
      mild traumatic brain injury (mTBI). The nature of the diffuse PCS makes corpus callosum (CC),
      thalamus (THA) and hippocampus (HIP) interesting because of their central position and
      connection to widespread motor, sensory and cognitive processes and other brain areas.

      In most prior studies conventional magnetic resonance imaging (MRI) has failed to detect
      pathology especially in the later phase. Diffusional Kurtosis Imaging (DKI) and Diffusional
      Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as
      biomarkers in the middle brain after mTBI.

      It is hypothesized that there will be a difference in the microstructure of the thalamus,
      corpus callosum and hippo campus as measured with DKI between two groups of mTBI subjects
      with and without PCS. Secondary it is hypothesized that DKI are more sensitive than DTI in
      the measure of microstructural changes.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Mild traumatic brain injury subjects with and without symptoms 3-4 months after trauma
Computer-based Skin Aging Simulation for Skin Cancer Prevention
Condition: Skin Aging
MeSH terms: Skin Neoplasms
Study type: Observational

Summary: 
      This pilot study is to assess the knowledge, attitudes, and practices regarding skin cancer
      prevention in young adults and to determine the impact of artificial intelligence-based
      simulation of facial skin aging on their attitudes regarding skin cancer prevention.
    

Detailed description: 
      In young adulthood an increasing UV-exposure often starts because of the belief that tanning
      increases attractiveness]. Raising awareness and educating students and adults regarding
      practices for skin cancer prevention are critical since skin cancer is increasing rapidly
      worldwide. Skin cancer preventive interventions for adolescents are needed to improve their
      motivation for sun safety behavior. This pilot study is to assess the knowledge, attitudes,
      and practices regarding skin cancer prevention in young adults and to determine the impact of
      artificial intelligence-based simulation of facial skin aging on their attitudes regarding
      skin cancer prevention.
    

Intervention name(s): artificial intelligence-based skin aging simulation; electronic questionnaire 1; electronic questionnaire 2
Intervention type(s): Other; Other; Other
Intervention description(s): Photographs of the volunteers' facial skin will be taken in the Department of Dermatology at baseline using a modern skin analysis photo system (VISIA®, Canfield Scientific, Parsippany, NJ, USA) and afterwards a simulation of the participants' facial skin aging will be performed with the VISIA® photo analysis System.; Electronic questionnaire about current sun-related knowledge and protective behaviours via link with smartphone before and after the skin aging simulation.; Participants report their perception of the interventions and their motivation for improved sun protection by completing an electronic questionnaire after the skin aging simulation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Young healthy female volunteers aged 18-35 years, e.g. medical students of the University
        Basel, who do not have any skin diseases requiring medical therapy
      
Keywords: skin cancer prevention; skin aging simulation; UV-exposure; skin analysis photo system; VISIA® photo analysis system
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of Alvesco (ciclesonide)
      Inhalation Aerosol in non hospitalized patients with symptomatic COVID-19 infection in a
      multicenter, randomized, double-blind, placebo controlled study
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group,
      efficacy, and safety study of ciclesonide MDI for the treatment of symptomatic COVID-19
      infection. Enrolled patients were male and female adults and adolescents 12 years of age or
      older with confirmed COVID-19 infection who were currently exhibiting symptoms of the disease
      and who were not currently hospitalized or under immediate consideration for hospitalization
      at the time of enrollment. The study consisted of an initial
      screening/enrollment/randomization visit, a 30-day treatment period, and a follow-up period.
    

Intervention name(s): Ciclesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 160mcg Inhaler; Matching Placebo Inhaler
Other intervention name(s): Alvesco
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Condition: Idiopathic Hypersomnia; Narcolepsy Without Cataplexy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Cataplexy; Idiopathic Hypersomnia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple
      crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without
      cataplexy (Type 2).
    


Intervention name(s): BTD-001; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sphingosine-1 Phosphate -Receptor Targeting and Microglial Activation
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      To evaluate the usability of positron emission tomography imaging as a novel outcome measure
      in multiple sclerosis studies
    

Detailed description: 
      Background and Rationale

      In multiple sclerosis (MS), significant pathology correlating to disease progression, to
      expanded disability status scale (EDSS) and to cognitive decline, takes place outside the
      plaque areas, i.e. in areas of normal appearing white matter and gray matter.
      Neuropathological studies suggest that mechanisms involved in this widespread pathology
      include activation of microglial cells, oxidative stress and deficiency in mitochondrial
      functions. Activated microglia can be detected in vivo with a translocator protein (TSPO),
      expressed in activated, but not resting microglia) binding radioligands and positron emission
      tomography (PET). 11Carbon-PK11195 radioligand is one such radioligand. Importantly, the
      possible effect of MS therapies on microglial activity can be evaluated in patients in vivo
      with PET-imaging performed before and after the treatment.
    

Intervention name(s): PET and MRI
Intervention type(s): Radiation
Intervention description(s): Patients will be imaged using PET and MRI at baseline, and twice during treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 patients with multiple sclerosis who will be initiated on fingolimod in the neurology
        outpatient clinic of the Turku University hospital in Turku, Finland.
Walk Assist Device to Improve Community Ambulation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this research study was to examine the immediate effects of a prototype wearable
      robotic stride management assist device (SMA) designed by Honda R&D® on clinical walking
      performance, walking energetics, gait kinematics and corticospinal excitability in
      individuals with stroke.
    

Detailed description: 
      The goal of this research study was to examine the immediate effectiveness of a prototype
      wearable robotic stride management assist device (SMA) designed by Honda R&D on clinical
      walking performance, walking energetics, gait kinematics and corticospinal excitability in
      individuals with stroke.

      The SMA assists walking by providing a flexion and extension torque assist at the hip joint.
      The subjects in this study are asked to perform two sets of experiments: one set with the
      device on and one set with the device turned off. The order in which the subjects performed
      these sets of experiments is selected randomly. Each set of experiments includes over-ground
      walking speed and endurance tests, a graded treadmill test with metabolic measures, motion
      capture and force treadmill analysis, and measures of corticospinal drive using transcranial
      magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected
      walking speed with the device on, the secondary outcome measures include metabolic,
      corticospinal and biomechanical analysis.
    

Intervention name(s): Honda Stride Assist Device ON; No Device Worn
Intervention type(s): Device; Other
Intervention description(s): Subjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device.; Subjects performed assessments of walking and motor performance without wearing the Honda Assist Device.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stroke; Gait Stride Management Assist; Stroke, post 1 year or longer
Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on
      HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality
      of Life between participants continuing to levodopa-carbidopa intestinal gel treatments
      versus participants continuing on oral therapy for Parkinson's Disease.
    

Detailed description: 
      Parkinson's disease (PD) is the second most common neurodegenerative disorder in the world.
      It can be treated sufficiently until motor complications with fluctuations of mobility and
      dyskinesia develop. The quality of life is relentlessly deteriorating with longer disease
      duration once the complications of conservative oral therapy develop. Continuous dopaminergic
      stimulation using Levodopa/Carbidopa Intestinal Gel (LCIG) improves the motor complications
      of Parkinson's disease and preliminary data suggest that also the quality of life is
      improved. Primary Objective is to assess the effect of LCIG on Health Related Quality of Life
      (HRQL) of patients according to selection criteria from German guidelines and compare
      improvement in HRQL between patients continuing to LCIG treatment and patients staying on
      oral treatment, despite being eligible according to these guidelines. In addition, current
      selection criteria recommended by the national guideline will be documented at baseline.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Advanced Parkinson Disease
      
Keywords: Advanced Parkinson's Disease; Levodopa Carbidopa Intestinal Gel; Observational Study; Quality of life; Jejunal Percutaneous Endoscopic Gastrostomy
Influence of Gender on Interaction of Propofol and Dexmedetomidine
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of gender on pharmacodynamic interaction
      of propofol and dexmedetomidine, exploring the effect of gender on propofol unconsciousness
      median effective concentration with different dose dexmedetomidine.
    

Detailed description: 
      60 cases male patients were randomly divided into four groups,and 60 female patients were
      also randomly divided into four groups.In each group, dexmedetomidine target plasma
      concentration are 0,0.4,0.6,0.8 ng/ml. Dexmedetomidine administered 15 min before target
      controlled infusion of propofol. The propofol infusion is started to provide a target
      effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of
      consciousness when the effect-site concentration and target concentration are equilibrium.
    

Intervention name(s): 0.0 ng/ml Dexmedetomidine; 0.4 ng/ml Dexmedetomidine; 0.6 ng/ml Dexmedetomidine; 0.8 ng/ml Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dexmedetomidine target plasma concentration is 0.0 ng/ml; Dexmedetomidine target plasma concentration is 0.4 ng/ml; Dexmedetomidine target plasma concentration is 0.6 ng/ml; Dexmedetomidine target plasma concentration is 0.8 ng/ml; The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gender; Propofol; Dexmedetomidine; Interaction
Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy
Condition: Neuromuscular Diseases in Children; Cerebral Palsy, Spastic; Spasticity, Muscle
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy; Neuromuscular Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate if a intervention with hippotherapy will improve
      spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will
      be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in
      addition to traditional treatment.
    

Detailed description: 
      The main aim of the present study is to determine the effects of hippotherapy on the hip
      aductors spasticity in children with spastic cerebral palsy. Furthermore, as a secondary
      objective is to evaluate the changes in Modified Ashworth Scale (MAS) after intervention in
      children ages 3-14.
    

Intervention name(s): Hippotherapy
Intervention type(s): Other
Intervention description(s): Children will receive the hippotherapy treatment, based on horse walking in a regular way led by an experienced leader. Sessions will be performed for 45 minutes once weekly for 12 consecutive weeks in an indoor riding area.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Radomized controlled trial with two groups: intervention group (hippotherapy + conventional treatment) and control group (conventional treatment).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hippotherapy; cerebral palsy; spasticity